Being an exceptional compounding professional means you never stop learning
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 Drugmakers have had a lot to say lately about compounded medications, but not all of it true. This week, scores of compounding pharmacists and technicians are on Capitol Hill to meet with members of Congress and share the truth about the essential role compounded drugs play in our healthcare system — and the compliance framework within which compounding pharmacies prepare custom medications based on the order of a licensed prescriber. Here you’ll find resources and explainers about compounded medications, so you won’t fall for drugmakers’ misrepresentations. Compounders on Capitol Hill 2025 Briefs
Pharmacy compounding basics |
You need to know this: Important background informationA Green List, huh. Good for FDA ... I guess?So who is FDA's announced "green list" really going to affect ... if anyone? (Hint: It's not legitimate compounders.) No Respect: How Misrepresenting Compounded Drugs Hurts PatientsCompounded medications aren’t “knockoffs.” They’re not “copycats.” And they’re certainly not counterfeits. Sorry, compounded drugs are NOT “unapproved”Drugmakers and their spokesminions have done a masterful job in recent months spreading the phrase “unapproved drugs” for compounded medications. But that's neither factually accurate nor logically compelling. Glossing over the prescriber's roleThe media (and regulators) seem to forget that "Nothing happens in a compounding pharmacy until a prescriber writes a prescription for a compounded drug." Compounded weight-loss drugs and one-handed reportingWhen it comes to writing about compounded versions of GLP-1 drugs, there are too many 'one-handed' reporters and not enough informed, accurate reporting. What's really going on with GLP-1 drugsAPC asked compounding pharmacy owners nationwide to tell us what real-world patients were experiencing when it came to getting their GLP-1 drugs. (Spoiler: They're having all sorts of trouble.) Biologics, like most peptides, aren't eligible for compoundingThere are strict rules under federal law about what active pharmaceutical ingredients are permitted for use in compounded medications. Most peptides, notably retatrutide, cannot be used in compounding. |
Our Blueprint...... for Eliminating Redundant, Unauthorized, or Ineffective Regulation that Impedes Patient Access to Compounded Drugs  The Trump administration wants to reduce unnecessary regulation — its goal is to remove 10 regulations for each new one introduced. Our Blueprint is what HHS Secretary Robert F. Kennedy, Jr., called "a target-rich environment" for doing just that. It highlights key federal policies or proposals that are redundant, unauthorized by statute, or unproven in their benefit to public health — and it offers constructive recommendations for smarter, more effective regulatory approaches — ones that preserve safety without undermining access or innovation. GET IT HERE. Our CEO’s “Compounding Interests” — background on the ideas in the Blueprint:
"Weaponizing the DDC Lists" — Congress didn’t intend that the demonstrably difficult to compound lists would become a tool for gamesmanship. 
"FDA’s Monograph Divide: Time to Fix It" — When it comes to dietary supplements, FDA has decided that “applicable” doesn’t mean what it says. 
"Let’s finally retire that MOU—and the 5% cap that comes with it" — The FDA’s memorandum of understanding with states is a relic of a looser regulatory framework that no longer exists. 
"The illogic of demanding efficacy data—for drugs that can’t make efficacy claims" — There’s a fundamental disconnect in how FDA evaluates substances for inclusion on the compounding bulks lists. 
"You can’t color inside the lines when there aren’t any" — In the case of FDA’s "Insanitary Conditions" guidance, there just aren’t many lines. Lots of examples, but not lines. And that’s a problem. 
"DDC Lists: When Process Becomes Pretext" — Congress gave FDA the green light years ago to create “Demonstrably Difficult to Compound” (DDC) lists, but the agency's draft proposed rule is a stark departure from what Congress authorized. 
"When bureaucratic overreach trumps veterinary care" — It’s not often you see such a perfect case study in federal overreach, but the FDA Center for Veterinary Medicine’s GFI 256 fits the bill. 
" When FDA Alarms Without Answers " — When the FDA issues a public alert about compounded therapies, those alerts are routinely devoid of context, detail, or guidance. 
"A Compounding Advisory Committee that sidelines compounders" — In principle, FDA's PCAC is a fine idea to offer reasoned guidance to the agency. In practice, though, it's a stacked deck. 
"A Code you can live by " — Now more than ever, we need to be adhering to the highest ethical and compliance standards. Cutting corners and taking shortcuts have no place in our profession. 
"What FDA gets wrong with its compounded DTE prohibition" — The FDA has quietly reclassified desiccated thyroid extract (DTE) as a biologic drug. That’s not only scientifically wrong, but it flatly contradicts the agency’s own policy. Semaglutide, tirzepatide, and more: Let’s talk GLP-1 compoundingGLP-1 Compounding Primer (2-page PDF) APC’s detailed statement on shortage drug compounding and GLP-1s Compounded GLP-1 reporting: Our CEO’s commentary Issue Brief: Compounded GLP-1 Drugs and Patient Adverse Events Guidance we give our members: |
Lawmakers have raised concerns with the FDA regarding Hims & Hers recent Super Bowl ad and its implications for compounded medication marketing. APC CEO Scott Brunner responds with a detailed statement, emphasizing the regulatory distinctions between compounded drugs and FDA-approved pharmaceuticals, the role of the FTC in oversight, and APC’s commitment to best practices in marketing transparency. Read the full statement to stay informed on this evolving discussion.
Drugmakers have asked FDA to prohibit compounded GLP-1s
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