HOUSTON — Compounding pharmacists nationwide are calling on lawmakers to thwart efforts that pharmacists fear would restrict patient access to compounded medications.

PCCA leaders said that as part of the group’s ACT Virtual Legislative Conference, compounding pharmacists nationwide are scheduled to meet Thursday with 110 members of Congress to raise concerns about regulations that potentially will disrupt their pharmacies and the patients they serve.

“Without congressional support of these issues, the future of personalized medicine is at risk,” said PCCA vice president of Public Affairs, Communications, Education and Human Relations Lizzie Harbin. “Human and animal patients need access to all available treatment options to live healthier, better lives. Prescribers should not be limited in their ability to treat patients as individuals, and pharmacists should be able to lawfully fill prescriptions for needed treatments.”

Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioner’s prescription in which individual ingredients are mixed together in the exact strength and dosage form required for the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.

More than 60 compounders are participating in this year’s conference to share critical patient access issues centering around compounded hormones and animal patient compounded medications with members of Congress.

A July 2020 Food and Drug Administration-commissioned and funded report (bit.ly/nasem-bhrt) issued by the National Academies of Sciences, Engineering, and Medicine (NASEM) recommends prescribing restrictions for compounded hormones and that the most commonly compounded hormones be considered for FDA’s Difficult to Compound list – meaning anything on that list would be illegal to compound. If implemented, these recommendations would restrict or eliminate patient access to compounded hormones, negatively impacting millions of women and men nationwide. While a range of evidence was provided to the NASEM committee by stakeholders, the committee elected to base their findings on just 13 studies, without a formal meta-analysis and without full consideration of all of the available evidence.

For an April 2022 article (bit.ly/NAMS-cBHT22) published in Menopause, the peer-reviewed journal of the North American Menopause Society (NAMS), PCCA’s Yi Liu, PharmD, PhD, Daniel Banov, MS, RPh, and A.J. Day, PharmD, executed a comprehensive process that reviewed more than 3,000 full-length papers to identify 29 randomized control trials examining the use of compounded bioidentical hormones by over 1,800 patients. Titled “Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials,” this article provides new insights on existing safety and efficacy data on compounded hormones. The publication of this latest article in Menopause shows that there is more evidence available than what was identified and considered by the NASEM committee and the evidence review process was not thorough, which contradicts and casts doubt on the scientific merit of the conclusions.

Another critical patient access issue involves compounded medications for veterinary patients. In April 2022, the FDA finalized guidance titled Compounding Animal Drugs from Bulk Drug Substances: Guidance for Industry (GFI) #256 (bit.ly/gfi-256), which adds unnecessary uncertainty, builds upon flawed concepts and ultimately restricts access to critical compounded medications for animal patients. The guidance is outside of the FDA’s statutory authority and would limit compounding to starting with FDA-approved products except in limited situations.

During the Thursday meetings, compounders will ask their members of Congress to:

• Contact the FDA to express support for patient access to compounded hormones and ensure that the agency is aware of the Menopause journal article and resulting evidence regarding the safety and efficacy of compounded hormone therapies; and
• Ensure continued uninterrupted access to compounded medications for animal patients by contacting the FDA to request the withdrawal of GFI #256 and to work with all stakeholders – including compounding pharmacists – on a new guidance that maintains animal patient access and safety.