CHAPTER 2

 

GENERAL PRACTICE OF PHARMACY REGULATIONS

 

Section 1.        Authority.     

 

These regulations are promulgated as authorized by the Act.

 

Section 2.        Purpose.         

 

The purpose of this regulation is to coordinate the requirements for pharmaceutical  care by providing minimum standards, conditions and physical guide­lines for facilities and pharmacists in professional set­tings.

 

Section 3.        Scope of Chapter.        

 

This Chapter applies to any person, partnership, corporation, limited liability com­pany or other entity engaging in the practice of pharmacy within this State.

 

Section 4.        Definitions.

 

(a)       “Administer” means the direct application of a drug, whether by injection,

inhalation, ingestion, or any other means, to the body of a patient or research subject by:

 

(i)        A practitioner (or by his authorized agent); or

 

(ii)       The patient or research subject at the direc­tion of the practitioner.

 

(b)       “Board of Pharmacy” or “Board” means the Wyoming State Board of

Pharmacy.

 

(c)       "Compounding" means and includes the preparation, mixing, or assembling  of a drug or device, and the packaging and labeling incident thereto for sale or dispensing:

 

                        (i)        As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of their professional practice.

 

                        (ii)       For the purpose of research, teaching, or chemical analysis, or

 

                        (iii)      In anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

 

However, "compounding" does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.

 

(d)       “Confidential Information” means information main­tained by the

pharmacist in the patient’s records or which is communicated to the patient as part of

patient coun­seling, which is privileged and may be released only to the patient or, as the

patient directs; to those practitioners and other pharmacists where, in the pharmacist’s

professional judgment, such release is necessary to protect the patient’s health and well

being; and to such other persons or governmental agencies authorized by law to investigate

controlled substance law violations.

 

(e)       “Consultant Pharmacist” shall mean a pharmacist who establishes policies

and procedures for the distribution and storage of drugs and visits the facility on a regularly

scheduled basis, but is not physically present at the facil­ity for a set number of hours on a

daily basis.

 

(f)        “Deliver” or “Delivery’ means the actual, construc­tive or attempted transfer

from one person to another of a drug or device whether or not there is an agency relationship.

 

(g)       “Device” means an instrument, apparatus, implement, machine, contrivance,

implant or other similar or related article, including any component part or accessory, which is required under Federal law to bear the label “Caution: Federal law restricts this device to sale by or on the order of a physician.”

 

(h)            “Digital Signature” means an electronic identifier that

 

(i)        is intended by the party using it to have the same force and effects as

 a manual signature;

 

(ii)       is unique to the authorized signer; 

 

(iii)      is capable of verification;

 

(iv)      is under the sole control of the authorized signer; 

 

(v)       is linked to the prescription in such a manner that if the prescription

information is changed,  the  signature is invalidated;  and

 

(vi)      conforms to Wyoming State Board of Pharmacy laws, rules and

regulations.

 

 

(i)        “Dispense” means to deliver a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery.


 

(j)        “Distribute” means the delivery of a drug or device other than by

administering or dispensing.

 

(k)       “Dosage Form” means the physical formulation or medium in which the product is manufactured and made available for use, including but not limited to: tablets, capsules, oral solutions, aerosols, inhalers, gels, lotions, creams, ointments, transdermals and suppositories.

(l)        “Drug” means articles recognized as drugs in any official compendium, or

supplement thereto designated for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals.

 

            (m)      “Electronic transmission”  means transmission of the digital representation of information from one computer or other similar electronic device to another computer, which is authenticated by a digital signature;  or transmission of the electronic representation of information from one computer  or other similar electronic device to a fax machine, which is authenticated by an electronic signature.

 

            (n)       "Electronic signature" means an electronic sound, symbol or process attached to or logically associated with a prescription and executed or adopted by a person with the intent to sign the prescription.

 

(o)       “Patient confidences” as used in W.S. §33-24-101(c)(iii) means information transmitted by the prescribing practitioner or agent to the pharmacist or agent for purposes of treating the patient and information transmitted by the patient or agent to the pharmacist or agent for purposes of treatment and includes the patient’s name, address, medical condition, and drugs lawfully prescribed for him.  Provided however the pharmacist may release otherwise confidential information pertaining to the patient’s treatment to a minor’s parent or guardian, the patient’s third party payor or the patient’s agent.

 

(p)       “Labeling” means the process of preparing and affixing a label to any drug container exclusive of the labeling by a manufacturer, packet or distributor. (See Section 11 of these regulations.)

 

(q)       “Non-resident Pharmacy” means a licensed pharmacy located outside this

State where drugs are dispensed and pharmaceutical care is provided to residents within the State.

 

(r)        “Patient Counseling” means the oral communication by the pharmacist of information, as defined in the rules of the Board, to the patient or caregiver, in order to improve therapy by ensuring proper use of drugs and devices.  Patient counseling may be supplemented with printed materials.

 

(s)        “Pharmaceutical Care” is the provision of drug therapy and other pharmaceutical patient care services intended to achieve outcomes related to the cure or preven­tion or management of an illness or injury.

 

(t)        “Pharmacist-in-Charge” or “PIC” means a pharmacist currently licensed in this State who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs.

 

(u)       “Pharmacy” means any place within this State where drugs are dispensed and pharmaceutical care is provided.

 

(v)       “Pharmacy Technician” means an individual other than an intern, who performs pharmacy functions under the direct supervision of a licensed pharmacist.

 

(w)      “Practitioner” means an individual currently licensed, registered or otherwise authorized by the juris­diction in which he/she practices to prescribe drugs in the course of professional practice.

 

(x)       “Prescription Drug” or “Legend Drug” means a drug which, under Federal Law, is required to be labeled with one of the following statements:

           

            (i)        “Caution: Federal law prohibits dispensing without prescription”;

 

            (ii)       “Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian”;

 

            (iii)      “Rx Only”; or

 

            (iv)      Is a drug included on the Wyoming Dangerous Substance Listing, as referenced in Wyoming Pharmacy Act Rules and Regulations, Chapter 11, Section 2,

and shall be dispensed pursuant to a prescription drug order.

 


(y)       “Prescription Drug Order” means a lawful order of a practitioner for a drug or

device for a specific patient.

 

(z)       “State Board”, as used in W.S. §33-24-136(b), shall mean the state boards of medicine, dental examiners, nursing, podiatry, optometry and veterinary medicine of the State of Wyoming and their similar counterpart boards of any of the states of the United States of America.

 

(aa)      “Registered Pharmacist” means an individual currently licensed by this State to engage in the practice of pharmacy.

 

            (bb)     “Wholesale Distributor” means any person or firm engaged in wholesale distribution of drugs, including but not limited to manufacturers; repackagers; own-label distri­butors; private-label distributors; jobbers; brokers; ware­houses, including manufacturers’ and distributors’ warehouses, chain drug warehouses and wholesale drug ware­houses; independent wholesale drug traders and retail phar­macies that conduct wholesale distributions.

 

(cc)      “Agreement” means a voluntary agreement, written and signed, between a

pharmacist and a prescribing physician that defines a collaborative practice for the purpose of drug therapy management of patients.

 

(dd)     “Collaborative pharmacy practice” means a practice in which a prescribing

physician makes a diagnosis, maintains ongoing supervision of patient care and refers the patient to a pharmacist under a protocol allowing the pharmacist to perform patient care functions authorized by the physician under specified conditions or limitations.

 

(ee)      “Drug therapy management” means the review of drug therapy regimen(s)

of patients by a pharmacist for the purpose of evaluating and rendering advice to the prescribing physician regarding adjustment of the regimen.   Decisions involving drug therapy management shall be made in the best interest of the patient.  “Drug therapy management” may include:

 

(i)        Implementing, modifying, and managing drug therapy according to

the terms of the agreement and the specific written orders.

 

(ii)       Collecting and reviewing patient drug histories;

 

(iii)      Obtaining and checking vital signs,  including but not limited to

pulse, temperature, blood pressure, and respiration; and

 

(iv)      Ordering and evaluating the results of laboratory tests directly

relating to drug therapy, when performed in accordance with approved protocols applicable to the practice setting.

 

(ff)      “Pharmacist’s collaborative scope of practice” means those duties and limitations of duties agreed upon by a pharmacist and the collaborating physician (subject to Board’s approval and applicable law), and includes the limitations implied by the specialty practiced by the collaborating physician.

 

(gg)     “Unit Dose Package” means a package, which contains one unit of medication.

 

(hh)     “Unit of Issue Package” means a package, which provides multiple units of doses separated in a medication card or other similarly designed container.

 

            (ii)       “Unit Dose Dispensing System” means a drug distribution system, which is in a pharmacy and uses unit dose packages or unit of issue packages that enable distribution of packaged doses in a manner that preserves the identity and the integrity of the drug until the time of administration.

 

            (jj)       “Traditional dispensing System” means a drug package system in which individual doses are not packaged in unit dose packages or unit of issue packages.

 

(kk)     “Prepackage” means to prepare a drug in a container in advance of actual, immediate need for dispensing, prior to the receipt of an order.  Such packaging may be in a unit dose or unit of issue package for use in a unit dose dispensing system or in a container suitable for a traditional dispensing system.

 

            (ll)       “Repackage” means to prepare a unit dose or unit of issue package or traditional dispensing system package for dispensing pursuant to an existing order.

 

            (mm)   “Pharmacy” means an area(s) where prescriptions are filled, counseling occurs, prescription drugs are stored, and patient records and other items required by law for the practice of pharmacy are maintained.

 

            (nn)     “Remodeled Pharmacy”  means an existing retail pharmacy, which is relocated to a different address, or a pharmacy, which undergoes remodeling at its present location, and the cost of such remodeling is equal to or greater than $25,000.00.

 

            (oo)     “Active Pharmacy Practice” means a pharmacist who engages in the practice of pharmacy as defined in W.S. §33-24-124 a minimum of 400 hours per calendar year.

 

            (pp)     "Foreign Pharmacy Graduate" means a pharmacist whose undergraduate pharmacy degree was conferred by a recognized school of pharmacy outside of the 50 United States, the District of Columbia, and Puerto Rico. United States citizens who have completed their pharmacy education outside the United States are "foreign pharmacy graduates".  Foreign nationals who have graduated from schools in the United States are not foreign pharmacy graduates.

 

 

Section 5.        Pharmacist Licensure by Examination.

 

(a)       The Board shall utilize those standardized examinations as prepared and administered by the National Association of Boards of Pharmacy.  These standardized examinations shall include the following;

 

                        (i)        North American Pharmacist Licensing Examination (NAPLEX®)

 

                        (ii)       Multistate Pharmacy Jurisprudence Examination (MPJE™)

 

 (b)      Applicants for licensure by examination will be licensed, provided they meet the following requirements.

 

            (i)        A properly completed “Pharmacist Licensure by Examination” application as provided by the Board with the proper fee and fee/fingerprints for a criminal background check has been submitted to the Board’s office.  However, any applicant who has on file at the board's office a criminal background history dated within twelve (12) months of their date of application need not resubmit fee/fingerprints;

 

            (ii)       Pass the NAPLEX® with a minimum score of 75;

 

                        (A)      Candidates who do not receive a passing grade on the NAPLEX® shall be allowed two (2) retakes for a total of three (3) examinations.

 

                        (B)       All retakes require payment of fees as required by the National Association of Boards of Pharmacy.

 

            (iii)      Pass the MPJE® for Wyoming with a minimum score of 75;

 

                        (A)      Candidates who do not receive a passing grade on the MPJE™ may retake the examination. 

 

(B)       All retakes require payment of fees as required by the National

Association of Boards of Pharmacy.

 

            (iv)      Meet the required practical experience requirement of 1,200 internship hours as specified in Chapter 3 of the Board’s Rules;

 

            (v)       Complete all requirements within two (2) years of the date of application  to the Board’s office; and,

 

            (vi)      Meet requirements of W.S. §33-24-116.

 

(c)       Applicants who have applied for score transfer of their NAPLEX® exam to Wyoming will be licensed by examination, provided they meet the following requirements.

 

            (i)        The  NAPLEX® score transferred is 75 or more;

 

(ii)       A properly completed  “Pharmacist Licensure by Examination”

application  as provided by the Board with the proper fee, has been submitted to the Board’s office;

 

(iii)      Pass the Multi State Pharmacy Jurisprudence Exam (MPJE™)

for Wyoming with a minimum score of 75;

 

                        (A)      Candidates who do not receive a passing grade on the MPJE™ may retake the examination. 

 

(B)       All retakes require payment of fees as required by the National

Association of Boards of Pharmacy.

 

 (iv)     Meet the required practical experience requirement of 2,000

internship hours as  specified in Chapter 3  of the Board’s Rules;

 

 (v)      Complete all requirements within one (1) year of the date of the

NAPLEX® exam, which was utilized for the score which was transferred to Wyoming; and

 

            (vi)      Meet requirements of W.S. §33-24-116.

 

(d)       No candidate will be licensed until the required practical experience as specified in Chapter 3, Section 3(a) of the Board's Rules has been met.

 

(e)       Candidates failing to meet all requirements within the time period allowed in Chapter 2, Section 5(b)(v) and Chapter 2, Section 5(c)(v) must file a new application, including payment of all fees or  if applicable seek licensure by license transfer as outlined in Chapter 2, Section 6.

 

(f)        The Board reserves the right to require an interview with any applicant seeking licensure by examination to practice pharmacy in Wyoming.

 

(g)       The Board shall charge fees to cover administrative costs, which shall include wall certificate, renewal certificate for current license year, and those costs associated in reviewing test questions for the jurisprudence exam (MPJE™).

 

(h)       Foreign pharmacy graduates, holding a FPGEC Certificate issued by the Foreign Pharmacy Graduate Examination Committee, .may apply for licensure as a pharmacist under this section..  To be eligible for FPGEC certification, applicants must satisfy the following requirements established by the Foreign Pharmacy Graduate Examination Committee:

 

            (i)        Verification of educational equivalency of an applicant's foreign pharmacy education and the applicants licensure or registration as a pharmacist outside the US;

 

            (ii)       Passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE); and

 

            (iii)      Obtaining a total score of 550 or higher on the paper-based Test of English as a Foreign Language (TOEFL) or 213 or higher on the computer-based TOEFL and 50 or higher on the Test of Spoken English (TSE); or

 

            (iv)      In lieu of the TOEFL and TSE , obtaining an acceptable score for the Test of English as a Foreign Language Internet-based Test (TOEFL iBT), with minimal scores of 18 for listening, 21 for reading, 26 for speaking, and 24 for writing.

 

 

Section 6.        Pharmacist Licensure by Reciprocal License Transfer.


Any pharmacist who is licensed by examination and is in good standing in any state which is a member of the National Association of Boards of Pharmacy (NABP) and who desires to be licensed by reciprocity into the State, shall proceed in the manner outlined by the NABP after first submitting the “Preliminary Application for Transfer of Pharmaceutic Licensure” obtained from any state or the NABP.

 

(a)       In the event of rejecting an application, the fee paid to the Board will not be refunded. 

 

(b)       All candidates for license transfer shall be required to:

 

                        (i)        File all appropriate applications with the board;

 

(ii)       Pay the required fee;

 

(iii)      Pass the Multi-State Pharmacy Jurisprudence Exam (MPJE™);

 

(iv)      Prove good moral character;

 

(v)       Prove they have been in active pharmacy practice as defined in Chapter

2, Section 4(oo), for the year preceding the date of their application for license transfer.  Applicants failing to show proof must complete an internship in Wyoming approved by the Board of no less than 400 hours.  An applicant will be considered as successfully completing the internship if the overall score given by the preceptor, utilizing the Wyoming State Board of Pharmacy's "Intern Evaluation Report" is no less than a "C";

 

(vi)      Meet all requirements under the Act and the Board's Rules; and

 

                        (vii)     If applying as a foreign pharmacy graduate, possess a FPGEC Certificate.

 

            (c)       The Board shall not issue a pharmacist license by license transfer until all conditions under Chapter 2, Section 6 (b) have been met.

 

(d)       All applications for transfer of licensure (reciprocity) shall expire one (1) year from date of issue by NABP if not filed with the Board and licensure completed.

 

(e)       The Board reserves the right to require an interview with any applicant seeking licensure by license transfer to practice pharmacy in Wyoming.

 

Section 7.        Minimum Structural and Equipment Requirements to Operate a Retail Pharmacy.

 

(a)       All retail pharmacies operating in Wyoming must meet the following requirements.

