[Code of Federal Regulations]
[Title 16, Volume 2]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR1701.1]

[Page 749-750]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
 
PART 1701--STATEMENTS OF POLICY AND INTERPRETATION--Table of Contents
 
Sec.  1701.1  Special packaging for substances subject to a standard 

that are distributed to pharmacies to be dispensed pursuant to an 
order of a licensed medical practitioner.

    (a) In order to assist manufacturers of prescription drugs in 
discharging their responsibilities under the act concerning such drugs 
that are distributed to pharmacies, the Consumer Product Safety 
Commission has codified this statement of its policy concerning which 
prescription drug packages supplied by manufacturers to pharmacies must 
comply with the ``special'' (child-resistant) packaging

[[Page 750]]

requirements contained in 16 CFR 1700.15.
    (b) Manufacturers of prescription drugs may package such drugs for 
distribution to pharmacies in different types of packages, depending on 
whether the manufacturer intends that the package will be the one in 
which the drug is ultimately given to the consumer or whether it is 
intended that the pharmacist will repackage the drug before it is 
dispensed to the consumer. If the drug is supplied in a bulk package 
from which individual prescriptions are intended to be repackaged by the 
pharmacist, the manufacturer need not utilize special packaging. 
However, the Commission interprets the provision of the act as requiring 
that all prescription drugs subject to a special packaging standard that 
are distributed to pharmacies shall be in special packaging if the 
immediate package in which the drugs are distributed by the manufacturer 
is intended to be the package in which the drugs are dispensed to the 
consumer. Examples of such packages include mnemonic dispensing devices; 
dropper bottles; packages with ``tear off'' labels; packages which 
incorporate ancillary instructions for consumer handling, storage, or 
use on permanently affixed portions of their labels; and products 
intended to be reconstituted in their original containers. The 
Commission believes that this interpretation is necessary in order to 
insure that the pharmacist will actually dispense the drug in the proper 
package. If the pharmacist receives a request from the consumer or an 
order from the prescribing medical practitioner for conventional 
(noncomplying) packaging, section 4(b) of the act permits the pharmacist 
to convert the package to conventional packaging or repackage the drug 
in conventional packaging.
    (c) Manufacturers should also note that section 4(a) of the act 
(which allows a product to be marketed in noncomplying packaging of a 
single size under certain circumstances) does not apply to prescription 
drugs subject to section 4(b) of the act. Thus, since the section 4(a) 
single-size exemption for over-the-counter drugs and other household 
substances does not apply to prescription drugs, every unit of a 
prescription drug subject to a special packaging standard which is 
distributed to a pharmacy in a package intended by the manufacturer to 
be dispensed to a consumer shall be in special packaging.
    (d) Nothing in this statement of policy and interpretation should be 
interpreted as relieving the pharmacist of the responsibility of 
insuring that all prescription drugs subject to a special packaging 
standard are dispensed to the consumer in special packaging unless 
otherwise ordered by the prescribing practitioner or otherwise requested 
by the consumer.

(Secs. 2-4, Pub. L. 91-601, 84 Stat. 1670, 1671 (15 U.S.C. 1471-1473); 
sec. 701(a), 52 Stat. 1055 (21 U.S.C. 371(a))

[43 FR 11980 Mar. 23, 1978]