[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR607.65]

[Page 65-66]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 607_ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF 
 
                          Subpart D_Exemptions
 
Sec. 607.65  Exemptions for blood product establishments.


    The following classes of persons are exempt from registration and 
blood product listing in accordance with this part 607 under the 
provisions of section 510(g)(1), (g)(2), and (g)(3) of the act, or 
because the Commissioner of Food and Drugs has found, under section 
510(g)(5), that such registration is not necessary for the protection of 
the public health. The exemptions in paragraphs (a), (b), (f), and (g) 
of this section are limited to those classes of persons located in any 
State as defined in section 201(a)(1) of the act.
    (a) Pharmacies that are operating under applicable local laws 
regulating dispensing of prescription drugs and that are not 
manufacturing blood products for sale other than in the regular course 
of the practice of the profession of pharmacy including the business of 
dispensing and selling blood products at retail. The supplying by such 
pharmacies of blood products to a practitioner licensed to administer 
such blood products for his use in the course of his professional 
practice or to other pharmacies to meet temporary inventory shortages 
are not acts which require such pharmacies to register.
    (b) Practitioners who are licensed by law to prescribe or administer 
drugs and who manufacture blood products solely for use in the course of 
their professional practice.
    (c) Persons who manufacture blood products which are not for sale, 
rather, are solely for use in research, teaching, or analysis, including 
laboratory samples.
    (d) Carriers, by reason of their receipt, carriage, holding, or 
delivery of blood products in the usual course of business as carriers.
    (e) Persons who engage solely in the manufacture of in vitro 
diagnostic blood products and reagents not subject to licensing under 
section 351 of the Public Health Service Act (42 U.S.C. 262). This 
paragraph does not exempt such persons from registration and listing for 
medical devices required under part 807 of this chapter.
    (f) Transfusion services which are a part of a facility that is 
certified under the Clinical Laboratory Improvement Amendments of 1988 
(42 U.S.C. 263a) and 42 CFR part 493 or has met equivalent requirements 
as determined by the Centers for Medicare and Medicaid Services and 
which are engaged in the compatibility testing and transfusion of blood 
and blood components, but which neither routinely collect nor process 
blood and blood components. The collection and processing of blood and 
blood components in an emergency situation as determined by a 
responsible person and documented in writing, therapeutic collection of 
blood or plasma, the preparation of recovered human plasma for further 
manufacturing use, or preparation of red blood

[[Page 66]]

cells for transfusion are not acts requiring such transfusion services 
to register.

[40 FR 52788, Nov. 12, 1975, as amended at 43 FR 37997, Aug. 25, 1978; 
45 FR 85729, Dec. 30, 1980; 49 FR 34449, Aug. 31, 1984; 66 FR 31162, 
June 11, 2001; 66 FR 59159, Nov. 27, 2001; 72 FR 45886, August 16, 2007]