PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE,
AND PHENYLPROPANOLAMINE - Subpart A--General Information
Sec. 1315.01 Scope.
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.
Sec. 1315.02 Definitions.
(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.
Sec. 1315.03 Personal use exemption.
A person need not register as an importer, file an import declaration, and
obtain an import quota if both of the following conditions are met:
(a) The person purchases scheduled listed chemical products at retail and
imports them for personal use, by means of shipping through any private or
commercial carrier or the Postal Service.
(b) In any 30-day period, the person imports no more than 7.5 grams of
ephedrine base, 7.5 grams of pseudoephedrine base, and 7.5 grams of
phenylpropanolamine base in scheduled listed chemical products.
Sec. 1315.05 Applicability.
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.
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
