[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26A App C]

[Page 253]

                        TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES

   PART 26_MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE
PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents

      Subpart A_Specific Sector Provisions for Pharmaceutical Good
                         Manufacturing Practices

Sec. Appendix C to Subpart A of Part 26--Indicative List of Products
                          Covered by Subpart A

Recognizing that precise definition of medicinal products and drugs are
to be found in the legislation referred to above, an indicative list of
products covered by this arrangement is given below:
    --human medicinal products including prescription and
nonprescription drugs;
    --human biologicals including vaccines, and immunologicals;
    --veterinary pharmaceuticals, including prescription and
nonprescription drugs, with the exclusion of veterinary immunologicals
(Under 9 CFR 101.2 ``veterinary immunologicals'' are referred to as
``veterinary biologicals'');
    --premixes for the preparation of veterinary medicated feeds (EC),
Type A medicated articles for the preparation of veterinary medicated
feeds (United States);
    --intermediate products and active pharmaceutical ingredients or
bulk pharmaceuticals (United States)/starting materials (EC).