Last month, FDA commissioner Scott Gottlieb released a statement regarding the implementation of the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. One of the limitations of these acts was in regards to the drug substances that outsourcing facilities can use for drug compounding. These documents direct FDA personnel to develop a bulk drug substance list, known as the 503B bulks list.
Recently, FDA personnel released documentation addressing how that 503B bulks list would be formulated, including what substances a facility can use to compound drugs.
Drug compounding involves mixing individual ingredients of exact dosages and strengths to create personalized medications. Compounding is essential for patients with unique medical conditions or needs that are not or cannot be treated with FDA-approved pharmaceuticals. A major downfall of compounded drugs is the fact that they do not undergo pre-market review for safety, effectiveness, and quality.
Compounding can be done two ways. First, by using an already FDA approved drug and changing the dosage form, or second, by starting with a bulk drug substance. However, compounding from a bulk substance presents greater risks due to the fact that safety and quality cannot be guaranteed.
The FDA released a draft guidance for how the agency will implement DQSA requirements while still preserving access to compounded drugs for patients who need them. Guidance includes interpreting language relating to “bulk drug substances” and naming factors that will be used to evaluate bulk drug substances.
Final guidance and regulations are still being discussed for drug compounding.