EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*sb0305*
SENATE BILL 305
J2 2lr1750
CF HB 260
By: Senator Lam
Introduced and read first time: January 20, 2022
Assigned to: Education, Health, and Environmental Affairs
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; and generally relating to the dispensing of drugs or 6
devices by licensed physicians. 7
BY repealing and reenacting, with amendments, 8
Article – Health Occupations 9
Section 12–102(a) and (c), 12–102.1, 12–102.2, and 14–509 10
Annotated Code of Maryland 11
(2021 Replacement Volume) 12
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 13
That the Laws of Maryland read as follows: 14
Article – Health Occupations 15
12–102. 16
(a) (1) In this section the following [terms] WORDS have the meanings 17
indicated. 18
(2) “In the public interest” means the dispensing of drugs or devices by a 19
licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 20
available to the patient. 21
(3) “Personally preparing and dispensing” means that the licensed 22
dentist[, physician,] or podiatrist: 23 2 SENATE BILL 305
(i) Is physically present on the premises where the prescription is 1
filled; and 2
(ii) Performs a final check of the prescription before it is provided to 3
the patient. 4
(c) (1) This subsection does not apply to a licensed dentist who obtains a 5
permit from the State Board of Dental Examiners under subsection (h) of this section. 6
(2) This title does not prohibit: 7
(i) A licensed veterinarian from: 8
1. Personally preparing and dispensing the veterinarian’s 9
prescriptions; or 10
2. Dispensing, in accordance with § 2–313(c) of the 11
Agriculture Article, compounded nonsterile preparations or compounded sterile 12
preparations provided by a pharmacy; 13
(II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 14
AND DISPENSING PRESC RIPTIONS IF THE PHYS ICIAN HAS OBT AINED A PERMIT 15
UNDER § 14–509 OF THIS ARTICLE; 16
[(ii)] (III) A licensed dentist[, physician,] or podiatrist from 17
personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 18
prescriptions when: 19
1. The dentist[, physician,] or podiatrist: 20
A. Has applied to the board of licensure in this State which 21
licensed the dentist[, physician,] or podiatrist; 22
B. Has demonstrated to the satisfaction of that board that the 23
dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 24
the public interest; 25
C. Has received a written permit from that board to dispense 26
prescription drugs or devices except that a written permit is not required in order to 27
dispense starter dosages or samples without charge; and 28
D. Posts a sign conspicuously positioned and readable 29
regarding the process for resolving incorrectly filled prescriptions or includes written 30
information regarding the process with each prescription dispensed; 31
SENATE BILL 305 3
2. The person for whom the drugs or devices are prescribed 1
is a patient of the prescribing dentist[, physician,] or podiatrist; 2
3. The dentist[, physician,] or podiatrist does not have a 3
substantial financial interest in a pharmacy; and 4
4. The dentist[, physician,] or podiatrist: 5
A. Complies with the dispensing and labeling requirements 6
of this title; 7
B. Records the dispensing of the prescription drug or device 8
on the patient’s chart; 9
C. Allows the Office of Controlled Substances Administration 10
to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 11
and in accordance with § 12–102.1 of this subtitle; 12
D. On inspection by the Office of Controlled Substances 13
Administration, signs and dates an acknowledgment form provided by the Office of 14
Controlled Substances Administration relating to the requirements of this section; 15
E. Except for starter dosages or samples without charge, 16
provides the patient with a written prescription, maintains prescription files in accordance 17
with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions; 18
F. Does not direct patients to a single pharmacist or 19
pharmacy in accordance with § 12–403(c)(8) of this title; 20
G. Does not receive remuneration for referring patients to a 21
pharmacist or pharmacy; 22
H. Complies with the child resistant packaging requirements 23
regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; 24
I. Complies with drug recalls; 25
J. Maintains biennial inventories and complies with any 26
