Maryland Attorney General Opinion 100OAG085

Gen. 85] 85

HEALTH OCCUPATIONS
ADMINISTRATIVE LAW – BOARD OF PHARMACY – DISPENSING
OF PRESCRIPTION DRUGS BY PHYSICIANS, DENTISTS, AND
PODIATRISTS

May 26, 2015

Lenna Israbian-Jamgochian
Board President
Maryland Board of Pharmacy

When a doctor writes a prescription, a patient will typically
take that prescription to a pharmacy. The pharmacist may only fill
the prescription and dispense the prescription drugs if he or she has
a license from the Maryland Board of Pharmacy (the “Board”). See
Md. Code Ann., Health Occupations (“HO”) § 12-301(a) (2014
Repl. Vol.). Under certain circumstances, physicians, dentists, and
podiatrists may also fill prescriptions and dispense prescription
drugs. See HO § 12-102(c). As long as these practitioners comply
with a number of other statutory and regulatory guidelines, they
may “personally prepar[e] and dispens[e]” drugs that they have
prescribed for their own patients if they (1) demonstrate to the
satisfaction of their respective licensing boards that their
dispensing of prescription drugs “is in the public interest” and (2)
receive a written permit from that board. HO § 12-102(c)(2)(ii)1.
On behalf of the Board, your predecessor, Michael Souranis,
asked three questions about this statutory scheme. First, he asked
whether there are any restrictions on the ability of the Department
of Health and Mental Hygiene (“DHMH”) or the Board to issue
regulations clarifying the meaning of “in the public interest.” This
first inquiry also raises the subsidiary question of which units
within DHMH have the authority to promulgate regulations
governing the dispensing permit regime for physicians, dentists,
and podiatrists. Second, Mr. Souranis asked whether physicians,
dentists, or podiatrists who hold permits to dispense prescription
drugs may delegate any part of the dispensing process to unlicensed
individuals in their practices. Finally, he asked whether the Board
of Pharmacy has the power under HO § 12-604(a) to inspect the
offices of practitioners who hold dispensing permits.

With respect to your first question, an agency generally may
issue regulations to clarify the meaning of ambiguous statutory
terms, but the regulations must be consistent with the statutory
86 [100 Op. Att’y

scheme and the provisions of the Administrative Procedure Act
(“APA”). The agency will thus have to consider whether any
particular regulatory change would conflict with the language of
the statute or its legislative history. As for which offices or units
within the Department may issue regulations in this context, it is
our view that the Secretary of DHMH and the Boards of Physicians,
Dental Examiners, and Podiatric Medical Examiners, but not the
Board of Pharmacy, may promulgate regulations governing the
dispensing permit regime at issue.
With respect to your second question, we conclude that HO
§ 12-102(a)(3) prohibits wholesale delegation of the entire
dispensing process but does not prohibit the delegation of specific
parts of the process so long as the prescriber is on the premises and
performs a final check before the drugs are given to the patient.
There are, however, some implicit limits on the scope of this
delegation, and the separate statutes and regulations governing
physicians, dentists, and podiatrists may place additional limits on
the authority of those practitioners to delegate certain tasks. For
example, it appears that the Board of Physicians has prohibited
physicians from delegating any of these tasks to unlicensed
individuals. See COMAR 10.32.12.04E(4).
Finally, as to your third question, it is our opinion that the
Board of Pharmacy is not authorized to inspect the offices of
physicians, dentist, and podiatrists who hold dispensing permits
because the General Assembly has explicitly entrusted that
authority to another entity. The statute might, however, permit the
Board of Pharmacy to inspect other places where drugs are
“manufactured, packaged, stocked, or offered for sale” that are not
within the jurisdiction of the other professional boards. See HO
§ 12-604(a).
I
Background
A. The Board of Pharmacy
The Board of Pharmacy is a unit within DHMH composed of
twelve members appointed by the Governor, ten of whom must be
pharmacists. HO §§ 12-201, 12-202. The Board licenses
pharmacists and pharmacy technicians, evaluates whether to grant
permits to particular pharmacies, and otherwise regulates the
pharmaceutical profession. See, e.g., HO §§ 12-301, 12-401, 12-
6B-01; see generally Title 12 of the Health Occupations Article. In
doing so, the Board may adopt “[r]ules and regulations to carry out
the provisions of [Title 12 of the Health Occupations Article]” as
Gen. 85] 87

well as regulations “that are necessary to protect the public health,
safety, and welfare and that establish standards for practicing
pharmacy and operating pharmacies,” including “[s]tandards for
filling and refilling prescriptions.” HO § 12-205(a)(2), (3).
The Board also has a number of investigatory powers.
“During business hours, the Secretary, the Board, or the agents of
either may enter any permit holder’s pharmacy and inspect” the
facility, its records, drugs or devices, and certain other materials
“for compliance with federal and State laws and regulations.” HO
§ 12-413(a). The Board or Secretary must conduct these
inspections of Maryland pharmacies annually. HO § 12-604(b)(1).
Pharmacies outside the State that do business in Maryland are
subject to inspection as well. HO § 12-604(b)(2). The Board also
has specific authority to inspect certain other properties over which
it has licensing authority, such as wholesaler distributors’ facilities.
See HO § 12-6C-07. Moreover, the Secretary and the Board have
the seemingly broader power to enter, during business hours, “any
place where drugs, devices, diagnostics, cosmetics, dentifrices,
domestic remedies, or toilet articles are manufactured, packaged,
stocked, or offered for sale” and inspect the drugs, devices, and
other articles there. HO § 12-604(a).
B. A Brief History of Drug Dispensing by Prescribers in
Maryland
Under Maryland law, “dispensing” means:
[T]he procedure which results in the receipt of
a prescription or nonprescription drug or
device by a patient or the patient’s agent and
which entails the:
(1) Interpretation of an authorized
prescriber’s prescription for a drug or device;
(2) Selection and labeling of the drug or
device prescribed pursuant to that pre-
scription; and
(3) Measuring and packaging of the
prescribed drug or device in accordance with
State and federal laws.
HO § 12-101(h). Generally speaking, an individual may not
dispense prescription drugs or devices without a license from the
Board of Pharmacy. See HO § 12-301(a) (prohibiting the practice
88 [100 Op. Att’y

