[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.10]

[Page 123-124]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 207_REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION--Table of Contents
 
                          Subpart B_Exemptions
 
Sec.  207.10  Exemptions for establishments.


    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.

[[Page 124]]

    (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 Sec.  
510.455 of this chapter, or medicated liquid feeds, as defined in Sec.  
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]