01
Tell patients clearly when a medication is compounded
Patients should understand the regulatory status of the medications they receive.
APC proposes requiring compounded medications to include a clear, factual disclosure that they have not been evaluated or approved by FDA. The disclosure should inform patients, not serve as a warning label.
02
Report serious adverse events
Regulators need useful information about events that may signal patient harm, contamination, compounding errors, or product-quality concerns.
APC proposes requiring traditional 503A compounding pharmacies to report serious adverse events — including death, life-threatening events, hospitalization, and significant disability — via FDA's MedWatch system.
03
Target deceptive marketing of products not lawful for human use
Consumers are finding substances labeled “research use only” or “not for human use” that are simultaneously marketed for weight loss, anti-aging, performance, or other human uses. A disclaimer should not provide cover for that conduct.
APC proposes prohibiting direct-to-consumer marketing that encourages human use of substances that are not lawful for use in human drugs. The substances themselves are illegal. Marketing them to consumers should be, too.
04
Close prescription-drug oversight gaps
Some medical spas, wellness clinics, and similar businesses procure, store, prepare, dispense, or administer prescription drugs outside traditional board of pharmacy oversight.
Patients deserve to know who is providing their care and that the products being used come through a lawful supply chain.
APC proposes targeted registration, transparency, and accountability requirements for businesses performing prescription-drug functions, including safeguards against counterfeit, adulterated, misbranded, and “research use only” products.
05
Protect lawful pharmacies from deceptive legal intimidation and abusive complaints
Drug manufacturers have the right to protect their intellectual property, pursue legitimate legal claims, and report suspected violations to regulators in good faith. Those rights should be preserved. But drug manufacturers are not regulators. They should not misrepresent their interpretation of the law as an official enforcement determination, or use poorly supported complaints to coerce pharmacies and outsourcing facilities to stop otherwise lawful activity.
APC proposes prohibiting materially false or misleading statements about the law, regulatory authority, or facts when those statements are intended to intimidate a state-licensed pharmacy or outsourcing facility into stopping lawful compounding. States should also establish appropriate safeguards against knowingly false or materially misleading regulatory complaints, including complaints submitted without reasonable diligence.
.png?width=17&height=16&name=folder%20(1).png){kind=small}
