yourstate.us
21 CFR 1315.02

§ 1315.02 Definitions.

United States · 21 CFR — Food and Drugs · Status: effective

Get this as JSONEmbed this
Cite this
Citation
21 CFR 1315.02, § 1315.02 Definitions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/92194
Permanent ID
ys:prov:92194@1
SHA-256
1c2854749948f0dc9b64eac0c3617502d521222292c77161fc3cbd60a0b7136e

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(a) Except as specified in paragraphs (b) and (c) of this section, 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. (b) The term net disposal means, for a stated period, the sum of paragraphs (b)(1) through (b)(3) of this section minus the sum of paragraphs (b)(4) and (b)(5) of this section: (1) The quantity of ephedrine, pseudoephedrine, or phenylpropanolamine distributed by the registrant to another person. (2) The quantity of that chemical used by the registrant in the production of (or converted by the registrant into) another chemical or product. (3) The quantity of that chemical otherwise disposed of by the registrant. (4) The quantity of that chemical returned to the registrant by any purchaser. (5) The quantity of that chemical distributed by the registrant to a registered manufacturer of that chemical for purposes other than use in the production of, or conversion into, another chemical or in the manufacture of dosage forms of that chemical. (c) Ephedrine, pseudoephedrine, and phenylpropanolamine include their salts, optical isomers, and salts of optical isomers.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.