§201.1. Drugs; name and place of business of manufacturer, packer, or distributor. — Inbound Citations

(e) All labeling described in paragraph (d) of this section bears conspicuously the name and place of business of the manufacturer, packer, or distributor, as required for the label of the drug under § 201.1.

(d) Notwithstanding § 201.1, a container filled with a designated medical gas (as defined in § 201.161(c)(1)) or medically appropriate combination of designated medical gases may bear a statement identifying the name of the owner of the container or the address to which the container should be returned after use. Such statement may appear on a separate sticker or decal. If the owner of the medical gas container is not the manufacturer, packer, or distributor of the designated medical gas or medically appropriate combination of designated medical gases, that shall be clearly stated on the container. The addition of such statement shall not cause the owner of the cylinder to be a “relabeler” for purposes of registration and listing under part 207 of this chapter.

(s) Manufacturer means any person who is a manufacturer as defined by § 201.1 of this chapter.

The following definitions apply to this part:

(g) Manufacturer means for a drug product that is not also a biological product, both the manufacturer as described in § 201.1 and the applicant as described in § 314.3(b) of this chapter, and for a drug product that is also a biological product, the manufacturer as described in § 600.3(t) of this chapter.

(1) § 201.1(h)(1) through (h)(2), (h)(5) through (h)(6), and (i);

(1) § 201.1(h)(1) through (h)(2), (h)(5) through (h)(6), and (i);

(1) § 201.1(h)(1) through (h)(2), (h)(5) through (h)(6), and (i);

(1) § 201.1(h)(1) through (h)(2), (h)(5) through (h)(6), and (i);

(1) § 201.1(h)(1) through (h)(2), (h)(5) through (h)(6), and (i);