Standard: HHS - 21 CFR PART 1315
IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE
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This part specifies procedures governing the establishment of an assessment of annual needs, procurement and manufacturing quotas pursuant to section 306 of the Act (21 U.S.C. 826), and import quotas pursuant to section 1002 of the Act (21 U.S.C. 952) for ephedrine, pseudoephedrine, and phenylpropanolamine.
This part applies to all of the following:
(a) Persons registered to manufacture (including repackaging or relabeling) or to import ephedrine, pseudoephedrine, or phenylpropanolamine as bulk chemicals.
(b) Persons registered to manufacture (including repackaging or relabeling) or to import prescription and over-the-counter drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine that may be lawfully marketed and distributed in the United States under the Federal Food, Drug, and Cosmetic Act
|Organization:||Food and Drug Administration (Medical Products Quality Assurance)|
|Document Number:||21 cfr part 1315|
|Change Type:||COMPLETE REVISION|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|21 CFR PART 1315||Change Type: COMPLETE REVISION||Update Date: 2015-04-01||Status: ACTV|
|21 CFR PART 1315||Change Type: COMPLETE REVISION||Update Date: 2016-04-01||Status: ACTV|
|21 CFR PART 1315||Change Type: COMPLETE REVISION||Update Date: 2018-04-01||Status: ACTV|
|21 CFR PART 1315||Change Type: STCH||Update Date: 2014-04-01||Status: INAC|