21 CFR 201.120 - Prescription chemicals and other prescription components.

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There is 1 rule appearing in the Federal Register for 21 CFR 201. View below or at eCFR (GPOAccess)
§ 201.120 Prescription chemicals and other prescription components.
A drug prepared, packaged, and primarily sold as a prescription chemical or other component for use by registered pharmacists in compounding prescriptions or for dispensing in dosage unit form upon prescriptions shall be exempt from section 502(f)(1) of the act if all the following conditions are met:
(a) The drug is an official liquid acid or official liquid alkali, or is not a liquid solution, emulsion, suspension, tablet, capsule, or other dosage unit form; and
(b) The label of the drug bears:
(1) The statement “For prescription compounding”; and
(2) If in substantially all dosage forms in which it may be dispensed it is subject to section 503(b)(1) of the act, the statement “Rx only”; or
(3) If it is not subject to section 503(b)(1) of the act and is by custom among retail pharmacists sold in or from the interstate package for use by consumers, “adequate directions for use” in the conditions for which it is so sold.
Provided, however, That the information referred to in paragraph (b)(3) of this section may be contained in the labeling on or within the package from which it is to be dispensed.
(c) This exemption shall not apply to any substance intended for use in compounding which results in a new drug, unless an approved new-drug application covers such use of the drug in compounding prescriptions.
[40 FR 13998, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-12-04; vol. 79 # 233 - Thursday, December 4, 2014
    1. 79 FR 72064 - Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 30, 2015. See section IV of this document for the implementation dates of this final rule.
      21 CFR Part 201

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 201 after this date.

  • 2014-12-18; vol. 79 # 243 - Thursday, December 18, 2014
    1. 79 FR 75506 - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by March 18, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 20, 2015 (see the “Paperwork Reduction Act of 1995” section of this document). See section XI for the proposed effective date of a final rule based on this proposed rule.
      21 CFR Parts 201, 606, and 610