May 10, 2018
"The FDA has been working to develop a comprehensive policy framework as part of our implementation of the Drug Quality and Security Act set forth by Congress. This law created a new category of compounders known as outsourcing facilities. While it may seem like a simple matter of semantics, determining whether an entity involved in compounding human drugs meets the definition of an outsourcing facility is a key element of advancing our policy with respect to compounding,” said FDA Commissioner Scott Gottlieb, M.D. “The new policy is designed to address any ambiguity around how to define the physical features and operations of outsourcing facilities, so that they’ll know what requirements they are subject to regarding product quality. In this way, health care providers and patients will also know the standards under which the compounded drugs they purchase are made."
The U.S. Food and Drug Administration today issued a final guidance entitled: Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act. This policy will help to ensure that compounded drugs are made under appropriate quality standards, provide transparency to patients and health care providers about the standards under which the compounded drugs that they purchase are made and respond to stakeholder feedback requesting guidance on the meaning of “facility” under section 503B.
The FDA has been asked whether compounding pursuant to patient-specific prescriptions under section 503A can occur in a separate suite adjacent to, but within the same building as, the outsourcing facility or within the outsourcing facility itself. Answers to these questions are important because drugs compounded in an outsourcing facility must meet current good manufacturing practice (CGMP) requirements, which help ensure the quality of compounded drug products. In contrast, drugs compounded pursuant to patient-specific prescriptions under section 503A are exempt from CGMP requirements. By answering these important questions, the guidance provides much needed clarity to stakeholders about the production standards that apply to their drugs and to health care professionals about the level of quality assurances associated with the compounded drugs they are providing to their patients.
In the guidance, the FDA explains that a section 503A establishment compounding drugs pursuant to patient-specific prescriptions may be located near or in the same building as the outsourcing facility provided that they are completely separate. As explained in the guidance, the boundaries between the section 503A establishment and outsourcing facility should be clear, and may include permanent physical barriers, such as walls or locked doors, and the two operations should not share rooms, equipment, supplies, or pass-through openings (e.g., they may not subdivide a room with temporary barriers such as curtains). The guidance further explains that the labeling should clearly identify the compounder who produced the drug. Lastly, the guidance reminds industry and stakeholders that all drug products compounded in an outsourcing facility are regulated under section 503B and subject to CGMP requirements, even if those drug products are compounded pursuant to patient-specific prescriptions.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.