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Threats to Patient Access
Patient access to compounded medications is under threat on a number of fronts. When Congress passed the Food and Drug Act, it specifically created a place for compounding pharmacy because traditional FDA-approved drugs cannot serve the needs of every patient.
As an advocacy organization, our commitment is to the entire compounding pharmacy profession, including pharmacists, patients (human and animal), prescribers and others. We work to ensure that the profession is not just preserved, but elevated as a key component of the health-care industry.
The threats to compounding, however, are real.
Regulatory
At APC, we believe in strong, science-based and practical regulation. In the same way we believe every compounding pharmacy and pharmacist must adhere to the highest code of ethics. We do, however, oppose regulatory efforts that show no evidence that the regulation makes patients safer or that restrict patient access to compounded medications their prescriber says they need.
A few of the regulatory issues we are working on today include:
The Difficult to Compound list (hormones, GLP-1s)
MOU, adverse effects framework
GFI #256 enforcement
Expanding the definition of “shortage” to allow compounders to help fill in the drug supply chain
Improve the representation and processes of the Pharmacy Compounding Advisory Committee
Supporting proposed changes to the DEA’s constructive transfer rules (Scott – do we want to include this?)
Providing feedback to stakeholders involved with passing the ADINA act, to improve labeling of drugs for patients with serious allergies (same here)
Shortages
The Food, Drug and Cosmetic Act of 1938 included a vital safety net for patients in times when the major drug manufacturers were unable to supply critical medicines, for whatever reason. The drug shortage list maintained by FDA allows compounding pharmacies to compound an exact version of a drug’s formulation to ensure patients retain access to their medicines when FDA drugs are not accessible by patients; this applies even to patented drugs.
APC supports expanding the definition of “shortage” and improving the FDA’s drug shortage list. There is proposed legislation that would allow the FDA to consider data submitted by prescribers and pharmacists, instead of just information submitted by manufacturers, when determining if a drug is in shortage. When drugs are listed “currently in shortage” on the FDA’s drug shortage list, compounders can help fill the gaps in the supply chain by making “essentially a copy” of an FDA-approved medication.
Critical Drugs in Short Supply:
Ozempic
You’ve probably seen the name of this drug, manufactured by Novo Nordisk, in the news lately. Ozempic® is one in a class of drugs, including Wegovy® (Novo Nordisk) and Mounjaro® (Lilly), used to lower cardiovascular risk in patients with diabetes. Semaglutide (the active pharmaceutical ingredient in Ozempic®) has also proven effective in helping patients with obesity lose weight and, as a result, demand for these drugs has made them nearly impossible to obtain from the manufacturers.
In March 2022, the shortage of these drugs became so acute that FDA listed semaglutide as “currently in shortage” on the agency’s Drug Shortages list. The drug has remained on that list ever since. That official action means that when a physician or other prescriber believes the drug is the right therapy for a patient, they can prescribe a compounded version of the FDA-approved drug.
Ketamine is an anesthetic drug that has been shown to be effective in treating some forms of severe mental illness, especially severe depression and post-traumatic stress disorder. It’s commonly used when other forms of treatment have been unsuccessful and exhausted. Unfortunately, ketamine has now joined Ozempic® and many other vital medications on the FDA’s Drug Shortages list. This is particularly dangerous because when a suicidal or severely depressed patient has been stabilized using ketamine, they need regular doses of the drug — or maintenance doses — to remain stable.
Like semaglutide, the FDA-approved active ingredient in Ozempic®, various strengths of ketamine, which is given intravenously or intramuscularly, can be compounded as long as ketamine remains on the Drug Shortages list, throwing severely depressed patients who depend on the drug a literal lifeline.
FDA Restriction
Compounding pharmacies do not oppose FDA or state regulatory oversight. Quite the opposite. Compounding pharmacies are highly regulated, and we welcome this regulation to ensure the safety of our products and our patients. However, we do oppose restrictions based on faulty evidence and misinterpreted data, and restrictions that will limit patient access to medications they desperately need.