The following classes of persons are exempt from registration and drug listing in accordance with this part under section 510(g)(1), (g)(2), and (g)(3) of the act, or because FDA has found, under section 510(g)(5) of the act, that their registration is not necessary for the protection of the public health. The exemptions in paragraphs (a) and (b) of this section are limited to pharmacies, hospitals, clinics, and public health agencies located in any State as defined in section 201(a)(1) of the act.
(a) Pharmacies that operate under applicable local laws regulating dispensing of prescription drugs and that do not manufacture or process drugs for sale other than in the regular course of the practice of the profession of pharmacy, including dispensing and selling drugs at retail. The supplying of prescription drugs by these pharmacies to a practitioner licensed to administer these drugs for his or her use in the course of professional practice or to other pharmacies to meet temporary inventory shortages are not acts that require pharmacies to register.
(b) Hospitals, clinics, and public health agencies that maintain establishments in conformance with any applicable local laws regulating the practices of pharmacy or medicine and that regularly engage in dispensing prescription drugs, other than human blood or blood products, upon prescription of practitioners licensed by law to administer these drugs to patients under their professional care.
(c) Practitioners who are licensed by law to prescribe or administer drugs and who manufacture or process drugs solely for use in their professional practice.
(d) Persons who manufacture or process drugs not for sale but solely for use in research, teaching, or chemical analysis.
(e) Manufacturers of harmless inactive ingredients that are excipients, colorings, flavorings, emulsifiers, lubricants, preservatives, or solvents that become components of drugs, and who otherwise would not be required to register under this part.
(f) Persons who only manufacture the following:
(1) Type B or Type C medicated feed using Category I, Type A medicated articles or Category I, Type B or Type C medicated feeds, and/or;
(2) Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds.
(3) Persons who manufacture free-choice feeds, as defined in 510.455 of this chapter, or medicated liquid feeds, as defined in 558.5 of this chapter, where a medicated feed mill license is required are not exempt.
(g) Any manufacturer of a virus, serum, toxin, or analogous product intended for treatment of domestic animals who holds an unsuspended and unrevoked license issued by the Secretary of Agriculture under the animal virus-serum-toxin law of March 4, 1913 (37 Stat. 832 (21 U.S.C. 151 et seq. )), provided that this exemption from registration applies only to the manufacture or processing of that animal virus, serum, toxin, or analogous product.
(h) Carriers, in their receipt, carriage, holding, or delivery of drugs in the usual course of business as carriers.
[45 FR 38043, June 6, 1980, as amended at 51 FR 7389, Mar. 3, 1986; 64 FR 63203, Nov. 19, 1999; 66 FR 59156, Nov. 27, 2001]