of pharmacy without a license); HO § 12-101(t) (defining “practice
pharmacy” to include “dispensing”). There is an exception,
however, that allows a physician, dentist, or podiatrist to
“personally prepar[e] and dispens[e]” her own prescriptions if she
receives a written dispensing permit from the board that licenses
her practice (i.e., the Board of Physicians for physicians, the Board
of Dental Examiners for dentists, and the Board of Podiatric
Medical Examiners for podiatrists).1 HO § 12-102(c)(2)(ii).
This exception has a long history in the United States and in
Maryland. Medicine and pharmacy did not develop into separate
professions in the United States until the late 1700s. See Richard
R. Abood, Physician Dispensing: Issues of Law, Legislation and
Social Policy, 14 Am. J. L. & Med. 307, 313 (1989). It was
therefore common for physicians to dispense drugs to their own
patients, rather than send the patients to a pharmacist. Id.
Accordingly, when the Maryland General Assembly first enacted a
law providing that only licensed pharmacists could fill
prescriptions, it carved out an exception allowing “physicians and
dentists to compound and dispense their own prescriptions.” 1902
Md. Laws, ch. 179 (codified as Md. Code Ann., Art. 43 § 141
(1904)).
The practice of dispensing by physicians waned after World
War II when “a general feeling emerged among physicians” that
they might “be tempted to overprescribe or prescribe
inappropriately only those medications which they inventoried.”
Abood, supra, at 313-14. As a result, “[p]hysician dispensing rates
dropped from thirty-nine percent in 1923 to one percent in 1986.”
Id. at 314. During the mid-1980s, however, physicians began
dispensing their own prescriptions more frequently because the
“advent and proliferation of drug repackagers”—firms that buy
drugs in bulk and repackage them in smaller amounts— made
“dispensing simple, convenient, and more profitable.” Id. at 310.
This potential profit motive again raised concerns among
health professionals about whether doctors might have incentives
to overprescribe drugs or prescribe only drugs that they had in
stock. See id. at 313-14. The American Medical Association urged
physicians “to avoid regular dispensing and retail sale of drugs,
devices or other products when the need of patients can be met

1
Nurse practitioners also may dispense prescription drugs under
certain limited circumstances set forth in the Maryland Nurse Practice
Act. See HO § 8-508. None of the questions you ask relates to
dispensing by nurses.
Gen. 85] 89

adequately by local ethical pharmacies or suppliers.” Id. at 330
n.123 (quoting AMA guidance entitled “Dispensing by Physicians
Raise[s] Ethical Issues”). Many states responded by passing laws
to regulate or restrict dispensing by physicians. Id. at 318. A
handful of states banned dispensing by physicians except in limited
circumstances, such as when pharmacy services were unavailable,
while many other states required physicians to comply with some
or all of the professional requirements imposed on pharmacists. Id.
at 319.
In Maryland, the General Assembly reacted to these concerns
by enacting the first iteration of what would eventually become the
permit scheme that is now embodied in HO § 12-102(c)(2)(ii). See
1986 Md. Laws, ch. 691. For the first time, the statute conditioned
the authority of physicians, dentists, and podiatrists to dispense
drugs on the approval of the providers’ respective licensing boards.
Id. The bill as introduced provided that physicians, dentists, and
podiatrists could only obtain those approvals if there were no
pharmacy within a certain distance of the doctor’s office. See 1986
Md. Laws, ch. 691. The bill was amended, however, to delete the
distance requirement; as enacted, it provided merely that the
physician must dispense “in the public interest.” See id. As the
Committee Report explained, “a physician would be able to apply
for permission to dispense [under the statute] if he had elderly
patients who might have difficulty obtaining transportation to a
pharmacy.” See 1986 Leg. Reg. Sess., Committee Report on S.B.
830. Three years later, the statute was further amended to clarify
the definition of “in the public interest” and require physicians,
dentists, and podiatrists to apply for formal, written dispensing
permits from their respective licensing boards. 1989 Md. Laws,
ch. 608.
C. Maryland’s Current Permit Scheme for Dispensing by
Prescribers
As the statute is currently written, a physician, dentist, or
podiatrist may dispense prescription drugs to her patients under the
following circumstances. As an initial matter, these practitioners
may administer a single dose of a drug directly to the patient,
provide a free drug sample to a patient, or dispense a starter dose
of prescription medication at no charge to a patient without any
special permit as long as certain other conditions are satisfied. HO
§ 12-102(d)-(f). More broadly, and more importantly for our
analysis, a practitioner may also “personally prepar[e] and
dispens[e]” her own prescriptions if (1) she applies to her
90 [100 Op. Att’y

