Administrative Rule Review Report  #AR09-057

Legislative Service Office

29-Sep-09

AGENCY: Wyoming Board of Pharmacy.

DATE SUBMITTED: September 22, 2009.

SUBJECT: Chapter 2, General Practice of Pharmacy; Chapter 3, Pharmacy Internship; Chapter 8, Wholesale Distributor; Chapter 12, Institutional Pharmacy Practice; Chapter 13, Compounding; Chapter 16, Immunization; and Chapter 17, Sterile Compounding.

NATURE OF RULES:                     Legislative and procedural.

STATUTORY AUTHORITY:         W.S. 33-24-102(c)

DETERMINATION OF PROCEDURAL COMPLIANCE BASED UPON INFORMATION SUBMITTED BY THE AGENCY TO LSO:  Apparently complete to date.

SUMMARY OF RULES:  These amendments generally update existing rules to implement national standards on sterile compounding of pharmaceuticals, to clarify and add definitions, to refine pharmacy notice and reporting requirements and to make non-substantive corrections.

Major changes include:

• An amended definition of "dispense";

• Requirement for receipt of a criminal background history before issuance of a license;

• Additional reporting requirements upon a change in pharmacy ownership;

• Amended definitions for "clean room," "investigational drug," and "remote order processing";

• Updating of reference materials which institutional pharmacies are required to maintain on site;

• A new chapter 17 to regulate sterile compounding of drugs in accord with guidelines of the United States Pharmacopeia organization.

FINDINGS:  The rules appear to be within the scope of statutory authority and legislative intent.

STAFF RECOMMENDATION:  That the rules be placed on the Consent List and be approved by the Council as submitted by the Agency.

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Gerald W. Laska

Staff Attorney

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Lynda G. Cook

Staff Attorney

GWL/