Request By:
Jackie H. Franks
Inspector General
Department for Human Resources
275 East Main Street
Frankfort, Kentucky 40601
Opinion
Opinion By: Steven L. Beshear, Attorney General; By: Kathleen F. Beyer, Assistant Attorney General
Your letter of November 13, 1980, requests an interpretation of the meaning of the words "direct supervision" as they appear in KRS 218A.150(2). That statute provides in pertinent part that:
(1) No person shall manufacture, compound, mix, cultivate, grow, or by any other process, produce, or prepare controlled substances, and no person as a wholesaler shall supply the same, without having first obtained a license so to do from the department for human resources. The department for human resources may adopt regulations and set reasonable fees relating to the issuance and renewal of such licenses. * * *
(2) No person shall manufacture any controlled substance except under the direct supervision of a pharmacist. (Emphasis added.)
KRS 218A.010 provides that the term "manufacture" :
. . . . includes any packaging or repackaging of the substance or labeling or relabeling of its container . . . .
You describe the following fact situation: A corporation has filed an application with the Department for Human Resources to repackage and relabel controlled substances. The office of the president of the corporation, who is a registered pharmacist, is located approximately four blocks from the repackaging facility.
An official of the corporation has informed your office that during the repackaging process there will be no pharmacist on the immediate premises. It is the apparent position of the corporation that the proximity of the president's office to the repackaging plant satisfies the requirement of KRS 218A.150 that the repackaging of controlled substances be carried on under the "direct supervision" of a pharmacist.
Your question is this: Under these circumstances, should the Department for Human Resources issue a license to the corporation to repackage and relabel controlled substances, or should the Department withhold the license since the repackaging of the controlled substances will not be under the "direct supervision" of a pharmacist as required by KRS 218A.150(2)?
It is our opinion that the plain meaning of the phrase "direct supervision" as it appears in KRS 218A.150(2) requires the presence of a licensed pharmacist on the immediate premises of the repackaging facility.
The word "direct" is defined by Websters Third New International Dictionary, Unabridged, to mean: "immediate"; "first-hand"; "active, personal and responsible"; "experienced personally;" p. 640. The word "supervision" is defined in various ways as "inspection," "direction" and "oversight, " p. 2296. Clearly, when used in conjunction with one another, the words imply more than a general type of supervision which is removed in time and space from the event.
The inclusion in KRS 218A.150(2) of the requirement that a pharmacist supervise the repackaging of controlled substances manifests the intent of the drafters of the legislation to bring the expertise of the pharmacist in his particular field to bear on the activity involved. We believe that the effectiveness of this expertise and supervision would be severely impaired were the pharmacist not physically present to actually oversee the repackaging and relabeling process.
In OAG 68-44, this office interpreted the words "immediate supervision" in a similar statute (KRS 315.020[2]) to require "direct, personal and visual oversight" by a licensed pharmacist of the activity involved (the compounding and dispensing of prescriptions by an unlicensed person), and thus to require the presence of a pharmacist on the immediate premises. In addition, Kentucky courts have strictly construed the word "supervision" in other situations where licensed professionals are required by statute to supervise the activities of others. (See Commonwealth of Kentucky v. Economy Optical Company, et al., Ky., 522 S.W.2d 444 [1975]).
For the reasons discussed above, it is our opinion that no license to repackage and relabel controlled substances should be issued to an applicant unless and until the Department is satisfied that a registered pharmacist will be physically present at the facility during the repackaging and relabeling process.