 

(i)        The pharmacy shall include a sink with a hot and cold water supply,

exclusive of restroom facilities, with adequate sewage disposal.

 

                        (ii)       The pharmacy shall be properly lighted and ventilated.  The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of pharmaceuticals.

 

                        (iii)      The pharmacy shall have adequate shelving and there shall be adequate counter on which to work and the working surface shall be kept clear and uncluttered at all times for the preparation or compounding of prescriptions to meet the requirements of the pharmacy.  Any pharmacy where compounding prescriptions occurs must meet the structural and equipment requirements identified in Chapter 13 of the Board’s rules.

 

                        (iv)      A Facsimile machine or similar electronic equipment capable of producing an identical document shall be located in the pharmacy.

 

                        (v)       A separate refrigerator located in the pharmacy, which is sufficient in capacity to serve the needs of the pharmacy that is equipped with a thermometer and providing a storage temperature of 36-46 degrees Fahrenheit (2-8 degrees Centigrade).  The use of such refrigerator shall be limited to the storage of drugs.  If a freezer compartment is utilized, it must maintain a temperature of  -14 to -4 degrees Fahrenheit (-20 to –10 degrees Centigrade).

 

                        (vi)      Class A prescription balance or electronic scale with 10 mg sensitivity.

 

(vii)     A professional reference library (text or electronic format) that shall

include the following;

 

                                    (A)      Current Wyoming pharmacy laws;

 

                                    (B)       Current edition of Facts and Comparisons or a comparable reference accepted by the Board;

 

                                    (C)       Current drug interaction text which provides at a minimum, quarterly updates;

 

                                    (D)      Wyoming State Board of Pharmacy News, maintained in a binder; and

 

                                    (E)       The current edition with supplements of the FDA “orange book” or an alternate reference that provides the same information as the FDA "orange book".

 

                        (viii)    Pharmacies must maintain adequate security to deter theft of drugs by personnel or public.  Security requirements for new or remodeled pharmacies must meet the requirements of Chapter 2, Section 7 (b)(ii)(D).  No person other than pharmacist, intern or technician employed by the pharmacy shall be permitted in the pharmacy without the express consent of the pharmacist-in-charge;

 

                              (A)      If the pharmacy is located in a facility in which the public has access and the pharmacy’s hours of operation are different from the rest of the facility, pharmacy must be designed so that it can be securely locked and made inaccessible when the pharmacy is not open.

 

                        (ix)      The pharmacy shall be arranged in an orderly fashion and kept clean.  All required equipment shall be clean and in good operating condition;

 

                        (x)       If automated counting devices are utilized, the pharmacy shall have a method to calibrate and verify the accuracy of the automated counting device; and shall verify the accuracy and document doing so on a quarterly basis.

 

                    (xi)     A sequential numbering machine or electronic data device for the consecutive numbering of all prescriptions must be maintained along with appropriate printing equipment to produce prescription drug labels.

 

                        (xii)     In addition to the requirements identified in Chapter 2, Section 7 (a) of these regulations all pharmacies involved in the preparation of sterile compounded products must meet the requirements of Chapter 13, Section 10 of the Board's rules.

 

(b)       In addition to the requirements of Chapter 2, Section 7, except for a change of ownership of an existing pharmacy, an individual or business who opens a new pharmacy or remodels an existing pharmacy after July 1, 2001 shall meet the following requirements.

 

(i)        Provide a set of blueprints or other acceptable documents, which

indicate physical layout of planned or remodeled pharmacy to the Board no later than thirty calendar days prior to commencing construction or remodeling of the pharmacy.

 

(ii)       The proposed new pharmacy or pharmacy to be remodeled must meet

the following minimum standards.

 

(A)      The pharmacy shall consist of no less than 250 square feet; 

 

(B)       The pharmacy shall include an identified counseling area,

which is apart from the cash register and offers sufficient privacy for counseling.  Pharmacies, which do not provide prescription services to “walk-in” customers, are not required to have a counseling area;

 

(C)       Located within or adjacent to the pharmacy, but not counted in

the square footage requirement of the pharmacy, shall be restroom facilities.  If the restroom facilities are located in the pharmacy,  access shall be limited to pharmacy staff only;

 

                                    (D)      Access to the pharmacy shall be secured as follows;

 

                                                (I)        If the pharmacy is located within another business, which does not have identical hours of operation, the pharmacy shall be secured with solid core or metal doors with a deadbolt and a locking doorknob.  If glassed areas are utilized, then adequate intrusion detectors must be in place.  Pharmacy walls must extend to the roof or provide security acceptable to the Board.  The pharmacy shall meet all other applicable federal or state regulations concerning security access.

 

                                                (II)       Those pharmacies not included in (I) must be secured with solid core, metal, or safety glass exterior doors secured with a deadbolt, and must utilize an adequate intrusion detector.  If the pharmacy shares a common wall with another business, this wall must extend to the roof.  The pharmacy shall meet all other applicable federal or state regulations concerning security access.

 

                                    (E)       A separate refrigerator, sufficient in capacity to serve the needs of the pharmacy staff, shall be available for storage of employee's food or beverage.  This refrigerator shall be identified for "Employee Use Only"; and

 

(F)       All prescription data shall be processed utilizing electronic

data processing equipment, and shall be sequentially numbered. There shall be adequate computer terminals and printers available to process anticipated prescription volume for the new or remodeled pharmacy.

 

(c)       Upon written request and for good cause, the Board may waive any of the requirements of Chapter 2, Section 7  of the Board’s Rules.  A waiver that is granted under this section shall only be effective when issued by the Board in writing.

 

Section 8.        Licensing of Facilities.

 

            (a)       Prior to the issuing of the registration to operate a pharmacy or prescription department, the Board will inspect the pharmacy for minimum standards including space, fixtures, sanitation, reference library, technical equipment and security.

 

            (b)       The facility application shall list the names of all licensed pharmacists employed specifically identifying the pharmacist-in-charge (PIC).  The pharmacist-in-charge determines which employees shall have keys to the pharmacy.

 

            (c)       The Board shall be notified with every change of pharmacist-in-charge (PIC).  A controlled substance inventory is required when there is a change in the pharmacist-in-charge, at the time of the change.  This inventory shall include the signatures of both the outgoing and incoming PIC, date, and time the inventory was taken.  If the inventory cannot be conducted with both pharmacists, then the incoming PIC shall conduct an inventory.  A copy of the controlled substance inventory shall be forwarded to the Board's office within fifteen  (15) days of conducting the inventory.  Pharmacists and interns must report any change of address or place of employment to the Board within fifteen (15) days of the change.


 

(d)       When a pharmacy changes ownership, the original license becomes void and a new license must be secured by the new owner or owners.  A new license is required even if there is no change in the name of the pharmacy or in the registered pharmacist in charge of the pharmacy.

 

In the case of a corporation, limited liability company or partnership holding a pharmacy license, the Board shall be notified and a new license applied for anytime the majority of stock in the corporation is sold or a majority of the partners of the partnership or members of the limited liability company change.  This shall constitute new ownership.  Requirements for the ownership are the same as outlined in this section.

 

(e)       A pharmacy license registers the pharmacy to which it is issued only at the location specified on the appli­cation and is not transferable.

 

(f)        The board shall be notified in writing of a pharmacy change in address.  The new location shall be inspected by the board prior to issuance of a pharmacy license for the new location.  The new location must meet all requirements for a new or remodeled pharmacy as noted in Chapter 2, Section 7 of the board’s rules.

 

(g)       All licenses and certificates issued by the Board shall be displayed in a prominent place within the facility and always in view to the public.

 

Section 9.        Pharmacist-in-Charge.

Every licensed pharmacy must be in the continuous daily charge of a registered pharmacist.  A pharmacist shall be designated as the pharmacist-in-charge and shall have direct control of the pharmaceutical affairs of said pharmacy.  A pharmacist may not serve as the pharmacist-in-charge unless said pharmacist is physically present in the pharmacy a minimum   of 32 hours per  week, or 80 percent of the time the store is open if opened less than 40 hours per week.

A pharmacist may not serve as pharmacist-in-charge for more than one pharmacy  at any one time.  The name of the pharmacist-in-charge shall be designated in the application of the pharmacy for license and in each renewal thereof.  A pharmacist may seek a waiver from the Board to serve as a pharmacist-in-charge for more than one pharmacy, provided those requirements for number of hours physically present in the pharmacy are met.

 


(a)       A corporation or other non-pharmacist owner must comply strictly with the above provisions and provide a pharmacist-in-charge who will have complete control over the pharmaceutical affairs of said pharmacy.

 

(b)       Responsibility as the pharmacist-in-charge includes requiring that all federal and State pharmacy laws and regu­lations are complied with and enforced.  It shall be the duty of the pharmacist-in-charge to report all pharmacy violations within their facility to the Board.    Provided however, whenever a pharmacist-in-charge or staff pharmacist reports a pharmacist or  pharmacy technician to the Wyoming Professional Assistance Program (W.P.A.P.) for suspected substance abuse, no further reporting to the board regarding the name of the suspected substance abuse impaired pharmacist or pharmacy technician needs to be done.  Any pharmacy technician-in-training or pharmacy intern suspected of substance abuse and reported to W.P.A.P shall  be reported to the board.

 

(c)       Additional responsibilities of the pharmacist-in-­charge shall be to:

 

                        (i)        Establish policies and procedures for the pro­curement, storage, compounding and dispensing of pharma­ceuticals.

 

                        (ii)       Supervise the professional employees of the pharmacy.

 

                        (iii)      Supervise the non-professional employees of the pharmacy.

 

                        (iv)      Establish and supervise the record keeping for and security of all pharmaceuticals.

 

                        (v)       Report any significant loss or theft of drugs to the Board and other authorities.

 

                        (vi)      Ensure that all staff: registered pharma­cists, interns, pharmacy technicians-in-training and certi­fied pharmacy technicians have valid licenses or registra­tions in good-standing and that all certificates are on display.

 

                        (vii)     Ensure that all pharmacy licenses, including state and federal controlled substances registrations are valid and posted.

 

                        (viii)    Develop and implement a procedure for drug recall.

 

                        (ix)      Be in full and actual charge of such pharmacy and responsible for whatever goes on in it.

 

                        (x)       Develop a  written policy for delivery of prescription drugs during non-pharmacy hours which shall include but not be limited to:

 

                                    (A)      An arrangement made ahead of time with the customer that delivery will occur under these circumstances;

 

                                    (B)       An arrangement which guarantees that the offer to counsel, and if accepted, counseling will occur on all new prescriptions;

 

                                    (C)       An arrangement which guarantees the security of the drugs and the confidentiality for the customer.

 

                                    (D)      A plan which provides that such delivery is used only when required by the customer and not used in all instances for delivery after closing hours.

 

                        (xi)      Assure that all expired drug products are removed from active stock and placed in an area designated for return.

 

(d)       Every pharmacy shall have at least one registered pharmacist on duty

and physically present in the pharmacy area at all times that the prescription department is open for the transaction of business.

 

If the pharmacist is absent from a licensed pharmacy, the prescription department must be locked and kept so until that pharmacists’ return and a sign saying - “Prescription Department Closed - No Registered Pharmacist on Duty” shall be conspicuously posted.

 

            (e)       No pharmacy shall be permitted to operate without a pharmacist-in-charge.  The Board shall be notified in writing of any newly designated pharmacist-in-charge.  The Board shall record the PIC change and issue a corrected copy of the license.

 

Section 10.      Transfer of Prescription Orders Between Prescription Drug Outlets.


A prescription label or a written copy of a prescription order from another pharmacy may be used for informational purposes only and shall not be considered to be a valid prescription order.  A pharmacist who receives such a label or prescription order copy shall either contact the prescribing practitioner for authorization to dispense the prescription, or, alternatively, shall comply with (a) through (j) of this Section.

            (a)       A pharmacist may transfer prescription order infor­mation for the purpose of refilling a prescription subject to the following requirements.  The information is communicated directly by one pharmacist to another pharmacist, or the information may be electronically transferred between pharmacies.  Pharmacies electronically transferring information must satisfy all information requirements of a transferred prescription which is communicated directly by one pharmacist to another pharmacist, including those requirements as identified in W.S. §33-24-136a.

 

(b)       The transferring pharmacist shall:

 

                        (i)        Write the word “void” across the face of the original prescription order to make the order invalid or electronically document that the prescription has been voided;

 

(ii)       Record on the reverse side of the invalidated prescription order or electronically document:

 

(A)      His/her name;

 

(B)       The name of the receiving pharmacist;

 

(C)       The name of the receiving pharmacy;

 

(D)      The telephone number of the receiving pharmacy and

 

(E)       The date of the transfer.

 

(c)       The pharmacist receiving the transferred prescrip­tion order information shall reduce the transferred infor­mation to writing; write the word “transfer” or a word of similar import on the face of the transferred prescription order or electronically document that the prescription has been transferred, and provide all information required by law or regula­tion to be on the prescription order, including:

 

(i)        The name of the patient, including the date of birth if available;

 

(ii)       The name of the prescribing practitioner and DEA number if a controlled

substance;

 

(iii)      The date of issue of the original prescription order;

 

(iv)      The date of initial compounding and dispensing of the original prescription order;

 

(v)       The number of refills authorized;

 

(vi)      The number of valid refills remaining;

 

(vii)     The date of the last refill of the original prescription order;

 

(viii)    The prescription order number from which the prescription order information was transferred;

 

(ix)      The name  of the trans­ferring pharmacist;


 

(x)       The name and telephone number of the transferring pharmacy.

 

(d)       The transferring pharmacy shall retain the original prescription order.

 

(e)       The receiving pharmacy shall retain the transferred prescription order.

 

(f)        The pharmacist at the receiving pharmacy at the time of the dispensing of the transferred prescription, shall inform the patient that the prescription order is now invalid at the pharmacy from which it was transferred.

 

(g)       A transferring pharmacy which utilizes a computer for recordkeeping of prescription order transactions shall comply with all requirements of this regulation including invalidation of the prescription order and deactivation of the order in the computer.

 

(h)       Nothing in this regulation shall be deemed to per­mit the transfer of a prescription order for a schedule II controlled substance.

 

(i)        A prescription order for a controlled substance in schedule III through V may be transferred only one time, that transfer being from the pharmacy where the prescription was originally filled.  It shall not be further transferred by, or to, any other pharmacy.

 

(j)        A prescription order for a non-controlled prescrip­tion drug may be transferred from one pharmacy to another pharmacy only so long as there are refills remaining and each pharmacy can establish that a valid refill existed at the time of dispensing.

 

Section 11.      Labeling Prescription Drug Containers.

(a)       All original or refill prescription drug containers utilized in a traditional dispensing system shall be labeled as follows: name of the patient, brand or generic name of the drug product dispensed unless otherwise specified;  drug strength and quantity; the name, address and phone number of the pharmacy; the practitioner’s name; the serialized number of the prescription; the date the prescription was filled or refilled; directions for use, including accessory cautionary information as required for patient safety;  the identifying initials  of the dispensing pharmacist and any other information required by federal or state law.

 

(b)       Effective January 1, 2004 all original or refill prescription drug containers utilized in a traditional dispensing system shall be labeled with its physical description, including any identification code that may appear on the tablets and capsules.  A waiver will be granted for new drugs for the first 120 days on the market and 90 days on drugs for which the national reference file has no description on file.

 

            (c)       All unit dose or unit of issue packaging shall be labeled as follows:

 

                        (i)        Brand name and/or generic name of the prescription drug;

 

                        (ii)       Strength;

 

                        (iii)      Manufacturers lot number; and

 

                        (iv)      Manufacturers expiration date, if prepackaged or repackaged by the pharmacy, the expiration date shall be the lessor of the manufacturers expiration date or twelve (12) months from the date of prepackaging or repackaging.

 

                        (v)       All unit of issue packaging dispensed shall include the following information on the label in addition to that required by Chapter 2, Section 11 (c) (i) through (iv) of the Board's rules:

 

                                    (A)      Name, address, and phone number of pharmacy;     

                       

                                    (B)       Prescription number;

 

                                    (C)       Name of the patient;

 

                                    (D)      Name of the practitioner;

                                   

                                    (E)       Directions for use;

 

                                    (F)       Date dispensed;

 

                                    (G)      Initials of dispensing pharmacist;

 

                                    (H)      Accessory cautionary labels for patient safety; and

 

                                    (I)        Quantity of medication.