respective licensing board for a dispensing permit, (2)
“demonstrate[s] to the satisfaction of that board that the dispensing
of prescription drugs or devices by [her] would be in the public
interest,” and (3) “receive[s] a written permit from that board.” HO
§ 12-102(c)(2)(ii).
The statute further defines the terms “personally preparing
and dispensing” and “in the public interest.” The former means
that the permit holder “[i]s physically present on the premises
where the prescription is filled” and “[p]erforms a final check of
the prescription before it is provided to the patient.” HO § 12-
102(a)(3). The phrase “in the public interest” is defined as “the
dispensing of drugs or devices by a licensed dentist, physician, or
podiatrist to a patient when a pharmacy is not conveniently
available to the patient.” HO § 12-102(a)(2). The statute offers no
guidance, however, about when a pharmacy is “conveniently
available.”
The Secretary of Health and Mental Hygiene (the
“Secretary”) has thus promulgated regulations clarifying both the
application process and the phrases “in the public interest” and
“conveniently available.” Under these regulations, an applicant
may demonstrate that granting a dispensing permit to her would be
“in the public interest” by certifying that: (1) she is “thoroughly
familiar” with the statutes and regulations governing the dispensing
of prescription drugs and (2) she will comply with certain other
requirements set forth in the regulations, COMAR
10.13.01.03B(2), including a requirement to “dispense prescription
drugs to a patient only when a pharmacy is not conveniently
available to the patient.” COMAR 10.13.01.04J. The regulations
then clarify that “[t]he decision whether a pharmacy is
conveniently available shall be made by the patient based upon
factors to be determined solely in the discretion of the patient.” Id.
Additionally, a dispensing permit holder must adhere to the
dispensing and labeling standards applicable to pharmacists,
purchase prescription drugs from a permitted distributor, complete
continuing education courses related to dispensing drugs, and allow
the Division of Drug Control within DHMH to inspect his office.
See HO § 12-102(c)(2)(ii)4. A permit is good for five years, after
which it may be renewed. COMAR 10.13.01.03C.
Gen. 85] 91

II
Analysis
A. Whether the Board or Department May Adopt New
Regulations Defining “In the Public Interest”
As described above, the statute allows a prescriber with a
dispensing permit to dispense prescription drugs to her patients
when it would be “in the public interest” to do so, and it defines “in
the public interest” to mean “when a pharmacy is not conveniently
available.” See HO § 12-102(a)(2), (b)(2)(i). The Department’s
regulations, however, leave it “solely” to the “discretion of the
patient” to decide whether a pharmacy is “conveniently available.”
COMAR 10.13.01.04J. The Board of Pharmacy has expressed
concern that these provisions essentially allow physicians, dentists,
or podiatrists to dispense prescription drugs whenever their patients
ask them to do so. That situation, the Board fears, does not
sufficiently limit the dispensing of drugs by prescribers and could
allow prescribers to pressure their patients into having their
prescriptions filled at the prescriber’s office instead of at a
pharmacy.
You have therefore asked whether the current regulations may
be amended to alter the meaning of “in the public interest” or
“conveniently available.” Your inquiry requires us to answer two
separate but related questions: May the regulations be amended at
all and, if so, by which units or offices within DHMH?
1. General Power of an Agency to Issue Regulations
Generally speaking, agencies may promulgate regulations to
define ambiguous terms in the statutes that they are charged with
administering. This is one of the most common ways in which
agencies exercise their regulatory powers, and they may do so even
in the absence of any express legislative authority. See 62 Opinions
of the Attorney General 36 (1977); see also State v. Copes, 175 Md.
App. 351, 379-80 (2007) (explaining the difference between
“interpretative” regulations and regulations with the force of law
based on explicit legislative authority). In fact, existing regulations
already define “conveniently available” to some extent. See
COMAR 10.13.01.04J (“The decision whether a pharmacy is
conveniently available shall be made by the patient based upon
factors to be determined solely in the discretion of the patient.”).
92 [100 Op. Att’y

There are, however, limits on an agency’s power to
promulgate regulations. Procedurally, the agency must adopt the
regulations in accordance with the requirements of the APA. See
generally Md. Code Ann., State Gov’t (“SG”) §§ 10-101 through
10-139 (2015 Repl. Vol.). In terms of substance, the regulation
must be “reasonable and consistent with the letter and spirit of the
law under which the agency acts,” Department of Transp. v.
Armacost, 311 Md. 64, 74 (1987), and may not “exceed[] the
statutory authority of the unit,” SG § 10-125(d)(2). In fact, if a
regulation is challenged, a court “shall” invalidate a regulation that
exceeds the agency’s statutory authority. SG § 10-125(d). Any
regulatory change must therefore be consistent with both the broad
statutory scheme and the specific statutory definition of “in the
public interest” as “when a pharmacy is not conveniently available
to the patient.” See HO § 12-102(a)(2). That leaves us with an
abstract answer to your first question: Yes, an agency may enact
regulations that define statutory terms so long as they do not
conflict with the statute.
2. Which Units May Promulgate Regulations?

Although we conclude that the “public interest” regulations
may be amended so long as the changes meet the substantive and
procedural requirements of State law, we do not believe that the
Board of Pharmacy is the governmental unit with the power to
amend them. The Board of Pharmacy is authorized to adopt
“[r]ules and regulations to carry out the provisions of [Title 12 of
the Health Occupations Article]” and rules “that establish standards
for practicing pharmacy and operating pharmacies,” including
“[s]tandards for filling and refilling prescriptions.” HO § 12-
205(a)(2), (3).
These provisions, taken alone, would seem broad enough to
authorize the Board to issue regulations that would amend the
current definitions. After all, the definitions in question were
promulgated to carry out a provision of Title 12, and the rules in
COMAR arguably set forth “standards for practicing pharmacy”
and “standards for filling . . . prescriptions.” See HO § 12-101(t)
(defining “practice pharmacy” to include “dispensing”). But the
Board of Pharmacy’s regulatory authority must not be viewed in
isolation; it must instead be read within the larger statutory scheme
governing the dispensing of prescription drugs by other health
professionals. See, e.g., Board of County Comm’rs of Garrett
County v. Bell Atlantic-Maryland, Inc., 346 Md. 160, 178 (1997)
(“[W]e must look to the entire statutory scheme, and not any one
Gen. 85] 93

