1
November 12, 2024
OAG 24-11
Subject:
(1)
Does the Kentucky Board of Pharmacy have any authority
to regulate non-resident pharmacists beyond what is specifically
stated in KRS Chapter 315?
(2)
Does the Board have authority to mandate in-state
licensing of non-resident pharmacists, generally, and as proposed
in the amendment to 201 KAR 2:030, specifically?
Requested by:
Representative Derek Lewis
Kentucky House of Representatives, District 90
Co-Chair, Administrative Regulation Review Subcommittee
Written by:
Aaron J. Silletto, Executive Director
Office of Civil and Environmental Law
Syllabus:
(1)
The Kentucky Board of Pharmacy lacks the legal authority
to regulate non-resident pharmacists beyond that which is
specifically conferred in KRS Chapter 315.
(2)
The Kentucky Board of Pharmacy may not mandate the
Kentucky licensure of non-resident pharmacists, except for
pharmacists in charge under KRS 315.0351(1)(g). Therefore, the
Board’s proposed amendment to 201 KAR 2:030 exceeds its
statutory authority.
Opinion of the Attorney General
The Kentucky Board of Pharmacy (“Board”) seeks to amend its administrative
regulations regarding licensing to practice pharmacy. Those regulations are currently
pending before the General Assembly’s Administrative Regulation Review
Subcommittee (“ARRS”), see KRS 13A.290(1), and essentially would require all non-
resident pharmacists filling prescriptions for Kentucky residents to hold a Kentucky
license. Currently, only the pharmacist in charge of an out-of-state pharmacy must2
be licensed in Kentucky. The ARRS Co-Chair has requested an Opinion from this
Office to answer several questions regarding the extent of the Board’s authority to
license and regulate non-resident pharmacists. For the reasons that follow, it is the
opinion of this Office that the Board’s proposed regulations exceed the Board’s
authority to regulate non-resident pharmacists.
To understand the Board’s proposed regulations, a brief overview of the steps
in the drug dispensing process is helpful. Kentucky patients may seek to have their
prescriptions filled at a pharmacy located inside or outside the Commonwealth. When
a patient seeks to have a prescription filled, he or his physician must deliver or send
the prescription to a pharmacy. Once received, the pharmacy’s staff enters the
prescription data into its computer system. A pharmacist then must conduct a drug
utilization review on new or refill prescriptions to determine if there may be any drug
interactions, allergies, or issues with the prescription based on the patient’s medical
history. After verification, the pharmacist or a pharmacy technician prepares the
medication. The medication is labeled with the required information, and the
pharmacist then conducts a final check on the prescription to ensure accuracy. If the
patient agrees to counseling, the pharmacist will provide counseling on how to take
the medication and on other clinically appropriate information such as expected
results or necessary warnings. The medication is then dispensed to the patient.
Delivery of the medication to the patient may occur in person, by pharmacy delivery
personnel, or by common carrier. Depending on how the pharmacy structures its
operations, some or all of the dispensing process may occur at more than one physical
location, inside or outside Kentucky.
The specific regulation mentioned in the request for an Opinion is the Board’s
proposed amendment to 201 KAR 2:030.1 As summarized in the request, the
amendment would “make[ ] significant changes to the existing regulation by creating
a licensing framework for all non-resident pharmacists. This will essentially require
all out-of-state pharmacists filling prescriptions for patients in Kentucky to be
licensed in-state.” The ARRS Co-Chair states that the Board has not sufficiently
answered the Subcommittee’s questions concerning the Board’s statutory authority
for this amendment. Thus, the issue is one of statutory construction.
“All statutes of this state shall be liberally construed with a view to promote
their objects and carry out the intent of the legislature[.]” KRS 446.080(1).
