FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

The US Food and Drug Administration (FDA) on Thursday issued a proposed rule to add six bulk pharmaceutical substances to a list of these substances that can be used in the composition and to remove four other bulk substances Included in the list.

If the proposed rule is finalized, the six bulk pharmaceuticals proposed to be included in the so-called bulk carrier list 503A. The FDA Pharmacy Advisory Committee (ABCP) discussed proposed additions and exclusions in 2015 and the committee met three times in 2016 to discuss the inclusion and exclusion of others Substances on the list.

"Due to the time elapsed between the publication of the proposed rule in 1999 and the promulgation of the DQSA [Drug Quality Security Act], the FDA considered it necessary to recommence the development of the 503A bulk carrier list," said The agency In the Federal register of Thursday.

In addition to new additions and exclusions, the FDA is also proposing, through this new rule,

"Due to the time elapsed between the publication of the proposed rule in 1999 and the promulgation of the DQSA [Drug Quality Security Act], the FDA considered it necessary to recommence the development of the 503A bulk carrier list," said The agency In the Federal register of Thursday.

In addition to new additions and exclusions, the FDA is also proposing, through this new rule,

1. 1 Physical and chemical characterization of the substance
2. 2 Safety Issues Raised with the Substance in Compounded Pharmaceuticals
3. 3 Available evidence of the efficacy or lack of efficacy of a drug product combined with the substance, if there is such evidence
4. 4 Historical use of the substance in compounded pharmaceutical products, including information on the medical condition (s) to which the substance was used to treat and any references in the peer reviewed medical literature.

The FDA proposes to examine each criterion and balance it on a substance-by-substance basis in order to decide whether a substance is appropriate for inclusion in the list.

The Federal Register's notice announcing the proposed rule provides additional details on the type of information proposed for each criterion and how the FDA proposes to weigh the information.

Inclusion in List 503A

Based on the FDA assessment and consultation with the Advisory Committee on Pharmaceutical Composition, the agency proposes to include six bulk pharmaceutical substances on the list:

1. 1 Brilliant Blue G, also known as Coomassie Brilliant Blue G-250, as a dye used for staining for visualization during ophthalmic procedures
2. 2 cantharidin (for topical use only), for the treatment of warts and molluscum contagiosum
3. 3 diphenylcyclopropenone (for topical use only) for the treatment of alopecia and non-genital warts
4. 4 N-acetyl-D-glucosamine (for topical use only) for the treatment of hyperpigmentation and other skin conditions
5. 5 dibutyl ester of squaric acid (for topical use only) for the treatment of alopecia areata and recalcitrant non-congenital warts
6. 6 thymol iodide (for topical use only) for ulcerations and skin infections, as well as intrapleural treatment for pleural effusions

Exclusion from List 503A

The FDA has proposed that the following four substances be included in List 503A:

1.  1 oxitriptan (evaluated as a treatment for depression and insomnia)
2.  2 piracetam (evaluated as a treatment to improve cognitive skills)
3.  3 light silver protein (for use as an anti-infective agent for ophthalmic use)
4.  It is approved in South Korea and Japan for the treatment of asthma, keloids and hypertrophic scars, and an ophthalmic solution for allergic conjunctivitis (4), transilast (for the treatment of allergic disorders, Arthritis, dry eye syndrome, keloids and hypertrophic scars )

Regulatory Action Against State Pharmacies

The FDA also notes in the proposed rule that it does not intend to take regulatory action against a government-approved pharmacy, a federal facility or a licensed physician to make a drug using a pharmaceutical Bulk that is not the object of a USP or NF