21 CFR 201.100 - Prescription Drug Labeling Exemption

What it says

A prescription drug for human use is exempt from the requirement to carry adequate directions for use by a layperson, because it can only be used safely under the supervision of a licensed practitioner. The exemption applies only when stated conditions are met: the drug is held by parties authorized to handle prescription drugs, its label carries the prescription statement and key product information, and its labeling gives practitioners the information needed to use it safely.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The exemption exists because directions a layperson could follow cannot be written for a drug that needs practitioner supervision. Complete professional labeling takes their place, which is why the content requirements for prescribing information carry so much weight.
• The container label must carry the information the regulation lists, such as the prescription statement, the recommended or usual dosage, the route of administration where it is not oral, the amount or proportion of the active ingredients, and the identity of the manufacturer, packer or distributor.
• The exemption is conditional. A drug whose label or labeling falls short of the listed conditions loses the benefit of the exemption and can be considered misbranded under the FD&C Act.

What FDA inspectors look for

• Whether labels and labeling in use carry the content the exemption depends on and match the approved labeling for the product.
• Whether labeling control procedures, including issuance, reconciliation and control of excess labels, prevent the wrong or incomplete labeling being used.
• Whether label changes are controlled so that outdated or unapproved text does not reach the market.

Related regulations