FDA Continues to Identify Appropriate Substances for Compounding

In mid-June, the FDA took another step forward for pharmacies, outsourcing facilities, regulators, and prescribers, by working to identify which prescription drugs can legally be compounded for use with humans.

This marks the second meeting at the FDA pharmacy compounding advisory committee since the enactment of the Drug Quality and Security Act, which included the Compounding Quality Act.

Three New Drugs Added to the Bulk Drug List

The committee did not agree with and FDA staff assessment of a particular substances appropriateness for inclusion on the bulk drug substances list. Most committee members said that Tranilast should be a permissible substance in topical drugs compounded by doctors and pharmacists. Nine of 13 voting committee members were convinced of the medical need for medication.

The substance is recognized by the Japanese Pharmacopoeia and available commercially in Japan as both an oral capsule and an ophthalmic solution. The FDA database says the drug has two orphan designations.

FDA personnel raised many points which were countered with evidence on the use of compounded topical drug products used to treat keloids and hypertrophic scars. In the presentation, there was emphasis on the lack of reported serious adverse events with topical applications.

All who voted in favor of including the medication on the list of approval applied it to topical formulations only, rather than oral formulation.

The other drugs added to the list were brilliant blue G and N-acetyl-D-glucosamine.

Four More Drugs Added to the Do Not Compound List

None of the committee’s voting members objected to the FDA’s idea to forbid compounding of the following drugs:

• Acetaminophen in doses higher than 325 mg
• Bromocriptine mesylate for the prevention of physiological lactation
• Ondansetron hydrochloride for IV use with more than 16 mg per dose
• Aprotinin

The do-not-compound list already has 59 entries. Pharmacists, pharmacies and outsourcing facilities are not allowed to compound these drugs that they want to be exempt from certain federal requirements.

Each one of the new additions to the do not compound list were supported by studies that found high risks, including frequency of death, associated with one or more of the drugs.

Investigational New Drug Application is Now an Option

There is no absolute prohibition against compounding a drug product from a substance that is not named on the bulk drug list, or a drug that is named in the do not compound list. A doctor or pharmacist may submit an application to use a substance or drug in compounding a product for a patient. The application, if approved by the FDA, would permit the use of the substance as an investigational drug under the expanded access, or compassionate use, pathway.