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Joined: Feb 2 2010
Posts: 12
User offline. Last seen 2 weeks 1 day ago.

i have a question that might have been answered before at some point but i cant find any reference.

 

does anyone know of the rules and or fda regulations regarding pill imprints. i know that all u.s. prescription drugs need an imprint , and i think all over the counter meds do to. dont know about supplements. any help/links would be awsome. i figured if i cant find the answer here, its not going to happen.

Joined: Dec 26 2004
Posts: 4299
User offline. Last seen 28 min 29 sec ago.
Regulations

This excerpt from http://law.justia.com/us/cfr/title21/21-4.0.1.1.6.html#21:4.0.1.1.6.0.1.4 should get you started with your research:

Quote:
(a) Unless exempted under §206.7, no drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product. Identification of the drug product requires identification of its active ingredients and its dosage strength. Inclusion of a letter or number in the imprint, while not required, is encouraged as a more effective means of identification than a symbol or logo by itself. Homeopathic drug products are required only to bear an imprint that identifies the manufacturer and their homeopathic nature.

This particular section is dealing with any drug.  All  RX, OTC and homeopathic meds are considered drugs.

Vitamins and supplements are not drugs so they do not need an imprint even though some of them do have distinguishing markings.