provision in isolation, to effect the statute’s general policies and
purposes.”).
When the General Assembly enacted the legislation creating
the dispensing permit regime at issue here, it entrusted regulatory
authority over that regime to the Board of Physicians (then called
the Board of Physician Quality Assurance), the Board of Dental
Examiners, and the Board of Podiatric Medical Examiners. More
specifically, the Legislature gave each of these three boards the
express power, “[a]fter consulting with the State Board of
Pharmacy, [to] adopt rules and regulations regarding the dispensing
of prescription drugs by” the health professionals they license.
1986 Md. Laws, ch. 691 (currently codified at HO §§ 4-205(a)(2)
(dentists), 14-205(b)(1)(ii) (physicians), 16-205(a)(2)
(podiatrists)). It thus appears that the General Assembly intended
that these three boards, rather than the Board of Pharmacy, would
control the dispensing permit process for their respective licensees.
In other words, the Board of Physicians would adopt regulations
governing dispensing by physicians, the Board of Dental
Examiners would adopt regulations governing dispensing by
dentists, and the Board of Podiatric Medical Examiners would
adopt regulations governing dispensing by podiatrists. Although
all three boards were required to consult with the Board of
Pharmacy about their rules, the authority to promulgate those rules
was given to the non-pharmacist boards.
The apparent intent of the General Assembly to place
regulatory authority with the non-pharmacist boards also comports
with the understanding expressed by the interested parties in the
years immediately following the statute’s enactment. The
Maryland Pharmacists Association, for example, pressed the
General Assembly in 1989 to clarify HO § 12-102 because the three
non-pharmacist boards had not yet issued any regulations on the
dispensing process. See 1989 Leg., Reg. Sess., Hearing Before the
Senate Economic and Environmental Affairs Committee on S.B.
732 (written testimony of the Maryland Pharmacists Association).
The Board of Physician Quality Assurance also thought that it was
responsible for issuing its own regulations and was working on
draft regulations at the time. See id. (written testimony of the Board
of Physician Quality Assurance, attaching draft regulations). And,
when the Secretary ultimately proposed regulations governing the
dispensing process, the notice he published in the Maryland
Register specifically noted that the regulations had been
“considered by” the Board of Dental Examiners, the Board of
Physician Quality Assurance, and the Board of Podiatric Medical
94 [100 Op. Att’y

Examiners but did not mention the Board of Pharmacy. See 19:1
Md. Reg. 54, 54-55 (Jan. 10, 1992); see also 26:24 Md. Reg. 1861
(Nov. 19, 1999) (noting that the same three boards had considered
a proposed amendment to the regulations, but not mentioning the
Pharmacy Board).
We think that the specific grant of regulatory authority to the
boards of physicians, dentistry, and podiatry to oversee the
dispensing permit regime for their respective licensees controls
over the general grant of authority to the Board of Pharmacy to
issue regulations under Title 12. See, e.g., Suter v. Stuckey, 402
Md. 211, 231 (2007) (explaining that, in the event of a conflict
between two statutes, “the more specific statute controls”).
Although the broad language of HO § 12-205 might otherwise
authorize the Board of Pharmacy to issue regulations in this
context, we doubt the General Assembly intended to convey
regulatory authority over the same administrative scheme to two
different entities within the Department and thereby risk that those
two entities would adopt contradictory rules governing the same
conduct by the same individuals. It seems instead that the
Legislature provided for the Board of Pharmacy to have input into
the other boards’ regulations by “consulting” with them rather than
by promulgating its own competing set of regulatory requirements.
We recognize that there may be other ways in which the
different boards’ regulatory powers could be harmonized, at least
in practice. The Secretary has the power to “review” and “revise
the rules and regulations of . . . [e]ach unit in the Department,” Md.
Code Ann., Heath-General (“HG”) § 2-104(b)(3) (2009 Repl. Vol.,
2014 Supp.), and thus could revise any regulations proposed by one
of the professional boards that would conflict with another board’s
regulations. Moreover, as we have previously observed, agencies
are expected to work together to avoid these types of conflicts as
much as possible. See 70 Opinions of the Attorney General 180,
186 (1985).
But here there is no evidence that the Legislature intended to
put the Board of Pharmacy in direct conflict with the other
professional boards and require the Secretary to resolve that
conflict. In fact, the General Assembly apparently attempted to
prevent that conflict from occurring in the first place by giving each
individual professional board the power to grant dispensing permits
to its own licensees, rather than requiring prescribers to get a permit
from the Board of Pharmacy. We accordingly conclude that Board
of Pharmacy does not have the authority, on its own, to adopt a
regulation to clarify when a pharmacy is “conveniently available”
to a patient. Rather, the boards of physicians, dentistry, and
Gen. 85] 95

