§353b Outsourcing Facilities

Summary

Allows a drug-making place to register with the FDA as an outsourcing facility and be treated differently from some drug rules if it follows safety, quality, and reporting steps. The drug must be made under the direct supervision of a licensed pharmacist and in a registered outsourcing facility that follows the rules. Bulk drug ingredients can only be used if the FDA has listed them for clinical need or they are on the official drug shortage list when made, and those ingredients must meet recognized standards, be made by a registered manufacturer, and come with a certificate of analysis. Other ingredients must meet compendial standards when those exist. The drug cannot be one that was withdrawn for safety or effectiveness, cannot be essentially a copy of an approved drug, and cannot be on a list of drugs that are too risky or hard to compound unless the facility follows any special conditions. If the drug is subject to special safety controls (a REMS), the facility must show it will use comparable controls before compounding. The facility must pay required federal fees and must label products to show they are compounded, identify the facility, give lot, name, strength, quantity, compound and expiration dates, storage instructions, NDC if available, “Not for resale” (and “Office Use Only” when not for an identified patient), ingredient information, safety reporting info (www.fda.gov/medwatch and 1–800–FDA–1088), and directions for use; unit containers may include some information on the outer container if space is limited. Compounding must follow these rules only. A facility must register with the FDA each year between October 1 and December 31, giving its name, address, unique facility identifier, and contact email, and say if it plans to compound shortage-list drugs next year. The FDA will publish a public list of registered outsourcing facilities. New registrants and registered facilities must report, initially and in June and December each year, the drugs they made in the prior six months and give details such as active ingredient, source, NDC (if any), strength, form, package, and number of units. Reports are usually submitted electronically. Outsourcing facilities are inspected on a risk-based schedule and must send adverse event reports as required. The FDA will make a rule listing drugs or categories that are hard to compound after consulting an advisory committee and giving at least 60 calendar days for public comment; temporary listings can be made before final rules but expire by the earlier of five years after November 27, 2013 or the final rule, and the FDA must review such lists at least every four years. Simple definitions: compounding = mixing or altering drugs to make a product; essentially a copy = almost the same as an approved drug; approved drug = a drug approved by FDA and not withdrawn for safety; outsourcing facility = a place that compounds sterile drugs, registers as such, and follows these rules; sterile drug = a drug meant to be sterile for injection, certain eye or inhaled aqueous drugs, or any drug required to be sterile. Paying the federal outsourcing fee does not replace any State pharmacy license fees.