1
Though not specifically mentioned in the ARRS Co-Chair’s request, the Board points out that two
other proposed regulations now pending before ARRS are also relevant. First, the Board proposes to
amend 201 KAR 2:050 to impose fees for an application for, or renewal of, a non-resident pharmacy
license. Second, the Board has proposed a new administrative regulation, to be numbered 201 KAR
2:465, which establishes the requirements to obtain a non-resident pharmacy permit. Though not
specifically addressed in this Opinion, the Office’s analysis of 201 KAR 2:030 will likely be relevant to
ARRS’s consideration of these other proposed regulations.3
“In construing statutes, our goal, of course, is to give effect to the intent
of the General Assembly. We derive that intent, if at all possible, from
the language the General Assembly chose, either as defined by the
General Assembly or as generally understood in the context of the
matter under consideration. . . . We presume that the General Assembly
intended for the statute to be construed as a whole, for all of its parts to
have meaning, and for it to harmonize with related statutes. . . . We also
presume that the General Assembly did not intend an absurd statute or
an unconstitutional one. . . .”
Shawnee Telecom Res., Inc. v. Brown, 354 S.W.3d 542, 551 (Ky. 2011) (citations
omitted). Where a statute is ambiguous, the “time-honored canons of statutory
construction” may be helpful in arriving at the statute’s meaning. Jefferson Cnty. Bd.
of Educ. v. Fell, 391 S.W.3d 713, 720 (Ky. 2012); see Shawnee, 354 S.W.3d at 551
(“Only if the statute is ambiguous or otherwise frustrates a plain reading, do we
resort to extrinsic aids such as . . . the canons of construction[.]”).
We turn first to the statutory text. The practice of pharmacy in Kentucky is
governed in large part by KRS Chapter 315, the purpose of which is to “promote,
preserve, and protect public health, safety, and welfare by and through . . . the
licensure, control, and regulation of all sites or persons who are required to obtain a
license, certificate, or permit from the Board of Pharmacy, whether located in or
outside the Commonwealth, that distribute, manufacture, or sell drugs within the
Commonwealth.” KRS 315.005 (emphasis added). KRS Chapter 315 provides for
permits to operate a pharmacy and licenses to engage in the practice of pharmacy.
Every “pharmacy within this Commonwealth” is required to have a permit
issued by the Board. KRS 315.035. In addition, every “out-of-state pharmacy” doing
business in the Commonwealth (e.g., a mail order or internet pharmacy) must hold a
permit from the Board. KRS 315.0351. Thus, KRS Chapter 315 clearly provides that,
wherever a pharmacy is physically located, if it is doing business in Kentucky, it must
hold a valid Kentucky permit.
But KRS Chapter 315 is less clear regarding the licensure of non-resident
pharmacists. KRS 315.020(3) provides that, with several exceptions not relevant
here, “no person shall engage in the practice of pharmacy unless licensed to practice
under the provisions of KRS Chapter 315.”2 That chapter prescribes the qualifications
for licensure of pharmacists, KRS 315.050; the continuing education requirements for
2
The “practice of pharmacy” includes the “interpretation, evaluation, and implementation of
medical orders and prescription drug orders; responsibility for dispensing prescription drug orders,
including radioactive substances; participation in drug and drug-related device selection;
administration of medications or biologics in the course of dispensing or maintaining a prescription
drug order; . . . drug evaluation, utilization, or regimen review; . . . and provision of patient counseling
and those professional acts, professional decisions, or professional services necessary to maintain and
manage all areas of a patient’s pharmacy-related care.” KRS 315.010(22).4
pharmacists, KRS 315.065; and the requirements for renewal of a pharmacist license,
KRS 315.110. But none of these statutes prescribes an express residency requirement
or geographic limitation on their reach.
