059-13 Wyo. Code R. §§ 13-3 - General Provisions

(a) Based on the existence of a pharmacist/patient/practitioner relationship and the presentation of a valid prescription, or in anticipation of prescription medication orders based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient, medications or dosage forms that are not commercially available in the marketplace.

(b) Pharmacists shall, when procuring active ingredients for compounding, obtain a Certificate of Analysis (COA) for each lot number procured, and shall retain each COA for a period of not less than two (2) years from the date the container is emptied. COAs shall be available for review by Board inspectors. Each COA. must be issued by a firm located in the United States. If one is not available from the vendor, the pharmacist shall procure one from a laboratory located in the United States. COAs are not required if the active ingredient utilized is designated USP or NF.

(i) If the product is not designated as USP or NF, then the following minimum information is required on the COA:

(A) Product name;

(B) Lot number;

(C) Expiration date; and

(D) Assay.

(c) Pharmacists may compound drugs prior to receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/practitioner relationship, and provided that they maintain the prescriptions on file for all such products compounded at the pharmacy as required by the Board, but not under other circumstances.

(d) Pharmacists shall not offer compounded medications to other pharmacies or licensed entities for resale; except pharmacists may offer for sale compounded medications to practitioners or institutional pharmacies for administration to patients in the practitioner's office or in the institutional facility, provided that the pharmacy does not violate Chapter 8. Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business by distributing unsolicited sampling to practitioners (e.g., like a manufacturer).

(e) All compounded products, which include as an ingredient a cytotoxic drug, shall be prepared in a Class II biological safety cabinet.

Notes

059-13 Wyo. Code R. §§ 13-3