21 C.F.R. § 1309.22 – Separate registration for independent activities.

(a) The following groups of activities are deemed to be independent of each other:
1. (1) Manufacturing of List I chemicals or drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine.
2. (2) Distributing of List I chemicals and scheduled listed chemical products.
3. (3) Importing List I chemicals or drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine.
4. (4) Exporting List I chemicals and scheduled listed chemical products.
(b) Except as provided in paragraphs (c) and (d) of this section, every person who engages in more than one group of independent activities must obtain a separate registration for each group of activities, unless otherwise exempted by the Act or §§ 1309.24 through 1309.26.
(c) A person registered to import any List I chemical shall be authorized to distribute that List I chemical after importation, but no other chemical that the person is not registered to import.
(d) A person registered to manufacture any List I chemical shall be authorized to distribute that List I chemical after manufacture, but no other chemical that the person is not registered to manufacture.

[75 FR 4981, Feb. 1, 2010]