FEATURED ISSUE
Proposed regulation changes for custom meds
Do you rely on customized medications? Perhaps your medication is not currently available, you are allergic to an ingredient, your physician wants to customize your dose, or you need a natural formulation of a medication. If so, then you are grateful that there are specialized pharmacies, known as “compounding pharmacies,” that custom make what you need, based on your physician’s prescription.

There is pending federal legislation, H.R.1959 – the Preserving Patient Access to Compounded Medications Act of 2019, that may impact your access to the compounded medication you may need in the future.

Although the federal Food and Drug Administration (FDA) regulates virtually all commercial pharmaceutical manufacturing, individual states regulate the pharmacies where you purchase your medications, including community “drug stores,” large chains, in-store pharmacy counters, and specialty pharmacies. The FDA has the authority to decide what ingredients compounding pharmacists are allowed use to make medications. For example, the FDA can classify a substance as “Demonstrably Difficult to Compound,” and then forbid your pharmacist from compounding your formulation with that substance. Also, while theFDA’s Pharmacy Compounding Advisory Committee (PCAC)can ban substances from compounding, interestingly there is no voting member of this committee who is an actual compounder.

In 2016, the FDA stopped accepting United States Pharmacopeia Convention(USP) monographs (all aspects of a product are objectively reviewed in a monograph)for supplements. Without the monographs, dietary supplements cannot be included as active ingredients in compounded medications. Although it is possible to compound customized natural medicines and supplements if they are on the FDA’s preapproved list, interestingly all nominations of supplements to be added to this list were rejected. H.R.1959 mandates that the FDA accept USP monographs for dietary supplements.

The pending legislation also addresses the industry’s need for clarifying definitions of “distribute” and “dispense” as related to interstate shipments. The goal is to make it clear that (1) “distribution” means sending compounded medicines interstate when there isn’t a specific patient prescription (which Congress gave the FDA authorization to regulate) and (2) “dispensing” refers to a compounded medication provided to an individual patient pursuant to a prescription or a doctor’s order (which the FDA does not regulate).

Finally, H.R.1959 amends section 503A of the Food, Drug, and Cosmetic Act (which pertains to “traditional” pharmacies, as opposed to larger “outsourcing” facilities) to unequivocally permit “office use” of compounded drugs, which allows doctors to keep a supply of certain medications in their office to provide immediate treatment to patients.

ISSUE: It is important to understand the significance of each of the compounding-related regulation changes

AHHA strives to maintain a neutral position on issues and viewsknowledge as power. As you read media reports on this pending legislation, you will want to understand the choices related to each of the many individual elements impacting compounding pharmacies. In addition to what is explained above, the following related articles were selected to provide you more in-depth coverage.

Frequently Asked Questions About Pharmaceutical Compounding
APhA (American Pharmacists Association)

State Oversight of Drug Compounding (2/26/18)
Pew Charitable Trusts

H.R.1959 – Preserving Patient Access to Compounded Medications Act of 2019 (3/28/19)
Congress.gov

Maintaining Patients’ Access To Personalized Medicine (4/24/19)
by Amy Shank
PCCA (Professional Compounding Centers of America)

New Bill Could Help Save Natural Medicines (4/10/19)
Alliance for Natural Health USA

Actions Following the FDA Compounding Priorities Plan (1/22/19)
by Ron Lanton III, Esq, and Tera Lynn A. Rule, PharmD, JD, RPh, Esq
Specialty Pharmacy Times

FDA Finalizes Rule on Bulk Drug Substances (2/15/19)
Pharmacy Times

Bioidentical Hormones: Some Good News, Some Troubling News (3/14/19)
Alliance for Natural Health USA

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