 

                        (vi)      All unit of issue packaging dispensed by a retail pharmacy to residents of  long term care facilities, as defined in Chapter 15 ,Wyoming Pharmacy Act, Rules and Regulations as well as prescriptions drugs dispensed from hospital emergency room departments as described in Chapter 12, Section 13, Wyoming Pharmacy Act, Rules and Regulations shall be labeled with the product’s physical description, including any identification code that may appear on the tablets and capsules. 

 

 

Section 12.      Child Resistant Packaging.

 

(a)       The Consumer Product Safety Commission enforces the Poison Prevention Packaging Act (PPPA) which requires that all prescription medication shall be dispensed in child­-resistant packaging.

 

(b)       Unless the prescription drug is expressly exempted from the federal regulations, the drug must be dispensed in a child-resistant package.  Exceptions to this requirement do exist as follows:

 


(i)        The purchaser may request either a one time or a blanket waiver from the requirement.  A one-time request shall be documented on the prescription or patient profile records by the pharmacist.

 

(ii)       The physician, at the request of the patient, may request a  one-time

waiver.  However, the physician cannot request a blanket waiver.

 

(c)       Child-resistant prescription containers cannot be reused for refills of prescriptions.  However, glass containers may be reused, provided that a new safety closure is used.

 

Section 13.      Record of Refills.

 

The following information shall be recorded in a readily retrievable manner when a prescription is refilled: date refilled, quantity, and pharmacist’s initials.  If a refill was not authorized on the original prescription or if no refills remain, the pharmacist may contact the prescriber to obtain a new prescription.  If authorization is obtained, the name of the practitioner authorizing this prescription, and if applicable, the name of the agent transmitting the prescription must be recorded as well the number of refills authorized. 

 

Both the supervising pharmacist and the intern must initial any prescription or prescription refilled by the intern.

 

Section 14.      Doctor-Patient Relationship as Affecting Prescriptions.

 

            (a)       Upon learning that a patient/practitioner relationship has been terminated for reasons other than discharge of the patient by the practitioner, a pharmacist utilizing his/her professional judgment may honor patient’s request for remaining medication refills, for a period not exceeding twelve months.

 

            (b)       It shall be unprofessional conduct for a resident or non-resident pharmacy or a pharmacist to dispense, sell or offer to sell prescription drugs to persons located within the State or any other state on the basis of a prescription generated solely through an Internet  questionnaire physician consultation.  Furthermore, all pharmacies or pharmacists included in this section are prohibited from linking an Internet site with or relating the site, in any way, to any other site, business, or physician that provides prescriptions for medications solely on the basis of an online medical consultation questionnaire.

 

Section 15.      Return or Exchange of Prescription Drugs.

 

(a)       Pharmacies (Hospital or Retail) are prohibited from accepting from patients or their agent any dispensed prescription drug for redispensing.  However, prescription drugs may be accepted for redispensing, if all the following are met;

 

(i)        Pharmacies may accept previously dispensed drugs for return from

locations that employ persons who are licensed to administer drugs, and the prescription drugs were maintained under the control of those persons licensed to administer drugs;

 

(ii)       Prescription drugs shall only be returned to the pharmacy

from which originally dispensed;

 

(iii)      The pharmacist-in-charge of the pharmacy accepting the prescription

drugs for redispensing shall ensure that conditions of transportation to, storage at the location, and during the return from the location, are such as to prevent deterioration and/or contamination by any means that would affect the efficacy and/or toxicity of the product to be redispensed;  and

 

(iv)      Prescription drugs accepted for redispensing must have been

initially dispensed as a unit dose package or unit of issue package.

 

            (b)       The following prescription drugs shall not under any circumstances be returned to the pharmacy for redispensing;

 

(i)        Any prescription drug declared to be a controlled substance under

state or federal law or regulation;

 

(ii)       Any prescription drug dispensed in other than a unit dose package or

unit of issue package, and/or

 

(iii)      Any prescription drug not labeled in accordance with Chapter 2,

Section 11.

 

 (c)      When prescription drugs are returned, the following shall apply:

 

 (i)       Prescription drug products in manufacturer’s unit dose or unit of issue

packages may be redispensed as often as necessary, provided that the integrity of the product and package are maintained, and the product remains in date.

 

 (ii)      Prescription drug products which have been prepackaged or

repackaged into unit dose packages and unit of issue package in the pharmacy may be redispensed one time only, provided that the integrity of the product and package are maintained, and then only in the package in which originally dispensed, except as provided in (iii) below. Partially used unit of issue packages may not be emptied and the drugs removed and repackaged, nor may additional units of medication be added to partially used unit of issue packages. 

 

 (iii)     Drug products, which have been prepackaged or repackaged into unit

of issue packages may be removed from such packages, for dispensing in a traditional dispensing system.   These drug products shall remain in their prepackaged unit of issue package until actual dispensing in a traditional dispensing system.

 

            (d)       In hospitals, which have a licensed institutional pharmacy, the pharmacy may accept prescription drugs for redispensing or reissue from all areas of the hospital under the effective control of professionally qualified personnel.  The labeling of such drugs shall meet the requirements of Chapter 2, Section 11 and the packaging shall meet the requirements of Chapter 2, Section 4.

 

(e)       When a drug has been packaged and prepared pursuant to a prescription order, but has not been delivered to either another location or to the ultimate consumer, it may be returned to stock.   A record shall be made on the prescription memorandum and the pharmacy’s computer indicating a return to stock and the date of such return.

 

Section 16.      Scope of Practice.

 

A prescription written outside the scope of practice of the prescribing practitioner shall not be considered a valid prescription.


 

Section 17.      Identification of a Patient.

 

(a)       The pharmacist or employee under supervision must verify the identity of the person presenting a controlled substance prescription to the pharmacy for dispensing.  This may be done by visual recognition.  If identity is not established by visual recognition, a driver’s license or similar photo identi­fication form is considered acceptable documentation.  The following information must be recorded on the reverse of the prescription if an ID is utilized:  name, type of identification, and identification number.

 

(b)       The name  of the person receiving the dispensed drug is to be recorded on  the prescription document, patient profile or signature log if an agent and not the patient receives the drug.

 

            (c)       This section shall not apply to pharmacies that mail prescriptions to their patients.  A note shall be entered on the prescription or patient’s profile with the name and address of where the medication was mailed.  Additionally, the date of such mailing shall be entered.

 

Section 18.      Reinstatement of Registered Pharmacist License After Failure to Renew, Returning from Inactive Status, Issuance of Duplicate License.

 

(a)       If a person requests the reinstatement of their registered pharmacist license when said license has lapsed only for failure to pay renewal fees, the person shall:

 

(i)        Write a letter requesting consideration of reinstatement;

 

(ii)       Pay all back renewal fees, including annual fines, up to a maximum fee;

 

(iii)      Provide approved continuing education cer­tificates up to a maximum required for five years;

 

(iv)      Provide at least two (2) recent letters attesting to good character;

 

(v)       Provide proof that pharmacist has been active in the practice of pharmacy and in good-standing in the state where practicing.

 

(b)       Minimum Competency for an Inactive Pharmacist Shall be Established to the Satisfaction of the Board.

 

When a registered pharmacist has been out of the prac­tice of pharmacy for an extended period of time and wishes to reactivate that license, the Board shall determine on an individual basis the requirements needed to reactivate that license.

 

The requirements may include some or all of the following:

 

(i)        Approved continuing education certificates for period in question up to a maximum of five years;

 

(ii)       Pass a jurisprudence exam;

 

(iii)      Any past license fees shall be paid including annual fines, up to a

maximum of five (5) years.

 

(iv)      Internship under direct supervision may be required.  Internship period may vary depending upon how long the individual was out of practice.


 

(v)       Individual shall produce at least two (2) recent letters of character reference.

 

(c)       Duplicate licenses may be issued upon request when licensee’s name changes or the license become damaged or destroyed.  There shall be a fee charged for the duplicate license.

 

Section 19.      Prescriptions in General.

 

(a)       To be valid the prescription as defined in W.S. §33-24-136(b) shall contain the following information:

 

(i)        Name of patient;

 

(ii)       Name and strength of drug;

 

(iii)      Quantity to be dispensed;

 

(iv)      Directions for using the drug;

 

(v)       Date of issuance by practitioner;

 

(vi)      Prescriptions for controlled substances shall include the DEA number and address of prescribing practitioner and address of the patient.

 

(vii)     Recognizable signature of the practitioner;

 

            (viii)    In the case of an oral order the name of the authorized agent if conveyed by other than the prescribing practitioner.

 

(b)       All oral orders shall be recorded on a written prescription memorandum and filed in accordance with W.S. §33-24-136(a).

 

(c)       Prescriptions may be transmitted to the pharmacist in written form; orally, including by telephone; by telephonic fac­simile (FAX); and electronic transmission.  Schedule II Controlled  Substance prescriptions may be transmitted by FAX if they meet the conditions as outlined in Chapter 2, Section 20 (c).  Controlled substance prescriptions may be transmitted electronically only to the extent allowed by federal law and Wyoming law.

 

            (d)       Prescriptions received from out of state practitioners are valid only to the extent a practitioner licensed in Wyoming may prescribe that medication in Wyoming.

 

The patient shall have the exclusive right to freedom of choice for any pharmacy to dispense their prescription orders.  No agreement between prescriber and pharmacy shall require that prescription orders be transmitted from the prescriber to only that pharmacy.

 

The pharmacist shall be required to determine the accuracy and authenticity of all prescriptions received.  Practitioners or their agents shall provide voice verifica­tion, when requested by the pharmacist.  If refused the prescription shall not be filled.

 

Section 20.  Transmission of Prescriptions by Telephonic Facsimile Machines (FAX).

 

Prescriptions transmitted by FAX shall include all of the features listed in Section 19 (a) including the prac­titioner’s recognizable signature.

(a)       Other requirements for FAX prescriptions include:

 

(i)        A notation that this is a FAX prescription.

 

(ii)       Telephone number and FAX number of the


practitioner.

 

(iii)      Name, address, telephone number and FAX number of pharmacy to which the prescription is being FAXed.

 

(iv)      Date and time of FAX, if not otherwise programmed into transmission.

 

(v)       Name of individual acting as practitioner’s agent, if other than practitioner.

 

The originating FAX prescription shall be put into practitioner’s patient file.  It shall not be given to the patient.

 

All FAX machines which are to be used in transmitting prescriptions shall be programmed with FAX identification number, so that document received will show the sender’s FAX identification number.

 

(b)       The FAX machine for any receiving pharmacy shall be in the prescription department to protect patient confiden­tiality and shall utilize non-fading paper.  Alternatively a non-fading photo copy or manually written copy of the FAXed prescription shall be stapled to the FAX copy.

 

 (c)      Prescriptions for Schedule III, IV, and V controlled substances may be transmitted by FAX.  Schedule II  controlled substance prescriptions may  be transmitted by FAX, if the schedule II controlled substance prescription meets one of the following conditions:

           

(i)        A prescription for a schedule II narcotic substance to be compounded  for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion or;

 

            (ii)       A prescription written for a schedule II substance for a resident of a Long Term Care Facility or;

 

            (iii)      A prescription written for a schedule II substance for a “terminally ill” patient.  The pharmacist shall so annotate a FAXED schedule II prescription as being for a “terminally ill” patient.

 

(d)       The FAX copy received by the pharmacist shall be deemed the original prescription order and shall be main­tained as required by statute.

 

(e)       A FAXed prescription may be dispensed only by the pharmacy receiving the FAX.

 

Section 21.      Prescription Refill Information.

 

(a)       Prescription refill permission may be obtained in written, FAX or electronic form, or by oral verification including telephone.

 

(b)       If prescription refill authorization is obtained by FAX, it shall be initialed by the authorizing practitioner on the document.  All other requirements for valid prescrip­tions shall apply, including pharmacist’s responsibility to determine authenticity of information obtained by FAX.

 

Section 22.      Telephonic Facsimile Machines (FAX) in General.

 


(a)       Using FAX equipment to circumvent documentation, authenticity, verification or other standards of pharmacy practice shall be considered unprofessional conduct.

 

 

Section 23.      Therapeutic Equivalents.

 

Therapeutic equivalents do not include therapeutic substitutions.  Therapeutic equivalent is defined in W.S. §33-24-147(a)(v).  Therapeutic substitution is that class of drug having the same or similar action, but not the iden­tical composition.

 

Pharmaceuticals which are considered to be therapeutic substitution instead of generic substitution, shall not be used for retail/non-resident pharmacies.  A hospital phar­macy using a formulary may reach a written agreement with members of the medical staff under which therapeutic substi­tution is permitted for use of formulary drugs.

 

 

Section 24.      Specific Requirements for Licensure of Non-Resident Pharmacies to Ship Prescription Drugs into the State.

 

(a)       Any pharmacy operating from outside the State which ships, mails or delivers, in any manner, a dispensed prescription drug or legend drug to a patient in Wyoming shall obtain and hold a non-resident pharmacy license and, if applicable, a controlled substance registration.

 


(b)       Said pharmacy license and controlled substance registration shall be on forms supplied by the Board and shall be accompanied by the following information.  Applicant shall:

 

(i)        submit a copy of the pharmacy license from the state of residence;

 

(ii)       submit a copy of the latest inspection report from the state of residence;

 

      (iii)      submit a copy of current D.E.A. registration;

 

(iv)      submit list of partners, members or principal

officers and registered agent for service of process, if any;

 

(v)       submit list of all registered pharmacists,

specifying pharmacist-in-charge.

 

(c)       Pharmacy license and controlled substance registrations shall be renewed annually by July 1st to con­tinue doing business in the State.

 

(d)       The Board office shall be notified of any change in ownership or the pharmacist-in-charge.

 

(e)       Each non-resident pharmacy shall comply with statu­tory or regulatory requirements of the Board, including, but not limited to:

 

The “Wyoming Drug Identification Act” and the Wyoming Generic Substitution Act.

 

(f)        Each non-resident pharmacy shall maintain records of all prescriptions dispensed to patients in the State in readily retrievable form.

 

(g)       Each non-resident pharmacy shall maintain pharmacy hours that permit the timely dispensing of prescriptions to patients in the State and provide a toll-free telephone ser­vice to facilitate communication between patients in this State and a pharmacist who has access to the patients’ records.

 

Counseling shall be accomplished on new prescriptions orally and/or by written information accompanying the dispensed prescription.

 

(h)       The Board may revoke, deny or suspend the licensure and registration of any non-resident pharmacy for violations of the Act - W.S. §33-24-152 and Board regulations, Chapter 2, Section 24.


 

Section 25.      Fees (including Exam, Re-exam, License, License Renewal, Registration, Registration renewal, Mailing list, and late fees).

 

(a)       The Board shall charge the following fees as indicated:

 

(i)        Pharmacist licensure by examination or reexamination shall be

seventy five dollars ($75.00) plus The National Association of Boards of Pharmacy’s (NABP) fee for the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE).

 

(ii)       Pharmacist licensure by reciprocity shall be two hundred dollars

($200.00) plus NABP’s fee for licensure transfer application and the MPJE.

 

(iii)      Pharmacist licensure renewal shall be one-hundred dollars ($100.00)

per year.

 

(iv)      Pharmacy intern licensure shall be fifteen dollars ($15.00) and shall

be renewed every 12 months.  Renewal fee shall be fifteen dollars ( $15.00).

 

(v)       Pharmacy technician licensure fee shall be fifty dollars

($50.00).

 

(vi)      Pharmacy technician-in-training permit shall be fifteen dollars

($15.00).

 

(vii)     Pharmacy technician renewal fee shall be fifty dollars

($50.00) per year.

 

(viii)    Resident retail pharmacy license and renewals shall be one hundred

fifty dollars ($150.00) per year.

 

(ix)      Non-resident pharmacy license and renewals shall be three hundred 

dollars ($300.00) per year.

 

(x)       A prescription drug manufacturer, distributor, reverse distributor, or

wholesaler license and renewals shall be two hundred fifty dollars ($250.00) per year.  Oxygen manufacturer or distributor license and renewals shall be one hundred dollars ($100.00) per year.

 

                        (xi)      Institutional pharmacy license and renewals shall be one hundred fifty dollars ($150.00) per year.

 

                        (xii)     The board shall charge a two hundred fifty dollar ($250.00) fee for preparing and sending mailing lists of pharmacists, pharmacy technicians, pharmacy interns, pharmacy technician in training, pharmacies, controlled substance registrants, and drug distributors.  Each list shall constitute a separate mailing list.  Federal and state agencies shall be exempt from payment of fees for mailing lists. 

