FDA Proposes Standards for Drugs on ‘Difficult to Compound’ List

The FDA is proposing to establish criteria for the lists of drug products or categories of drug products that present difficulties for compounding under certain sections of the Federal Food, Drug, and Cosmetic Act.

The Food and Drug Administration’s proposed rule (RIN 0910-AI3) would amend its regulations to add two lists identifying drug products or categories of drug products. The products or categories that appear on those lists can’t qualify for certain statutory exemptions, and may not be compounded under either Section 503A or Section 503B of the FDCA, the agency said in the proposal Tuesday.

Those sections refer to compounding that is done by a licensed physician at either a state-licensed pharmacy or federal facility, or within an outsourcing facility.

Compounded drugs involve “combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” according to the FDA. Some of the drugs the agency proposes to add on the lists present safety risks if drugs were to be compounded.

“Having two separate lists will make it easier to address situations that could arise where a drug product or category of drug products would present demonstrable difficulties for compounding under section 503A but may not present demonstrable difficulties for compounding under section 503B of the FD&C Act,” the agency said in the proposal.

First Three Categories

The FDA is proposing to identify the first three categories of drug products on both lists: oral solid modified-release drug products that employ coated systems; liposome drug products; and drug products produced using hot melt extrusion.

The proposed rule laid out potential risks and safety concerns if improper selection of inactive ingredients or improper mixing were to occur with the drugs.

The nomination for the drugs is based on the results of the FDA’s evaluation of certain categories of drug products that the public has nominated for consideration, as well consultation with the Pharmacy Compounding Advisory Committee.

For drug evaluation, the FDA proposes to establish the following criteria: the formulation complexity; drug delivery mechanism complexity; dosage form complexity; complexity of achieving or assessing bioavailability; compounding process complexity; and complexity of physicochemical or analytical testing of the drug product or category of drug products.

“There may be situations in which FDA’s findings, with respect to whether a drug product or category of drug products presents demonstrable difficulties for compounding, indicate that the difficulty in compounding is limited to a subset of such drug products or categories of drug products,” the agency said in the proposal.

“In those cases, the Agency may tailor the entry on the DDC Lists to reflect its findings and conditions that the Agency determines are necessary to prevent the drug or category of drugs from presenting the demonstrable difficulties,” the agency said.

The public may nominate drug products or categories of drug products for the lists or comment on nominated categories of products.