Private Label Distributors (PLDs)
A firm that does not participate in the manufacture or processing of a drug but instead markets and distributes under its own trade name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.
- PLDs do not have a registration or listing obligation for drugs they do not manufacture or process
- PLDs may elect to submit listing information for a drug they do not manufacture or process directly to the FDA
- If they list, they assume full responsibility for compliance with all listing requirements
- If they do not list, the registered establishment producing the drug(s) must submit the drug listing information
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