It's not an accident that drug labels all look the same.
The Code of Federal Regulations (CFR) is composed of rules from federal government agencies. Food and drug regulations are outlined in Title 21 of the CFR. And, Part 201 of Title 21 includes FDA drug label regulations divided into seven subparts, A through G.
General Guidelines
Subpart A provides general guidance for the labeling of drugs including: placing of the name and address of the drug maker; defining the adequacy of drug usage directions; preventing misleading statements about the drug's ingredients; ensuring the prominence of required statements; defining infant; and declaring the presence of
FD&C Yellow No. 5, FD&C Yellow No. 6, phenylalanine and sulfites.
Prescription Drugs
Subpart B provides guidelines for the labeling of prescription drugs and insulin. These guidelines include: statement of identity of the drug maker, declaration of quantity of drug (e.g., number of pills), statement of the recommended or usual dosage and requirements for content and formatting.
OTC Drugs
Subpart C provides guidelines for the labeling of over-the-counter (OTC) drugs. These guidelines are similar to those for prescription drugs, but also include: requirements for the front panel of the drug package; statement of warning for women that that are pregnant or breastfeeding; and requirements for the inclusion of sodium, calcium, magnesium and potassium content.
Exemptions
Subpart D provides instances in which required directions of use are not applicable. Subpart E details other exemptions related to processing and repackaging of the drug and for drugs that contain gases like carbon dioxide.
Efficacy Claims
Subpart F provides guidelines for promotional and marketing claims related to the drug's effectiveness.
Specific Drugs
Subpart G provides additional guidelines for specific drugs. For example, there is a suggested warning for OTC drugs that are used to treat minor sore throats.
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