Pharmaceutical FDA Compliance

All domestic and foreign establishments that manufacture, repack, relabel, or salvage drug products must register with FDA. Registration is done electronically through FDA's Structured Product Labeling (SPL) system using the Drug Registration and Listing System (DRLS). Registration must be renewed annually between October 1 and December 31. Foreign establishments must also designate a US Agent.

The National Drug Code (NDC) is a unique 10-digit, 3-segment identifier for drug products. It identifies the labeler, product, and package. To obtain an NDC, you must first obtain a labeler code from FDA, then assign product and package codes. NDCs are required for all commercially distributed drugs and must be included in drug listing submissions and on product labels.

All commercially marketed drug products must be listed with FDA using the electronic SPL submission system. Initial listing must be submitted within 5 days of beginning commercial distribution. Updates are required in June and December of each year, or within 30 days of certain changes. Listing information includes product composition, labeling, and establishment information.

The OTC Drug Monograph system provides conditions under which certain OTC drugs are generally recognized as safe and effective (GRASE). If your product conforms to an applicable monograph, it can be marketed without individual FDA approval. The monograph specifies: acceptable active ingredients and doses, labeling requirements, and testing standards. Products not conforming to a monograph require a New Drug Application (NDA).

Drug cGMP regulations (21 CFR Parts 210 and 211) require manufacturers to maintain quality systems covering: organization and personnel, buildings and facilities, equipment, production and process controls, laboratory controls, packaging and labeling, holding and distribution, and records. FDA conducts inspections to verify compliance. Non-compliance can result in warning letters, seizures, and injunctions.

It depends. Prescription drugs require either a New Drug Application (NDA) for new drugs or an Abbreviated New Drug Application (ANDA) for generics. OTC drugs that conform to applicable monographs can be marketed without individual approval. OTC drugs with new active ingredients or those not covered by a monograph need an NDA. The OTC Monograph Reform Act of 2020 modernized this process.

Drug labeling must comply with 21 CFR Part 201. Requirements include: established name and proprietary name, quantity of contents, name and address of manufacturer/distributor, adequate directions for use, required warnings, active and inactive ingredients, and lot number and expiration date. OTC Drug Facts labeling format is required for over-the-counter drugs. Prescription drugs have additional labeling requirements.

Yes, all foreign drug establishments must designate a US Agent when registering with FDA. The US Agent must reside or maintain a place of business in the US and serves as a communication link between FDA and the foreign establishment. The agent must be available during regular business hours to assist FDA with emergency situations and respond to inquiries.