FDA’s Role in Pharmacy Compounding

FDA’s Role in Pharmacy Compounding

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ALEXANDRIA, VA (29 March, 2019) – The International Academy of Compounding Pharmacists today cheered the reintroduction of The Preserving Patient Access to Compounded Medications Act, H.R. 1959, by Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX), which would clarify provisions of the Drug Quality Security Act of 2013 related to pharmacy compounding.

That clarification is necessary, according to IACP Executive Vice President Scott Brunner, CAE. “The U.S. Food & Drug Administration has misinterpreted congressional intent, overstepped its regulatory authority, and is jeopardizing patient access to compounded medications as a result,” Brunner said. “This legislation, which has broad support both in Congress and from an impressive coalition of groups representing pharmacists, physicians, and patients, seeks to assure that FDA’s role and actions in regulating compounding pharmacies are in line with Congress’ stated aims when it passed DQSA in 2013.”

The bipartisan legislation would require FDA to develop policies regulating compounding through the formal rulemaking process, rather than via agency guidance documents. “Those policies should better balance patient safety with patient access,” said Brunner. The bill also would formally recognize state boards of pharmacy as the primary regulators of pharmacy compounding.

Specifically, the Griffith/Cuellar legislation would:

  • Authorize “office-use” compounding by 503A pharmacies where permitted by state law.
  • Clarify that dietary supplements with USP or NF monographs are appropriate ingredients for compounding.
  • Define the terms “distribute” and “dispense” consistent with the NABP model pharmacy act and other state and federal law definitions.
  • Clarify that compounding pharmacies are retail pharmacies for purposes of FDA inspection authority.
  • Require FDA to go through the formal rulemaking process for establishing DQSA policies rather than issuing “guidance documents” that circumvent requirements for public notice and input.

In the previous Congress, more than sixty members co-sponsored the legislation. Brunner said he anticipates those lawmakers will renew their support for the measure in this Congress.

“We appreciate Congressmen Griffith’s and Cuellar’s leadership on this important issue,” said Brunner.

The International Academy of Compounding Pharmacists is the voice for compounding pharmacy, representing more than 4,000 compounding pharmacists, technicians, students, and suppliers. Compounding pharmacists work directly with prescribers to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. IACP’s mission is to protect, promote and advance the art and science of pharmacy compounding.