Looking to other parts of KRS Chapter 315 provides a clue as to the geographic
reach of KRS 315.020(3). Every out-of-state pharmacy is required to “have a
pharmacist in charge who is licensed to engage in the practice of pharmacy by the
Commonwealth.” KRS 315.0351(1)(g) (emphasis added). Notably, the statute requires
only the “pharmacist in charge” of an out-of-state pharmacy to be licensed by the
Board. In addition, the out-of-state pharmacy need only “disclose to the [B]oard the
location, names, and titles of . . . all pharmacists who are dispensing prescription
drugs to residents of the Commonwealth.” KRS 315.0351(1)(b) (emphasis added). The
upshot of these requirements is that, with the exception of the pharmacist in charge,
an out-of-state pharmacy need only disclose the identities of its pharmacists to the
Board. There is no explicit licensure requirement in the statute for these other
pharmacists for them to “dispens[e] prescription drugs to residents of the
Commonwealth.” Id.
On the other hand, the Board contends that “[t]here is no language [in KRS
Chapter 315] distinguishing between a pharmacist located in Kentucky and a
pharmacist located outside of Kentucky.” It is true that nothing in KRS 315.020(3)
specifically excludes pharmacists located outside Kentucky. Thus, the statute is
ambiguous with respect to whether “no person” refers to a person located in the
Commonwealth, or instead, to a person no matter where he is located. And so, we
turn to the “time-honored canons of statutory construction” to determine the meaning
of KRS 315.020(3). Fell, 391 S.W.3d at 720.
Under the “extraterritoriality canon,” it must be presumed that a statute has
no extraterritorial application. Scalia & Garner, Reading Law: The Interpretation of
Legal Texts (West 2012), at 268–72; see also Restatement (First) of Conflict of Laws
§ 57 (1934) (observing that, in general, “a state cannot exercise executive jurisdiction
within the territory of another state”). Kentucky law has embraced “the well-
established presumption against extraterritorial operation of statutes.” Union
Underwear Co. v. Barnhart, 50 S.W.3d 188, 190 (Ky. 2001). In other words, “unless a
contrary intent appears within the language of the statute, we presume that the
statute is meant to apply only within the territorial boundaries of the
Commonwealth.” Id. (citation omitted). Kentucky courts do not infer the
extraterritorial reach of a statute “absent a positive showing . . . that the General
Assembly intended that the Act be applied extraterritorially.” Id. at 191. And the
statutory use of broad adjectives such as “any” and “all” when referring to persons
covered by the law “does not imply that the enacting legislature intended that the
legislation be applied extraterritorially.” Id. (emphasis in original).
Applying the extraterritoriality canon to this case, it must be presumed that
KRS 315.020(3) does not apply to persons located outside Kentucky. While the5
presumption can be overcome by a “positive showing” of legislative intent “within the
language of the statute” itself, Barnhart, 50 S.W.3d at 190–91, it is not overcome
here.3
The Board makes several arguments in favor of its claimed authority to require
the Kentucky licensure of all non-resident pharmacists dispensing medications to
Kentucky residents. First, the Board points to “the policy statement conveyed in KRS
315.005 that jurisdiction is to be applied to ‘sites and persons’ located outside the
Commonwealth.” But that is not exactly what KRS 315.005 says. Rather, it states
that the purpose of KRS Chapter 315 is to allow the licensure and regulation of “all
sites or persons who are required to obtain a license . . . from the Board of Pharmacy”
(emphasis added). In other words, as a statement of legislative purpose, KRS 315.005
does not itself provide any statutory authority to the Board to license or regulate. It
merely evinces the purpose that the Board license and regulate those pharmacies and
pharmacists “who are required” by another statute in the chapter “to obtain a
license.” Read in its entirety, KRS 315.005 does not authorize the Board to require
the licensure of all non-resident pharmacists serving Kentuckians.
Next, the Board points to the titles of KRS 315.035 and KRS 315.0351 as some
evidence of its authority to “exercise[e] jurisdiction over pharmacists not located in
Kentucky.” But the titles are not part of the law, as they are not subject to the
bicameralism and presentment requirements in the Kentucky Constitution. See Ky.
Const. §§ 46, 56, 88. Rather, they are added by the Reviser of Statutes after a bill
becomes law. See KRS 7.136(1)(b); KRS 7.140(1). Thus, the titles of statutes “do not
constitute any part of the law.” KRS 446.140. The titles of KRS 315.035 and KRS
315.0351 therefore provide no support for an extraterritorial application of KRS
315.020(3).
