In a Federal Register Notice (here) published today, the FDA announced a Compliance Policy which will exercise enforcement discretion relative to 503A compounders using the bulk drug, Oxitriptan, for compounding oral forms of the drug. Remember, “FDA issued a final rule (84 FR 4696) (“February 19, 2019, final rule”), which established the list of bulk drug substances that can be used to compound drug products under Section 503A of the FD&C Act even though they are not the subject of an applicable USP or NF monograph or a component of an FDA approved drug product (the 503A Bulks List).” Oxtriptan was specifically excluded from that list.
We love reading other regulatory pieces, and particularly liked the one written by Regulatory Focus’ Michael Mezher (here) concerning the “agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.” While this may provide a better focus for the FDA to coordinate efforts through CDER resources, it could also mean a tougher enforcement stance from the Agency.
As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs. As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the public if not prepared properly.
A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas. According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products. “The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.
The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here). After the posting of the draft guidance, the FDA says that it received approximately sixty comments from stakeholders and,
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,
On Monday, the FDA revised the “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance” (here). The initial draft guidance issued in 2014.
According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “[t]his revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.” The FR Notice also provides additional background on its thinking in making the revisions to the draft guidance.
In a prepublication Notice from the Federal Register (here), the field of products permitted for compounding by 503A and 503B compounders decreased by two. The Agency will publish a final rule on Tuesday titled List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness.