FDA Adds Quinacrine Hydrochloride (quinacrine) to the List of BulkDrug Substances that May Be Used in Compounding by OutsourcingFacilities (503B Bulks List)

As part of FDA’s efforts to help ensure Americans have access to compounded medicines when a patient’s medical needs cannot be met by an FDA-approved drug, the agency has added quinacrine hydrochloride (quinacrine) to the list of bulk drug substances that may be used in compounding by outsourcing facilities (503B Bulks List). FDA has also posted a Compounding Safety Information Sheet to provide patients with better understanding of risks of using a product containing quinacrine.

FDA also identified ten bulk drug substances the agency has considered and is not including on the 503B Bulks List at this time: hydroxyzine HCl, mannitol, methacholine chloride, metoclopramide HCl, nalbuphine HCl, potassium acetate, procainamide HCl, sodium bicarbonate, sodium nitroprusside, and verapamil HCl. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.

FDA has implemented a careful and deliberative process to consider whether a bulk drug substance should be included in the 503B Bulks List. This process is also informed by external research partners, feedback from industry stakeholders, and other public commenters. Federal law places conditions on compounded drugs that qualify for the exemptions in section 503B of the Federal Food, Drug, and Cosmetic Act. One condition is that a drug must be compounded by an outsourcing facility that only compounds drugs using bulk drug substances for which FDA has determined there is a clinical need unless the compounded drug appears on the FDA’s drug shortage list at the time of compounding, distribution and dispensing.