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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter CPart 201Subpart D → §201.120

Title 21: Food and Drugs
Subpart D—Exemptions From Adequate Directions for Use

§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]

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