EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
*hb0260*
HOUSE BILL 260
J2 2lr0069
CF SB 305
By: Delegate Carr
Introduced and read first time: January 13, 2022
Assigned to: Health and Government Operations
Committee Report: Favorable with amendments
House action: Adopted
Read second time: February 25, 2022
CHAPTER ______
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) 22
2 HOUSE BILL 260
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1
That the Laws of Maryland read as follows: 2
Article – Health Occupations 3
12–102. 4
(a) (1) In this section the following [terms] WORDS have the meanings 5
indicated. 6
(2) “In the public interest” means the dispensing of drugs or devices by a 7
licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 8
available to the patient. 9
(3) “Personally preparing and dispensing” means that the licensed 10
dentist[, physician,] or podiatrist: 11
(i) Is physically present on the premises where the prescription is 12
filled; and 13
(ii) Performs a final check of the prescription before it is provided to 14
the patient. 15
(c) (1) This subsection does not apply to a licensed dentist who obtains a 16
permit from the State Board of Dental Examiners under subsection (h) of this section. 17
(2) This title does not prohibit: 18
(i) A licensed veterinarian from: 19
1. Personally preparing and dispensing the veterinarian’s 20
prescriptions; or 21
2. Dispensing, in accordance with § 2 –313(c) of the 22
Agriculture Article, compounded nonsterile preparations or compounded sterile 23
preparations provided by a pharmacy; 24
(II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 25
AND DISPENSING PRESC RIPTIONS IF THE PHYS ICIAN HAS OBTAINED A PERMIT 26
UNDER § 14–509 OF THIS ARTICLE; 27
[(ii)] (III) A licensed dentist[, physician,] or podiatrist from 28
personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 29
prescriptions when: 30
1. The dentist[, physician,] or podiatrist: 31 HOUSE BILL 260 3
A. Has applied to the board of licensure in this State which 1
licensed the dentist[, physician,] or podiatrist; 2
B. Has demonstrated to the satisfaction of that board that the 3
dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 4
the public interest; 5
C. Has received a written permit from that board to dispense 6
prescription drugs or devices except that a written permit is not required in order to 7
dispense starter dosages or samples without charge; and 8
D. Posts a sign conspicuously positioned and readable 9
regarding the process for resolving incorrectly filled prescriptions or includes written 10
information regarding the process with each prescription dispensed; 11
2. The person for whom the drugs or devices are prescribed 12
is a patient of the prescribing dentist[, physician,] or podiatrist; 13
3. The dentist[, physician,] or podiatrist does not have a 14
substantial financial interest in a pharmacy; and 15
4. The dentist[, physician,] or podiatrist: 16
A. Complies with the dispensing and labeling requirements 17
of this title; 18
B. Records the dispensing of the prescription drug or device 19
on the patient’s chart; 20
C. Allows the Office of Controlled Substances Administration 21
to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 22
and in accordance with § 12–102.1 of this subtitle; 23
D. On inspection by the Office of Controlled Substances 24
Administration, signs and dates an acknowledgment form provided by the Office of 25
Controlled Substances Administration relating to the requirements of this section; 26
E. Except for starter dosages or samples without charge, 27
provides the patient with a written prescription, maintains prescription files in accordance 28
with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions; 29
F. Does not direct patients to a single pharmacist or 30
pharmacy in accordance with § 12–403(c)(8) of this title; 31
4 HOUSE BILL 260
G. Does not receive remuneration for referring patients to a 1
pharmacist or pharmacy; 2
H. Complies with the child resistant packaging requirements 3
regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; 4
I. Complies with drug recalls; 5
J. Maintains biennial inventories and complies with any 6
other federal and State record–keeping requirements relating to controlled dangerous 7
substances; 8
K. Purchases prescription drugs from a pharmacy or 9
wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 10
the Board of Pharmacy; 11
L. Annually reports to the respective board of licensure 12
whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 13
prescription drugs within the previous year; and 14
M. Completes ten continuing education credits over a 5–year 15
period relating to the preparing and dispensing of prescription drugs, offered by the 16
Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 17
consultation with each respective board of licensure, as a condition of permit renewal; OR 18
[(iii) A licensed physician from dispensing a topical medication 19
without obtaining the permit required under item (ii)1C of this paragraph or completing 20
the continuing education required under item (ii)4M of this paragraph when the physician: 21
1. Otherwise complies with item (ii) of this paragraph; and 22
2. Has obtained a special written permit under § 14–509 of 23
this article; 24
(iv) A licensed physician who complies with the requirements of item 25
(ii) of this paragraph from personally preparing and dispensing a prescription written by: 26
1. A physician assistant in accordance with a delegation 27
agreement that complies with Title 15, Subtitle 3 of this article; or 28
2. A nurse practitioner who is authorized to practice under 29
Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 30
or] 31
[(v)] (IV) A hospital–based clinic from dispensing prescriptions to 32
its patients. 33
HOUSE BILL 260 5
12–102.1. 1
(a) This section does not apply to [a]: 2
(1) A licensed dentist who obtains a permit from the State Board of Dental 3
Examiners under § 12–102(h) of this subtitle; OR 4
(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 5
STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 6
(b) The Office of Controlled Substances Administration shall enter and inspect 7
the office of a dentist[, physician,] or podiatrist who holds: 8
(1) An initial dispensing permit: 9
(i) Within 6 months after receiving the report required under § 10
12–102(l)(1) of this subtitle; and 11
(ii) At least one more time during the duration of the permit; and 12
(2) A renewed dispensing permit at least two times during the duration of 13
the permit. 14
(c) The Office of Controlled Substances Administration promptly shall report the 15
results of the inspections required under subsection (b) of this section to the respective 16
board of licensure. 17
12–102.2. 18
(a) This section does not apply to [a]: 19
(1) A licensed dentist who obtains a permit from the State Board of Dental 20
Examiners under § 12–102(h) of this subtitle; OR 21
(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 22
STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 23
(b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 24
Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 25
holds a dispensing permit in an amount that will produce funds to approximate but not 26
exceed the documented costs to the Office of Controlled Substances Administration for 27
inspection of dispensing permit holders. 28
(c) Revenues collected by the Board of Dental Examiners [, the Board of 29
Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 30
into the General Fund of the State. 31 6 HOUSE BILL 260
14–509. 1
(a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 2
INDICATED. 3
(2) “ACCME” means the Accrediting Council for Continuing Medical 4
Education. 5
(3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 6
SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 7
OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 8
(4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 9
BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 10
OR DEVICES TO A PATI ENT. 11
(5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 12
OR DEVICES BY A LICE NSED PHYSICIAN TO A PATIENT WHEN A PHARM ACY IS NOT 13
CONVENIENTLY AVAILAB LE TO THE PATIENT . 14
(6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 15
LICENSED PHYSICIAN : 16
(I) IS PHYSICALLY PRESENT ON THE PREMISES WHER E THE 17
PRESCRIPTION IS FILL ED; AND 18
(II) PERFORMS A FINAL CHEC K OF THE PRESCRIPTIO N BEFORE 19
IT IS PROVIDED TO TH E PATIENT. 20
(7) “SAMPLE UNIT ” HAS THE MEANING STAT ED IN 21 C.F.R. § 21
203.3(AA). 22
(8) “STARTER DO SAGE” MEANS AN AMOUNT OF D RUG OR DEVICE 23
SUFFICIENT TO BEGIN THERAPY: 24
(I) FOR A SHORT DURATION OF 72 HOURS OR LESS ; OR 25
(II) PRIOR TO OBTAINING A LARGER QUANTITY OF T HE DRUG 26
OR DEVICE TO COMPLET E THE THERAPY . 27
(9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERMIT 28
ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DISPENSE TOPICAL 29
MEDICATIONS THAT ARE APPROVED BY THE FEDE RAL FOOD AND DRUG 30
ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 31 HOUSE BILL 260 7
(b) [A physician may dispense a topical medication that is approved by the federal 1
Food and Drug Administration for the treatment of hypotrichosis without obtaining a 2
dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 3
of this article if the physician: 4
(1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 5
article; and 6
(2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 7
(1) (I) Has received a [special class of written] TOPICAL MEDICATION 8
permit from the Board[.]; 9
[(c) The Board may issue a special class of written permit to a physician under 10
subsection (b) of this section if the physician: 11
(1)] (II) DISPENSES ONLY A TOPI CAL MEDICATION THAT IS 12
APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 13
TREATMENT OF HYPOTRI CHOSIS; 14
(III) Completes 1 hour of continuing medical education per year on 15
the dispensing of topical medications developed by an ACCME–accredited Maryland 16
nonprofit or governmental entity; and 17
[(2)] (IV) Pays to the Board a $100 permit fee[.]; 18
(2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 19
PATIENT IF: 20
(I) THE SAMPLE COMPLIES W ITH THE LABELING 21
REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 22
(II) NO CHARGE IS MADE FOR THE SAMPLE; AND 23
(III) THE AUTHORIZED PRESCR IBER ENTERS AN APPRO PRIATE 24
RECORD IN THE PATIEN T’S CHART; 25
(3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 26
OF TREATING A PATIEN T; 27
(4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 28
DRUG OR DEVICE TO A PATIENT IF: 29
8 HOUSE BILL 260
(I) THE STARTER DOSAGE CO MPLIES WITH THE LABE LING 1
REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 2
(II) NO CHARGE IS MADE FOR THE STARTER DOSAGE ; AND 3
(III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 4
RECORD ON THE PATIEN T’S CHART; OR 5
(5) DISPENSES A PRESCRIPT ION DRUG OR DEVICE I N THE COURSE OF 6
TREATING A PATIENT A T: 7
(I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 8
NONPROFIT BASIS ; 9
(II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 10
INSTITUTION OF HIGHE R EDUCATION; OR 11
(III) A PUBLIC HEALTH FACILI TY, A MEDICAL FACILITY U NDER 12
CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 13
WITH PUBLIC FUNDS . 14
(C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 15
PRESCRIPTIONS ONLY I F: 16
(1) THE PHYSICIAN: 17
(I) HAS AN ACTIVE LICENSE IN GOOD STANDING ; 18
(II) HAS APPLIED TO THE BOARD FOR A DISPENSIN G PERMIT; 19
(III) HAS PAID A FEE DETERM INED BY THE BOARD TO PRODUCE 20
FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 21
BOARD FOR CONDUCTING INSPECTIONS OF DISPE NSING PERMIT HOLDERS ; 22
(IV) HAS DEMONSTRATED TO T HE SATISFACTION OF T HE BOARD 23
THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 24
IN THE PUBLIC INTERE ST; 25
(V) HAS RECEIVED A DISPEN SING PERMIT FROM THE BOARD; 26
AND 27
(VI) HAS A SIGN CONSPICUOU SLY POSITIONED AND R EADABLE 28
REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PRESCRIPTIONS 29 HOUSE BILL 260 9
OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 1
PRESCRIPTION DISPENS ED; 2
(2) THE INDIVIDUAL FOR WH OM THE DRUG OR DEVIC E IS 3
PRESCRIBED IS A PATI ENT OF: 4
(I) THE PRESCRIBING PHYSI CIAN; 5
(II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 6
DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 7
ARTICLE; OR 8
(III) A NURSE PRACTITIONER W HO IS AUTHORIZED TO PRACTICE 9
UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 10
PHYSICIAN IN THE SAM E OFFICE SETTING; 11
(3) THE PHYSICIAN DOES NO T HAVE A SUBSTANTIAL FINANCIAL 12
INTEREST IN A PHARMA CY; AND 13
(4) THE PHYSICIAN: 14
(I) COMPLIES WITH THE DIS PENSING AND LABELING 15
REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE , AND THE BOARD’S 16
REGULATIONS ; 17
(II) RECORDS THE DISPENSIN G OF THE PRESCRIPTIO N DRUG 18
OR DEVICE ON THE PAT IENT’S CHART; 19
(III) PROVIDES THE PATIENT WITH A WRITTEN PRESC RIPTION, 20
MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 21
ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 22
(IV) DOES NOT DIRECT PATIE NTS TO A SINGLE PHAR MACIST OR 23
PHARMACY IN ACCORDAN CE WITH § 12–403(C)(8) OF THIS ARTICLE; 24
(V) DOES NOT RECEIVE REMU NERATION FOR REFERRI NG 25
PATIENTS TO A PHARMA CIST OR PHARMACY ; 26
(VI) COMPLIES WITH THE CHI LD RESISTANT PACKAGI NG 27
REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 28
OF THE HEALTH – GENERAL ARTICLE; 29
(VII) COMPLIES WITH DRUG RE CALLS; 30
