EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*sb0161*
SENATE BILL 161
J2 3lr1325
HB 260/22 – HGO CF 3lr1831
By: Senator Lam (By Request – State Board of Physicians)
Introduced and read first time: January 18, 2023
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
State Board of Physicians – Dispensing Permits 2
FOR the purpose of transferring oversight of the inspection of the offices of dispensing 3
physicians from the Office of Controlled Substances Administration to the State 4
Board of Physicians; altering the circumstances under which a physician may 5
dispense drugs or devices; requiring that certain appropriations be transferred to the 6
Board on a certain date; providing for the transfer of certain functions, powers, 7
duties, property, records, fixtures, credits, assets, liability, obligations, rights, and 8
privileges; requiring that certain employees of the Office be transferred to the Board 9
without diminution of their rights, benefits, employment, or retirement status; 10
requiring that certain positions at the Office be transferred to the Board; providing 11
for the continuity of certain transactions affected by or flowing from this Act; 12
providing for the continuity of certain laws, regulations, standards and guidelines, 13
policies, orders and other directives, forms, plans, membership, contracts, property, 14
investigations, administrative and judicial responsibilities, rights, and other duties 15
and responsibilities; and generally relating to the dispensing of drugs or devices by 16
licensed physicians. 17
BY repealing and reenacting, with amendments, 18
Article – Health Occupations 19
Section 12–102(a) and (c), 12–102.1, 12–102.2, and 14–509 20
Annotated Code of Maryland 21
(2021 Replacement Volume and 2022 Supplement) 22
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 23
That the Laws of Maryland read as follows: 24
Article – Health Occupations 25
12–102. 26
2 SENATE BILL 161
(a) (1) In this section the following [terms] WORDS have the meanings 1
indicated. 2
(2) “In the public interest” means the dispensing of drugs or devices by a 3
licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 4
available to the patient. 5
(3) “Personally preparing and dispensing” means that the license d 6
dentist[, physician,] or podiatrist: 7
(i) Is physically present on the premises where the prescription is 8
filled; and 9
(ii) Performs a final check of the prescription before it is provided to 10
the patient. 11
(c) (1) This subsection does not apply to a licensed dentist who obtains a 12
permit from the State Board of Dental Examiners under subsection (h) of this section. 13
(2) This title does not prohibit: 14
(i) A licensed veterinarian from: 15
1. Personally preparing and dispensing the veterinarian’s 16
prescriptions; or 17
2. Dispensing, in accordance with § 2 –313(c) of the 18
Agriculture Article, compounded nonsterile preparations or compounded sterile 19
preparations provided by a pharmacy; 20
(II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 21
AND DISPENSING PRESC RIPTIONS IF THE PHYS ICIAN HAS OBTAINED A PERMIT 22
UNDER § 14–509 OF THIS ARTICLE; 23
[(ii)] (III) A licensed dentist[, physician,] or podiatrist from 24
personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 25
prescriptions when: 26
1. The dentist[, physician,] or podiatrist: 27
A. Has applied to the board of licensure in this State which 28
licensed the dentist[, physician,] or podiatrist; 29
B. Has demonstrated to the satisfaction of that board that the 30
dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 31
the public interest; 32 SENATE BILL 161 3
C. Has received a written permit from that board to dispense 1
prescription drugs or devices except that a written permit is not required in order to 2
dispense starter dosages or samples without charge; and 3
D. Posts a sign conspicuously positioned and readable 4
regarding the process for resolving incorrectly filled prescriptions or includes written 5
information regarding the process with each prescription dispensed; 6
2. The person for whom the drugs or devices are prescribed 7
is a patient of the prescribing dentist[, physician,] or podiatrist; 8
3. The dentist[, physician,] or podiatrist does not have a 9
substantial financial interest in a pharmacy; and 10
4. The dentist[, physician,] or podiatrist: 11
A. Complies with the dispensing and labeling requirements 12
of this title; 13
B. Records the dispensing of the prescription drug or device 14
on the patient’s chart; 15
C. Allows the Office of Controlled Substances Administration 16
to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 17
and in accordance with § 12–102.1 of this subtitle; 18
D. On inspection by the Office of Controlled Substances 19
Administration, signs and dates an acknowledgment form provided by the Office of 20
