USP 800 discusses Environmental Quality and Control (Section 6) related to environmental wipe sampling for hazardous drug (HD) surface residue. This is not a requirement in USP 800; instead, it is stated that this should be performed routinely. What does this mean for those who handle HDs and why should compounders consider performing routine HD wipe sampling?

Sections of the FDA’s Drug Quality and Security Act (DQSA) distinguish compounding pharmacies (503A) from outsourcing facilities (503B). Due to several factors, many of which are related to drug shortages and the USP 797/USP 800 updates, 503A pharmacies are considering partnering with 503B entities for compounded sterile preparations and/or hazardous materials. We’ll discuss the differences between 503A pharmacies and 503B outsourcing facilities, review Section 503B and summarize how to effectively evaluate 503B compounding pharmacies for a potential partnership.

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?

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.

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?

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.

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.