The Board also disputes that the pharmacist identification and pharmacist-in-
charge requirements of KRS 315.0351(1)(b) and (g) do not weigh against its broad
claim to extraterritorial jurisdiction. But this argument runs headlong into another
canon of construction: expressio unius est exclusio alterius, meaning “the mention of
one thing implies the exclusion of another.” Fox v. Grayson, 317 S.W.3d 1, 8 (Ky.
2010). Under the statute, out-of-state pharmacies are required to have only a licensed
pharmacist in charge. Other pharmacists working at the out-of-state pharmacy need
only be identified on the pharmacy’s annual report to the Board. These statutory
requirements imply that further licensure of the non-resident pharmacists, beyond
merely identifying them, is not required.
Finally, in assessing the Board’s claimed authority to require the licensure of
every non-resident pharmacist dispensing medications to Kentucky residents, it must
3
Further, the use of “no” to modify “person” in KRS 315.020(3) is no more evidence of legislative
intent that the statute should apply extraterritorially than “any” or “all” were in Barnhart, 50 S.W.3d
at 191.6
be remembered that “Executive Branch agencies or administrative agencies have no
inherent authority and may exercise only such authority as may be legislatively
conferred.” Herndon v. Herndon, 139 S.W.3d 822, 826 (Ky. 2004). “[A]n
administrative agency’s authority ‘is limited to a direct implementation of the
functions assigned to the agency by the statute.’” United Sign, Ltd. v. Commonwealth,
Transp. Cabinet, Dep’t of Highways, 44 S.W.3d 794, 798 (Ky. App. 2000) (quoting
Flying J Travel Plaza v. Commonwealth, Transp. Cabinet, Dep’t of Highways, 928
S.W.2d 344, 347 (Ky. 1996)). “Any doubts concerning the existence or extent of an
administrative agency’s power should be resolved against the agency.” Id. (citing
Henry v. Parrish, 211 S.W.2d 418, 422 (Ky. 1948)). The Board is only authorized to
promulgate administrative regulations that are “necessary to regulate and control all
matters set forth in [KRS Chapter 315] relating to pharmacists.” KRS 315.191(1)(a)
(emphasis added).4 At a minimum, the Board’s claimed authority to further regulate
non-resident pharmacists is unclear and lacks express legislative authorization. Such
authority is certainly not “set forth in” KRS Chapter 315 but requires a strained
reading of the statutory text. Without clear legislative authorization, the Board may
not impose greater regulations on non-resident pharmacists.
In sum, considering both the statutory text and the applicable canons of
construction, it is the opinion of this Office that the Board lacks the legal authority
to regulate non-resident pharmacists beyond that which is specifically conferred in
KRS Chapter 315. Absent greater statutory authority, the Board may not mandate
the Kentucky licensure of non-resident pharmacists, except for pharmacists in charge
under KRS 315.0351(1)(g). Therefore, it is also the opinion of this Office that the
Board’s proposed amendment to 201 KAR 2:030 exceeds its statutory authority.5
Russell Coleman
Attorney General
Aaron J. Silletto, Executive Director
Office of Civil and Environmental Law
4
The Board also cites its authority to promulgate administrative regulations that are “necessary
and [sic] to control the storage, retrieval, dispensing, refilling, and transfer of prescription drug orders
within and between pharmacists and pharmacies licensed or issued a permit by it.” KRS 315.191(1)(f).
But authority to regulate the transfer or dispensing of medications by licensed pharmacists does not
carry with it the authority to determine which pharmacists must be licensed.
5
The ARRS Co-Chair’s request for an Opinion also asked, “[T]o what extent does the Board have
authority to impose requirements and restrictions that accompany licensing of non-resident
pharmacists, such as those in the amendment to 201 KAR 2:030?” But given the answers provided to
the other questions asked, it is not necessary to reach this issue.