Request By:
Honorable Dandridge F. Walton
314 Wilkinson Street
P.O. Box 79
Frankfort, Kentucky 40602
Opinion
Opinion By: Steven L. Beshear, Attorney General; By: Sarah M. Jackson, Assistant Attorney General
You have written to request an Opinion from this office concerning a policy adopted by the Division for Licensing and Regulation with regard to the legal requirements attached to bulk over-the-counter (hereinafter, "OTC") drugs utilized by long term care facilities. More specifically, you ask what effect this policy adopted by the Division for Licensing and Regulation may have on the Certificate of Need and Licensure Board's Administrative Regulation 902 KAR 20:026, Section 4 (5)(f) 3.a.
The policy adopted by the Division for Licensing and Regulation is set forth below:
"There are no legal requirements that bulk over-the-counter (OTC) drugs be individually labeled by the pharmacist. Long term care facilities may utilize OTC drugs as long as no repackaging is done and the medication remains in the manufacturer's original container, properly labeled, and is accompanied by and administered in conformance with the physician's order."
The Certificate of Need and Licensure Board's administrative regulation 902 KAR 20:026, Section 4(5)(f) 3.a reads as follows:
"Labeling and storing medications. All medications shall be plainly labeled with the patient's name, the name of the drug, strength, name of pharmacy, prescription number, date, physician name, caution statements and direction for use except where accepted modified unit dose systems conforming to federal and state laws are used. The medications of each patient shall be kept stored in their original containers and transferring between containers shall be prohibited. All medicines kept by the facility shall be kept in a locked place and the persons in charge shall be responsible for giving the medicines and keeping them under lock and key. Medications requiring refrigeration shall be kept in a separate locked box of adequate size in the refrigerator in the medication area. Drugs for external use shall be stored separately from those administered by mouth and injection. Provisions shall also be made for the locked separate storage of medications of deceased and discharged patients until such medication is surrendered or destroyed in accordance with federal and state laws and regulations.
You have asked to what extent, if any, the policy of the Division for Licensing and Regulation may conflict with the Board's regulation. It is the opinion of this office that OTC drugs need not be individually labeled (on a patient-by-patient basis) and that such drugs may be utilized by long term care facilities provided such OTC drugs remain in the manufacturer's original package/container, are properly labeled, and are administered only by and in conformity with the physician's order.
Although the first sentence of 902 KAR 20:026, Section 4(5)(f) 3.a. states that "all medications shall be plainly labeled with the patient's name, . . .", it appears that the term "medications" as used in the first sentence of that regulation does not include bulk OTC drugs. This is especially apparent upon further reading of the sentence in question, for the sentence continues by requiring that such "medications" be labeled with, among other things, the name of the pharmacy and the prescription number. This language certainly suggests that the first sentence of 902 KAR 20:026, Section 4(4)(f) 3.a. relates only to legend drugs. In view of such, the term "medications" as used in the first sentence of 902 KAR 20:026, Section 4(5)(f) 3.a. has no bearing on OTC drugs. Lending additional support to this interpretation is the fact that neither KRS 217.005 to KRS 217.215 (Kentucky Food, Drug and Cosmetic Act) nor KRS Chapter 315 (relating to pharmacists and pharmacies) requires such labeling on OTC drugs.
It appears that the remainder of 902 KAR 20:026, Section 4(5)(f) 3.a., dealing with the storing of medications, would indeed apply to OTC drugs. The general intent of these storage requirements would apply equally to both legend and OTC drugs. Furthermore, the policy adopted by the Division of Licensing and Regulation makes clear that long term care facilities must utilize OTC drugs only in conformity with a physician's order. It is only possible, therefore, to administer the drugs pursuant to a physician's order and/or directions.
In conclusion, it is the opinion of this Office that the policy adopted by the Division for Licensing and Regulation does not conflict with the Certificate of Need and Licensure Board's regulations. I hope that, by way of the foregoing, I have satisfactorily responded to your inquiry.
Please do not hesitate to contact me if I can be of further help.