An order of the Pharmacy Examining Board to repeal and recreate ch. Phar 15 relating to compounding pharmaceuticals.
Analysis prepared by the Department of Safety and Professional Services.
Statutes interpreted: ss. 450.01 (16),
Statutory authority: ss. 15.08 (5) (b), and 450.02 (3) (d) and (e), Stats.
Explanation of agency authority:
The Board shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains, and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession. [s. 15.08 (5) (b), Stats.]
The board may promulgate rules necessary for the administration and enforcement of this chapter and ch. 961 and establish minimum standards for the practice of pharmacy. [s. 450.02 (3) (d) and (e), Stats.]
Related statute or rule: N/A
Plain language analysis:
This proposed rule repeals and recreates the Pharmacy Examining Rules related to compounding pharmaceuticals.
Phar 15.01 creates the definitions which will be used throughout the chapter.
Subchapter I are the general provisions which provide requirements for all types of compounding.
Phar 15.10 requires a facility which has a designated area for compounding and orderly placement of equipment, materials and components so that errors are minimized. The compounding area is to be maintained in a clean and sanitary manner, be easily accessible to hot and cold running water, soap and single-use towels and all compounding equipment, materials and components stored off the floor and in a way that prevents contamination.
Phar 15, 11 requires a pharmacy to possess equipment and drug preparation containers or packaging that is appropriate to the compounding performed at the pharmacy, minimize contamination and not alter stability of the compounded preparation. The equipment needs to be maintained consistent with the manufacturer’s recommendations.
Phar 15.12 requires compounding documentation necessary to trace, evaluate and replicate the compounding steps throughout the process of a preparation to be maintained for a period of 5 years after the date of the last refill of the preparation.
Phar 15.13 requires a final check of the compounding, investigate any discrepancies and take corrective action before the prescription is dispensed.
Phar 15.14 requires all personnel involved in the compounding, evaluation, packaging and dispensing of compounded preparations be properly trained and competency tested for the type of compounding conducted. It is the managing pharmacist’s responsibility to ensure personnel training and competency assessments are completed and documented. The pharmacy shall establish written policies and procedures governing compounding and reflect current compounding practice.
Phar 15.15 requires in addition to the regular labeling requirements, to include storage conditions, beyond use date and special handling instructions.
Phar 15.16 Active pharmaceutical ingredients or added substances shall be manufactured by an FDA registered facility or accompanied by a certificate of analysis and USP or NF monograph specifications when available. Components for human use may not be used if they have been withdrawn or removed from the market based by the FDA. Compounding for food producing animal use may not use any components prohibited for use in food producing animals.
Phar 15.17 Compounded preparations dispensed or distributed directly to a practitioner to be administered to an individual patient without a patient specific prescription shall meet the following: the prescription shall include the name, address, drug, quantity and purpose of the compounded preparation; the label shall include the practitioner’s name and state “For Administration Only – Not for Dispensing or Distribution” and marked for “Single Dose Only” if the sterility or integrity is not maintained after the opening of the container; the pharmacist shall record the name and address of the location the compounded preparation was dispensed or distributed, the lot number and beyond use date; and there shall be a procedure for immediate notification to all practitioners of a preparation which is recalled.
Subchapter II provisions relate to non-sterile compounding.
Links to Admin. Code and Statutes in this Register are to current versions, which may not be the version that was referred to in the original published document.