FDA Reveals Plans for Oversight of Pharmacy Compounding

by pharmacy on November 23, 2016

pharmacy compounding restrictionsOver the spring and summer, the FDA released several guidance documents that reveal what they think about pharmacy compounding now that relevant federal law provisions are in place, and there’s a budget available for oversight.

Right now, there is no final version of the guidances, but there are a number of ideas that could be hard for health systems and hospitals across the country to implement. There are some hospitals and health systems that may not be worried right now, but as more hospitals continue to affiliate with one another or create health systems with multiple hospitals, their places to centralize compounding may need to be revisited.

Guidances aren’t regulations. The Drug Quality and Security Act (DQSA) didn’t do anything to change section 503A of the federal Food, Drug, and Cosmetic Act (FDCA) other than removing the prohibition of advertising specific compounded drugs, because it was considered unconstitutional.

Section 503A is responsible for exempting pharmacy-compounded medications from three subsections of the FDCA, which went into effect in 1998, but was invalidated by the Supreme Court just four years later.

After that happened, the FDA started using a compliance policy guide along with an enforcement policy guidance to preserve the traditional compounding practices and keep tracking of when those pharmacy practices look like conventional manufacturing.

When the DQSA was enacted in 2013, the FDA withdrew the policy documents, leaving section 503A in the federal law, without any guidance for compounders, or enforcement regulations.

In December 2014, Congress worked to change the situation, because they wanted to incorporate funds into the FDA budget for dealing with the pharmacy compounding oversight.

These aren’t the only expected guidances to come from the FDA in regard to compounding medication, but what we know so far is:

  • Compounded drugs can still qualify for 503A’s exemptions, but don’t exempt them from the FDA taking action against the pharmacy. This is because the 503A exemptions don’t apply to the entire FDCA.
  • Some details for pharmacy contamination that would render the drugs unaltered under federal law, such as visible mold, were also outlined in the draft guidance.
  • Final versions for guidances related to section 503B have been released to outline what and how the FDA thinks about the pharmacy’s duty to report adverse events, as well as registration and fees.
  • Another draft guidance outlines how much compounded product can be prepared before the pharmacist receives a patient-specific order for the product from a prescriber.

 

More information is expected to be released in the future as drafts are edited and become final, however, there are many who feel guidances need to be adjusted for the differences between compounding at a small community pharmacy compared to compounding at a large hospital system pharmacy.

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