 

(b)       The Board shall assess a late fee in addition to the license or registration renewal fee of licensees or registrants as follows:

 

(i)        A pharmacist whose license renewal application is postmarked or

hand delivered to the Board’s office after December 31 shall be assessed a late fee of seventy-five dollars ($75.00) in addition to the license renewal fee;

 

(ii)       A pharmacy technician whose license renewal application is

postmarked or hand delivered to the Board’s office after December 31 shall be assessed a late fee of thirty-five dollars ($35.00) in addition to the license renewal fee;

 

(iii)      A resident retail pharmacy whose license renewal application is

postmarked or hand delivered to the Board’s office after June 30 shall be assessed a late fee of two hundred dollars ($200.00) in addition to the license renewal fee;

 

(iv)      A non-resident pharmacy whose license renewal application is

postmarked or hand delivered to the Board’s office after June 30 shall be assessed a late fee of three hundred dollars ($300.00) in addition to the license renewal fee; and

 

(v)       A manufacturer, distributor, or wholesaler of prescription drug

products (drugs or oxygen) whose license renewal application is postmarked or hand delivered to the Board’s office after June 30 shall be assessed a late fee of two hundred dollars ($200.00) in addition to the license renewal fee.

 

                        (vi)      An institutional pharmacy whose license renewal application is postmarked or hand delivered to the Board's office after June 30 shall be assessed a late fee of two hundred dollars ($200.00) in addition to the license renewal fee.

 

            Section 26.      Emergency Drug Supply for Nursing Homes, Hospices, Extended Care Facilities or Intermediate Care Facilities.

 

            (a)       Nursing Homes, Hospices, Extended Care Facilities, or Intermediate Care Facilities licensed by the Department of Health may be issued a permit, by the Board of Pharmacy, to maintain an emergency supply of drugs, both scheduled and non-scheduled, subject to approval by the Board.  The drugs maintained in the emergency drug supply shall remain the property of the pharmacy to whom the permit was jointly issued.

 

(i)        The pharmacy servicing the facility or facilities listed in Section 26(a)

shall make application to the Board, on an application provided by the Board.  The Board may issue a permit, if the conditions of Section 26 are met, in the name of the facility and the pharmacy authorizing the storage and use of a emergency drug supply at the facility.  This registration shall be valid until June 30 of each year.  The permit must be renewed annually.

 

(ii)       The fee for the permit shall be fifteen dollars ($15.00) annually.

 

(iii)      The permit may be revoked by the Board if conditions as outlined in

this  section are not followed, or for other violations of the Wyoming Pharmacy Act or Wyoming Controlled Substance Act and/or rules and regulations promulgated under said Acts.

 

(b)       The number of drugs provided by a pharmacy to a facility listed in Section 26(a) shall be limited to forty eight (48). Additional quantities require submission of an application listing the additional drugs requested with justification, and must be approved by the Board. The number of doses of each drug available shall be limited to thirty (30) doses of any separate drug dosage form in each emergency supply.

 

(c)       The facility and the pharmacy servicing the facility shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of the emergency drug supply. Copies of the most recent policy and procedure manual shall be on file at both the facility and the pharmacy servicing the facility.

 

(i)        The emergency drug supply policy and procedure’s manual shall be

reviewed and approved annually, during the anniversary month of when the original permit was issued by the Board, by the pharmacist-in-charge of the pharmacy servicing the facility and the facility’s director of nursing.

 

(e)       The emergency drug supply may only be stocked and restocked by a pharmacist licensed by this Board or a technician under his supervision.  Discrepancies in controlled substance inventories shall be documented and reported to the Board of Pharmacy, within seven days of discovery.

 

(f)        Drugs administered from the emergency drug supply shall be limited to the following:

 

(i)        A new drug order given by a prescriber for a patient of the facility for

administration prior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less.  The drugs shall be administered only upon authorization by a pharmacist and after the pharmacist has reviewed the prescriber’s order and patient’s profile for potential contraindications and adverse drug reactions.

 

(ii)       Drugs that a prescriber has ordered for a patient on an as-needed basis,

if the utilization and administration of those drugs are subject to ongoing review by a pharmacist.

 

(iii)      Drugs designated by the patient care policy committee or similar

facility committee as an “emergency drug” may be administered from the emergency drug supply pursuant to the order of a prescriber for emergency or immediate administration to a patient of the facility.  Within 72 hours after administration under this paragraph, the case shall be reviewed by a pharmacist.

 

(g)       If the pharmacy servicing the facility discontinues their service, the Board must be notified and the permit surrendered.  If the new pharmacy provider desires to maintain an emergency drug supply, they must make application to the Board.

 

            (h)       Facilities described in Section 26(a) are exempt from the provisions of Section 26  provided the pharmacy providing their emergency drug supply is physically located at the same site as the facility and this pharmacy possesses a DEA registration and is licensed by the Wyoming State Board of Pharmacy.

 

            Section 27.      Reinstatement of a Revoked or Suspended Pharmacist,  Pharmacy Technician License.

 

(a)       A pharmacist or pharmacy technician whose license has been revoked or suspended by the Board may file an application, supplied by the Board, requesting a hearing to present evidence to show why his pharmacist or pharmacy technician license should be reinstated subject to the following:

 

(i).       A pharmacist or pharmacy technician whose license was revoked

by the Board, may not file an application requesting a hearing until twelve (12) months has elapsed from the date the order revoking his pharmacist or pharmacy technician license has become final;

 

(ii)       A pharmacist or pharmacy technician whose license was

suspended by the Board, may not file an application requesting a hearing until one half (1/2) of the suspension so ordered by the Board has elapsed, or the order of suspension has become final, whichever is later;

 

(iii)      A pharmacist shall submit an application fee of two hundred fifty

dollars ($250.00), and pay for the cost of the hearing if the Board issues an order denying reinstatement.  The $250.00 application fee shall be submitted with the application and is nonrefundable.

 

(iv)      A pharmacy technician shall submit an application fee of one

hundred twenty five dollars ($125.00), and pay for the cost of the hearing if the Board issues an order denying reinstatement.  The $125.00 application fee shall be submitted with the application and is nonrefundable.

 

(v)       The applicant must complete all questions and provide all information

as requested on the application. 

 

(vi)      Incomplete applications and fee will be returned, and a  hearing date

will not be set by the Board.

 

(vii)     In the application the pharmacist or the pharmacy technician shall

authorize any health professional who has examined or treated the applicant to disclose his diagnosis and the reasons for it to the Board and the Board’s staff.

 

(b)       Applications received by the Board, will be reviewed by the Executive Director.  The Executive Director shall:

 

(i)        Review the application for completeness.  If  information or

attachments are missing, the application and fee will be returned to the applicant with a letter stating the reason(s) for the rejection. 

 

(ii)       If the application is complete, the Executive Director in consultation

with the Board’s inspector, an ex-officio member of the Board, and legal counsel shall make a decision if the evidence submitted supports reinstatement or not.  A hearing shall be scheduled by the Executive Director.  The Executive Director will notify the applicant whether the Board’s staff will support or oppose the request for reinstatement. 

 

(c)       The Board’s Staff may require the applicant to submit to a health examination by a health professional chosen by the Board Staff.  The health professional shall report on his examination to the Board’s staff and may testify at a hearing on reinstatement. Cost for the examination shall be the responsibility of the applicant.

 

(d)       To be reinstated, a pharmacist must prove that he has been rehabilitated so that further violation of the Board’s statutes and/or rules is not likely to occur, and that he is competent to practice pharmacy.  The Board may, as a condition to establish competency, require successful completion of one or more of the following:

 

(i)        Complete the North American Pharmacist Licensure Examination

(NAPLEX) with a minimum score of 75;

 

(ii)       Complete the Multistate Pharmacy Jurisprudence Examination

(MPJE) with a minimum score of 75; and/or

 

(iii)      Complete an internship, not to exceed 2000 hours, as prescribed by

the Board.

 

(e)       To be reinstated, a pharmacy technician must prove that he has been rehabilitated so that further violation of the Board’s statutes and/or rules is not likely to occur, and that he is competent to function as a pharmacy technician.  The Board, as a condition to establish competency, may require successful completion of pharmacy technician examination.

 

Section 28.      Collaborative Pharmaceutical Care.

 

(a)       A pharmacist planning to engage in collaborative practice shall have on file at his place of practice a written signed agreement approved by the Board.  The agreement allows the pharmacist, acting within the pharmacist’s collaborative scope of practice, to conduct drug therapy management approved by a prescribing physician acting within the scope of the physician’s current practice.

 

(b)       The agreement shall include:

 

(i)        The names of the prescribing physician and the pharmacist who are

parties to the agreement;

 

(ii)       The specific  types of drug therapy management decisions that the

pharmacist is allowed to make, which shall include:

 

(A)      The types of diseases, drugs, or drug categories involved, and

the extent of drug therapy management allowed in each case;

 

(B)       The methods, procedures, decision criteria, and plan the

pharmacist is to follow when conducting drug therapy management; and

 

(C)       The procedures the pharmacist is to follow in the course of

conducting drug therapy management, including documentation of decisions made and a plan or appropriate mechanism for communication and reporting to the prescribing physician concerning specific decisions made.  Documentation shall  occur in the prescribing physician’s patient medical chart and shall also occur in the pharmacist’s patient medical chart located within the pharmacist practice site.

 

(iii)      A method for the prescribing physician to monitor compliance with

the agreement and clinical outcomes when drug therapy management by the pharmacist has occurred and to intercede when necessary;

 

(iv)      A provision that allows the prescribing physician to override the

agreement whenever he deems it necessary or appropriate;

 

                        (v)       A provision allowing the physician, pharmacist, and patient or patient’s agent, parent, or guardian to cancel the agreement at any time by written notice to all parties.  The pharmacist shall retain the original notice of cancellation for two (2) years; and

                       

                        (vi)      The signatures of the pharmacist and the prescribing physician who are entering into the collaborative practice agreement, and the dates when signed.

 

(c)       Drug therapy management shall occur only for a particular patient pursuant to a specific written order from the prescribing physician.  The written order shall conform to the format established by the Board of Pharmacy and shall include the following as a minimum.

 

            (i)        Patient’s name, gender, date of birth, height, and weight;

 

            (ii)       Allergies;

 

            (iii)      Medical diagnoses;

 

            (iv)      All current medication(s) including current dosages (include OTC and prescription products);

 

            (v)       Pertinent lab values;

 

            (vi)      Drug therapy management authorized (including any lab test);

 

            (vii)     Method of communicating information between pharmacist and physician;

 

            (viii)    Frequency of physician follow-up;

 

            (ix)      Date order will be renewed (specific order must be renewed annually); and,

 

            (x)       Signatures of physician, pharmacist, and patient or the patient’s agent, parent, or guardian and date signed.

 

(d)       A pharmacist providing drug therapy management for a patient, shall obtain written consent from the patient or the patient’s agent, parent or guardian prior to providing this service.  Drug therapy management shall not be implemented for a particular patient, if the patient or the patient’s agent, parent or guardian,  refuses to give written consent after being informed of the responsibility for payment.

 

(e)       At a minimum, the written agreement shall be reviewed/renewed annually.  If necessary, the agreement may be revised. The Board of Pharmacy must approve all revisions, once signed by the pharmacist and the prescribing physician, prior to implementation.

 

(f)        The Board shall review and approve all agreements including revisions prior to implementation.  This shall be accomplished as follows:

 

(i)        The Board shall appoint a Collaborative Practice Advisory

Committee.  This Committee shall be composed of five (5) members.  Composition shall be two (2) pharmacists currently licensed by the Board and in active practice in Wyoming, one of whom is a current member of the Board of Pharmacy, two (2) physicians currently licensed by the Wyoming State Board of Medicine and in active practice in Wyoming, one of whom is a current member of the Board of Medicine, and the Board of Pharmacy’s  Executive Director.

 

(ii)       A pharmacist who has developed an agreement shall forward five

copies of the signed agreement to the Board of Pharmacy.  The Executive Director shall convene the Collaborative Practice Advisory Committee to review pending agreements.  The Committee shall have authority to recommend approval or rejection of the agreement. 

 

(iii)      The recommendation of the Collaborative Practice Advisory

Committee shall be reported to the Board of Pharmacy at their next regularly scheduled meeting or as needed.  The Board of Pharmacy’s decision will be delivered to the pharmacist and prescribing practitioner within ten days of the Board’s decision.

 

(iv)      The pharmacist submitting an agreement or revisions to an approved

agreement to the Board of Pharmacy  shall not practice under the agreement until notified of approval by the Executive Director.

 

(g)       A pharmacist and prescribing physician entering into an agreement must be currently licensed by their respective Board and authorized to practice in the State of Wyoming.

 

            (h)       Nothing in this Section shall be interpreted to permit a pharmacist to accept delegation of a physician’s authority outside the limits included in W.S. §33-26-202 of the Medical Practice Act and the Board of Medicine’s regulations.

 

Section 29.      Electronic Prescription Transmission.

 

(a)             All non-controlled substance prescription drug orders communicated by   way of electronic transmission shall fulfill these requirements to be valid:

 

(i)              Be transmitted to a licensed pharmacy of the patient’s choice,

exactly as transmitted by the prescribing practitioner or designated agent;

 

(ii)            Identify the transmitter’s phone number for verbal confirmation, the

time and date of transmission, and the identity of the pharmacy intended to receive the transmission, as well as any other information required by federal or state laws and regulations;

 

                        (iii)      Be transmitted by an authorized practitioner using an electronic signature unique to the practitioner, if the transmission is from computer to computer or from computer to fax machine;

 

(iv)      The electronic transmission shall be deemed the original prescription

drug order provided it is readily retrievable through the pharmacy computer system, and meets those requirements as outlined in W.S. 33-24-136.  The electronic transmission shall be maintained for two years from the date of last use; and  

 

(v)       Contain all other information as required by state or federal law.

 

(b)            The pharmacist shall exercise professional judgement regarding the accuracy,

validity, and authenticity of the prescription  communicated by  electronic transmission, consistent with existing federal or state laws and regulations.

 

(c)             All electronic equipment for receipt of prescriptions communicated by way

of electronic transmission shall be maintained  to prevent unauthorized access.

 

            (d)       Hard copy prescriptions presented to the patient, which are generated from electronic media utilizing an electronic signature shall be applied to paper that utilizes security features that will ensure that the prescription is not subject to any form of copying and/or alterations.

 

            (e)       However, prescriptions may be transmitted from fax to fax as allowed in Chapter 2, Section 20 of these regulations.

 

            (f)        Controlled substance prescriptions shall not be communicated by way of electronic transmission except by fax as allowed in Chapter 2, Section 20 (c) of the Board's rules.

 

Section 30.      Retail Pharmacy Closure.

 

(a)       Not less than twenty-one (21) days prior to a resident retail pharmacy, licensed by the board, permanently ceases operation, the board shall receive written notice of the following:

 

(i)        The last day the retail pharmacy will be open for business.

 

                                    (ii)       The proposed disposition of all prescription files, both hard copy and electronic records.

 

                                    (iii)      The proposed disposition of all prescription drug inventory including controlled and non-controlled prescription drug products.

 

(iv)      The proposed method of communicating to the public the last day the pharmacy will be open for business, the location of prescription records after the store closes, and how patients can arrange for transfer of their prescription records to a pharmacy of their choice.  Included in this communication shall be a description of the method of transfer of prescription records, including the last day a transfer may be made from the store closing and the initial date the prescription may be transferred from the pharmacy that acquired the prescription records.  Communication to the public must begin no later than fourteen (14) days prior to the last day the pharmacy will be open for business.

 

(v)       If prescription records are not transferred to another pharmacy, the

name, address, and phone number of the custodian of prescription records must be provided.  Prescription records must be maintained for two (2) years from the date of closure.

 

                        (vi)      The scheduled date to have all signage, which includes the wording  "drug", "pharmacy", "drugstore", "Rx", "apothecary" or  other terms that might indicate or signify by any advertising medium that such establishment is a licensed pharmacy removed from the exterior and interior of the building.

 

                        (vii)     The name, address, and phone number of the custodian of records for the following documents, which must be maintained for two (2) years from the date of closure:

 

                                    (A)      Completed DEA 222 forms or retrievable electronic equivalent.

 

                                    (B)       Invoices for purchases of schedule III, IV and V controlled substances.

 

                                    (C)       Patient signature logs.

 

                        (viii)    The date the Drug Enforcement Administration (DEA) was contacted regarding the closure and that DEA was notified that all invoices and DEA 222 forms referencing the sale of controlled substances at closure, blank DEA 222 forms, and the DEA registration certificate will be delivered to the board for disposition.

