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.