Controlled Substances Administration relating to the requirements of this section; 21
E. Except for starter dosages or samples without charge, 22
provides the patient with a written prescription, maintains prescription files in accordance 23
with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions; 24
F. Does not direct patients to a single pharmacist or 25
pharmacy in accordance with § 12–403(c)(8) of this title; 26
G. Does not receive remuneration for referring patients to a 27
pharmacist or pharmacy; 28
H. Complies with the child resistant packaging requirements 29
regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; 30
I. Complies with drug recalls; 31
4 SENATE BILL 161
J. Maintains biennial inventories and complies with any 1
other federal and State record–keeping requirements relating to controlled dangerous 2
substances; 3
K. Purchases prescription drugs from a pharmacy or 4
wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 5
the Board of Pharmacy; 6
L. Annually reports to the respective board of licensure 7
whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 8
prescription drugs within the previous year; and 9
M. Completes ten continuing education credits over a 5–year 10
period relating to the preparing and dispensing of prescription drugs, offered by the 11
Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 12
consultation with each respective board of licensure, as a condition of permit renewal; OR 13
[(iii) A licensed physician from dispensing a topical medication 14
without obtaining the permit required under item (ii)1C of this paragraph or completing 15
the continuing education required under item (ii)4M of this paragraph when the physician: 16
1. Otherwise complies with item (ii) of this paragraph; and 17
2. Has obtained a special written permit under § 14–509 of 18
this article; 19
(iv) A licensed physician who complies with the requirements of item 20
(ii) of this paragraph from personally preparing and dispensing a prescription written by: 21
1. A physician assistant in accordance with a delegation 22
agreement that complies with Title 15, Subtitle 3 of this article; or 23
2. A nurse practitioner who is authorized to practice under 24
Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 25
or] 26
[(v)] (IV) A hospital–based clinic from dispensing prescriptions to 27
its patients. 28
12–102.1. 29
(a) This section does not apply to [a]: 30
(1) A licensed dentist who obtains a permit from the State Board of Dental 31
Examiners under § 12–102(h) of this subtitle; OR 32
SENATE BILL 161 5
(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 1
STATE BOARD OF PHYSICIANS UNDE R § 14–509 OF THIS ARTICLE . 2
(b) The Office of Controlled Substances Administration shall enter and inspect 3
the office of a dentist[, physician,] or podiatrist who holds: 4
(1) An initial dispensing permit: 5
(i) Within 6 months after receiving the report required under § 6
12–102(l)(1) of this subtitle; and 7
(ii) At least one more time during the duration of the permit; and 8
(2) A renewed dispensing permit at least two times during the duration of 9
the permit. 10
(c) The Office of Controlled Substances Administration promptly shall report the 11
results of the inspections required under subsection (b) of this section to the respective 12
board of licensure. 13
12–102.2. 14
(a) This section does not apply to [a]: 15
(1) A licensed dentist who obtains a permit from the State Board of Dental 16
Examiners under § 12–102(h) of this subtitle; OR 17
(2) A LICENSED PHYSICIAN W HO OBTAINS A PER MIT FROM THE 18
STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 19
(b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 20
Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 21
holds a dispensing permit in an amount that will produce funds to approximate but not 22
exceed the documented costs to the Office of Controlled Substances Administration for 23
inspection of dispensing permit holders. 24
(c) Revenues collected by the Board of Dental Examiners[, the Board of 25
Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 26
into the General Fund of the State. 27
14–509. 28
(a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 29
INDICATED. 30
6 SENATE BILL 161
(2) “ACCME” means the Accrediting Council for Continuing Medical 1
Education. 2
(3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 3
SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 4
OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 5
(4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 6
BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 7
OR DEVICES TO A PATI ENT. 8
(5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 9
OR DEVICES BY A LICENSED PHYSICIAN TO A PATIENT WHEN A PHARMACY IS NOT 10
CONVENIENTLY AVAILAB LE TO THE PATIENT . 11
(6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 12