 

            (b)       At the close of business on the last day the retail pharmacy is open for business a controlled substance inventory, including all schedule II, III, IV and V controlled substances shall be taken.  This inventory shall be dated and signed by the pharmacist-in-charge.   A copy shall be provided to the board.

 

            (c)       An inspection of the pharmacy shall be conducted by the board after the retail pharmacy has closed for business and all prescription drug stock has been removed.  At the time of inspection, the following documents shall be provided to the board inspector/compliance officer:

 

                        (i)        A copy of the final controlled substance inventory.

 

                        (ii)       Documentation as noted in Chapter 2, Section 30 (a)(iv), regarding notification to the public of the closure of the retail pharmacy.

 

                        (iii)      The Wyoming retail pharmacy license.

 

                        (iv)      Documentation of the transfer of all prescription drug inventory (controlled and non-controlled) to a third party authorized to have such possession of inventory.  Under no circumstance, may prescription drug inventory remain in the possession of a person or business that is not authorized by law to have possession. 

 

                        (v)       Any changes to information previously provided to the board as required in Chapter 2, Section 30 (a). 

 

                        (vi)      DEA registration certificate and blank DEA 222 forms.

 

            (d)       It is unprofessional conduct for a retail pharmacy to close in a manner other than that prescribed in Chapter 2, Section 30 (a)(b)(c), Wyoming Pharmacy Act, Rules and Regulations.

 

            (e)       If a retail pharmacy purchases the patient prescription records (electronic and hard copy prescriptions), those records shall be maintained by the acquiring retail pharmacy for a minimum of two (2) years from the date of closure.

 

            Section 31.      Institutional Pharmacy Closure.

 

(a)       Not less than twenty-one (21) days prior to an institutional pharmacy, licensed by the board, permanently ceases operation, the board shall receive written notice of the following:

 

(i)        The last day the institutional pharmacy will be open for business.

 

                                    (ii)       The proposed disposition of all prescription drug inventory including controlled and non-controlled prescription drug products.

 

                        (iii)      The name, address, and phone number of the custodian of records for the following documents, which must be maintained for two (2) years from date of closure:

 

                                    (A)      Completed DEA 222 forms or retrievable electronic equivalent.

 

                                    (B)       Invoices for purchases of schedule III, IV and V controlled substances.

 

                                    (C)       Patient specific records.

 

                        (iv)      The date the Drug Enforcement Administration (DEA) was contacted regarding the closure and that DEA was notified that all invoices and DEA 222 forms referencing the sale of controlled substances at closure, blank DEA 222 forms, and the DEA registration certificate will be delivered to the board for disposition.

 

            (b)       At the close of business on the last day the institutional pharmacy is open for business a controlled substance inventory, including all schedules II, III, IV and V controlled substances shall be taken.  This inventory shall be dated and signed by the pharmacist-in-charge.   A copy shall be provided to the board.

 

            (c)       An inspection of the pharmacy shall be conducted by the board after the institutional pharmacy has closed for business and all prescription drug stock has been removed.  At the time of inspection, the following documents shall be provided to the board inspector/compliance officer:

 

                        (i)        A copy of the final controlled substance inventory.

 

                        (ii)       The Wyoming institutional pharmacy license.

 

                        (iii)      Documentation of the transfer of all prescription drug inventory (controlled and non-controlled) to a third party authorized to have such possession of inventory.  Under no circumstance, may prescription drug inventory remain in the possession of a person or business that is not authorized by law to have possession

 

                        (iv)      Any changes to information previously provided to the board as required in Chapter 2, Section 31 (a). 

 

                        (v)       DEA registration certificate and blank DEA 222 forms

 

            (d)       It is unprofessional conduct for an institutional pharmacy to close in a manner other than that prescribed in Chapter 2, Section 31 (a)(b)(c), Wyoming Pharmacy Act, Rules and Regulations.

 

            Section 32.      Drug Samples.

 

            It is unprofessional conduct for a licensee in an institutional or a retail  pharmacy to  distribute or dispense prescription drug samples.

 

            Section 33.      Centralized Prescription Processing.

 

            (a)       The purpose of this section is to provide standards for centralized prescription processing.

 

            (b)       “Centralized Prescription Processing” as used in this section means the processing by a pharmacy of a request from another pharmacy to refill a prescription drug order or to perform functions such as, DUR, claims adjudication, refill authorizations, and therapeutic interventions.

 

            (c)       "Dispensing Pharmacy" as used in this section means a pharmacy that may out source the processing of a prescription drug order to another pharmacy licensed by the board.

 

            (d)       "Central Fill Pharmacy" as used in this section means a pharmacy that processes a prescription drug order that was outsourced by a dispensing pharmacy licensed by the board.

 

            (e)       "Real-time" as used in this section means the transmission of information through data links is so rapid that the information is available to the dispensing pharmacy and requesting pharmacy sites simultaneously.

 

            (f)        Minimum Requirements:

 

                        (i)        A dispensing pharmacy may outsource prescription drug order processing to another pharmacy licensed by the board. provided the pharmacies:

 

                                    (A)      have the same owner; or

 

                                    (B)       have entered into a written agreement, which complies with federal and state laws and regulations, specifying the services to be provided and the responsibilities and accountabilities of each pharmacy;

 

(C)           share a real-time database; and

 

(D)           maintain the original prescription at the dispensing pharmacy for a time period not less than two (2) years from the date last filled or refilled.

 

                        (ii)       The pharmacist-in-charge of the central fill pharmacy shall ensure that:

 

                                    (A)      the pharmacy maintains and uses storage or shipment containers and shipping processes which ensure drug stability and potency.  Shipping processes shall include the use of appropriate packaging material; and/or devices which ensure the drug is maintained at a temperature range which will maintain the integrity of the medication throughout the delivery process; and

 

                                    (B)       the dispensed prescriptions are shipped in containers  sealed in such a manner as to show evidence of opening or tampering.

 

                        (iii)      A resident dispensing or central fill pharmacy shall comply with the provisions of W.S. § 33-24-113 and this section.

 

                        (iv)      A non resident dispensing or central fill pharmacy shall comply with the provisions of W.S. § 33-24-152 and this section.

 

                        (v)       A dispensing or central fill pharmacy dispensing compounded non-sterile or sterile pharmaceuticals shall comply with the provisions of Chapter 13, Wyoming Pharmacy Act, Rules and Regulations.

 

            (g)       Notifications to patients.

 

                        (i)        A pharmacy that out-sources prescription processing to another pharmacy shall:

 

                                    (A)      Notify patients that their prescription may be outsourced to another pharmacy prior to outsourcing the prescription via posted signage, written notification or refill phone message.

 

                                    (B)       If the prescription is delivered to the patient directly by the central fill pharmacy, the pharmacist employed by the central fill pharmacy shall ensure that the patient receives written notice of available counseling.  Such notice shall include days and hours of availability, location of pharmacy, and a toll-free number the patient may utilize to contact a pharmacist for counseling or to answer questions.  Such notice shall be included in each prescription delivery to the patient.

 

            (h)       Prescription Labeling.

 

                        (i)        The prescription label shall clearly indicate which pharmacy filled the prescription  and which pharmacy dispensed the prescription ; and

 

                        (ii)       The prescription label shall comply with Section 11 of this chapter.

 

            (i)        Policies and Procedures.  A policy and procedure manual relating to centralized processing shall be maintained at both pharmacies and be available for inspection.  Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations.  The manual shall:

 

                        (i)        outline the responsibilities of each of the pharmacies;

 

                        (ii)       include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription processing; and                 

 

                        (iii)      include policies and procedures for:

 

                                    (A)      notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription processing and providing the name of that pharmacy;

 

                                    (B)       protecting the confidentiality and integrity of patient information;

 

                                    (C)       dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received;

 

                                    (D)      complying with federal and state laws and regulations;

 

                                    (E)       operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems;

 

                                    (F)       identifying the pharmacist responsible for each aspect of prescription preparation including, but not limited to, the drug regimen review, the initial electronic entry, any changes or modifications to the prescription record or patient profile, and the final check of the completed prescription;

 

                                    (G)      identifying the pharmacist responsible for making the offer to counsel to the patient as required by Chapter 9, Wyoming Pharmacy Act, Rules and Regulations; and

 

                                    (H)      documentation of annual review of the written policies and procedures.

                                                                       

            (j)        Records.

 

                        (i)        Records shall be maintained in a real-time electronic database.

 

                        (ii)       Each pharmacy shall comply with all the laws and rules relating to the maintenance of records and be able to produce an audit trail showing all prescriptions dispensed by the pharmacy and each pharmacist's or technician's involvement in dispensing.

 

                        (iii)      The dispensing pharmacy shall maintain records which indicate:

 

                                    (A)      The date and time the request for processing was transmitted to the central fill pharmacy; and

 

                                    (B)       The date and time the dispensed prescription was received from the central fill pharmacy by the dispensing pharmacy, including the method of delivery (e.g., private, common, or contract carrier) and the name of the person accepting delivery.

 

                        (iv)      The central fill pharmacy shall maintain records which indicate:

 

                                    (A)      The date the prescription was shipped to the dispensing pharmacy.

 

            Section 34.      Automated Storage and Distribution Systems.

 

            (a)       Before using an automated storage and distribution system, a pharmacy licensee or pharmacist in charge shall:

 

                        (i)        Ensure that the automated storage and distribution system and the policies and procedures comply with subsection (b); and

 

                        (ii)       Notify the board in writing of the intent to use an automated storage and distribution system, including the type or name of the system.

 

            (b)       A pharmacy licensee or pharmacist in charge shall establish policies and procedures for appropriate performance and use of the automated storage and distribution  system that:

 

                        (i)        Ensure that the automated storage and distribution system is in good working order while maintaining appropriate recordkeeping and security safeguards.  This is to include the ability to store at the required temperature.

 

                        (ii)       Ensure that an automated storage and distribution system used by a pharmacy that allows access to drugs or devices by a patient:

 

                                    (A)      Only allows patient access to prescriptions that;

 

                                                (I)        Do not require an offer to counsel by a pharmacist as specified in W.S. §33-24-136(c);

 

                                                (II)       Are properly labeled and verified by a pharmacist before placement into the automated storage and distribution system and subsequent release to patients; and

 

                                                (III)      Are not a schedule II controlled substance under the Wyoming Controlled Substance Act.

 

                                    (B)       Allows a patient to choose whether or not to use the system;

 

                                    (C)       Is located inside of  a building in a wall of a licensed pharmacy where the pharmacy staff has access to the device from within the pharmacy and patients have access from outside of the pharmacy and is attached to the wall in such a manner that prevents unauthorized removal;

 

                                    (D)      Provides a method to identify the patient and only release the identified patient’s prescriptions;

 

                                    (E)       Is secure from access and removal of drugs or devices by unauthorized individuals;

 

                                    (F)       Provides a method for a patient to obtain  consultation with a pharmacist, if requested by the patient; and

 

                                    (G)      Prevents dispensing of  refilled prescriptions if a pharmacist determines that the patient requires counseling.

 

                        (iii)      Ensure that an automated storage and distribution system used by a pharmacy that allows access to drugs or devices for the purposes of administration only by authorized licensed personnel based on a valid prescription order or medication order:

 

                                    (A)      Provides for adequate security to prevent unauthorized individuals from accessing or obtaining drugs or devices; and

 

                                    (B)       Insures the filling, stocking, or restocking of all drugs or devices in the system may be done only by a pharmacist, pharmacy intern or pharmacy technician.

 

                        (iv)      Implement an ongoing quality assurance program that monitors compliance with the established policies and procedures of the automated storage and distribution system and federal and state law.

 

            (c)       A pharmacy licensee or pharmacist in charge shall:

 

                        (i)        Ensure that policies and procedures for the performance and use of an automated storage and distribution system are prepared, implemented, and complied with;

 

                        (ii)       Review and document annually and, if necessary, revise the policies and procedures required under this section;

 

                        (iii)      Make the policies and procedures available for employee reference and inspection by the board within the pharmacy and at any location outside the pharmacy where the automated storage and distribution system is used.

 

            (d)       The board may prohibit a pharmacy licensee or pharmacist in charge from using  an automated storage and distribution system if the pharmacy licensee or the pharmacy licensee’s employees do not comply with the requirements of this section.

 


CHAPTER 3

 

PHARMACY INTERNSHIP REGULATIONS

 

Section 1.        Authority.      

 

These regulations are promulgated as authorized by The Act.

 

Section 2.        Interns in Pharmacy.

 

(a)       "Intern" means any person who has begun class-work in their first professional year in an approved college or school of pharmacy, who is in good standing; or a graduate of an approved  college or school of pharmacy seeking licensure by exam or score transfer who lacks the required amount of practical experience for licensure; or those applicants for reciprocity who have not been in active practice and must complete an internship; or those applicants for reinstatement of a lapsed license that must complete a required amount of practical experience; or those applicants for licensure who are considered foreign pharmacy graduates and possess a FPGEC Certificate who must complete 1200 hours of practical experience for licensure .     

 

            (b)       Every Intern shall be registered with the Board  prior to employment or training in any capacity as a pharmacy intern in a resident retail or institutional pharmacy.  Registration fee of $15.00 together with the proper application, including the Intern Waiver and fee/fingerprints for a criminal background check shall be forwarded to the Board. If the applicant has a criminal background history on file at the Board's office, which is dated within twelve months of the date of application, the applicant need not resubmit fee/fingerprints for a criminal background check. Applications for Internship will be furnished by the Board and a cer­tificate of registration will be issued to the qualified applicant.  A license issued to an Intern shall expire one year from the date of its issuance.  However, the license may be renewed on or before the date of expiration or the date of expiration of any renewal for a period of one year.  An intern license may not be renewed beyond 24 months from the date of graduation from a school or college of pharmacy where the initial degree in pharmacy was obtained, unless a waiver is obtained from the board. The fee for renewal of Intern license shall be $15.00.  The place of employment and the name of the registered phar­macist serving as the preceptor of the Intern shall be supplied to the Board.

 

            (c)                   Internship credit hours shall not be approved by the Board unless all requirements of this Chapter are adhered to by an Intern.

 

            Section 3.        Internship Training Requirements.

 

            (a)   The practical experience requirement for licensure as a pharmacist in Wyoming by examination or score transfer shall be met by the successful completion of a clinical clerkship program during a student's fourth professional year at an approved school or college of pharmacy; provided the clinical clerkship consists of a minimum of 1200 hours of practical experience.

            (b)   The board shall annually review and approve the clinical clerkship program offered by the University of Wyoming, School of Pharmacy. 

 

(c)    Experience obtained in another state shall be accepted provided that the regulatory agency in the state where the experience is obtained provides satisfactory proof of such experience or the approved college or school of pharmacy provides satisfactory proof of successful completion of a clinical clerkship program during the student's fourth professional year and provides the total hours of practical experience gained.

 

 (d)      The Board may approve up to 500 hours of practical experience for periods of non-traditional internships.  Non­traditional internship is any period of experience other than experience gained in a traditional retail or hospital pharmacy setting.  Interns participating in non-traditional internships under this subsection:

 

(i)        May request prior review of the experience by the Board;

 

(ii)       Shall be supervised by a licensed pharmacist if no preceptor is

available; and

 

(iii)      Shall adhere to all requirements of this Chapter, including but not

limited to, proper reporting to the Board on approved forms.

 

Section 4.        Intern Training.

 

(a)       Interns shall, under the direct supervision of the preceptor:

 

(i)        Fill prescriptions, including I.V. orders, and comment on any

unusual prescription.  The Intern shall evaluate prescriptions as to drug, dose and therapeutic effect.  This evaluation may be submitted in written form or discussed orally with the preceptor.

 

                        (ii)       Be instructed in the proper handling of controlled substances and all other drugs requiring special attention, including over-the-counter products.

 

(iii)      Gain familiarity with brand names, generic names and dosage

forms.

 

(iv)      Become familiar with the proper handling of poisons, insecticides

and veterinarian products if pertinent to the practice setting.

 

(v)       Be supervised in the appropriate counseling of patients regarding

self-administration of drugs.

 

(vi)      Be directed by their preceptor if in a hospi­tal or non-traditional

pharmacy setting.

 

                        (vii)     Make the offer to counsel and provide counseling to patients regarding prescription drugs and over the counter drug products.

 

                        (viii)    Accept verbal medication orders from a prescribing practitioner.

 

                        (ix)      Transfer prescriptions as provided in Chapter 2, Section 10 of the Board's rules.

