NPHLA Intelligence
A complex issue translated into plain professional language. Plain-English explainers on complex pharmacy, compounding, regulatory and clinical questions — built from official sources, reviewed by an editor before publication and updated when the facts change.
Phase labels appear in every drug-pipeline headline. Here is what each phase is designed to answer, how large the studies typically are, and what a phase label does not tell you.
AI-assisted · Editor reviewed2 sources2 min read
Pharmacy benefit managers sit between drug manufacturers, health plans and pharmacies. Reform proposals target how PBMs are paid, how they reimburse pharmacies and what they must disclose. Here is what is already in force and what is only proposed.
AI-assisted · Editor reviewed4 sources2 min read
When FDA lists a drug as in shortage, some federal limits on compounding copies of that drug stop applying; when FDA resolves the shortage, they return. Here is how that works for 503A pharmacies and 503B outsourcing facilities.
AI-assisted · Editor reviewed6 sources2 min read
Federal law gives compounders two routes, with different rules on prescriptions, quality standards, oversight and copies of approved drugs. Here is how they compare, using GLP-1 compounding as the worked example.
AI-assisted · Editor reviewed6 sources3 min read
The DSCSA builds an electronic, interoperable system to trace prescription drugs at the package level. For pharmacies — “dispensers” in the law — it sets rules on trading partners, tracing documentation, suspect and illegitimate products, and records.
AI-assisted · Editor reviewed6 sources2 min read
