CR 16-085 Rule Text

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.

Phar 15.20 allows components with an expiration date from the manufacturer or distributor may be used before the expiration date provided the component is stored in its original container and there is minimal exposure of the remaining component each time component is withdrawn from the container. Components without an expiration date assigned by the manufacturer or supplier shall be assigned an expiration date based upon the nature of the component and its degradation mechanism, the container in which it is packaged and the storage conditions.

Phar 15.21 requires the beyond use date not be later than the expiration date on the container of any component. In the absence of stability information the beyond use date if based upon the type of formulations. Assignment of the beyond use date includes an assessment of the need for antimicrobial agents or refrigeration to protect against contamination introduced during or after the compounding.

Subchapter III provisions relate to sterile compounding.

Phar 15.30 contains definitions of words used throughout the subchapter.

Phar 15.31 indicates the requirements necessary for the segregated compounding area and the classified area to ensure there is not contamination. The primary engineering control shall be certified prior to initial use and then every six months in addition to a redesign of facility, or the replacement or relocation of the primary engineering control.

Phar 15.32 indicates the personnel hygiene, garbing and protective gear required to ensure there is not contamination.

Phar 15.33 requires the compounding area to be cleaned and disinfected with designated minimum frequency. The pharmacy shall have written standard operating procedures which are followed by all compounding and environmental services personnel for cleaning and disinfecting the compounding area. Storage sites for the compounding ingredients and supplies shall remain free from dust and debris. Supplies and equipments removed from shipping cartons shall be disinfected. Entry points on bags and vials shall be disinfected before piercing.

Phar 15.34 requires urgent use compounded sterile preparations to be prepared within one hour and administration shall begin within one hour of the completion of the preparation. Aseptic technique shall be followed and procedures to minimize contamination. Unless immediately and completely administered or witnessed by the person who prepared the preparation, the preparation shall have a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who did the preparation and the 1 hour beyond use date and time.

Phar 15.35 indicates the sterilization methods for maintaining physical and chemical stability and the packaging integrity of the compounding sterile preparations. The sterilization methods are by filtration, steam heat or dry heat based upon the components utilized in the preparation. Dry heat depyrogenation shall be used to render glassware and other thermostable containers pyrogen free.

Phar 15.36 requires after the completion of compounding, the preparation shall be physical inspected and upon any observed defects be discarded or segregated in a manner which prevents it from being dispensed and pass a sterility test. Any preparation containing a preservative shall also pass an antimicrobial effectiveness testing before being dispensed.

Phar 15.37 indicates the requirements for establishing a beyond use date. Sterility and stability considerations shall be considered when establishing a beyond use date. Administration date and times based upon the requirements listed in the rule can’t be exceeded or extended without verifiable supporting valid scientific sterility and stability information that applies to the specific preparation or compound. If the beyond use date is based upon storage in a freezer, the integrity of the container closure system with the specific preparation in it shall have been demonstrated for 45 days at frozen storage.

Phar 15.38 provides that the managing pharmacist, all pharmacists, technicians, interns and externs involved in compounding sterile preparations shall successfully complete didactic and practical training initially and then annually. All personnel shall be evaluated initially and annually on all of the following: visual observation of hand hygiene and garbing; visual observation of aseptic technique; gloved fingertip and thumb sampling; and media-fill tests. Records of the training and evaluations shall be maintained by the pharmacy for 5 years.

Summary of, and comparison with, existing or proposed federal regulation:

None. There is federal compounding regulation relating to outsourcing facilities.

Comparison with rules in adjacent states:

Illinois: Illinois requires a specific area for compounding; records to be kept of each compounded prescription and the components; reference books; and a pharmacy operations manual with policies and procedures pertinent to the complexity and size of the compounding operations. The pharmacy may compound drug products to be sued by practitioners in their office for administration to patients. Sterile compounding requires: a designated area of sufficient size to accommodate a laminar airflow hood, barrier isolation chamber and proper storage of drugs and supplies; the laminar airflow hood shall be certified annually; sink with hot and cold water; refrigerator and/or freezer with a thermometer or temperature recording device; current resource materials and texts; patient profile or medication system; specific labeling requirements including beyond use date and time; and compounding records are to be maintained for 5 years.

Iowa: Iowa requires compliance with United States Pharmacopeia, Chapters 795 and 797. In addition, an FDA registered outsourcing facility must be licensed as a pharmacy in Iowa.

Michigan: Michigan requires a pharmacy that provides compounding services to be licensed as a pharmacy and authorized to provide compounding services. The pharmacy must be accredited by the Pharmacy Compounding Accreditation Board and be in compliance with United States Pharmacopeia standards. In addition, any outsourcing facility must be licensed as a pharmacy in Michigan.

Minnesota: Minnesota requires pharmacies compounding nonsterile drug preparations to follow United States Pharmacopeia, chapter 795 standards and pharmacies compounding sterile drug preparations to follow United States Pharmacopeia, chapter 797 standards.

Summary of factual data and analytical methodologies:

The Pharmacy Examining Board primarily utilized United States Pharmacopeia chapters 795 and 797 which are the recognized pharmacopeial standards. In addition, the Pharmacy Examining Board reviewed the code of other states which have been revised since the New England Compounding Center meningitis outbreak in 2012.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:

The Board does not know how many or which pharmacies are compounding sterile pharmaceuticals and UPS 795 and 797 are the recognized pharmacopeial standards. Therefore the Board was unable to determine whether there will be an effect on small businesses. This rule was posted for 30 days for economic comments and none were received.

Fiscal Estimate and Economic Impact Analysis:

The Fiscal Estimate and Economic Impact Analysis is attached.

Effect on small business:

These proposed rules were submitted to the Small Business Regulatory Review Board. The Small Business Regulatory Review Board determined the rules will not have a significant economic impact on a substantial number of small businesses. The Department’s Regulatory Review Coordinator may be contacted by email at [e-mail], or by calling [phone]

Agency contact person:

Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail].