The use of bulk drug substances can serve an important role for patients for whom an FDA-approved drug product is not appropriate, such as patients who, for example, have an allergy and need a medication to be made without a certain dye or a different kind of inactive ingredient.
In such cases, certain physicians and pharmacists (in accordance with section 503A) or outsourcing facilities may be able to provide compound drug products, having to meet several regulatory demands. Outsourcing facilities as nominators, for instance, need to be registered under section 503B of the Federal Food, Drug, and Cosmetic Act (to be found in the Federal register).
Additionally, only compound drugs may be produced that are included in the FDA drug shortage list. Otherwise, an appearance of the nominated bulk drug substance in FDA’s 503B bulks list (a list of bulk drug substances with clinical need) is required.
Pharmacists and physicians, as well, need to comply with various regulations in the production of bulk drug substances – an applicable United States Pharmacopeia (USP) and National Formulary monographs, for instance, need to be taken into account.
In order to be approved, any bulk drug substance must be manufactured by an establishment that is registered under section 510 of the FD&C Act (Federal Food, Drug and Cosmetic Act), and additionally it must be accompanied by a valid certificate of analysis.2