16 CFR 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.
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(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 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]
Title 16 published on 2014-01-01
no entries appear in the Federal Register after this date.