Request By:
Julio Polio, R. Ph.
Pharmacy/Drug Inspector
Kentucky Board of Pharmacy
P.O. Box 553
Frankfort, Kentucky 40602
Opinion
Opinion By: Steven L. Beshear, Attorney General; Paul E. Reilender, Jr., Assistant Attorney General
I am in receipt of your letter of July 20, 1983, regarding the retail sale by pharmacists of packages of birth control pills that are labeled for "clinic use only." Additionally, you mention in your letter that these "clinic use only" packages are purchased with government funds for as little as $ .50 per monthly package, to be used by a family planning or other such agency under the auspices of state or county social service programs. You further state in your letter that, under normal retailing circumstances, a retail pharmacist must pay $8.00 to $9.00 per monthly package, which he then markets to the consuming public in the standard packs provided.
Your concern over this situation, as expressed in your letter, is as follows:
"This, of course, creates a lucrative loophole that some entrepreneurs seem unable to resist. As a result, from time to time, some clinic packages have found their way into Kentucky distributors and retailers to be offered for sale to the general public. The ripple effect being, government funds are misdirected, misappropriated, and ultimately embezzled to make this offering possible."
The question you ask is: does the fact that a package so labeled, "clinic use only", having found its way to nonclinic settings and avenues of distribution, put the holder of such package in violation of KRS 217.065(1) - the misbranding provisions of the Food, Drug, and Cosmetic Act?
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 and the receipt in commerce of any drug that is adulterated or misbranded. The penalties for a violation of KRS 217.175 can be found in KRS 217.992.
It is the Opinion of this office that the distribution and sale of packages of birth control pills marked "clinic use only", in a nonclinical setting, makes these misbranded drugs as defined in KRS 217.065(1), because these drugs are being distributed and sold in a manner contrary to what appears on the label.
You also raise the question regarding whether any other statute of the Commonwealth would be violated by the distribution and/or sale of these drugs. KRS 517.020(1)(e) provides that a person is guilty of deceptive business practices when, in the course of engaging in a business, occupation or profession, he knowingly sells, offers, or exposes for sale mislabeled commodities. As mentioned earlier, the packages of birth control pills marked "clinic use only", become misbranded when they are distributed or sold in a nonclinical setting.
The final question you ask deals with the right of pharmacy inspectors to seize the misbranded drugs. KRS 217.215(1) gives the state board of pharmacy the same powers of enforcement and inspection as inspectors for the Cabinet for Human Resources. KRS 217.115 sets forth the procedure regarding the detention or quarantine of articles that may be misbranded. There is only one situation where seizure of the articles can take place without intervention of the courts, and that is where seizure of the questioned article is accomplished by agreement made in writing with the owner of the property. KRS 217.115(2).
I hope this answers your questions.