podiatry have the express authority to issue regulations governing
their respective licensees in consultation with the pharmacy board.
In addition to those three boards, however, we think the
Secretary of DHMH also has the power to amend the dispensing
regulations governing physicians, dentists, and podiatrists and, in
doing so, could ask the Board of Pharmacy for assistance in
drafting those amendments. One source of the Secretary’s power
to issue regulations in this context might be § 2-104(b)(3) of the
Health-General Article, which, as discussed above, authorizes the
Secretary to “review” and “revise” the regulations of “[e]ach unit
in the Department.”2 In addition, the Secretary has broad power to
“adopt rules and regulations to carry out the provisions of law that
are within the jurisdiction of the Secretary.” HG § 2-104(b)(1).
Although the statute does not explicitly delineate which provisions
are within the Secretary’s jurisdiction, he has wide-ranging
authority to regulate the manufacture, distribution, and dispensing
of prescription drugs prescription drugs under both the Maryland
Controlled Dangerous Substances Act and the Maryland Food,
Drug, and Cosmetic Act.
The Controlled Dangerous Substances Act requires a person
to register with the Department before manufacturing, distributing,
or dispensing a “controlled dangerous substance” and criminalizes,
among many other things, the dispensing of drugs without a
prescription. Md. Code Ann., Crim. Law (“CR”) §§ 5-301, 5-701
(2012 Repl. Vol., 2014 Supp.). The Act explicitly authorizes the
Department to “enforce” the Act and “adopt regulations to
implement” its provisions. CR §§ 5-201(a)(1), 5-203. Similarly,
the Food, Drug, and Cosmetic Act, which regulates certain aspects
of the dispensing of prescription drugs, see HG § 21-220, provides
2
We say “might be” because it is our understanding that the
Secretary has traditionally exercised this authority only with respect to
regulatory changes that have already been proposed by a unit within the
Department, not to initiate regulations on his or her own. That practice
seems to be based on the recognition that the health occupations boards
“are created to function as independent boards” when it comes to
regulating their respective occupations, HO § 1-102(b), and that any
authority over departmental units that is not “specifically granted to the
Secretary by law” is “reserved to those units free of the control of the
Secretary.” HG § 2-106(c). Although all regulations proposed by the
constituent units of DHMH are formally proposed by the Secretary on
behalf of those units, see SG § 8-206, it is at the proposal stage of the
regulatory process that the Secretary has traditionally exercised his
power to “review” and “revise” those regulations.
96 [100 Op. Att’y

that “[t]he Secretary may adopt rules and regulations to carry out
the provisions of this subtitle.” HG § 21-234(a). The Secretary
also has regulatory authority over drugs under the Prescription
Drug Monitoring Program, which assists prescribers and
dispensers in the prevention of prescription drug abuse. HG §§ 21-
2A-02(b), 21-2A-04. Finally, the Division of Drug Control, which
is within the Secretary’s office, plays an important role in the
dispensing permit regime by inspecting the offices of permit
holders to ensure that they are in compliance with the statutory
requirements. See HO § 12-102.1(b).
We think the Secretary’s general authority over health-related
regulations and his more specific authority over prescription drugs
mean that the dispensing process for prescribers lies within the
Secretary’s “jurisdiction” and that he has the power under HG
§ 2-104 to issue or amend regulations governing dispensing permits
for physicians, dentists, and podiatrists.3 Therefore, while the
Board of Pharmacy may not issue regulations in this area on its
own, the Secretary may do so and might well ask the Board for
assistance in considering changes to the regulations.4 After all, the
Board of Physicians, Board of Dental Examiners, and Board of
Podiatric Medical Examiners are required to consult with the
Board of Pharmacy before they issue dispensing regulations. See
HO §§ 4-205(a)(2), 14-205(b)(1)(ii), 16-205(a)(2).
B. Whether Physicians, Dentists, and Podiatrists May Delegate
to Unlicensed Individuals the Tasks Involved in Dispensing
By statute, the process of “dispensing” a prescription drug
entails at least the following steps: interpreting the prescription,
selecting the proper drug, measuring the correct amount of the
drug, packaging the drug, and correctly labeling the package. See
3
We do not mean to suggest that every regulation involving drugs
would necessarily fall within the jurisdiction of the Secretary. The
General Assembly, for example, may well have intended to delegate the
regulation of the pharmaceutical profession exclusively to the Board of
Pharmacy even where it overlaps with the Secretary’s authority over
prescription drugs. See HO § 1-102(b) (explaining that the health
occupations boards were “created to function as independent boards”
when it comes to regulating their respective occupations).
4
The Secretary, in fact, recently asked the Board of Pharmacy to
review the current dispensing regulations and make recommendations
about potential amendments. See 41:11 Md. Reg. 614 (May 30, 2014)
(DHMH proposing amendments to dispensing regulations and noting
that the amendments had been “considered by” the Board of Pharmacy).
The draft regulations are currently pending.
Gen. 85] 97

HO § 12-101(h). Pharmacists must normally conduct all of these
tasks themselves. See HO § 12-101(t)(1)(ii) (defining the practice
of pharmacy to include “dispensing”); see also HO § 12-313(b)(4)
(prohibiting a pharmacist from delegating a pharmacy act “to an
un-authorized individual”). A pharmacist may, however, delegate
the tasks to a licensed pharmacy technician. See HO § 12-6B-06
(allowing registered pharmacy technicians to perform “delegated
pharmacy acts”). You have asked whether physicians, dentists, and
podiatrists who hold dispensing permits may similarly delegate the
dispensing function or any of the relevant steps in the process.
We have already advised multiple times that a physician may
not delegate the dispensing function in its entirety because the
Pharmacy Act requires a dispensing permit holder to personally
prepare and dispense the drugs. See 86 Opinions of the Attorney
General 157, 163-64 (2001); 80 Opinions of the Attorney General
173, 178 (1995); 44 Opinions of the Attorney General 300, 301
(1959); see also HO § 12-102(c)(2)(ii). Although in each of those
instances we stated our conclusion in broad terms, we have never
explicitly considered whether a physician, dentist, or podiatrist
could delegate individual steps in the dispensing process, such as
counting the drugs, packaging them, and preparing the label, as
long as the prescriber retained overall control of the process.
A dispensing permit holder must dispense the drugs
“personally,” see HO § 12-102(c)(2)(ii), but the statute defines
“personally preparing and dispensing” to require only that the
permit holder “[i]s physically present on the premises where the
prescription is filled” and “[p]erforms a final check of the
prescription before it is provided to the patient.” HO § 12-
102(a)(3). Section 12-102, therefore, seems to allow a prescriber
to delegate specific tasks within the dispensing process as long as
the prescriber is on the premises and performs a final check.5 The
5
The Secretary has proposed draft regulations that, if adopted,
would clarify the steps a prescriber must take to fulfill his or her statutory
responsibility to perform a “final check” of the prescription. These
proposed regulations provide that “final check” means “the verification
by the licensee that the prescription is correct before the prescription is
dispensed to the patient.” 41:11 Md. Reg. 614, 615 (May 30, 2014)
(proposed COMAR 10.13.01.02B(2)(a)). According to the proposed
regulations, “final check” includes “the assumption of responsibility for
the filled prescription, including, but not limited to: (i) Appropriateness
of the dose; (ii) Correct expiration date; (iii) Accuracy of drug, strength,
and labeling; (iv) Verification of ingredients; and (v) Proper container.”
Id. (proposed COMAR 10.13.01.02B(2)(b)).
98 [100 Op. Att’y

