§ 432.5 - Labeling requirements.

(a) If an antibiotic drug is packaged for dispensing:

(1) It shall be labeled in accordance with the requirements prescribed by § 201.100 of this chapter, issued under section 502(f) of the act, unless the regulations pertaining to such drug specifically exempt it from such requirements.

(2) Its labeling shall bear any additional information required for the drug by specific regulations.

(3) Each package shall bear on its outside wrapper or container and the immediate container an expiration date prescribed for the drug by specific regulations; except that in lieu of the expiration date prescribed by specific regulations, a date may be used that is 12, 18, 24, 30, 36, 42, 48, 54, or 60 months after the month during which the batch was certified if the person who requests certification has submitted to the Commissioner results of tests and assays showing that such drug as prepared by him is stable for such period of time. If the specific regulation does not stipulate an expiration period, it shall be as prescribed by this section. If the manufacturer or repacker of the drug has been exempted from the certification requirements, such date shall be the number of months after the month during which the batch was last assayed and released by the manufacturer or repacker. If an expiration date is used that is longer than the minimum date provided for the drug by specific regulations, it may be used only if the manufacturer has submitted information to the Commissioner adequate to prove that the drug is stable for such time.

(b) If it is packaged solely for manufacturing use or for repacking, each package shall bear on its outside wrapper or container and the immediate container, the following:

(1) The number of units or micrograms of activity per milligram or per gram, and the number of grams or kilograms in the immediate container.

(2) The batch mark.

(3) The statement “Caution: Federal law prohibits dispensing without prescription.”

(4) The statement “For manufacturing use,” “For repacking,” or “For manufacturing use or repacking,” and, if it is not sterile, the statement “nonsterile.”

(5) The required expiration date.

(c) The expiration date prescribed for a drug by the regulations in this chapter may be omitted from the label of the immediate container if such container contains a single dose and it is packaged in an individual wrapper or container that bears the date prescribed.