LICENSED PHYSICIAN : 13
(I) IS PHYSICALLY PRESENT ON THE PREMISES WHER E THE 14
PRESCRIPTION IS FILL ED; AND 15
(II) PERFORMS A FINAL CHEC K OF THE PRESCRIPTIO N BEFORE 16
IT IS PROVIDED TO TH E PATIENT. 17
(7) “SAMPLE UNIT ” HAS THE MEANING STAT ED IN 21 C.F.R. § 18
203.3(AA). 19
(8) “STARTER DOSAGE” MEANS AN AMOUNT OF A DRUG OR A DEVICE 20
SUFFICIENT TO BEGIN THERAPY: 21
(I) FOR A DURATION OF 72 HOURS OR LESS ; OR 22
(II) PRIOR TO OBTAINING A LARGER QUANTITY OF T HE DRUG 23
OR DEVICE TO COMPLET E THE THERAPY . 24
(9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERM IT 25
ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DISPENSE TOPICAL 26
MEDICATIONS THAT ARE APPROVED BY THE FEDE RAL FOOD AND DRUG 27
ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 28
(b) [A physician may dispense a topical medication that is approved by the federal 29
Food and Drug Administration for the treatment of hypotrichosis without obtaining a 30
dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 31
of this article if the physician: 32
SENATE BILL 161 7
(1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 1
article; and 2
(2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 3
(1) (I) Has received a [special class of written] TOPICAL MEDICATION 4
permit from the Board[.]; 5
[(c) The Board may issue a special class of written permit to a physician under 6
subsection (b) of this section if the physician: 7
(1)] (II) DISPENSES ONLY A TOPI CAL MEDICATION THAT IS 8
APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 9
TREATMENT OF HYPOTRICHOSIS ; 10
(III) Completes 1 hour of continuing medical education per year on 11
the dispensing of topical medications developed by an ACCME–accredited Maryland 12
nonprofit or governmental entity; and 13
[(2)] (IV) Pays to the Board a $100 permit fee; 14
(2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 15
PATIENT IF: 16
(I) THE SAMPLE COMPLIES W ITH THE LABELING 17
REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 18
(II) NO CHARGE IS MADE FOR THE SAMPLE; AND 19
(III) THE AUTHORIZED PRESCR IBER ENTERS AN APPROPRIATE 20
RECORD IN THE PATIEN T’S CHART; 21
(3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 22
OF TREATING A PATIEN T; 23
(4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 24
DRUG OR DEVICE TO A PATIENT IF: 25
(I) THE STARTER DOSAGE CO MPLIES WITH THE LABELIN G 26
REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 27
(II) NO CHARGE IS MADE FOR THE STARTER DOSAGE ; AND 28
(III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 29
RECORD ON THE PATIEN T’S CHART; OR 30 8 SENATE BILL 161
(5) DISPENSES A PRESCRIPT ION DRUG OR DEVICE IN THE COURSE OF 1
TREATING A PATIENT A T: 2
(I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 3
NONPROFIT BASIS ; 4
(II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 5
INSTITUTION OF HIGHE R EDUCATION; OR 6
(III) A PUBLIC HEALTH FACILI TY, A MEDICAL F ACILITY UNDER 7
CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 8
WITH PUBLIC FUNDS . 9
(C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 10
PRESCRIPTIONS ONLY I F: 11
(1) THE PHYSICIAN: 12
(I) HAS AN ACTIVE LICENSE IN GOOD STANDING ; 13
(II) HAS APPLIED TO THE BOARD FOR A DISPENSIN G PERMIT; 14
(III) HAS PAID A FEE DETERM INED BY THE BOARD TO PRODUCE 15
FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 16
BOARD FOR CONDUCTING INSPECTION S OF DISPENSING PERM IT HOLDERS; 17
(IV) HAS DEMONSTRATED TO T HE SATISFACTION OF T HE BOARD 18
THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 19
IN THE PUBLIC INTERE ST; 20
(V) HAS RECEIVED A DISPEN SING PERMIT FROM THE BOARD; 21
AND 22
(VI) HAS A SIGN CONSPICUOU SLY POSITIONED AND R EADABLE 23
REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PRESC RIPTIONS 24
OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 25
PRESCRIPTION DISPENS ED; 26
(2) THE INDIVIDUAL FOR WH OM THE DRUG OR DEVICE IS 27
PRESCRIBED IS A PATI ENT OF: 28
(I) THE PRESCRIBING PHYSI CIAN; 29
SENATE BILL 161 9
(II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 1
DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 2
ARTICLE; OR 3
(III) A NURSE PRACTITIONER W HO IS AUTHORIZE D TO PRACTICE 4
UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 5
PHYSICIAN IN THE SAM E OFFICE SETTING ; 6
(3) THE PHYSICIAN DOES NO T HAVE A SUBSTANTIAL FINANCIAL 7
INTEREST IN A PHARMA CY; AND 8
(4) THE PHYSICIAN: 9
(I) COMPLIES WITH THE DIS PENSING AND LABELING 10
REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE , AND THE BOARD’S 11
REGULATIONS ; 12
(II) RECORDS THE DISPENSIN G OF THE PRESCRIPTIO N DRUG 13
OR DEVICE ON THE PAT IENT’S CHART; 14
(III) PROVIDES THE PATIENT WITH A WRITTEN PRESCRIPTION , 15
MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 16
ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 17
(IV) DOES NOT DIRECT PATIE NTS TO A SINGLE PHAR MACIST OR 18