legislative history confirms this reading of the Pharmacy Act. As
originally drafted, the definition of “personally preparing and
dispensing” also required that the prescriber actually “witness the
preparation of the prescription,” but the bill was later amended to
delete this requirement. See 1989 Leg., Reg. Sess., Floor Report of
the Senate Economic and Environmental Affairs Committee on
S.B. 732; 1989 Md. Laws, ch. 608. The statute thus appears to
authorize a dispensing permit holder to delegate limited tasks in the
dispensing process, such as the counting, packaging, and labeling
of drugs.
Still, the statute does not specify either to whom the prescriber
may delegate these tasks or how the delegation should operate. In
the absence of any express statutory restrictions on delegation, the
Board of Pharmacy has expressed concern about potential risks to
public health if prescribers delegate some tasks to unlicensed,
untrained individuals. Indeed, it would seem strange to give
prescribers nearly unlimited authority to delegate to unlicensed
individuals when a pharmacist may usually delegate only to a
trained pharmacy technician.6
But we doubt the Legislature enacted these provisions with
the understanding that prescribers, in the absence of statutory
restrictions, would delegate these tasks indiscriminately to
untrained individuals in their practice, particularly when the actions
6
There does not appear to be any clear consensus among other states
as to whether, and to what extent, physicians may delegate certain steps
in the dispensing process. See, e.g., Abood, supra, at 322-23
(summarizing some of the differences in this area as of 1989). The
Mississippi State Board of Medical Licensure, for example, recently
issued a notice reminding its physicians that they “may NOT delegate
any part of” the dispensing process. See Letter from Mississippi State
Board of Medical Licensure to Mississippi Licensed Physicians (May
22, 2013), available at http://www.methodistmd.org/dotAsset/3bfa0f02-
2cc1-499b-9fe3-e30f51d1b15d.pdf (last visited May 20, 2015)
(emphasis in original). Oregon, however, apparently allows its
physicians to delegate “nonjudgmental dispensing functions” to staff
assistants so long as the “accuracy and completeness of the prescription
is verified by the physician.” Or. Rev. Stat. § 677.089. “Nonjudgmental
dispensing functions” could include “preparing the bottle or label or
handing the bottle to the patient after the physician has checked its
accuracy.” See Oregon Medical Board Report Vol. 124, No. 3, at 2
(Summer 2012), available at http://www.oregon.gov/OMB/newsletter/
Summer%202012.pdf (last visited May 20, 2015). The physician must
nevertheless “determine the correct drug, confirm the contents and label
of the final package or bottle, and counsel the patient.” Id.
Gen. 85] 99

in question constitute the practice of pharmacy for which a license
would normally be required. See HO § 12-101(t). Rather, the only
reasonable way to read the statute is that it implicitly requires that
permit holders delegate tasks only to competent individuals who
have been properly trained. This is consistent with standard
principles of medical ethics, which generally prohibit medical
professionals from delegating tasks to unqualified individuals.7
The General Assembly must have expected that the medical
professionals in question would follow these basic ethical
requirements.
We also think that the General Assembly expected the boards
of physicians, dentistry, and podiatry to flesh out the requirements
for the appropriate delegation of tasks involved in the dispensing
process and, if necessary, to place additional limits on a
prescriber’s ability to delegate these tasks. After all, these boards
have explicit authority to adopt regulations “regarding the
dispensing of prescription drugs,” see HO §§ 4-205(a)(2)
(dentists), 14-205(b)(1)(ii) (physicians), 16-205(a)(2) (podiatrists),
and they also are more attuned to specific restrictions on delegation
that might be necessary for their specific professions.
The Board of Physicians, for example, has apparently
determined that physicians should not delegate the tasks involved
in dispensing to unlicensed individuals. The General Assembly has
granted physicians broad authority to delegate a wide array of
duties—more than just those involved in the dispensing process—

