21 C.F.R. PART 1302—LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
Title 21 - Food and Drugs
Authority: 21 U.S.C. 821, 825, 871(b), 958(e).
Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.
Requirements governing the labeling and packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d)) are set forth generally by those sections and specifically by the sections of this part. [36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. [62 FR 13958, Mar. 24, 1997] (a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Administrator pursuant to §1308.31 of this chapter) shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, must bear a label complying with the requirement of this part. (b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him the symbol designating the schedule in which such controlled substance is listed. (c) The following symbols shall designate the schedule corresponding thereto: The word “schedule” need not be used. No distinction need be made between narcotic and nonnarcotic substances. (d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper. (e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user. (f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies. [36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] The symbol shall be prominently located on the label or the labeling of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance. The symbol on labels shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf. The symbol on all other labeling shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling. [62 FR 13958, Mar. 24, 1997] All labels on commercial containers of, and all labeling of, a controlled substance which either is transferred to another schedule or is added to any schedule shall comply with the requirements of §1302.03, on or before the effective date established in the final order for the transfer or addition. [62 FR 13958, Mar. 24, 1997] On each bottle, multiple dose vial, or other commercial container of any controlled substance, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper or such container a seal to disclose upon inspection any tampering or opening of the container. [62 FR 13958, Mar. 24, 1997] (a) The symbol requirements of §§1302.03–1302.05 apply to every commercial container containing, and to all labeling of, controlled substances imported into the jurisdiction of and/or the customs territory of the United States. (b) The symbol requirements of §§1302.03–1302.05 do not apply to any commercial containers containing, or any labeling of, a controlled substance intended for export from the jurisdiction of the United States. (c) The sealing requirements of §1302.06 apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in schedule I or II, or any narcotic controlled substance listed in schedule III or IV, imported into, exported from, or intended for export from, the jurisdiction of and/or the customs territory of the United States. [62 FR 13958, Mar. 24, 1997]
Title 21: Food and Drugs
PART 1302—LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
Section Contents
§ 1302.01 Scope of part 1302.
§ 1302.02 Definitions.
§ 1302.03 Symbol required; exceptions.
§ 1302.04 Location and size of symbol on label and labeling.
§ 1302.05 Effective dates of labeling requirements.
§ 1302.06 Sealing of controlled substances.
§ 1302.07 Labeling and packaging requirements for imported and exported substances.
§ 1302.01 Scope of part 1302.
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§ 1302.02 Definitions.
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§ 1302.03 Symbol required; exceptions.
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Schedule Schedule I................................ CI or C-I.Schedule II............................... CII or C-II.Schedule III.............................. CIII or C-III.Schedule IV............................... CIV or C-IV.Schedule V................................ CV or C-V.
§ 1302.04 Location and size of symbol on label and labeling.
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§ 1302.05 Effective dates of labeling requirements.
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§ 1302.06 Sealing of controlled substances.
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§ 1302.07 Labeling and packaging requirements for imported and exported substances.
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