Sec. 305. labeling and packaging requirements
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## Sec. 305 labeling and packaging requirements **[**[21 U.S.C. 825](/us/usc/t21/s825)**]** ###
(a)It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in section 201(k) of the Federal Food, Drug, and Cosmetic Act) containing an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of controlled substances. ###
(b)It shall be unlawful for the manufacturer of any controlled substance to distribute such substances unless the labeling (as defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act) of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under subsection (a). ###
(c)The Secretary shall prescribe regulations under section 503(b) of the Federal Food, Drug, and Cosmetic Act which shall provide that the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient. ###
(d)It shall be unlawful to distribute controlled substances in schedule I or II, and narcotic drugs in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General. ###
(e)False Labeling of Anabolic Steroids ####
(1)It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, an anabolic steroid or product containing an anabolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC). ####
(2)#####
(A)A product described in subparagraph
(B)is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act. #####
(B)A product is described in this subparagraph if the product— ######
(i)is the subject of an approved application as described in section 505(b) or
(j)of the Federal Food, Drug, and Cosmetic Act; or ######
(ii)is exempt from the provisions of section 505 of such Act relating to new drugs because— ######
(I)it is intended solely for investigational use as described in section 505(i) of such Act; and ######
(II)such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.
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Sec. 305
labeling and packaging requirements
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