7
See, e.g., American Med. Ass’n, Code of Ethics, Opinion 3.03,
available at http://www.ama-assn.org/ama/pub/physician-resources/
medical-ethics/code-medical-ethics/opinion303.page? (“It is ethical
for a physician to work in consultation with or employ allied health
professionals, as long as they are appropriately trained and duly licensed
to perform the activities being requested.”) (last visited May 20, 2015);
American Dental Ass’n, Code of Professional Conduct, Section 2.C,
available at http://www.ada.org/en/about-the-ada/principles-of-ethics-
code-of-professional-conduct (stating that “[d]entists shall be obliged to
protect the health of their patients by only assigning to qualified
auxiliaries those duties which can be legally delegated”) (last visited
May 20, 2015); American Podiatric Med. Ass’n, Code of Ethics, BE4.0,
available at http://apma.files.cms-plus.com/2013%20Code%20of%20
Ethics.pdf (“The podiatrist reasonably delegates aspects of medical care
to auxiliary health care personnel. The podiatrist shall ensure that such
personnel are qualified and adequately supervised.”) (last visited May
20, 2015).
100 [100 Op. Att’y

to unlicensed individuals in their practices, but it has also mandated
that the Board of Physicians promulgate regulations “to delineate
the scope” of permissible delegation. HO § 14-306(a), (c). Those
regulations, in turn, expressly prohibit physicians from delegating
the task of “[d]ispensing medications” to unlicensed individuals.8
COMAR 10.32.12.04E(4).
It is less clear to what extent dentists and podiatrists may,
under their own regulations, delegate tasks involved in the
dispensing process. Unlike physicians, there is no statute that gives
dentists or podiatrists general authority to delegate tasks to
unlicensed individuals, compare HO § 14-306, but there is also no
express regulation that prohibits them from delegating dispensing-
related tasks. Ultimately, the professional boards themselves are
best equipped to determine whether delegation is permissible under
their regulations, and we expect that a court would defer to those
determinations. See, e.g., Maryland Transp. Auth. v. King, 369
Md. 274, 288 (2002) (explaining that “a great deal of deference is
owed to an administrative agency’s interpretation of its own
regulation”).
We also note that, if delegation is allowed, both boards have
statutes or regulations that would put limits on the delegation of the
dispensing process. The Board of Podiatric Medical Examiners,
for instance, has defined “unprofessional conduct” to include
“[d]elegating podiatric medical responsibilities to a person when
the podiatrist delegating these responsibilities knows or has reason
to know that the person is not qualified by training, experience, or
licensure to perform them.” COMAR 10.40.08.02B(4)(e).

8
This regulation could be read as prohibiting a physician from
delegating the dispensing function in its entirety, as opposed to discrete
steps within that process. We note, however, that the Board of Physicians
expressly allows delegation in one limited context. See COMAR
10.32.03.08B (physicians may delegate the dispensing of starter doses
and drug samples to physician assistants). In any event, it is for
the Board of Physicians to resolve any ambiguity about the scope
of its regulations. But if the board were to interpret its regulations to
allow delegation more generally, there are other regulatory limits that
would apply. The board’s regulations authorize a physician to
delegate to unlicensed assistants “only routine technical acts” that do
not involve medical judgment and “for which the assistant has
been trained.” COMAR 10.32.12.02B(1), 10.32.12.03A(3).
Furthermore, the physician bears ultimate responsibility for the acts
of the assistant, COMAR 10.32.12.03A(4), and a physician who
delegates technical acts to an unlicensed assistant must always keep
in mind the potential “risk to the patient.” COMAR 10.32.12.03A(1).
Gen. 85] 101

Similarly, a dentist may be disciplined if she “violates a
professional code of ethics pertaining to the dentistry profession,”
HO § 4-315(a)(16), and the American Dental Association’s Code
of Professional Responsibility provides that dentists may only
delegate duties to “qualified auxiliaries” who are properly
supervised. ADA Code of Professional Conduct, Section 2.C.
In sum, we conclude that § 12-102 of the Pharmacy Act
allows prescribers to delegate specific tasks in the dispensing
process as long as the prescriber performs a final check, delegates
the tasks only to competent, trained individuals, and exercises the
authority in accordance with other limits imposed by statute and
regulation on the prescriber’s particular profession.
C. Whether the Board of Pharmacy May Inspect the Offices of
Dispensing Permit Holders Under HO § 12-604(a)
The Board of Pharmacy has the express power to “[e]nter any
place where drugs . . . are manufactured, packaged, stocked, or
offered for sale” and “inspect” those drugs. HO § 12-604(a). On
its face, this provision would seem to authorize the Board to inspect
the offices of physicians, dentists, and podiatrists who hold
dispensing permits because they are places where prescription
drugs are “packaged” and “offered for sale.” Moreover, the
legislative history of § 12-604 makes clear that the Board of
Pharmacy has the power to inspect more than just traditional
“pharmacies.” When originally enacted in 1935, the relevant
provision read:
The members of the Board of Pharmacy . . .
shall have the power to inspect in a lawful
manner the medicines or drugs or drug
products or domestic remedies which are
manufactured, packed, packaged, made, sold,
offered for sale, exposed for sale, or kept for
sale, in the state and for this purpose shall
have the right to enter and inspect during
business hours any pharmacy or any other
place in the State of Maryland where
medicines or drugs or drug products or
domestic remedies are manufactured, packed,
packaged, made, sold, offered for sale,
exposed for sale, or kept for sale.
102 [100 Op. Att’y

