Request By:
Mr. J. H. Voige, R. Ph.
Executive Secretary
Kentucky Board of Pharmacy
P.O. Box 553
Frankfort, Ky. 40602
Opinion
Opinion By: Robert F. Stephens, Attorney General; George Geoghegan, III, Assistant Deputy Attorney General
In a letter to this office you requested an opinion of the Attorney General to determine which of three governmental agencies had "primary jurisdiction" to inspect pharmacies within the Commonwealth of Kentucky. You indicated in your letter that the three governmental agencies involved are the Kentucky Board of Pharmacy, the Kentucky Drug Formulary Council and the Consumer Health Protection Services Division of the Department for Human Resources. This office has considered your request and has decided to render an opinion thereon.
The powers and duties of the Kentucky Board of Pharmacy are set out in KRS Chapter 315. The Board is authorized to issue, deny, suspend, revoke and renew licenses for pharmacists and permits to operate pharmacies. KRS 315.020, 315.035, 315.050, 315.110, 315.123, 315.127 and 315.191. Inspectors, agents or officers of the Board are authorized under KRS 315.220 "to enter upon premises at all reasonable times for the purpose of making inspections and carrying out the provisions of this chapter."
The Kentucky Drug Formulary Council was created by KRS 217.818. KRS 217.819 provides that the Council shall prepare a formulary of therapeutically equivalent drugs and pharmaceuticals. The Council shall provide for the distribution of the formulary and its revisions and additions among practitioners and pharmacists licensed to practice in the Commonwealth. KRS 217.819 also requires the Council to revise the formulary from time to time as new and pertinent information becomes available. KRS 217.821 provides an appeal to any party aggrieved by a finding or report of the Formulary Council. There is no provision contained within KRS 217.815 - 217.826 which authorizes the Kentucky Drug Formulary Council to inspect pharmacies. While KRS 217.822 is included in the sections dealing with generic drugs, the Formulary Council is not authorized to conduct a hearing for violation of same. A violation of KRS 217.822 is criminal in nature and can be prosecuted in the courts of the Commonwealth of Kentucky. The only kind of investigation which the Kentucky Formulary Council is authorized to make under KRS 217.819 is one to determine whether certain drugs are therapeutically equivalent. How this investigation is to be conducted is open to the Council. Since the Council is not authorized to inspect pharmacies, a duplicate inspection is not involved.
The other inspecting agency with which we are concerned is the Division of Consumer Health Protection Services created by the Governor in Executive Order 75-551, issued on June 16, 1975. That Division is charged with carrying out certain duties contained in KRS 211.180. More specifically, the Executive Order states that the Division for Consumer Health Protection Services is responsible for:
". . . the prevention of the manufacture, distribution, and sale of adulterated, mishandled, or falsely advertised foods and cosmetics; the minimization of radiation exposure to the population; the reduction of the risk of personal injury from unsafe consumer products and chemicals; the prevention of the transmission of disease and the existence of unsanitary conditions in public facilities and the individual's personal environment, and other such responsibilities which may be assigned by the Secretary of the Department for Human Resources from time to time. "
KRS 211.180(2) provides that the Department for Human Resources has the power to regulate and control "narcotics, barbiturates and other drugs . . . ." The Secretary of the Department for Human Resources has the authority under KRS 211.180(2) to order his agents to inspect pharmacies to ascertain that there are no violations of the Kentucky drug or controlled substance law. Executive Order 75-551 states that the Division of Consumer Health Protection Services may perform such other duties as may be assigned by the Secretary. The Secretary has apparently made such an assignment as the Division for Consumer Health Protection Services is conducting investigations of pharmacies.
Although it was unnecessary in the case of the Drug Formulary Council to examine the "duplicative inspection" statute, KRS 15.610, such is not the case with the Division of Consumer Health Protection Services. KRS 15.610 provides that when inspecting agencies cannot determine among themselves as to which has primary jurisdiction the question shall be submitted to the Attorney General.
Both the Kentucky Board of Pharmacy and the Division of Consumer Health Protection Services are authorized by law to conduct inspections of pharmacies. However, only the Board of Pharmacy is authorized to make a regular, on-site periodic investigation in connection with issuing or renewing licenses or permits. This type of inspection is that described in KRS 15.605(1). The Board is the watchdog agency for pharmacies and pharmacists. On the other hand the inspections conducted by the Division of Consumer Health Protection Services have no relation to licensing and are not regular or periodic. These investigations may only be performed when the agent conducting them has either obtained a search warrant upon a showing of probable cause or gathered sufficient information to constitute probable cause and an exception to the warrant requirement exists. Camara v. Municipal Court, 387 U.S. 523, 18 L. Ed. 2d 930, 87 S. Ct. 1727 (1967); and Marshall v. Barlow's, Inc., U.S., 56 L. Ed. 2d 305, 98 S. Ct. (decided May 23, 1978). Note however that probable cause as it exists in the criminal law is not required. It may be shown by specific evidence of an existing violation or by evidence that reasonable legislative or administrative standards for inspecting a particular pharmacy are satisfied. The latter may be impossible when the Board of Pharmacy is already conducting regular and periodic on-site inspections. The inspections ordered by the Division of Consumer Health Protection Services are not of the type described in KRS 15.605(1). Therefore the inspections are not duplicative.
Your exhibits indicate that there is a possibility that such an investigation is also required by the federal government under the Consumer Product Safety Act of 1972. 15 USC §§ 2051-2081. However, under 15 USC § 2052(a)(1)(H) drugs are specifically excluded from the coverage of the Act.
In summary, the Kentucky Drug Formulary Council is not authorized by law to conduct inspections of pharmacies. While the Division of Consumer Health Protection Services is authorized to inspect pharmacies it may not do so on a regular basis. Said investigations may take place only when probable cause exists. The Kentucky Board of Pharmacy is the only agency authorized to conduct an inspection of the sort contemplated by KRS 15.605(1). Therefore, a question of primary jurisdiction does not exist.