[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1304.26]

[Page 63-64]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1304_RECORDS AND REPORTS OF REGISTRANTS--Table of Contents
 
Sec. 1304.26  Additional recordkeeping requirements applicable to 
drug products containing gamma-hydroxybutyric acid.

    In addition to the recordkeeping requirements for dispensers and 
researchers provided in Sec. 1304.22, practitioners dispensing gamma-
hydroxybutyric acid that is manufactured or distributed in accordance 
with an application under section 505 of the Federal Food, Drug, and 
Cosmetic Act must maintain and make available for inspection and copying 
by the Attorney General, all of the following information for each 
prescription:
    (a) Name of the prescribing practitioner.
    (b) Prescribing practitioner's Federal and State registration 
numbers, with

[[Page 64]]

the expiration dates of these registrations.
    (c) Verification that the prescribing practitioner possesses the 
appropriate registration to prescribe this controlled substance.
    (d) Patient's name and address.
    (e) Patient's insurance provider, if available.

[70 FR 293, Jan. 4, 2005]

                                 Reports