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).