[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR607.65]

[Page 59-60]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                          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), (2), and (3) of the act, or because 
the Commissioner has found, under section 510(g)(4), that such 
registration is not necessary for the protection of the public health.
    (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 approved for 
Medicare reimbursement and 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 
cells for transfusion are not acts requiring such transfusion services 
to register.

[[Page 60]]

    (g) Clinical laboratories that are approved for Medicare 
reimbursement and are engaged in the testing of blood products in 
support of other registered blood establishments.

[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]