10 HOUSE BILL 260
(VIII) MAINTAINS BIENNIAL IN VENTORIES AND COMPLI ES WITH 1
ANY OTHER FEDERAL AN D STATE RECORD –KEEPING REQUIREMENTS RELATING TO 2
CONTROLLED DANGEROUS SUBSTANCES; 3
(IX) PURCHASES PRESCRIPTIO N DRUGS FROM A PHARM ACY OR 4
WHOLESALE DISTRIBUTO R THAT HOLDS A PERMI T ISSUED BY THE STATE BOARD OF 5
PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 6
(X) COMPLIES WITH CONTINU ING EDUCATION REQUIR EMENTS 7
RELATING TO THE PREP ARING AND DISPENSING OF PRESCRIPTION DRUG S AS 8
PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 9
(D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS OF THIS 10
SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 11
SHALL: 12
(1) HAVE THE DISPENSING P ERMIT REVOKED ; AND 13
(2) BE SUBJECT TO DISCIPL INARY ACTION BY THE BOARD. 14
(E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITI AL 15
DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 16
INSPECT THE OFFICE O F THE PHYSICIAN. 17
(II) IF THE BOARD RENEWS A DISPEN SING PERMIT TO A 18
LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 19
PHYSICIAN AT LEAST O NE TIME DURING THE D URATION OF THE RENEW ED PERMIT. 20
(2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 21
SUBSTANCES ADMINISTRATION ANY VI OLATION RELATED TO C ONTROLLED 22
DANGEROUS SUBSTANCES FOUND DURING AN INSPECTION REQUIRED UNDER 23
PARAGRAPH (1) OF THIS SUBSECTION . 24
SECTION 2. AND BE IT FURTHER ENACTED, That, on the effective date of this 25
Act, the following shall be transferred to the State Board of Physicians: 26
(1) all appropriations, including State and federal funds, held by the Office 27
of Controlled Substances Administration for the purposes of conducting inspections of 28
offices of physicians who hold dispensing permits under § 14–509 of the Health Occupations 29
Article on the effective date of this Act; and 30
(2) all books and records including electronic records, real and personal 31
property, equipment, fixtures, assets, liabilities, obligations, credits, rights, and privileges 32
held by the Office of Controlled Substances Administration for the purposes of conducting 33 HOUSE BILL 260 11
inspections of offices of physicians who hold dispensing permits under § 14–509 of the 1
Health Occupations Article on the effective date of this Act. 2
SECTION 3. AND BE IT FURTHER ENACTED, That all employees of the Office of 3
Controlled Substances Administration who are assigned more than 50% of the time to a 4
function related to conducting inspections of offices of physicians who hold dispensing 5
permits under § 14–509 of the Health Occupations Article on the effective date of this Act 6
shall be transferred to the State Board of Physicians without diminution of their rights, 7
benefits, employment, or retirement status. 8
SECTION 4. AND BE IT FURTHER ENACTED, That all positions of the Office of 9
Controlled Substances Administration who are assigned more than 50% of the time to a 10
function related to conducting inspections of offices of physicians who hold dispensing 11
permits under § 14–509 of the Health Occupations Article on the effective date of this Act 12
shall be transferred to the State Board of Physicians. 13
SECTION 5. AND BE IT FURTHER ENACTED, That any transaction affected by 14
the transfer of oversight of the conducting of inspections of offices of physicians who hold 15
dispensing permits under § 14–509 of the Health Occupations Article and validly entered 16
into before the effective date of this Act, and every right, duty, or interest flowing from it 17
remains valid after the effective date of this Act and may be terminated, completed, 18
consummated, or enforced under the law. 19
SECTION 6. AND BE IT FURTHER ENACTED, That all existing laws, regulations, 20
proposed regulations, standards and guidelines, policies, orders and other directives, forms, 21
plans, memberships, contracts, property, investigations, administrative and judicial 22
responsibilities, rights to sue and be sued, and all other duties and responsibilities 23
associated with the oversight of the conducting of inspections of offices of physicians who 24
hold dispensing permits under § 14–509 of the Health Occupations Article prior to the 25
effective date of this Act shall continue and, as appropriate, are legal and binding on the 26
State Board of Physicians until completed, withdrawn, canceled, modified, or otherwise 27
changed under the law. 28
SECTION 2. 7. AND BE IT FURTHER ENACTED, That this Act shall take effect 29
October 1, 2022. 30