FDA to Make Compounding ‘Difficulty’ Lists

FDA is proposing to establish criteria to use in evaluating drugs or categories of drugs that present demonstrable difficulties for compounding (lists of DDC drugs). A Federal Register notice says the agency also proposes to identify three categories of drug products on two DDC lists, with the possibility of adding more categories in the future.

Drug categories or products that are placed on DDC lists cannot qualify for statutory exemptions under the applicable section of the Federal Food, Drug, and Cosmetic Act.

The notice says the criteria FDA proposes to use in evaluating drug products or categories of drug products are the formulation complexity, drug delivery mechanism complexity, dosage form complexity, complexity of achieving or assessing bioavailability, compounding process complexity, and complexity of physiochemical or analytical testing of the drug product or category of drug products.

“FDA proposes to consider these criteria and the risks and benefits to patients of the compounded drug product or category of drug products in determining whether to add the drug product or category of drug products to one or both lists,” the notice says.

FDA says that based on the results of its evaluation of certain categories of drug products nominated by the public for consideration as presenting demonstrable difficulties for compounding, in consultation with the Pharmacy Compounding Advisory Committee, it is planning to include these three categories of drug products on the DDC lists: (1) oral solid modified-release drug products that employ coated systems; (2) liposome drug products; and (3) drug products using hot metal extrusion.

Before finalizing the rulemaking, FDA will consider whether any changes to the proposed criteria would alter its analysis of whether the categories listed present demonstrable difficulties for compounding.

Comments must be received within 90 days.