A notice from the Federal registry announced that the FDA added four bulk drug substances into the comprehensive 503B Bulks list. The 503B Bulks list can be utilized by outsourcing facilities to determine which substances may be used for compounding purposes. This action was initiated as part of the FDA's efforts to ensure patient access to compounded medications. In the compounding space, patients' needs are personalized to better address their medical ailments, especially since their needs are not met by an FDA-approved agent.

The four added bulk drug substances include diphenylcyclopropene, glycolic acid, squaric acid dibyutyl ester, and trichloroacetic acid. Each of these substances have specified routes of administrations. All four substances are intended for topical use only, with an additional limitation in concentration for glycolic acid of up to 70%. These bulk drug substances are not components of any FDA-approved medication. In addition to the four, the following bulk drugs were evaluated but are not currently on the list: diazepam, dipyridamole, dobutamine hydrochloride (HCl), dopamine HCl, edetate calcium disodium, folic acid, glycopyrrolate, and sodium thiosulfate.

An outsourcing facility is an entity located at a location specifically designated for sterile drug compounding. In November 2013, the Drug Quality and Security Act was signed and the creation of section 503B was made under the Federal Food, Drug and Cosmetic Act. Under section 503B, compounders may become an outsourcing facility. Within this facility, a medication can be compounded using bulk drug substances if the substance appears on the 503B bulk list or if bulk drug substance used for compounding appears in the FDA's drug shortage list. Each bulk drug substance needs to have a certificate of analysis that ascertains proper quality and manufacture by an establishment registered with the FDA under section 510 of the FD&C act. The 503B Bulk list includes substances proven to aid in clinical needs.

In January 2017, a guidance was issued while the 503B bulk list was being created. This guidance discussed conditions when no actions would be brought against the facility for compounding using bulk drug substances. This guidance was in place to prevent potential disruption in patient treatment. Three categories were introduced as nominees of bulk drug substances used for compounding.

Category 1 represents substances eligible to be placed in the 503B bulk list with appropriate information included to be assessed by the FDA. Substances in this category should not be found in any other list. The use of substances for compounding medications under category 1 by outsourcing facilities may not be penalized by the FDA. Category 2 consist of substances with supporting evidence for the FDA to evaluate, but significant safety risks were identified. These risks would need be to be further assessed and are not eligible to be used for compounding, unlike category 1 substances. If category 2 substances were found to be used for compounding by outsourcing facilities, action would be enforced against them by the FDA. Category 3 are bulk drug substances with the potential to be part of the 503B bulk list but lack sufficient evidence for evaluation. If sufficient data were found, a renomination could be applicable. Similar to category 2, these substances are not allowed to be used for compounding.

Over a periodic basis, the 503B Bulk list will continue to update as more nominations and changes occur.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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