Over-the-Counter drugs (OTC) also known as nonprescription drugs are medications sold directly to consumers without a prescription from a physician. OTC drugs are in general considered as safe and effective for use by the consumers without getting treatment from a healthcare professional. There are more than 300,000 OTC drugs are marketed with about 800 active ingredients.
Although there are more than 80 therapeutic categories of OTC drugs, starting from acne products to weight management drugs, FDA is not approving OTC products, but Center of Drug Evaluation and Research (CDER) ensures that OTC drugs are properly labeled and its ingredients listings. For each category, FDA developed an OTC drug monograph and published in the Federal Register. OTC drug monograph provided guidance which covers doses, acceptable ingredients, formulations and labelling requirements. When the company adheres to OTC monograph, it can make and market an OTC drugs without FDA’s pre-approval. OTC monographs defines the safety, efficiency and labeling of all OTC active ingredients. The drugs for which the active ingredients is not OTC monograph, has to apply for New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
FD&C acts requires firms that manufacture, contract manufacture, repack or re-label or salvaging of OTC drugs in the United States or that are offered for import in the U.S are required to register with FDA and renew their registration annually. Also domestic and foreign establishments must list all drugs that they manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign firms are required to identify a U.S agent and importers at the time of registration.
FDA Drug establishment registration needs to be submitted electronically using Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. The firms must use FDA’s Electronic Submission Gateway (ESG) to submit SPL files.
Private Label Distributors (PLD) are not required to register their establishment with FDA, however they have to apply for their own Labeler code and list their drugs with FDA. FDA has a released a list of summary of registration and listings requirements for the manufacture or distribution of human pharmaceuticals, which can be seen at https://www.fdahelp.us/Pdf/Drug.pdf
Drug establishments that are registered with FDA must list all the products they manufacture for commercial distribution under their own labeler code, which includes the API manufacturers, bulk manufacturers, contract manufacturers, re-packers and re-labelers.
FDA has published a regulation establishing standardized content and format for the labeling of OTC drug products (Drug Facts labeling). The Drug Facts labeling for OTC drug products is intended to make it easier for consumers to read and understand OTC drug product labeling and use OTC drug products safely and effectively. All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements.
Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.
Sudha S
Regulatory Consultant
Mail: office@libertymanagement.us