April 5, 2024

Input needed: FDA’s demonstrably difficult rule

As we reported last week, a proposed FDA rule, Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act, has been published in the Federal Register.   

In previous comments, APC and others raised procedural concerns with FDA proposing categories of drugs for the list prior to the criteria for evaluation being finalized. The criteria that the FDA has proposed for determining if a compound presents demonstrable difficulties for a pharmacy to prepare are: 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. FDA has indicated that it intends to consider these criteria individually and collectively, and to take into account the risks and benefits to patients of the compounded drug product or categories of drug products. 

Before APC determines its position and prepares comments to FDA on the proposed rule, we want to hear from you. Do you compound solid modified-release drug products that employ coated systems, liposome drug products, or drug products produced using hot melt extrusion? (Yes/No) We hope to ascertain if these products/processes being added to the DDC list will affect our members and your ability to serve patients..Additionally, please share input on any other comments you might want APC to include in its letter to FDA. Just email tenille@a4pc.org