One of my patients cannot afford the high cost of a commercially prepared product. Do you have a formulation for it so that I can help this patient?
The short answer is that you can help this patient, but not in this scenario as it is presented. Extemporaneous compounding has been a cornerstone of our profession’s practice since its inception. In the 1800s in the United States, food and drug manufacturing and marketing were essentially unregulated. Abuses led to the 1906 Federal Pure Food and Drug Act, which inaugurated a trend toward increasing regulation of drug manufacturing by federal agencies. The FDA is empowered by acts of Congress to promulgate regulations and enforce US Pharmacopeia standards. The Current Good Manufacturing Practices (cGMP 21CFR§§210&211) are key to pharmaceutical manufacturing regulations. In addition, the FDA promulgates informal Compliance Policy Guidance (CPG) documents for different aspects of the drug and medical device industries. CPG Section 460.200 addresses pharmacy compounding.
Pharmacists and pharmacies are licensed and inspected by the states; if a state inspection uncovers “manufacturing under the guise of compounding,” it refers the matter to the FDA, which can apply cGMP expectations to the pharmacist/pharmacy. CPG 460.200 provides a brief list of factors that the FDA uses when considering whether a pharmacy’s practices might be pharmaceutical manufacturing. The list is narrowly drawn but important: it provides sufficient latitude for professional judgment and usual and customary pharmacy practice.
Compounding preparations extemporaneously on lawful prescription for individual patients is within the pharmacist’s purview. When a pharmacist engages in large-scale production of preparations without prescription or evidence of pending refills, trending, etc, the practice can be regarded as manufacturing; cGMP compliance will be expected, including an approved new drug application (NDA) or abbreviated new drug application (ANDA). If a pharmacist duplicates an NDA/ANDA product without a documented medical basis for doing so (eg, patient allergy to a component in the commercially manufactured product) or if no shortage exists (see FDA current drug shortages), the FDA may consider the act to be duplication or “manufacturing under the guise of compounding.”
Mr. Erickson is director of professional affairs and director of professional services at Gallipot, a Fagron company.