                        (x)       Conduct prospective and retrospective drug utilization reviews, including the identification of problems and steps required to resolve the problem identified.

 

                        (xi)      Become familiar with drug therapy management including communicating with health care providers and patients regarding drug therapy management.

 

                        (xii)     Become familiar with pharmacy record-keeping requirements

 

Section 5.        Preceptor Rules.

 

            (a)       Any pharmacist serving as a preceptor for pharmacy interns in Wyoming shall register with the Board.  The initial registration fee and renewal fee shall be ten dollars ($10.00).  Preceptor registrations shall expire every two years from the date issued.  Renewal notices will be mailed by the Board the month preceding the date of expiration.

 

(b)       Upon application to the Board and payment of fee, a certificate shall be issued identifying the preceptor pharmacist and pharmacy.

 

(c)       A preceptor pharmacist shall be licensed in this State and active in the profession for a minimum of two years. 

 

(d)       The preceptor shall instruct the Intern in the necessity of the strict observance of the Code of Ethics of the pharmacy profession; shall assist the Intern in the per­formance of professional services so as to enhance the pro­fessional ability of the Intern; and shall train the Intern to become oriented in every phase of pharmacy practice, including those topics identified in Section 4 of this Chapter.

 

(e)       A preceptor pharmacist shall not supervise more than two (2) pharmacy interns at any one time.

 

(f)        The preceptor shall submit to the Board at the end of each period of employment - an "Intern Evaluation Report" and affidavit as provided by the Board for the following:

 

            (i)        Applicants for licensure by exam or score transfer who will not have 1200 hours of practical experience after completion of a clinical clerkship during the student's fourth professional year at an approved college or school of pharmacy.

 

            (ii)       Applicants for licensure by reciprocity who do not have the required practical experience as specified in Chapter 2, Section 6. Wyoming Pharmacy Act, Rules and Regulations.

 

            (iii)      Applicants for reinstatement of a pharmacist license who must complete a required amount of practical experience.

 

            (iv)      Foreign pharmacy graduates who must complete 1200 hours of practical experience for licensure.

 


CHAPTER 4

 

CODE OF ETHICS

 

Section 1.        Authority.       These regulations are promulgated as authorized by the Act.

 

Section 2.        Code of Ethics.

 

(a)       A pharmacist shall hold the health and safety of patients to be of first

consideration and shall render to each patient the full measure of ability as an essential health practitioner.

 

(b)       A pharmacist shall not condone the dispensing, promoting or distributing of

drugs or medical devices which are not of good quality, do not meet standards required by law or which lack therapeutic value for the patient.

 

(c)       A pharmacist shall strive to perfect and enlarge professional knowledge and

shall utilize and make available that knowledge as required in accordance with professional judgement.

 

(d)       A pharmacist has the duty to observe the law, uphold the dignity and honor

of the profession and to accept its ethical principles.

 

(e)       It shall be considered unprofessional conduct for a pharmacist  to  deliver a prescription drug without having a valid drug order as  described in Chapter 2, section 19, of the Board’s Rules from a practitioner authorized by law to prescribe.

 

(f)        Pharmacists shall not agree to participate in tran­sactions with health

professionals or any other person under which fees are divided or which may cause financial or other exploitation in connection with the rendering of profess­ional services.

 

(g)       A pharmacist shall respect the confidential and personal nature of patient

records and shall not disclose the information without proper patient authorization except when required by law.  However, when the best interest of the patient requires it or in an emergency medical situation, the patient's records may be released to another pharmacist or other medical personnel involved in treating the patient.

 

(h)       A pharmacist shall not agree to practice under terms or conditions which may

interfere with or impair the proper exercise of professional judgement or skill.

 

(i)        A pharmacist shall provide information to patients regarding professional

services truthfully, accurately and fully and shall avoid misleading patients regarding the nature, cost or value of the pharmacist's professional services.

 

(j)        A pharmacist shall not provide untruthful infor­mation to the patient or

insurance company regarding cost of medication to the patient.

 

(k)       A pharmacist shall not provide practitioners with pre-printed prescription

blanks bearing the pharmacy or pharmacist name or address.

 

(l)        A pharmacist shall not advertise in an untruthful or misleading manner,

including any form of "bait and switch".

 

            (m)      A pharmacist shall not work in an unlicensed pharmacy.

 

            (n)       Any behavior by a pharmacist toward a patient, another licensee, or an employee of a pharmacy that exploits the position of trust, knowledge, emotions or influence of the licensee or any behavior by a pharmacist which involves offers to exchange pharmacy services for some form of sexual gratification shall be considered unprofessional conduct.


CHAPTER 6

 

ISSUING, FILING AND FILLING OF PRESCRIPTIONS

 

Section 1.        Scope of Chapter 6.

 

Rules governing the issuance, filling, and filing of prescriptions pursuant to Section 30 of the Act (Section 308 of the Federal Act).

 

Section 2.        Persons Entitled to Issue Prescriptions.

 

A prescription for a controlled substance may be issued only by a practitioner who is either registered or exempted from registration under the Act.

 

            Section 3.        Purpose of Issue of Prescription.

 

(a)       A prescription for a controlled substance to be effective must be issued for a

legitimate medical purpose by a practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription within the meaning and intent of Section 30 of the Act (Section 308 of the Federal Act) and the person knowingly filling such a purported prescription, as well, as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

 

(b)       A prescription may not be issued in order for an individual practitioner to

obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

 

(c)       A prescription may not be issued for the dispensing of narcotic drugs listed in

any schedule to a narcotic drug dependent person for the purpose of continuing his dependence upon such drugs, in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program.

 

Section 4.        Manner of Issuance of Written, Typed or Computer Generated Prescriptions.

 

 (a)      Effective January 1, 2007, all controlled substance prescriptions written by a Wyoming practitioner shall be issued on security paper.  Any controlled substance prescriptions written by a Wyoming practitioner issued on non-security paper may not be dispensed by a pharmacist if signed after January 1, 2007.

 

            (b)       Any written, typed or computer generated prescription issued by a Wyoming practitioner for a schedule II-V controlled substance except those issued as a medication order for administration in a long-term care facility or institutional facility shall meet the following requirements:

 

                        (i)        Shall be printed on security paper, which includes the following features:

 

                                    (A)      If scanned or copied, "void" is displayed prominently throughout the front side of the document;

 

                                    (B)       Erasure protection on green or blue background is utilized on the front side;

 

                                    (C)       Clear instructions printed on the paper indicating the front and back sides; and

 

                                    (D)      Security warning list on the blank.

 

                        (ii)       All suppliers of security paper must be approved by the Board.  Approval will be based on the suppliers' product meeting the requirements of Chapter 6, Section 4 (a) (i).  The Board shall make available a listing of all approved suppliers, which is updated at least annually.

 

                        (iii)      All Board approved suppliers of security paper shall provide the Board written assurance that they will distribute prescription pads or paper only to practitioners duly authorized to prescribe controlled substances in Wyoming.

 

                        (iv)      All controlled substance prescriptions written by a Wyoming practitioner shall be manually signed in the same manner as the practitioner would sign a check or legal document.  The use of electronic or digital signatures or signature stamps are not allowed.

 

                        (v)       Prescriptions may be prepared for dating and signature of the practitioner by an authorized agent of the practitioner and the use of preprinted prescriptions is allowed.  Under no circumstance may stickers be utilized for information relating to drug, strength, quantity, or directions.

 

                        (vi)      Prescriptions shall be dated as of, and signed on, the day when issued and shall bear the full name, address, telephone number and DEA registration number of the issuing practitioner.  No post dating of controlled substance prescriptions are allowed.

 

                        (vii)     Prescriptions shall be written in ink, typed or electronically generated.

 

                        (viii)    The prescribing practitioner and dispensing pharmacist share the responsibility to assure compliance with this section.

 

            (c)       A refill request for a schedule III-V controlled substance generated and faxed by the pharmacy to a practitioner for refill authorization need not be printed on security paper.

 

            (d)       A schedule III-V controlled substance prescription faxed by the practitioner to the pharmacy need not be printed on security paper.

 

(e)             An intern, resident, or foreign physician exempted from registration under Chapter 3 Section 24 shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in Chapter 3 Section 24, in lieu of the registration number of the practitioner required by this section. Each prescription shall have the name of the intern, resident, or foreign physician stamped or printed on it, as well as the signature of the physician.

 

(f)        An official exempted from registration under Chapter 3 Section  25 shall include on all prescriptions issued by him, his branch of service or agency (e.g., "U. S. Army" or "Public Health Service") and his service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his Social Security identification number. Each prescription shall have the name of the officer stamped or printed on it, as well as the signature of the officer.

 

Section 5.        Persons Entitled to Fill Prescriptions.

 

A prescription for controlled substances may only be filled by a pharmacist or intern under direct supervision, acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy or by a registered practitioner.

 

Section 6.        Dispensing of Narcotic Drugs for Maintenance Purposes.

 

The administering or dispensing directly (but not prescribing) of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his dependence upon such drugs in the course of conducting a federally authorized clinical investigation in the development of a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term "in the course of his professional practice or research" in Section 2(a)(xx) of the Act (Section 101(t) of the Federal Act]

 

Sections 7 through 10 reserved for future use.

 

Section 11.      Requirement of Prescription for Schedule II Substances.

 

(a)       A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the prescribing individual practitioner, except as provided in paragraph (c) and (e) of this section.

 

(b)       A practitioner may administer or dispense directly a controlled substance listed in Schedule II in the course of his professional practice without a prescription, subject to Section 6.

 

(c)       In the case of an emergency situation, as defined by paragraph (g) of this section, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing practitioner, provided that:

 

            (i)        The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing practitioner;

 

(ii)       The prescription shall be immediately reduced to writing by the

pharmacist and shall contain all information required in Chapter 6, Section 4, except for the

signature of the prescribing practitioner;

 

(iii)      If the prescribing practitioner is not known to the pharmacist, he must

make a reasonable effort to determine that the oral authorization came from a registered practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to ensure his identity; and

 

(iv)      Within 7 days  after authorizing an emergency oral prescription, the

prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of Section 4, the prescription shall have written on its face "Authorization for Emergency Dispensing", and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the 7 day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the Board if the prescribing individual fails to deliver a written prescription to him, failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing practitioner.

 

            (d)       A prescription for a schedule II controlled substance shall be valid up to six months from the date issued by the practitioner.

           

            (e)       A pharmacist shall cancel all schedule II controlled substance prescriptions when dispensed by dating and signing the face of the prescription.

 

            (f)        Information that can be changed on a schedule II prescription shall meet the following requirements:

 

                        (i)        After consultation/approval of the prescribing practitioner, the pharmacist is permitted to change the following:

 

                                    (A)      Drug strength

 

                                    (B)       Drug quantity

 

                                    (C)       Directions for use

 

                                    (D)      Dosage form

 

                        (ii)       The pharmacist is permitted to change the patient's address with proper verification without consulting the prescribing practitioner.

 

                        (iii)      Any change made by the pharmacist shall be documented on the face of the hard copy and shall include the date, name of person consulted, and initials of the pharmacist.

 

                        (iv)      A pharmacist is not permitted to change the patient's name, controlled

substance prescribed (except for generic substitution permitted by state law), date issued, or the prescriber's signature.

 

(g)       For the purposes of authorizing an oral prescription of a controlled substance listed in Schedule II of the Controlled Substances Act, the term "emergency situation" means those situations in which the prescribing practitioner determines:

 

(i)        That immediate administration of the controlled substance is necessary,

for proper treatment of the intended ultimate user;

 

(ii)       That no appropriate alternative treatment is available, including

administration of a drug which is not a controlled substance under Schedule II of the Act; and

 

(iii)      That it is not reasonably possible for the prescribing practitioner to

provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing.

 

            (h)       A schedule II controlled substance prescription may be faxed if it meets the criteria as specified in Chapter 2, General Practice of Pharmacy Regulations, Section 20 (c).

 

Section 12.      Refilling Prescriptions - Schedule II. 

 

The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.

 

Section 13.      Partial Filling of Prescriptions - Schedule II. 

 

The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

 

Section 14.      Labeling of Substances - Schedule II.

 

The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law.

 

Section 15.      Filing of Prescriptions - Schedule II.

 

All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of Chapter 4, Section 1 of these regulations.

 

Section 16 through 20 reserved for future use.

 

Section 21.      Requirement of Prescription for Schedule III and IV Substances.

 

(a)       A pharmacist may dispense a controlled substance listed in Schedules III or IV, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to either a written prescription signed by a prescribing practitioner or an oral prescription made by a prescribing practitioner and promptly reduced to writing by the pharmacist containing all information required in Section 4, except for the signature of the prescribing practitioner, or an electronically transmitted prescription provided it meets all requirements in Chapter 2, Section 29 of the Board's Rules and federal law, or a FAXed prescription provided it meets all requirements in Chapter 2, Section 20 of the Board's Rules.

 

(b)       A practitioner may administer or dispense a controlled substance listed in Schedules III or IV in the course of his professional practice without a prescription.

 

(c)       A practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedules III or IV pursuant to a written prescription signed by a prescribing practitioner, or pursuant to an oral prescription made by a prescribing practitioner and promptly reduced to writing by the pharmacist (containing all information required in Chapter 6, Section 4 except for the signature of the prescribing practitioner, or pursuant to an order for medication made by a practitioner which is dispensed for immediate administration to the ultimate user, subject to Section 6).

 

Section 22.      Refilling of Prescriptions - Schedules III and IV.

 

No prescription for a controlled substance listed in Schedules III or IV shall be filled or refilled more than six (6) months after the date on which such prescription was issued.  No such prescription authorized to be refilled may be refilled more than five (5) times. Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate uniformly maintained readily retrievable record, such as medication records, which indicate the date, quantity, and name of dispensing pharmacist for each prescription initialed, and dated by the pharmacist as of the date of dispensing, and shall state the amount dispensed. If the pharmacist merely initials and dates the back of the prescription, he shall be deemed to have dispensed a refill for the full face amount of the prescription. Additional quantities of controlled substances listed in Schedules III or IV may only be authorized by a prescribing practitioner through issuance of a new prescription as provided in Section 21 which shall be a new and separate prescription.

 

Section 23.      Partial Filling of Prescriptions - Schedules III and IV.

 

The partial filling of a prescription for a controlled substance listed in Schedules III, IV, or V is permissible, provided that:

 

(a)       Each partial filling is recorded in the same manner as a refilling;

 

            (b)       The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

 

(c)       No dispensing occurs after six (6) months after the date on which the prescription was issued.

 

Section 24.      Labeling of Substances - Schedule III and IV.

 

The pharmacist filling a prescription for a controlled substance listed in Schedules III or IV shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use, and cautionary statements, if any, contained in such prescription as required by law.

 

 

Section 25.      Filing Prescriptions - Schedules III and IV. 

 

All prescriptions for controlled substances listed in Schedules III and IV shall be kept in accordance with Chapter 4, Section 1 of these regulations.

 

Sections 26 through 30 reserved for future use.

 

            Section 31.      Requirement of Prescription for Schedule V Substances.

 

(a)       A pharmacist may dispense a controlled substance listed in Schedule V pursuant to a prescription as required for controlled substances listed in Schedules III and IV in Section 21. A prescription for a controlled substance listed in Schedule V may be refilled only as expressly authorized by the prescribing practitioner on the prescription; if no authorization is given, the prescription may not be refilled. A pharmacist dispensing such substance pursuant to a prescription shall label the substance in accordance with Section 23 and file the prescription in accordance with Section 24.

 

(b)       A practitioner may administer or dispense a controlled substance listed in Schedule V in the course of his professional practice without a prescription subject to Section 24.

 

Section 32.      Dispensing Without Prescription.

 

A controlled substance listed in Schedule V, and a controlled substance listed in Schedules II, III, or IV which is not a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:

 

(a)       Such dispensing is made only by a pharmacist and not by a non-pharmacist employee even if under the direct supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery may be completed by a non-pharmacist);

 

(b)       Not more than 240 cc. (8 ounces) of any such controlled substance may be distributed at retail to the same purchaser in any given 48-hour period;

 

            (c)       The purchaser is at least eighteen (18) years of age;

 

(d)       The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish suitable identification (including proof of age where appropriate);

 

(e)       A bound record book for dispensing of controlled substances (other than by prescription) is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the record keeping requirements of Chapter 4, Section 1 of these regulations); and

 

(f)        A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State, or local law.


CHAPTER 8

 

PRESCRIPTION DRUG MONITORING PROGRAM

 

            Section 1.        Authority.

