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Pharmacy compounding's source for clinical information, regulatory updates, and opportunities

THE PCCA BLOG

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Stay current on PCCA news and events, market trends, and all things compounding!

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You’re likely familiar with semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) used in commercially available prescription medicines for treatment of type 2 diabetes and obesity. Are you aware that GLP-1 — the hormone semaglutide is designed to induce — is naturally produced by the body to help promote healthy blood sugar levels, curb cravings and maintain a healthy weight? Or aware of the bacterium in the gut microbiota that induces natural production of GLP-1?

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Many regulatory and nonprofit agencies, including the FDA and the Institute for Safe Medication Practices (ISMP), recommend use of tall man lettering on drug labels. Learn why PCCA is adopting the technique for our active pharmaceutical ingredient (API) labels.

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In February, the FDA approved the first and only oral treatment for eosinophilic esophagitis (EoE) that contains the active pharmaceutical ingredient (API) budesonide at a strength of 2 mg/10mL, which may sound familiar to many compounders.1 How does this affect compounders and what other potential options are available to patients?

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Imagine having a clinical support team on-call 24/7, who is able to resolve tricky formula issues, research literature for new compounding developments, provide marketing and business support, and navigate esoteric government agency regulations. If you’re a PCCA member with clinical services access, you don’t have to imagine it — this “extension of your pharmacy staff” already exists! Members without clinical services access may not know what they’re missing — all for just $27 a day.

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On November 1, 2023, revisions to USP Chapter 795 and Chapter 797 became official and made USP 800 compendially applicable and potentially enforceable. However, other regulatory agencies — including state boards of pharmacy and the FDA — may impact whether USP 800 is enforceable in your pharmacy.