other federal and State record–keeping requirements relating to controlled dangerous 27
substances; 28
K. Purchases prescription drugs from a pharmacy or 29
wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 30
the Board of Pharmacy; 31
4 SENATE BILL 305
L. Annually reports to the respective board of licensure 1
whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 2
prescription drugs within the previous year; and 3
M. Completes ten continuing education credits over a 5–year 4
period relating to the preparing and dispensing of prescription drugs, offered by the 5
Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 6
consultation with each respective board of licensure, as a condition of permit renewal; OR 7
[(iii) A licensed physician from dispensing a topical medication 8
without obtaining the permit required under item (ii)1C of this paragraph or completing 9
the continuing education required under item (ii)4M of this paragraph when the physician: 10
1. Otherwise complies with item (ii) of this paragraph; and 11
2. Has obtained a special written permit under § 14–509 of 12
this article; 13
(iv) A licensed physician who complies with the requirements of item 14
(ii) of this paragraph from personally preparing and dispensing a prescription written by: 15
1. A physician assistant in accordance with a delegation 16
agreement that complies with Title 15, Subtitle 3 of this article; or 17
2. A nurse practitioner who is authorized to practice under 18
Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 19
or] 20
[(v)] (IV) A hospital–based clinic from dispensing prescriptions to 21
its patients. 22
12–102.1. 23
(a) This section does not apply to [a]: 24
(1) A licensed dentist who obtains a permit from the State Board of Dental 25
Examiners under § 12–102(h) of this subtitle; OR 26
(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 27
STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 28
(b) The Office of Controlled Substances Administration shall enter and inspect 29
the office of a dentist[, physician,] or podiatrist who holds: 30
(1) An initial dispensing permit: 31
SENATE BILL 305 5
(i) Within 6 months after receiving the report required under § 1
12–102(l)(1) of this subtitle; and 2
(ii) At least one more time during the duration of the permit; and 3
(2) A renewed dispensing permit at least two times during the duration of 4
the permit. 5
(c) The Office of Controlled Substances Administration promptly shall report the 6
results of the inspections required under subsection (b) of this section to the respective 7
board of licensure. 8
12–102.2. 9
(a) This section does not apply to [a]: 10
(1) A licensed dentist who obtains a permit from the State Board of Dental 11
Examiners under § 12–102(h) of this subtitle; OR 12
(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 13
STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 14
(b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 15
Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 16
holds a dispensing permit in an amount that will produce funds to approximate but not 17
exceed the documented costs to the Office of Controlled Substances Administration for 18
inspection of dispensing permit holders. 19
(c) Revenues collected by the Board of Dental Examiners [, the Board of 20
Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 21
into the General Fund of the State. 22
14–509. 23
(a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 24
INDICATED. 25
(2) “ACCME” means the Accrediting Council for Continuing Medical 26
Education. 27
(3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 28
SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 29
OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 30
6 SENATE BILL 305
(4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 1
BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 2
OR DEVICES TO A PATI ENT. 3
(5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 4
OR DEVICES BY A LICENSED PHYSICIAN TO A PATIENT WHEN A PHARMACY IS NOT 5
CONVENIENTLY AVAILAB LE TO THE PATIENT . 6
(6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 7
LICENSED PHYSICIAN : 8
(I) IS PHYSICALLY PRESENT ON THE PREMISES WHER E THE 9
PRESCRIPTION IS FILL ED; AND 10
(II) PERFORMS A FINAL CHEC K OF THE PRESCRIPTIO N BEFORE 11