 

            These regulations are promulgated as authorized by the Wyoming Controlled Substance Act.

 

            Section 2.        Transmission of Information Regarding Dispensing of Controlled Substances to Certain Persons.

 

            a.         Each resident/nonresident retail pharmacy that uses a computerized system to record information concerning prescriptions and that dispenses a controlled substance that is listed in Schedule II, III or IV to a person who is not an inpatient of a hospital, correctional institution or nursing facility shall transmit to the board or its agent the information set forth in the "ASAP Telecommunications Format for Controlled Substances", May 1997 edition, published by the American Society for Automation in Pharmacy, which is hereby adopted by reference.  The information relating to the following field names shall be transmitted:

 

                        i.          Pharmacy number;

 

                        ii.         Birth date;

 

                        iii.       Sex Code;

 

                        iv.        Date filled;

 

                        v.         Rx number;

 

                        vi.        New/refill code;

 

                        vii.       Metric quantity;

 

                        viii.     Date Rx written;

 

                        ix         Days supply;

 

                        x.         NDC number;

 

                        xi.        Prescriber ID number;

 

                        xii.       Patient last name;

 

                        xiii.     Patient first name;

 

                        xiv.      Patient street address; and

 

                        xv.       Patient zip code.

 

            b.         The resident/nonresident retail pharmacy shall ensure that, not later than the 10th day of the month immediately following the month in which the prescription was dispensed, the information required pursuant to Section 2 (a) of this chapter is transmitted to the board or its agent by one of the following methods:

 

                        i.          Computer modem that can transmit information at the rate of 2400 baud or more;

 

                        ii.         Computer disk;

 

                        iii.       Cassette containing magnetic tape, which is 1/4 of an inch wide and is used to transmit information between computerized systems;

 

                        iv.        Paper printout.

 

            d.         Upon a showing of good cause, the board may, for a period of 90 days, waive the requirements set forth in this section for a pharmacy that cannot transmit the information required pursuant to Section 2 (a) of this chapter before October 1, 2004.  The board may renew the waiver.

 

            Section 3.        Solicited Patient Profiles.

 

            a.         Occupational licensing boards may request licensee profiles from the board provided the following are met:

 

                        i.          All requests must be on a form provided by the board and include the name and license number of the licensee;

 

                        ii.         The purpose of the request, the date range requested, and the specific reasons for this request;

 

                        iii.       The signature of the authorized agent and mailing address for the occupational licensing board;

 

                        iv.        The request shall be mailed or faxed to the board's office; and

 

                        v.         No licensee profile will be generated by the board until the request is received, and no licensee profile will be sent to an occupational licensing board unless those requirements identified in W.S. §35-7-1060 (c)(ii) have been met.  All profiles generated by the board will be mailed to the occupational licensing board, and marked "confidential, to be opened by addressee only".

 

            b.         Pharmacists and practitioners are under no obligation to, but may request patient profiles from the board provided the following conditions are met:

 

                        i.          All requests must be submitted on a form provided by the board and must be mailed or faxed to the board's office;

 

                        ii.         All requests must be signed by the pharmacist or practitioner requesting the information and include the business name/address of the pharmacist or practitioner;

 

                        iii.       All requests shall include the patient's name, date of birth, purpose of the request, and the date range for the profile;

 

                        iv.        A statement indicating a pharmacist/patient or practitioner/patient relationship exists; and

 

                        v.         All profiles generated by the board shall be faxed or mailed to the pharmacist or practitioner at their business address, and if mailed marked "confidential, to be opened by addressee only".

 

            c.         Patients, their authorized agent, or in the case of a minor, the minor's parent or guardian may request a copy of the patient's profile from the board's office provided the following are met:

 

                        i.          All requests shall be made in person at the board's office.  The patient requesting the profile or an authorized agent of the patient or parent's or guardians of minors requesting a profile must have proof of identification acceptable to the board;

 

                        ii.         Any person making a request for a profile shall complete a form provided by the board.  Any profile generated by the board will be available at the board's office, the same day of the request.

 

            Section 4.        Unsolicited Patient Profiles

 

            The board may generate patient profiles based on information showing use of controlled substances, which is in excess of established parameters.  Profiles generated will be mailed to each pharmacy and practitioner where the patient was seen.  A letter of explanation will accompany each profile.

 

            Section 5.        Reports.

 

            a.         The board shall maintain a register for solicited patient profile requests.  The register shall include the following:

 

                        i.          Date received;

 

                        ii.         Name of patient, patient's date of birth or the name of the practitioner and practitioner's DEA registration number;

 

                        iii.       Name, title, business, and address of individual requesting the profile; and

 

                        iv.        Date profile mailed or faxed.

 

            b.         The board shall maintain a register for any unsolicited patient profile generated by the board.  The register shall include the following:

 

                        i.          Date generated;

 

                        ii.         Criteria used for profile generation; and

 

                        iii.       Number of profiles/cover letters mailed.

 

            Section 6.        Statistical Profiles

 

            The board may generate statistical profiles upon request, provided no patient/practitioner/pharmacy specific information is included.  The board shall charge a fee of $25.00 per profile generated for any government agency and $500.00 per profile for all others.

 

 

            Section 7.        Reporting of Non-Controlled Prescription Drugs.

 

            Resident and nonresident retail pharmacies shall ensure that, not later than the 10th day of the month immediately following the month in which the prescription was dispensed, the information required pursuant to Section 2 (a) of this chapter is transmitted to the board or its agent for the following prescription drugs:

 

            (a)       Tramadol, including any combination product where tramadol is an active ingredient.

 

            (b)       Carisprodol, including any combination product where carisprodol is an active ingredient.

 


CHAPTER 16

IMMUNIZATION REGULATIONS

 

            Section 1.        Authority.

            These regulations are promulgated as authorized by W.S. 33-24-157.

 

            Section 2.        Definitions.

 

            (a)       "Healthy Adults" means for the purpose of this chapter those individuals who are nineteen (19) years of age or older and have no absolute contraindications to receive immunizations allowed in this chapter.

 

            (b)       "High Risk Adults" means for the purpose of this chapter those adults nineteen (19) years of age or older who may have an absolute or relative contraindication to receive immunizations as allowed by this chapter for whom a physician has issued a prescription authorizing a pharmacist to dispense and administer an immunization.  Only those pharmacists that meet the qualifications of this chapter may administer an immunization to a high risk adult.

 

(c)             "Immunizations" means for the purpose of this chapter those vaccines which a pharmacist may prescribe or administer to healthy adults or those vaccines which may be administered on a specific order of a physician for high risk adults and shall be restricted to the following vaccines:

 

(i)              Tetanus, diphtheria, pertussis  (Td, Tdap)

 

(ii)            Measles, mumps, rubella (MMR)

 

(iii)          Varicella

 

                        (iv)      Influenza

 

                        (v)       Pneumococcal (Polysaccharide)

 

                        (vi)      Hepatitis A

 

                        (vii)     Hepatitis B

 

                        (viii)    Meningococcal

 

                        (ix)      Human papillomavirus (HPV)

 

            Section 3.        Qualifications.

 

            (a)       A pharmacist licensed by the board may prescribe and administer immunizations to healthy adults or administer immunizations to high risk adults authorized by a physician provided the pharmacist has:

 

                        (i)        Registered with the board to prescribe and administer immunizations;

 

                        (ii)       Successfully completed the American Pharmaceutical Association's (APhA) immunization training certification program entitled "Pharmacy-Based Immunization Delivery" or the Washington State Pharmacy Association's immunization training certification program entitled "Vaccinating Adults and Adolescents:  An Immunization Program Practicum Session" ;

 

                        (iii)      Current certification in basic cardiopulmonary resuscitation (CPR) offered by the American Heart Association or the American Red Cross; and

 

                        (iv)      Completed  a minimum of one (1) contact hour (0.1 CEU) of continuing education related to immunizations annually.  The continuing education must be by a provider approved by the Accreditation Council for Pharmacy Education (A.C.P.E.). 

 

            (b)       It is unprofessional conduct for a pharmacist, to prescribe or administer an immunization, who is not in compliance with this Chapter.

 

            Section 4.        Registration.

 

            (a)       Prior to prescribing or administering immunizations a pharmacist shall submit an application supplied by the board and a $10.00 fee.  Provided all requirements of Section 3(a) have been met, the board shall issue a registration.  Registrations shall expire on December 31 of each year.

 

            (b)       Renewal applications will be mailed by the board annually on or about November 1st. 

 

            (c)       A pharmacist may not prescribe or administer an immunization unless currently registered with the board under this Chapter.

 

            Section 5.        Immunizations.

 

            (a)       Immunizations authorized by this Chapter shall be prescribed in accordance with the latest notice from the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC).  Specifically, CDC's "Recommended Adult Immunization Schedule, by Vaccine and Age Group" and "Recommended Adult Immunization Schedule, by Vaccine and Medical and Other Indications", including the footnotes provided for each schedule, shall be utilized by the pharmacist when considering the eligibility of a healthy adult to receive an immunization. The latest notice from CDC may be found at CDC’s website (http://www.cdc.gov) or (http://www.cdc.gov/nip/recs/adult-schedule-bw.pdf)

 

            (b)       In addition to the requirements of Section 5(a) of this chapter, the pharmacist shall utilize the manufacturer’s package insert for indications, contraindications, adverse reactions, adult dosing, route of administration, specifics regarding administration, and storage requirements for each specific immunization authorized by this chapter.

 

            Section 6.        Vaccine Information Statement.

 

            A current Vaccine Information Statement, as provided by CDC, shall be provided to each person receiving an immunization for each immunization administered.  The Vaccine Information Statement is available from CDC’s website  (http://www.cdc.gov) or (http://www.cdc.gov/nip/publications/VIS/default.htm)  

 

            Section 7.        Record-keeping.

 

            (a)       An Immunization Questionnaire and Consent Form, as provided by the board, shall be completed for each person receiving an immunization.  Two (2) copies shall be provided to the patient.

 

            (b)       The Immunization Questionnaire and Consent Form shall be filed in a manner that will allow timely retrieval.  All records shall be maintained in the pharmacy where the pharmacist who administered the immunization is employed.

 

            (c)       The Immunization Questionnaire and Consent Form shall be kept on file for a time period not less than six (6) years from the date of the immunization.

 

            Section 8.        Emergencies.

 

            (a)       A pharmacist authorized to prescribe and administer immunizations under this chapter may administer auto-inject epinephrine in the management of an acute allergic reaction to an immunization following guidelines issued by the American Pharmacy Association's (APhA) or Washington State Pharmacy Association's immunization training certification program.

 

            (b)       A pharmacist shall post a protocol as outlined in APhA’s or Washington State Pharmacy Association's immunization training certification program and maintain an emergency kit which is readily retrievable to manage an acute allergic reaction to an immunization administered.


ATTACHMENT “A”

 

Wyoming Pharmacy Act, Rules and Regulations

Chapter 2 , General Practice of Pharmacy

 Proposed Revisions

 

Section 4.              Definitions.

 

               (pp)         "Foreign Pharmacy Graduate" means a pharmacist whose undergraduate pharmacy degree was conferred by a recognized school of pharmacy outside of the 50 United States, the District of Columbia, and Puerto Rico. United States citizens who have completed their pharmacy education outside the United States are "foreign pharmacy graduates".  Foreign nationals who have graduated from schools in the United States are not foreign pharmacy graduates.

 

 

Section 5.              Pharmacist Licensure by Examination.

 

(a)           The Board shall utilize those standardized examinations as prepared and administered by the National Association of Boards of Pharmacy.  These standardized examinations shall include the following;

 

                              (i)            North American Pharmacist Licensing Examination (NAPLEX®)

 

                              (ii)           Multistate Pharmacy Jurisprudence Examination (MPJE™)

 

 (b)          Applicants for licensure by examination will be licensed, provided they meet the following requirements.

 

               (i)            A properly completed “Pharmacist Licensure by Examination” application as provided by the Board with the proper fee and fee/fingerprints for a criminal background check has been submitted to the Board’s office.  However, any applicant who has on file at the board's office a criminal background history dated within twelve (12) months of their date of application need not resubmit fee/fingerprints;

 

               (ii)           Pass the NAPLEX® with a minimum score of 75;

 

                              (A)          Candidates who do not receive a passing grade on the NAPLEX® shall be allowed two (2) retakes for a total of three (3) examinations.

 

                              (B)          All retakes require payment of fees as required by the National Association of Boards of Pharmacy.

 

               (iii)          Pass the MPJE® for Wyoming with a minimum score of 75;

 

                              (A)          Candidates who do not receive a passing grade on the MPJE™ may retake the examination. 

 

(B)          All retakes require payment of fees as required by the National

Association of Boards of Pharmacy.

 

               (iv)          Meet the required practical experience requirement of 2,000 1,200 internship hours as specified in Chapter 3 of the Board’s Rules;

 

               (v)           Complete all requirements within two (2) years of the date of application  to the Board’s office; and,

 

               (vi)          Meet requirements of W.S. §33-24-116.

 

(c)           Applicants who have applied for score transfer of their NAPLEX® exam to Wyoming will be licensed by examination, provided they meet the following requirements.

 

               (i)            The  NAPLEX® score transferred is 75 or more;

 

(ii)           A properly completed  “Pharmacist Licensure by Examination”

application  as provided by the Board with the proper fee, has been submitted to the Board’s office;

 

(iii)          Pass the Multi State Pharmacy Jurisprudence Exam (MPJE™)

for Wyoming with a minimum score of 75;

 

                              (A)          Candidates who do not receive a passing grade on the MPJE™ may retake the examination. 

 

(B)          All retakes require payment of fees as required by the National

Association of Boards of Pharmacy.

 

 (iv)         Meet the required practical experience requirement of 2,000  1200

internship hours as  specified in Chapter 3  of the Board’s Rules;

 

 (v)          Complete all requirements within one (1) year of the date of the

NAPLEX® exam, which was utilized for the score which was transferred to Wyoming; and

 

               (vi)          Meet requirements of W.S. §33-24-116.

 

(d)          No candidate will be licensed until the required practical experience as specified in Chapter 3, Section 3(a) of the Board's Rules has been met.

 

(e)           Candidates failing to meet all requirements within the time period allowed in Chapter 2, Section 5(b)(v) and Chapter 2, Section 5(c)(v) must file a new application, including payment of all fees or  if applicable seek licensure by license transfer as outlined in Chapter 2, Section 6.

 

(f)           The Board reserves the right to require an interview with any applicant seeking licensure by examination to practice pharmacy in Wyoming.

 

(g)           The Board shall charge fees to cover administrative costs, which shall include wall certificate, renewal certificate for current license year, and those costs associated in reviewing test questions for the jurisprudence exam (MPJE™).

 

(h)           Foreign pharmacy graduates, holding a FPGEC Certificate issued by the Foreign Pharmacy Graduate Examination Committee, .may apply for licensure as a pharmacist under this section..  To be eligible for FPGEC certification, applicants must satisfy the following requirements established by the Foreign Pharmacy Graduate Examination Committee:

 

               (i)            Verification of educational equivalency of an applicant's foreign pharmacy education and the applicants licensure or registration as a pharmacist outside the US;

 

               (ii)           Passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE); and

 

               (iii)          Obtaining a total score of 550 or higher on the paper-based Test of English as a Foreign Language (TOEFL) or 213 or higher on the computer-based TOEFL and 50 or higher on the Test of Spoken English (TSE); or

 

               (iv)          In lieu of the TOEFL and TSE , obtaining an acceptable score for the Test of English as a Foreign Language Internet-based Test (TOEFL iBT), with minimal scores of 18 for listening, 21 for reading, 26 for speaking, and 24 for writing;

 

Section 6.              Pharmacist Licensure by Reciprocal License Transfer.

Any pharmacist who is licensed by examination and is in good standing in any state which is a member of the National Association of Boards of Pharmacy (NABP) and who desires to be licensed by reciprocity into the State, shall proceed in the manner outlined by the NABP after first submitting the “Preliminary Application for Transfer of Pharmaceutic Licensure” obtained from any state or the NABP.

 

(a)           The Board in its discretion may recognize the qualifications of the applicant as determined by NABP.  Persons who have become registered as pharmacists by exami­nations in other states may be required to satisfy only the requirements which existed in this State at the time they became registered in the other state, provided that the state in which said persons is registered shall under like conditions grant reciprocal registration as pharmacist, without examination, to pharmacists duly registered by exa­mination in this State.  The Board reserves the right to reject any applicant pursuant to the Act.