1935 Md. Laws, ch. 165 (emphasis added). The specific power to
inspect pharmacies was moved to a different section when the
Health Occupations Article was codified in 1981, but the broader
power to inspect “any place” remained. See 1981 Md. Laws, ch. 8,
at 506.
Although this history shows that the Board of Pharmacy’s
general inspection powers are broad, these powers do not expressly
include the authority to inspect the offices of physicians, dentists,
and podiatrists who hold dispensing permits. The General
Assembly instead gave that specific responsibility to the Division
of Drug Control (“DDC”) within DHMH. See 1989 Md. Laws, ch.
608. Then, in 2012, the Legislature further required the DDC to
inspect the office of a dispensing permit holder at least two times
during the duration of the permit. See HO § 12-102.1(b); see also
2012 Md. Laws, ch. 267. As the more recent and more specific
legislative provision, § 12-102.1 would seem to authorize the DDC,
and not the Board of Pharmacy, to inspect dispensing permit
holders. See, e.g., Suter, 402 Md. at 231 (reasoning that the more
specific statute controls in the event of a conflict); Farmers &
Merchants Nat’l Bank of Hagerstown v. Schlossberg, 306 Md. 48,
61 (1986) (more recent statute controls).
Although, in theory, the General Assembly could have
authorized both units to inspect these permit holders, the recent
legislative history of the dispensing law tends to confirm our
conclusion that the Legislature delegated that duty to the DDC. In
2011, the Board of Pharmacy grew concerned that the DDC was
not conducting inspections with enough frequency and, more
generally, that dispensing permit holders were not held to the same
safety standards as pharmacists. It therefore urged the General
Assembly to adopt legislation that would have required dispensing
physicians, dentists, and podiatrists to get a permit from the Board
of Pharmacy (in addition to the ones from their own boards) and
would have given explicit inspection authority to the Board in
addition to the DDC. See 2011 Leg., Reg. Sess., S.B. 884 (First
Reader). The bill did not pass but was referred for interim study
by the Senate Education, Health, and Environmental Affairs
Committee. See 2012 Leg., Reg. Sess., S.B. 603, Revised Fiscal
and Policy Note.
During the interim, representatives from the boards of
pharmacy, physicians, dentistry, and podiatry met to discuss these
issues and “generally agreed” upon the provisions of new
legislation that was ultimately introduced in the 2012 session. See
id. One element of this consensus legislation was to keep the
inspection power with the DDC, rather than give it to the Board of
Gen. 85] 103

Pharmacy, but at the same time require DDC to conduct more
inspections. See 2012 Leg., Reg. Sess., S.B. 603 (proposed § 12-
102.1). As a representative from the Board of Physicians
explained, the physicians felt it was important for the inspections
to be done by the DDC and not by the Board of Pharmacy because
the DDC is “a neutral, outside agency.” See 2012 Leg., Reg. Sess.,
Hearing Before the Senate Education, Health, and Environmental
Affairs Committee on S.B. 603 (testimony of Robin Bailey).
During the hearings on the bill, the Board of Pharmacy proposed
an amendment that would have transferred inspection authority
from the DDC to the “Secretary or an agent of the Secretary.” See
id. (written testimony of the Board of Pharmacy). The Legislature
rejected the amendment and instead enacted the inspection section
of the consensus legislation as proposed. See 2012 Md. Laws, ch.
267.
The mere rejection of a proposed amendment is not
necessarily strong evidence of legislative intent; there may have
been other considerations that caused the amendment here to fail.
But the overall legislative history indicates that the General
Assembly intended that the DDC, and not the Board of Pharmacy,
would have the power to inspect dispensing permit holders. See
NCR Corp. v. Comptroller, 313 Md. 118, 125 (1988) (“While a
committee’s rejection of an amendment is clearly not an infallible
indication of legislative intent, it may help our understanding of
overall legislative history.”). That indication is particularly strong
here, where the plain language of HO § 12-102.1 indicates that the
Board of Pharmacy does not hold the power to inspect the practices
of dispensing permit holders and the historical record indicates that
the Board has not exercised that power. See 77 Opinions of the
Attorney General 110, 115 n.7 (1992) (“[W]here there are serious
doubts about statutory authority for an action, coupled with an
agency’s longstanding failure to act upon such authority, legislative
rejection of amendments designed to provide specific authority
may ‘strengthen’ the conclusion that statutory authority is
lacking.”) (citing Bosley v. Dorsey, 191 Md. 229 (1948)).9

9
We recognize that a later-enacted piece of legislation exempted a
small subset of dentists from DDC inspections. See 2014 Md. Laws, ch.
496 (codified at HO § 12-102.1(a)). But these dentists receive special,
limited dispensing permits that allow them “to dispense only prescription
strength home fluoride products, dentin-enamel mineralizing products,
and antimicrobial rinse.” See HO § 12-102(h). Dentists who hold these
limited permits remain subject to the Board of Dental Examiners’
104 [100 Op. Att’y

We therefore conclude that the specific grant of authority to
the DDC under § 12-102.1 controls over the general grant of
authority to the Board of Pharmacy under § 12-604(a). Although
we do not need to decide this issue here, we also note that the broad
language of the statute, which states that the Board may inspect
“any place where drugs . . . are manufactured, packaged, stocked,
or offered for sale,” could well authorize the Board to inspect other
places that are not subject to the regulatory authority of a different
professional board.
III
Conclusion
For the reasons discussed above, we conclude: (1) the Board
of Pharmacy may not itself amend the regulations governing
dispensing permit holders, but the Secretary of DHMH (and the
boards of physicians, dentistry, and podiatry) may do so as long as
the amendments are consistent with the statutory scheme; (2)
prescribers may not delegate the entire dispensing function, but
may delegate certain tasks in the dispensing process subject to the
“final check” requirement in the Pharmacy Act and further
restrictions and regulations imposed by their respective licensing
boards; and (3) the Board of Pharmacy may not inspect the offices
of prescribers who hold dispensing permits because the General
Assembly has assigned that function to the Division of Drug
Control.
Brian E. Frosh
Attorney General of Maryland

Patrick B. Hughes
Assistant Attorney General
Adam D. Snyder
Chief Counsel, Opinions & Advice

authority to inspect “the work authorization forms and files kept by a
licensed dentist or dental laboratory,” HO § 4-407(a)(1), which would
seem to include the chart notations required by HO § 12-102(h)(2).