The US Food and Drug Administration (FDA) on Monday identified three bulk drug substances that it is proposing to not include in a list of such substances for which there is a clinical need (known as the 503B bulks list).
Bumetanide, nicardipine hydrochloride and vasopressin are the three bulk drug substances that FDA has considered and is proposing not to include on the list, as they can be obtained through already approved products. The nominations for these three active ingredients also did not give any reason why they should be included in the 503B bulks list. Vasopressin, meanwhile, is the active ingredient in Vasostrict, and was the subject of Endo's lawsuit over
how the FDA regulates drug compounding.
“Our preliminary assessment is that the FDA-approved drug products containing these substances can either be used or adapted to treat patients instead of compounding new drugs from bulk drug substances as proposed by the nominations. So, at this point, we don’t see a clinical need for outsourcing facilities to compound from these bulk substances,” FDA Commissioner Scott Gottlieb said in a statement.
This is the first time since the passage of the Drug Quality and Security Act
(DQSA) that FDA has issued a proposal regarding whether to include bulk drug substances
in the 503B bulks list. Additional nominated substances for inclusion on this list are currently under consideration and will be the subject of future notices, FDA said.
FDA also said it intends to consider whether input from the Pharmacy Compounding Advisory Committee (PCAC) on the nomination of substances to the 503B bulks list would be helpful to the agency.
Before the end of the year, and as part of its implementation of the DQSA, FDA will issue:
- a revised draft Memorandum of Understanding with states that will describe a more flexible approach to addressing certain distributions of compounded products by 503A compounders
- a revised draft guidance on insanitary conditions at compounding facilities that will address concerns raised by providers around the potential implications of the agency’s prior draft guidance
- a revised guidance on current good manufacturing practice (CGMP) requirements for outsourcing facilities that will take a more tailored approached to make it more feasible for more 503A pharmacies to become 503B outsourcing facilities.
Compounded drug products can help patients whose clinical needs cannot be met by FDA-approved drug products, such as patients who have an allergy and need a medication to be made without a certain inactive ingredient.
However, compounded drugs also pose a higher risk to patients than FDA-approved drugs.
In 2012, contaminated injectable drug products that a state-licensed compounding pharmacy shipped to patients and healthcare practitioners across the country caused a fungal meningitis outbreak that resulted in more than 60 deaths and 750 cases of infection.
In response to this outbreak, Congress enacted the DQSA, which, among other things, added new section 503B to the FD&C Act
and created a new category of compounders known as outsourcing facilities.
Drug products compounded under the conditions in section 503B are not exempt from CGMP requirements, but are exempt from winning approval, labeling and certain drug supply chain security requirements.