Tuesday, June 12, 2012

Wyoming Law: Honing in on Compounding Regulations

The Wyoming Pharmacy for June contains the following article entitled Honing in on Compounding Regulations, which is found here.

Honing in on Compounding Regulations
By Calvin Culver, PharmD Candidate
Pharmacy compounding is the art and science of preparing personalized medication for patients. Compounding is the result of individual ingredients mixed, prepared, or assembled together in the exact strength and dosage form required by the patient. A compound provides the patient a unique product that is tailored for his or her individual need.
Producing a compound is an art; however, every compounding pharmacy must comply with the regulations set forth by the Wyoming State Board of Pharmacy. Wyoming Pharmacy Act 33-24-114 states, “To secure and retain a license, a pharmacy shall be equipped with facilities, apparatus, utensils, and stock of drugs and medicines sufficient to permit the prompt and efficient compounding of prescriptions and shall be maintained in a sanitary and orderly manner.” Therefore, if a
pharmacy is equipped to produce a compound then there are important regulations to abide by.
Practicing within the scope of the regulations requires proper written and recorded policies and procedures for everything from compounding controls to the facility. Essential documentation that may easily be overlooked is the requirement for pharmacy employees. According
to Wyoming Pharmacy Act, Rules and Regulations Chapter 13, Section 4, Subsection (b), the “competency and proficiency in the art of compounding for all pharmacists shall be evaluated, documented, and maintained in the files of the pharmacy by the Pharmacist-in-Charge
(PIC).” The PIC should determine what would be appropriate for his or her staff pharmacists.
Ensuring the competencies of pharmacy technicians is required. Wyoming Pharmacy Act, Rules and Regulations Chapter 10, Section 3(c) states, “The PIC shall certify competency of the pharmacy technician prior to allowing a pharmacy technician to assist the pharmacist in compounding, and annually thereafter.” A minimum checklist of competencies for pharmacy technicians can be found in Wyoming Pharmacy Act, Rules and Regulations, Chapter 10, to help the PIC determine some necessary items to include on the checklist. Technicians in-training may not compound.
Remember as you ensure all the proper documentation of your staff  that the records and reports shall be retained for a minimum period of two years from the date of last activity and be available for inspection by the Board.

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