§353b Outsourcing Facilities

Summary

Licensed pharmacists may make compounded drugs at places that sign up as "outsourcing facilities" and follow rules so they do not have to meet some usual drug-approval laws. These places must register every year between October 1 and December 31, give basic contact and identifier information, say if they will compound drugs on the drug-shortage list, pay required fees under section 379j–62, and report what they make when they first register and again each June and December. They may only use bulk drug substances if those substances are on a government list made after at least 60 days for public comment, or if the drug is on the official drug-shortage list. Ingredients must meet recognized pharmacopeia standards when those exist. They cannot make drugs that were removed from the market for being unsafe or ineffective, or make drugs that are basically copies of approved drugs unless a prescribing doctor says there is a real clinical difference. Outsourcing facilities must follow any special safety controls for drugs with approved REMS, avoid selling drugs through others (though hospitals can use them and pharmacies can dispense on prescription), label products clearly as compounded drugs and include the facility name/address/phone, lot number, drug name, strength, quantity, compounding and expiration dates, storage instructions, NDC if available, the words “Not for resale” (and “Office Use Only” when not for an identified patient), and list ingredients; the container must also show the ingredient list if the label cannot, give MedWatch reporting info (www.fda.gov/medwatch and 1–800–FDA–1088), and give directions for use. Outsourcing facilities that make sterile drugs are inspected on a risk-based schedule and must send adverse event reports as required in 21 C.F.R. section 310.305. Key terms in one line each: compounding — combining or changing drug ingredients to make a drug; essentially a copy of an approved drug — a product identical or nearly identical to an FDA-approved drug unless a shortage or a prescribing doctor finds a clinical difference; approved drug — a drug approved under section 355 and not withdrawn for safety; outsourcing facility — a place that compounds sterile drugs, registers as an outsourcing facility, and follows these rules (it need not be a pharmacy and may or may not take patient-specific prescriptions); sterile drug — a drug that must be free of microbes for injection, certain eye or inhaled liquid drugs, or any drug required to be sterile by law. State pharmacy licensing fees still must be paid when required by a State.