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Zdrowie i gospodarka · 12/12/2006

Over-the-Counter Human Drugs; Labeling Requirements; Proposed Rule

The Food and Drug Administration (FDA) is proposing to amend its final rule that established standardized format and content requirements for the labeling of over-the-counter (OTC) drug products (Drug Facts Rule, codified at 21 CFR 201.66). This amendment proposes a definition and the option of alternative labeling requirements for "convenience-size" OTC drug packages.

Source: Federal Register — Food and Drug AdministrationOpen original release →