The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access to investigational new drugs and what components can be used in compounded products, among other topics.
The FDA’s Pharmacy Compounding Advisory Committee is scheduled to meet over the course of two days on June 17 and 18, 2015, less than four months after holding its initial meeting in February 2015. The regulatory scheme governing compounded drugs changed significantly in 2013 with the enactment of the Drug Quality and Security Act (DQSA). Among other changes, the DQSA created a new category of “outsourcing facilities” that can compound medications for office-use, unlike traditional state-licensed pharmacies. In addition, by complying with the requirements imposed under Section 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA), an outsourcing facility can compound drugs without a patient-specific prescription. However, state-licensed pharmacies can still compound drugs under Section 503A of the FFDCA. One of the conditions a 503A pharmacy must satisfy is that a bulk drug substance used in the compounded product either (1) comply with a United States Pharmacopeia or National Formulary monograph, (2) be a component of an FDA-approved drug, or (3) appear on a list of approved bulk drug substances. In order to comply with either Section 503A or 503B, a compounded drug cannot appear on a list of drugs that have been withdrawn or removed from the market because they have been found to be unsafe or not effective; the drug must also not appear on a list of drugs that present “demonstrative difficulties” for compounding.
Developing the 503A bulk drug substances list is one of the issues the Committee is scheduled to address. Specifically, the Committee will discuss four bulk drug substances that have been nominated for inclusion on the list: Brilliant Blue G, tranilast, N-acetyl-Dglucosamine, and oxitriptan. These drugs’ nominators will be invited to make short presentations supporting their nominations. The Committee will also receive an update on an issue discussed at the first meeting – the processes FDA plans to use to add or remove drugs from the 503A bulk substances list.
FDA will also seek the Committee’s input on proposed revisions to the list of drugs that cannot be compounded because they have been withdrawn or removed from the market. A list of those drugs is currently codified at 21 CFR 216.24, and FDA is considering whether to add four more drugs to the list: aprotinin, ondansetron hydrochloride, bromocriptine mesylate, and acetaminophen. The list may specify that a drug cannot be compounded in any form, or just a particular formulation, indication, dosage form, or route of administration.
Two other topics will also be on the agenda. The Committee will discuss the criteria FDA is proposing to use to evaluate drug products or categories of drugs to be identified as demonstrably difficult to compound. Finally, the Committee will continue its discussion on options for obtaining access to investigational new drugs.
An official agenda has not yet been posted on the Committee’s website, but FDA published a notice summarizing the issues to be discussed, as well as the procedure for requesting authority to make a formal oral presentation at the meeting, and to present data, information, or views on issues pending before the Committee.