FDA Addition of Hydroxychloroquine to the 503B Bulks List

March 25, 2020  |   By: Martha M. Rumore Pharm.D., Esq. and John E. Morrone, Esq.

Outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act may use a bulk drug substance to compound a drug if:

- the Food and Drug Administration (FDA) has determined there is clinical need to compound with the substance and places it on a list of such drugs, or

- the drug compounded appears on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing.

FDA evaluates bulk drug substances that were nominated for inclusion on the 503B bulks list, and has now added hydroxychloroquine sulfate, the antimalarial and anti-rheumatic drug that is under investigation for the treatment of COVID-19 to Category 1 for nonsterile compounding. Literature to support stability has been published.[1],[2] Chloroquine phosphate is currently under evaluation for inclusion on the list.

FDA will not take action against any outsourcing facility for compounding using bulk drug substances identified in Category 1 provided that the conditions described in the March 2019 Guidance, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act[3], are followed. The guidance describes FDA’s interpretation of the statutory term, “bulk drug substance for which there is a clinical need,” and factors FDA intends to consider when determining whether to include a bulk drug substance on the 503B bulks list.

[1] McHenry A, et al. Stability of extemporaneously prepared hydroxychloroquine sulfate 25 mg/mL suspensions in plastic bottles and syringes. Int J Pharm Compounding 2017; 21(3):251-254.

[2] Loyd A. Hydroxychloroquine sulfate 25 mg/mL in Oral Mix or Oral Mix SF. Int J Pharm Compounding 2017; 21(6):494.

[3] FDA, Guidance For Industry. Available at https://www.fda.gov/media/121315/download.