By Amy Shank, PCCA Director of Government Relations

In June 2021, Congressmen Henry Cuellar, D-TX, and Morgan Griffith, R-VA, introduced H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021. If enacted, this proposal will ensure critical patient access to urgently needed medications as well as ensure that pharmacies can continue to assist with drug shortages.

When the Food and Drug Administration (FDA) published its 2020 guidance document that temporarily expanded what medications 503A pharmacies can compound as well as the circumstances when they can compound them, the FDA acknowledged that urgent patient need should outweigh prescription requirements for 503A compounding, provided that other safeguards are in place. H.R. 3662 is in line with this guidance document and strikes that critical balance.

It Helps Compounders Meet Urgent Patient Needs

A delay in providing medication can result in patient harm, and the requirement for a patient-specific prescription for an urgent patient need may hamper care. For instance, certain patients may need antibacterial, antifungal or antiviral compounded medications to treat eye infections in immediate if not emergent circumstances.

To address these concerns, the legislation waives the patient-specific prescription requirement and allows a licensed provider to administer compounded medications to human patients in a clinical setting, provided that patient information be paired with the prescription within seven days of administration or seven days of patient discharge. This would only be allowable if four criteria are met:

• The prescriber certifies that the medication is not otherwise available.
• The medication is compounded in a limited quantity.
• The medication is assigned an appropriate beyond-use date.
• Adverse events are reported.

It Helps Compounders Assist With Drug Shortages

During the COVID-19 pandemic, the FDA used enforcement discretion for compounding drugs with respect to the “essentially a copy” requirements, as outlined in the temporary guidance document mentioned above. Thus, if a drug was in shortage, 503A pharmacies and 503B outsourcing facilities could produce the drug in shortage, and the FDA would not enforce statutory requirements that compounded drugs cannot be essentially a copy of a commercially available product.

H.R. 3662 would codify that flexibility while also providing safeguards to protect patients from further drug shortages. It would accomplish this by expanding the shortage definition to include the FDA’s list of drug shortages as well as shortages identified by the American Society of Health-System Pharmacists (ASHP), given that ASHP’s list encompasses a larger number of drug products on shortage and not only those that are deemed medically necessary.

You can read H.R. 3662 online as well as the FDA’s 2020 temporary compounding guidance document and the FDA’s “essentially a copy” guidance document . PCCA members can contact our Public Affairs team with any questions they may have about this bill.

Also on The PCCA Blog: How to Cultivate a Relationship With Your Lawmakers

Amy Shank, PCCA’s Director of Government Relations, previously served as Vice President of Capitol Hill Consulting Group, where she advised pharmacy, pharmaceutical and university clients on federal legislative priorities. Amy also has over 10 years of experience in the United States Senate. She was the Director of Oversight and Investigations for the Senate Health, Education, Labor and Pensions Committee. She was also a senior policy advisor to the Senate HELP Committee. Amy was a senior analyst for the Chairman of the Senate Budget Committee, former Senator Don Nickles, R-OK, and began her legislative career in his Republican Whip office as a policy advisor.

A version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.