PHARMACY IN ACCORDAN CE WITH § 12–403(C)(8) OF THIS ARTICLE; 19
(V) DOES NOT RECEIVE REMU NERATION FOR REFERRI NG 20
PATIENTS TO A PHARMA CIST OR PHARMACY ; 21
(VI) COMPLIES WITH THE CHI LD RESISTANT PACKAGI NG 22
REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 23
OF THE HEALTH – GENERAL ARTICLE; 24
(VII) COMPLIES WITH DRUG RE CALLS; 25
(VIII) MAINTAINS BIENNIAL IN VENTORIES AND COMPLI ES WITH 26
ANY OTHER FEDERAL AN D STATE RECORD –KEEPING REQUIREMENTS RELATING TO 27
CONTROLLED DANGEROUS SUBSTANCES; 28
(IX) PURCHASES PRESCRIPTIO N DRUGS FROM A PHARMACY OR 29
WHOLESALE DISTRIBUTO R THAT HOLDS A PERMI T ISSUED BY THE STATE BOARD OF 30
PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 31
10 SENATE BILL 161
(X) COMPLIES WITH CONTINU ING EDUCATION REQUIR EMENTS 1
RELATING TO THE PREP ARING AND DISPENSING OF PRESCRIPTION DRUGS AS 2
PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 3
(D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS OF THIS 4
SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 5
SHALL: 6
(1) HAVE THE DISPENSING P ERMIT REVOKED ; AND 7
(2) BE SUBJECT TO DISCIPL INARY ACTION BY THE BOARD. 8
(E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITI AL 9
DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 10
INSPECT THE OFFICE O F THE PHYSICIAN. 11
(II) IF THE BOARD RENEWS A DISPEN SING PERMIT TO A 12
LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 13
PHYSICIAN AT LEAST O NE TIME DURING THE D URATION OF THE RENEW ED PERMIT. 14
(2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 15
SUBSTANCES ADMINISTRATION ANY VI OLATION RELATED TO C ONTROLLED 16
DANGEROUS SUBSTANCES FOUND DURING AN INSP ECTION REQUIRED UNDE R 17
PARAGRAPH (1) OF THIS SUBSECTION . 18
SECTION 2. AND BE IT FURTHER ENACTED, That, on the effective date of this 19
Act, the following shall be transferred to the State Board of Physicians: 20
(1) all appropriations, including State and federal funds, held by the Office 21
of Controlled Substances Administration for the purposes of conducting inspections of 22
offices of physicians who hold dispensing permits under § 14–509 of the Health Occupations 23
Article on the effective date of this Act; and 24
(2) all books and records including electronic records, real and personal 25
property, equipment, fixtures, assets, liabilities, obligations, credits, rights, and privileges 26
held by the Office of Controlled Substances Administration for the purposes of conducting 27
inspections of offices of physicians who hold dispensing permits under § 14–509 of the 28
Health Occupations Article on the effective date of this Act. 29
SECTION 3. AND BE IT FURTHER ENACTED, That all employees of the Office of 30
Controlled Substances Administration who are assigned more than 50% of the time to a 31
function related to conducting inspections of offices of physicians who hold dispensing 32
permits under § 14–509 of the Health Occupations Article on the effective date of this Act 33
shall be transferred to the State Board of Physicians without diminution of their rights, 34
benefits, employment, or retirement status. 35 SENATE BILL 161 11
SECTION 4. AND BE IT FURTHER ENACTED, That all positions of the Office of 1
Controlled Substances Administration who are assigned more than 50% of the time to a 2
function related to conducting inspections of offices of physicians who hold dispensing 3
permits under § 14–509 of the Health Occupations Article on the effective date of this Act 4
shall be transferred to the State Board of Physicians. 5
SECTION 5. AND BE IT FURTHER ENACTED, That any transaction affected by 6
the transfer of oversight of the conducting of inspections of offices of physicians who hold 7
dispensing permits under § 14–509 of the Health Occupations Article and validly entered 8
into before the effective date of this Act, and every right, duty, or interest flowing from it 9
remains valid after the effective date of this Act and may be terminated, completed, 10
consummated, or enforced under the law. 11
SECTION 6. AND BE IT FURTHER ENACTED, That all existing laws, regulations, 12
proposed regulations, standards and guidelines, policies, orders and other directives, forms, 13
plans, memberships, contracts, property, investigations, administrative and judicial 14
responsibilities, rights to sue and be sued, and all other duties and responsibilities 15
associated with the oversight of the conducting of inspections of offices of physicians who 16
hold dispensing permits under § 14–509 of the Health Occupations Article prior to the 17
effective date of this Act shall continue and, as appropriate, are legal and binding on the 18
State Board of Physicians until completed, withdrawn, canceled, modified, or otherwise 19
changed under the law. 20
SECTION 7. AND BE IT FURTHER ENACTED, That this Act shall take effect 21
October 1, 2023. 22