Click here for the PDF version of this Pharmacy Law Brief
Earlier this month the Food and Drug Administration released policy guidance documents explaining the agency's thinking on the two central sections of the recently amended Food, Drug, and Cosmetic Act (FDCA)- Sections 503A and 503B. These guidance documents provide more detail as to how the agency plans to implement the new provisions of the law pertaining to pharmacy compounding. For many stakeholders, these documents are critical in ensuring the agency is continuing to work with state boards of pharmacy and to continue protecting patients who depend on compounded medication.
Presented here is the digested language of the guidance document for Section 503A- one of two sections essentially bisecting the compounding industry. 503A defines 'traditional compounding' and 503B, outsourcing facilities. Although the agency expects state boards of pharmacy to continue their oversight and regulation of pharmacy compounding, the extent to which they will allow the state boards of pharmacy to regulate practice in accordance with their respective provisions cannot be known for sure. It is implied that the definitions and criteria set forth by these two sections of the FDCA will become the regulatory magnifying glass by which state boards of pharmacy must examine pharmacy compounding in their states. Furthermore, state boards and the FDA must work together to address pharmacy practices that fall outside the lines of these two sections. Provided here are the requirements the agency will enforce for compounding pharmacies not registered as outsourcing facilities.
Section 503A
To qualify as a traditional compounding pharmacy, a pharmacy practice must:
1. Compound a drug product for an identified individual patient pursuant to a valid prescription
2. Have a licensed pharmacist compound drugs in a licensed state or federal facility
3. Compound a drug in limited quantities prior to receipt of a valid prescription for an individual and based on a history of the pharmacist or physician receiving those prescriptions and there is an established relationship between pharmacist/physician and patient
4a. Compound drugs in compliance with USP chapters on pharmacy compounding that comply with USP or NF monographs
- If there is no monograph, the drug must be a component of an FDA-approved human drug
4b. If it is not a component of an FDA-approved human drug, it must be on the FDA approved list of bulk drug substances for use in human compounding
5. Use bulk ingredients that are manufactured by a FDA registered entity
6. Use bulk ingredients that have an accompanying certificate of analysis or purity
7. Use ingredients that comply with USP/NF monographs, if applicable, and USP chapters on compounding
8. Not compound with bulk ingredients on the FDA 'do not compound' list
9. Not regularly compound or compound in large amounts drugs that are essentially copies of commercially available drugs
10. Not compound drugs identified by the FDA to be demonstrably difficult to compound
11. Not ship a quantity of compounded drugs that represents more than 5% of total prescription orders out of state - unless the state has entered into a memorandum of understanding (MOU) with the FDA regarding interstate distribution of compounded medication.
Notes:
- Provisions pertaining to physician compounding were not discussed
- These guidance documents and federal regulations apply only to compounded drugs for human use; drugs for veterinary use are not affected by these regulations.
- Many of these provisions requiring submissions in order to establish a list of drugs will not be enforceable until the FDA announces an official list and sets forth implementation regulations.
- A state may enter into a MOU with the FDA only after the FDA releases a draft MOU for comments and consideration. Following this release, the FDA will then enforce the 5% limit in states that have not signed and entered into the MOU.
- In regulating pharmacy compounding in accordance with these provisions, a risk-based inspection criteria will be used, as described in the Drug Quality and Security Act and will place greatest importance on what is deemed to pose the greatest risk to public health.