Compounding: FDA Revises Insanitary Conditions Guidance, Finalizes Guidance on Radiopharmaceuticals

Regulatory NewsRegulatory News | 25 September 2018 |  By 

The US Food and Drug Administration (FDA) on Tuesday issued a revised draft guidance on insanitary conditions at compounding facilities and two final guidances on compounding and repackaging radiopharmaceuticals as it works to ramp up enforcement of compounders and outsourcing facilities.
In recent years, FDA has updated its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 2013.
In January, FDA released a new set of priorities aimed at increasing its oversight of compounded drugs while making it easier for certain compounders to transition to registered outsourcing facilities.
In addition to issuing new guidance on compounding, those priorities include laying out manufacturing standards for outsourcing facilities, restricting what drugs can be compounded and increasing partnerships with state regulators that oversee pharmacists and compounders.
Despite these efforts, Anna Abram, FDA’s deputy commissioner for policy, planning, legislation and analysis, told attendees of the 2018 Intergovernmental Meeting on Drug Compounding that the agency “continues to see concerning conditions during our inspections and learn of serious adverse events associated with compounded drugs.”
However, Abram said that FDA has seen many compounders address insanitary conditions at their facilities since FDA first issued its draft guidance in 2016, though Abram noted that FDA has also issued warning letters and worked with the Department of Justice to issue injunctions against other facilities that “have neglected to take appropriate action.”
For instance, in a warning letter sent to outsourcing facility Atlas Pharmaceuticals earlier this month, FDA cited the firm for multiple violations that created insanitary conditions, such as failing to disinfect equipment and supplies, and failing to use a sporicidal agent to disinfect aseptic processing areas.
According to FDA, the draft guidance on insanitary conditions at compounding facilities has been revised to provide more clarification on the insanitary conditions detailed in the guidance and on the actions FDA intends to take when such conditions are identified.
FDA says these revisions “will help compounding facilities to identify insanitary conditions so that they can implement appropriate corrective actions and will assist states in identifying insanitary conditions during their inspections.”
FDA is also clarifying that it generally does not intend to take action against physicians who compound or repackage drugs in their own offices where the products are administered or dispensed to patients.
The two final guidances lay out FDA’s policies towards repackaging and compounding radiopharmaceuticals by outsourcing facilities and by state-licensed nuclear pharmacies, federal facilities and other entities that hold a radioactive materials (RAM) license.
Radiopharmaceuticals are explicitly excluded from Section 503A of the Food Drug and Cosmetic Act (FD&C Act), which provides exemptions for new drug approval, labeling and good manufacturing practice (GMP) requirements for compounded drugs.
However, in its final guidance, FDA says it recognizes that there are circumstances in which facilities that hold a RAM may need to compound or repackage radiopharmaceuticals to meet specific patient needs and describes the circumstances in which the agency does not intend to take action against such facilities.
Because the FD&C Act does not exclude radiopharmaceuticals from being compounded or repackaged by outsourcing facilities, FDA spells out its policies towards those facilities in a separate guidance.
Abram Remarks
Insanitary Conditions at Compounding Facilities, Federal Register Notice
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities, Federal Register Notice
Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities, Federal Register Notice


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy