[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: 21CFR1306.24]

[Page 86-87]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1306_PRESCRIPTIONS--Table of Contents
 
Sec. 1306.24  Labeling of substances and filing of prescriptions.

    (a) The pharmacist filling a prescription for a controlled substance 
listed in Schedule III, IV, or V shall affix to the package a label 
showing the pharmacy name and address, the serial number and date of 
initial filling, the name of the patient, the name of the practitioner 
issuing the prescription, and directions for use and cautionary 
statements, if any, contained in such prescription as required by law.
    (b) If the prescription is filled at a central fill pharmacy, the 
central fill pharmacy shall affix to the package a label showing the 
retail pharmacy name and address and a unique identifier, (i.e. the 
central fill pharmacy's DEA registration number) indicating that the 
prescription was filled at the central fill pharmacy, in addition to the 
information required under paragraph (a) of this section.
    (c) The requirements of paragraph (a) of this section do not apply 
when a controlled substance listed in Schedule III, IV, or V is 
prescribed for administration to an ultimate user who is 
institutionalized: Provided, That:
    (1) Not more than a 34-day supply or 100 dosage units, whichever is 
less, of the controlled substance listed in Schedule III, IV, or V is 
dispensed at one time;
    (2) The controlled substance listed in Schedule III, IV, or V is not 
in the possession of the ultimate user prior to administration;
    (3) The institution maintains appropriate safeguards and records the 
proper administration, control, dispensing, and storage of the 
controlled substance listed in Schedule III, IV, or V; and
    (4) The system employed by the pharmacist in filling a prescription 
is adequate to identify the supplier, the product and the patient, and 
to set forth the directions for use and cautionary statements, if any, 
contained in the prescription or required by law.

[[Page 87]]

    (d) All prescriptions for controlled substances listed in Schedules 
III, IV, and V shall be kept in accordance with Sec. 1304.04(h) of this 
chapter.

[62 FR 13965, Mar. 24, 1997, as amended at 68 FR 37411, June 24, 2003]