21 U.S.C. § 353b — Outsourcing facilities

This section creates a special category called an "outsourcing facility" — a place that compounds drugs, often in larger batches than a regular pharmacy, without needing normal FDA drug approval or certain labeling rules, as long as strict conditions are met. (a) In general. Three of the FDA's usual rules (on labeling, approval, and standards for outsourcing facilities) do not apply to a drug compounded by or under a licensed pharmacist's direct supervision at a registered outsourcing facility, if all of the following are true: (1) Registration and reporting. The facility follows the registration and reporting rules in subsection (b). (2) Bulk drug substances. The facility does not compound with bulk drug substances unless the substance is on the Secretary's list of substances with a real clinical need (built through a public notice, a comment period of at least 60 days, and a final listing notice), or the resulting drug is currently on the official drug shortage list; and, either way, the substance must meet an applicable pharmacy standard if one exists, come from a registered manufacturing facility, and arrive with a valid certificate of analysis. (3) Other ingredients. Any non-bulk ingredients used must meet the applicable pharmacy standard, if one exists. (4) Withdrawn or unsafe drugs. The drug must not be on the Secretary's list of drugs pulled from the market as unsafe or ineffective. (5) Not essentially a copy. The drug must not be essentially a copy of an already-approved drug. (6) Demonstrable difficulties. The drug must not be on the Secretary's list (built under subsection (c)) of drugs too risky to safely compound — or, if it is on that list, the facility must follow every condition the list requires to compound it safely. (7) Elements to assure safe use. If the drug is compounded from a drug (or its bulk ingredient) that carries special safety controls under section 355–1, the facility must show the Secretary beforehand that it will use comparable controls. (8) No wholesaling. The drug cannot be sold or transferred onward by anyone except the outsourcing facility that made it — though this does not stop a health care setting from giving the drug to a patient, or a pharmacy from dispensing it under a normal prescription. (9) Fees. The facility must have paid all fees it owes under section 379j–62. (10) Labeling. The drug's label must say it is a compounded drug, and must show the facility's name, address, and phone number, the lot number, the drug's established name, dosage form and strength, quantity, compounding date, expiration date, storage instructions, National Drug Code number if there is one, a "Not for resale" statement (and "Office Use Only" if it was not dispensed for one named patient), and a list of active and inactive ingredients. The container the drug comes out of for dispensing must carry that ingredient list if there was no room on the label, plus FDA adverse-event-reporting contact information and directions for use. The Secretary can require additional label information by regulation. (11) Outsourcing-only compounding. The facility must compound drugs only under this section's rules — nothing else. (b) Registration of outsourcing facilities and reporting of drugs. A facility registers with the Secretary every year between October 1 and December 31, giving its name, address, a unique facility ID, a contact email, and whether it plans to compound a drug from the shortage list the next year. The Secretary makes these registrations available on request and publishes a public list online of registered facilities, showing their states and whether they compound from bulk substances. Each facility must also report to the Secretary — when it first registers, and every June and December — which drugs it compounded in the past six months, with details like the active ingredient, its source, strength, dosage form, and how many units were made; these drug reports stay confidential unless the Secretary decides that would hurt public health. Registrations and reports must be filed electronically unless the Secretary waives that for good reason. Outsourcing facilities are subject to FDA inspection and do not get the inspection exemption other facilities sometimes get; the Secretary inspects them on a risk-based schedule that weighs their compliance history, recall record, the inherent risk of what they compound, how recently they were last inspected, and whether they compound from the shortage list. They must also report adverse events to the Secretary under standard FDA rules. (c) Regulations. The Secretary carries out the "demonstrable difficulties" list from subsection (a)(6) through regulations, and before issuing them must convene an advisory committee including the National Association of Boards of Pharmacy, the U.S. Pharmacopeia, experienced compounding pharmacists and physicians, and patient advocacy groups. Before those final regulations take effect, the Secretary may build an interim list the same way — public notice, at least 60 days of comment, then a final notice — but any such interim notice stops working after five years from November 27, 2013, or once the final regulations take effect, whichever comes first. The Secretary must review and update this list of risky drugs at least once every four years, though anyone can ask for updates at any time. (d) Definitions. "Compounding" means combining, mixing, diluting, or otherwise altering a drug or bulk substance to make a drug. A drug is "essentially a copy of an approved drug" if it is identical or nearly identical to an approved or already-marketed drug (unless that approved drug is currently on the shortage list), or if it uses a bulk substance that is also in an approved or marketed drug, unless the change makes a real clinical difference for an individual patient, as judged by the prescriber. An "approved drug" is one approved under section 355 that has not been pulled from the market as unsafe or ineffective. An "outsourcing facility" is a single-location facility that compounds sterile drugs, has chosen to register as an outsourcing facility, and follows this section's rules — it does not need to be a licensed pharmacy, and it may or may not fill prescriptions for named patients. A "sterile drug" is one meant to be injected or infused, certain eye or inhaled drugs in liquid form, or any drug that federal or state law requires to be sterile. Finally, paying the fee required under subsection (a)(9) does not excuse an outsourcing facility from also paying any separate pharmacy licensing fees owed to a state that licenses it as a pharmacy.