In the various states, the state's Board of Pharmacy is the primary regulator of pharmacies, including traditional (503A) compounding pharmacies. Each State Board of Pharmacy has written legislations that govern and legally hold compounding pharmacies accountable for all their operations, including compounding itself.
State Boards of Pharmacy typically adopt in full, in part, or adapted versions of the USP General Chapters that detail standards of practice. For compounding practices, the most noteworthy USP standards of practice are General Chapters USP <795> (Non-Sterile Compounding), USP <797> (Sterile Compounding), and USP <800> (Hazardous Drugs).
Under Federal law, the FDA has authority over pharmacy compounding and has issued policies on when compounding is appropriate, as well as on the standards for the production of compounded products. Under its authority, the FDA, typically in conjunction with the respective states, inspects compounding pharmacy facilities to ensure compliance with production standards mandated by the USP, and, in the case of outsourcing facilities, with Current Good Manufacturing Practice requirements.
Health Canada oversees the regulation of drugs and health products in Canada, ensuring that the public has access to safe and effective products. Health Canada defines compounding as the combining or mixing of two or more ingredients (of which at least one is a pharmacologically active component) to create a final product in an appropriate dosage form. Health Canada’s Policy of Manufacturing and Compounding Drug Products in Canada (POL-0051) provides information on compounding and establishes a framework to assist in distinguishing between compounding and manufacturing activities of drug products. Under Health Canada’s policy, healthcare professionals engaged in drug compounding must comply with applicable federal/provincial/territorial regulations and standards.
NAPRA is an association of provincial, territorial and Canadian Armed Forces pharmacy regulatory bodies. The association provides a platform for members to discuss and take a national approach to the practice of pharmacy and pharmaceutical compounding in Canada. NAPRA’s model standards for pharmacy compounding represent the minimum requirements to be implemented by compounding pharmacists across Canada. These standards of practice include those for non-hazardous sterile preparations, hazardous sterile preparations, and non-sterile preparations. The pharmacy regulatory authority of each province or territory can review these model standards and determine how to best implement them in their jurisdiction.
The pharmacy regulatory authority of each province or territory is the primary regulator of licensed pharmacists and pharmacies, including those who specialize in compounding. The pharmacy regulatory authorities are responsible for administering provincial pharmacy legislation, including legislation on compounding which may be adapted from NAPRA’s model standards for pharmacy compounding. The required adoption of compounding practice standards in each province or territory ensures nation-wide compounding pharmacy accountability, compounding personnel safety, and patient safety.
Compounded medicines are not required to be entered on the Australian Register of Therapeutic Goods if they are extemporaneously prepared for a specific person for a therapeutic use. Additionally, a license to manufacture is not required if the pharmacist is practising in a pharmacy open to the public or a public hospital. However, despite these exemptions, pharmacists are not exempt from meeting advertising requirements or quality standards of the Therapeutic Goods Act 1989 for compounded medications.
The PBA has developed codes, guidelines and policies to provide guidance on the profession of pharmacy in Australia. Detailed guidance to pharmacists who compound medicines is also provided by the PBA to ensure product quality, safety and efficacy. The TGA recommends compounding pharmacists to consider these guidelines in addition to the requirements of the therapeutic goods legislation. The guidelines set forth by the PBA detail the Board’s guidance to registered pharmacists in relation to the compounding (extemporaneous preparation) of medicines, not set out in legislation or a registration standard.
Pharmacists must meet their obligations outlined in relevant state or territory (and Commonwealth) legislation as they relate to the preparation, labelling, maintenance of records, storage, dispensing, supply and advertising of compounded medicines. These guidelines outlined from each state or territory also require pharmacists to refer and to meet quality standards set by (but not limited to) the PBA, Australian Pharmaceutical Formulary and Handbook, Therapeutic Goods Act 1989, Pharmaceutical Inspection Convention’s publication, Health Practitioner Regulations Law, or the United States Pharmacopeia for Pharmaceutical Compounding (non-sterile and sterile compounding, Chapters <795> and <797>).