Request By:
J. H. Voige, R. Ph.
Executive Director
Kentucky Board of Pharmacy
P.O. Box 553
Frankfort, Kentucky 40602
Opinion
Opinion By: Steven L. Beshear, Attorney General; By: Paul E. Reilender, Jr., Assistant Attorney General
This is written in response to your letter of October 11, 1983. In your letter you requested an extended discussion of OAG 83-333 to include markings of any solid dosage forms, tablets or capsules which indicate "sample," "not for sale," "physician pack, " or like wording.
Your question is as follows:
"If the markings on any solid dosage forms, tablets or capsules, indicate 'sample,' 'not for sale,' or like wording and they are held, offered for sale, delivered or sold (KRS 217.175), would such be deemed misbranded? "
As was stated in OAG 83-333, KRS 217.065(1) provides that a drug or device shall be deemed to be misbranded if its labeling is false or misleading in any particular. Further, KRS 217.175(1), (2) and (3) prohibits the misbranding and adulteration of any drug, along with the manufacture, sale, delivery, holding or offering for sale of any drug that is adulterated or misbranded.
It is the opinion of this office that the sale, delivery, holding or offering for sale of drugs marked "sample," "not for sale," "physician pack, " or similar wording, makes the drugs misbranded because they would be distributed and sold in a manner contrary to what appears on the label.
I trust this answers your question.