 

(ba)         In the event of rejecting an application, the fee paid to the Board will not be refunded. 

 

(cb)         All candidates for license transfer shall be required to:

 

                              (i)            File all appropriate applications with the board;

 

(ii)           Pay the required fee;

 

(iii)          Pass the Multi-State Pharmacy Jurisprudence Exam (MPJE™);

 

(iv)          Prove good moral character;

 

(v)           Prove they have been in active pharmacy practice as defined in Chapter

2, Section 4(oo), for the year preceding the date of their application for license transfer.  Applicants failing to show proof must complete an internship in Wyoming approved by the Board of no less than 400 hours.  An applicant will be considered as successfully completing the internship if the overall score given by the preceptor, utilizing the Wyoming State Board of Pharmacy's "Intern Evaluation Report" is no less than a "C"; and

 

(vi)          Meet all requirements under the Act and the Board's Rules; and

 

(vii)         If applying as a foreign pharmacy graduate, possess a FPGEC Certificate.

 

               (dc)         The Board shall not issue a pharmacist license by license transfer until all conditions under Chapter 2, Section 6 (cb) have been met.

 

(ed)         All applications for transfer of licensure (reciprocity) shall expire one (1) year from date of issue by NABP if not filed with the Board and licensure completed.

 

(fe)         The Board reserves the right to require an interview with any applicant seeking licensure by license transfer to practice pharmacy in Wyoming.

 

Section 11.            Labeling Prescription Drug Containers.

(a)           All original or refill prescription drug containers utilized in a traditional dispensing system shall be labeled as follows: name of the patient, brand or generic name of the drug product dispensed unless otherwise specified; drug strength and quantity; the name, address and phone number of the pharmacy; the practitioner’s name; the serialized number of the prescription; the date the prescription was filled or refilled; directions for use, including accessory cautionary information as required for patient safety;  the identifying initials  of the dispensing pharmacist and any other information required by federal or state law.

 

(b)           Effective January 1, 2004 all original or refill prescription drug containers utilized in a traditional dispensing system shall be labeled with its physical description, including any identification code that may appear on the tablets and capsules.  A waiver will be granted for new drugs for the first 120 days on the market and 90 days on drugs for which the national reference file has no description on file.

 

            (c)           All unit dose or unit of issue packaging shall be labeled as follows:

                              (i)            Brand name and/or generic name of the prescription drug;

 

                              (ii)           Strength;

 

                              (iii)          Manufacturers lot number; and

 

                              (iv)          Manufacturers expiration date, if prepackaged or repackaged by the pharmacy, the expiration date shall be the lessor of the manufacturers expiration date or twelve (12) months from the date of prepackaging or repackaging.

 

                              (v)           All unit of issue packaging dispensed shall include the following information on the label in addition to that required by Chapter 2, Section 11 (c) (i) through (iv) of the Board's rules:

 

                                             (A)          Name, address, and phone number of pharmacy;            

                             

                                             (B)          Prescription number;

 

                                             (C)          Name of the patient;

 

                                             (D)          Name of the practitioner;

                                            

                                             (E)          Directions for use;

 

                                             (F)          Date dispensed;

 

                                             (G)          Initials of dispensing pharmacist; and

 

                                             (H)          Accessory cautionary labels for patient safety.

                                            

                                             (I)           Quantity of medication

 

                              (vi)          All unit of issue packaging dispensed by a retail pharmacy to residents of  long term care facilities, as defined in Chapter 15 ,Wyoming Pharmacy Act, Rules and Regulations as well as prescriptions drugs dispensed from hospital emergency room departments as described in Chapter 12, Section 13, Wyoming Pharmacy Act, Rules and Regulations shall be labeled with the product’s physical description, including any identification code that may appear on the tablets and capsules

 

 

               Section 33.            Centralized Prescription Processing.

 

               (a)           The purpose of this section is to provide standards for centralized prescription processing.

 

               (b)           “Centralized Prescription Processing” as used in this section means the processing by a pharmacy of a request from another pharmacy to refill a prescription drug order or to perform functions such as, DUR, claims adjudication, refill authorizations, and therapeutic interventions.

 

               (c)           "Dispensing Pharmacy" as used in this section means a pharmacy that may out source the processing of a prescription drug order to another pharmacy licensed by the board.

 

               (d)          "Central Fill Pharmacy" as used in this section means a pharmacy that processes a prescription drug order that was outsourced by a dispensing pharmacy licensed by the board.

 

               (e)           "Real-time" as used in this section means the transmission of information through data links is so rapid that the information is available to the dispensing pharmacy and requesting pharmacy sites simultaneously.

 

 

               (f)           Minimum Requirements:

 

                              (i)            A dispensing pharmacy may outsource prescription drug order processing to another pharmacy licensed by the board. provided the pharmacies:

 

                                             (A)          have the same owner; or

 

                                             (B)          have entered into a written agreement, which complies with federal and state laws and regulations, specifying the services to be provided and the responsibilities and accountabilities of each pharmacy;

 

(E)              share a real-time database; and

 

(F)              maintain the original prescription at the dispensing pharmacy for a time period not less than two (2) years from the date last filled or refilled.

 

 

                              (ii)           The pharmacist-in-charge of the central fill pharmacy shall ensure that:

 

                                             (A)          the pharmacy maintains and uses storage or shipment containers and shipping processes which ensure drug stability and potency.  Shipping processes shall include the use of appropriate packaging material; and/or devices which ensure the drug is maintained at a temperature range which will maintain the integrity of the medication throughout the delivery process; and

 

                                             (B)          the dispensed prescriptions are shipped in containers  sealed in such a manner as to show evidence of opening or tampering.

 

                              (iii)          A resident dispensing or central fill pharmacy shall comply with the provisions of W.S. § 33-24-113 and this section.

 

                              (iv)          A non resident dispensing or central fill pharmacy shall comply with the provisions of W.S. § 33-24-152 and this section.

 

                              (v)           A dispensing or central fill pharmacy dispensing compounded non-sterile or sterile pharmaceuticals shall comply with the provisions of Chapter 13, Wyoming Pharmacy Act, Rules and Regulations.

 

               (g)           Notifications to patients.

 

                              (i)            A pharmacy that out-sources prescription processing to another pharmacy shall:

 

                                             (A)          Notify patients that their prescription may be outsourced to another pharmacy prior to outsourcing the prescription via posted signage, written notification or refill phone message.

 

                                             (B)          If the prescription is delivered to the patient directly by the central fill pharmacy, the pharmacist employed by the central fill pharmacy shall ensure that the patient receives written notice of available counseling.  Such notice shall include days and hours of availability, location of pharmacy, and a toll-free number the patient may utilize to contact a pharmacist for counseling or to answer questions.  Such notice shall be included in each prescription delivery to the patient.

 

 

               (h)           Prescription Labeling.

 

                              (i)            The prescription label shall clearly indicate which pharmacy filled the prescription  and which pharmacy dispensed the prescription ; and

 

                              (ii)           The prescription label shall comply with Section 11 of this chapter.

 

               (i)            Policies and Procedures.  A policy and procedure manual relating to centralized processing shall be maintained at both pharmacies and be available for inspection.  Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations.  The manual shall:

 

                              (i)            outline the responsibilities of each of the pharmacies;

 

                              (ii)           include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription processing; and                       

 

                              (iii)          include policies and procedures for:

 

                                             (A)          notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription processing and providing the name of that pharmacy;

 

                                             (B)          protecting the confidentiality and integrity of patient information;

 

                                             (C)          dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received;

 

                                             (D)          complying with federal and state laws and regulations;

 

                                             (E)          operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems;

 

                                             (F)          identifying the pharmacist responsible for each aspect of prescription preparation including, but not limited to, the drug regimen review, the initial electronic entry, any changes or modifications to the prescription record or patient profile, and the final check of the completed prescription;

 

                                             (G)          identifying the pharmacist responsible for making the offer to counsel to the patient as required by Chapter 9, Wyoming Pharmacy Act, Rules and Regulations; and

 

                                             (H)          documentation of annual review of the written policies and procedures.

                                                                                         

               (j)            Records.

 

                              (i)            Records shall be maintained in a real-time electronic database.

 

                              (ii)           Each pharmacy shall comply with all the laws and rules relating to the maintenance of records and be able to produce an audit trail showing all prescriptions dispensed by the pharmacy and each pharmacist's or technician's involvement in dispensing.

 

                              (iii)          The dispensing pharmacy shall maintain records which indicate:

 

                                             (A)          The date and time the request for processing was transmitted to the central fill pharmacy; and

 

                                             (B)          The date and time the dispensed prescription was received from the central fill pharmacy by the dispensing pharmacy, including the method of delivery (e.g., private, common, or contract carrier) and the name of the person accepting delivery.

 

                              (iv)          The central fill pharmacy shall maintain records which indicate:

 

                                             (A)          The date the prescription was shipped to the dispensing pharmacy.

 

               Section 34.            Automated Storage and Distribution Systems.

 

               (a)           Before using an automated storage and distribution system, a pharmacy licensee or pharmacist in charge shall:

 

                              (i)            Ensure that the automated storage and distribution system and the policies and procedures comply with subsection (b); and

 

                              (ii)           Notify the board in writing of the intent to use an automated storage and distribution system, including the type or name of the system.

 

               (b)           A pharmacy licensee or pharmacist in charge shall establish policies and procedures for appropriate performance and use of the automated storage and distribution  system that:

 

                              (i)            Ensure that the automated storage and distribution system is in good working order while maintaining appropriate recordkeeping and security safeguards.  This is to include the ability to store at the required temperature.

 

                              (ii)           Ensure that an automated storage and distribution system used by a pharmacy that allows access to drugs or devices by a patient:

 

                                             (A)          Only allows patient access to prescriptions that;

 

                                                            (I)           Do not require an offer to counsel by a pharmacist as specified in W.S. §33-24-136(c);

 

                                                            (II)          Are properly labeled and verified by a pharmacist before placement into the automated storage and distribution system and subsequent release to patients; and

 

                                                            (III)        Are not a schedule II controlled substance under the Wyoming Controlled Substance Act.

 

                                             (B)          Allows a patient to choose whether or not to use the system;

 

                                             (C)          Is located inside of  a building in a wall of a licensed pharmacy where the pharmacy staff has access to the device from within the pharmacy and patients have access from outside of the pharmacy and is attached to the wall in such a manner that prevents unauthorized removal;

 

                                             (D)          Provides a method to identify the patient and only release the identified patient’s prescriptions;

 

                                             (E)          Is secure from access and removal of drugs or devices by unauthorized individuals;

 

                                             (F)          Provides a method for a patient to obtain  consultation with a pharmacist, if requested by the patient; and

 

                                             (G)          Prevents dispensing of  refilled prescriptions if a pharmacist determines that the patient requires counseling.

 

                              (iii)          Ensure that an automated storage and distribution system used by a pharmacy that allows access to drugs or devices for the purposes of administration only by authorized licensed personnel based on a valid prescription order or medication order:

 

                                             (A)          Provides for adequate security to prevent unauthorized individuals from accessing or obtaining drugs or devices; and

 

                                             (B)          Insures the filling, stocking, or restocking of all drugs or devices in the system may be done only by a pharmacist, pharmacy intern or pharmacy technician.

 

                              (iv)          Implement an ongoing quality assurance program that monitors compliance with the established policies and procedures of the automated storage and distribution system and federal and state law.

 

               (c)           A pharmacy licensee or pharmacist in charge shall:

 

                              (i)            Ensure that policies and procedures for the performance and use of an automated storage and distribution system are prepared, implemented, and complied with;

 

                              (ii)           Review and document annually and, if necessary, revise the policies and procedures required under this section;

 

                              (iii)          Make the policies and procedures available for employee reference and inspection by the board within the pharmacy and at any location outside the pharmacy where the automated storage and distribution system is used.

 

               (d)          The board may prohibit a pharmacy licensee or pharmacist in charge from using  an automated storage and distribution system if the pharmacy licensee or the pharmacy licensee’s employees do not comply with the requirements of this section.

 

 

Wyoming Pharmacy Act, Rules and Regulations

Chapter 3, Pharmacy Internship Regulations

 Proposed Revisions

 

Section 1.              Authority.            

 

These regulations are promulgated as authorized by The Act.

 

Section 2.              Interns in Pharmacy.

 

(a)           "Intern" means any person who has begun class-work in their first professional year in an approved college or school of pharmacy, who is in good standing; or a graduate of an approved  college or school of pharmacy seeking licensure by exam or score transfer who lacks the required amount of practical experience for licensure; or those applicants for reciprocity who have not been in active practice and must complete an internship; or those applicants for reinstatement of a lapsed license that must complete a required amount of practical experience; or those applicants for licensure who are considered foreign pharmacy graduates and possess a FPGEC Certificate who must complete 1200 hours of practical experience for licensure .     

 

Section 5.              Preceptor Rules.  

 

               (f)           The preceptor shall submit to the Board at the end of each period of employment - an "Intern Evaluation Report" and affidavit as provided by the Board for the following:

 

                              (i)            Applicants for licensure by exam or score transfer who will not have 1200 hours of practical experience after completion of a clinical clerkship during the student's fourth professional year at an approved college or school of pharmacy.

 

                              (ii)           Applicants for licensure by reciprocity who do not have the required practical experience as specified in Chapter 2, Section 6. Wyoming Pharmacy Act, Rules and Regulations.

 

                              (iii)          Applicants for reinstatement of a pharmacist license who must complete a required amount of practical experience.

 

                              (iv)          Foreign pharmacy graduates who must complete 1200 hours of practical experience for licensure.

 

Section 6.              Violations, Hearings, and Penalties.

 

Interns violating the Act or Board Regulations shall be subject to administrative procedures under Chapter I of these Regulations.

 

CHAPTER 4, CODE OF ETHICS, WPA, R&R

 

Section 2.              Code of Ethics.

 

               (n)           Any behavior by a pharmacist toward a patient, another licensee, or an employee of a pharmacy that exploits the position of trust, knowledge, emotions or influence of the licensee or any behavior by a pharmacist which involves offers to exchange pharmacy services for some form of sexual gratification shall be considered unprofessional conduct.

 

 

 

Wyoming Pharmacy Act, Rules and Regulations

Chapter 16, Immunization Regulations

Proposed Revisions

 

               Section 2.             

 

(d)              "Immunizations" means for the purpose of this chapter those vaccines which a pharmacist may prescribe or administer to healthy adults or those vaccines which may be administered on a specific order of a physician for high risk adults and shall be restricted to the following vaccines:

 

(i)                Tetanus, diphtheria, pertussis  (Td, Tdap)

 

(ii)              Measles, mumps, rubella (MMR)

 

(iii)             Varicella

 

                              (iv)          Influenza

 

                              (v)           Pneumococcal (Polysaccharide)

 

                              (vi)          Hepatitis A

 

                              (vii)         Hepatitis B

 

                              (viii)        Meningococcal

 

                              (ix)          Human papillomavirus (HPV)

 

                             

 

 

Wyoming Controlled Substance Act, Rules and Regulations

Chapter 6, Issuing, Filing and Filling of Prescriptions

Proposed Revisions

 

Section 4.              Manner of Issuance of Written, Typed or Computer Generated Prescriptions.

 

.

 

               (d)          A schedule III-V controlled substance prescription faxed by the practitioner to the pharmacy need not be printed on security paper.

 

               (de)         An intern, resident, or foreign physician exempted from registration under Chapter 3 Section 24 shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in Chapter 3 Section 24, in lieu of the registration number of the practitioner required by this section. Each prescription shall have the name of the intern, resident, or foreign physician stamped or printed on it, as well as the signature of the physician.

 

(ef)         An official exempted from registration under Chapter 3 Section  25 shall include on all prescriptions issued by him, his branch of service or agency (e.g., "U. S. Army" or "Public Health Service") and his service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his Social Security identification number. Each prescription shall have the name of the officer stamped or printed on it, as well as the signature of the officer.

 

Wyoming Controlled Substance Act, Rules and Regulations

Chapter 8, Prescription Drug Monitoring Program

Proposed Revisions

 

 

               Section 7.              Reporting of Non-Controlled Prescription Drugs.

 

               Resident and nonresident retail pharmacies shall ensure that, not later than the 10th day of the month immediately following the month in which the prescription was dispensed, the information required pursuant to Section 2 (a) of this chapter is transmitted to the board or its agent for the following prescription drugs:

 

               (a)           Tramadol, including any combination product where tramadol is an active ingredient.

 

               (b)           Carisprodol, including any combination product where carisprodol is an active ingredient.