IT IS PROVIDED TO TH E PATIENT. 12
(7) “SAMPLE UNIT ” HAS THE MEANING STAT ED IN 21 C.F.R. § 13
203.3(AA). 14
(8) “STARTER DOSAGE ” MEANS AN AMOUNT OF D RUG OR DEVICE 15
SUFFICIENT TO BEGIN THERAPY: 16
(I) FOR A SHORT DURATION OF 72 HOURS OR LESS ; OR 17
(II) PRIOR TO OBTAINING A LARGER QUANTITY OF T HE DRUG 18
OR DEVICE TO COMPLET E THE THERAPY . 19
(9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERM IT 20
ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DI SPENSE TOPICAL 21
MEDICATIONS THAT ARE APPROVED BY THE FEDE RAL FOOD AND DRUG 22
ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 23
(b) [A physician may dispense a topical medication that is approved by the federal 24
Food and Drug Administration for the treatment of hypotrichosis without obtaining a 25
dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 26
of this article if the physician: 27
(1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 28
article; and 29
(2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 30
(1) (I) Has received a [special class of written] TOPICAL MEDICATION 31
permit from the Board[.]; 32 SENATE BILL 305 7
[(c) The Board may issue a special class of written permit to a physician under 1
subsection (b) of this section if the physician: 2
(1)] (II) DISPENSES ONLY A TOPI CAL MEDICATION THAT IS 3
APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 4
TREATMENT OF HYPOTRICHOSIS ; 5
(III) Completes 1 hour of continuing medical education per year on 6
the dispensing of topical medications developed by an ACCME–accredited Maryland 7
nonprofit or governmental entity; and 8
[(2)] (IV) Pays to the Board a $100 permit fee[.]; 9
(2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 10
PATIENT IF: 11
(I) THE SAMPLE COMPLIES W ITH THE LABELING 12
REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 13
(II) NO CHARGE IS MADE FOR THE SAMPLE; AND 14
(III) THE AUTHORIZED PRESCR IBER ENTERS AN APPROPRIATE 15
RECORD IN THE PATIEN T’S CHART; 16
(3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 17
OF TREATING A PATIEN T; 18
(4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 19
DRUG OR DEVICE TO A PATIENT IF: 20
(I) THE STARTER DOSAGE CO MPLIES WITH THE LABELIN G 21
REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 22
(II) NO CHARGE IS MADE FOR THE STARTER DOSAGE ; AND 23
(III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 24
RECORD ON THE PATIEN T’S CHART; OR 25
(5) DISPENSES A PRESCRIPT ION DRUG OR DEVICE IN THE COURSE OF 26
TREATING A PATIENT A T: 27
(I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 28
NONPROFIT BASIS ; 29
8 SENATE BILL 305
(II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 1
INSTITUTION OF HIGHE R EDUCATION; OR 2
(III) A PUBLIC HEALTH FACILI TY, A MEDICAL F ACILITY UNDER 3
CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 4
WITH PUBLIC FUNDS . 5
(C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 6
PRESCRIPTIONS ONLY I F: 7
(1) THE PHYSICIAN: 8
(I) HAS AN ACTIVE LICENSE IN GOOD STANDING; 9
(II) HAS APPLIED TO THE BOARD FOR A DISPENSIN G PERMIT; 10
(III) HAS PAID A FEE DETERM INED BY THE BOARD TO PRODUCE 11
FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 12
BOARD FOR CONDUCTING INSPECTIONS OF DISPE NSING PERMIT HOLDERS ; 13
(IV) HAS DEMONSTRATED TO T HE SATISFACTION OF T HE BOARD 14
THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 15
IN THE PUBLIC INTERE ST; 16
(V) HAS RECEIVED A DISPEN SING PERMIT FROM THE BOARD; 17
AND 18
(VI) HAS A SIGN CONSPICUOU SLY POSITIONED AND R EADABLE 19
REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PR ESCRIPTIONS 20
OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 21
PRESCRIPTION DISPENS ED; 22
(2) THE INDIVIDUAL FOR WH OM THE DRUG OR DEVIC E IS23
PRESCRIBED IS A PATI ENT OF: 24
(I) THE PRESCRIBING PHYSI CIAN; 25
(II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 26
DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 27
ARTICLE; OR 28
(III) A NURSE PRACTITIONER W HO IS AUTHORIZED TO PRACTICE 29
UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 30
PHYSICIAN IN THE SAME OF FICE SETTING; 31 SENATE BILL 305 9
(3) THE PHYSICIAN DOES NO T HAVE A SUBSTANTIAL FINANCIAL 1
INTEREST IN A PHARMA CY; AND 2
(4) THE PHYSICIAN: 3
(I) COMPLIES WITH THE DIS PENSING AND LABELING 4
REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE , AND THE BOARD’S 5
REGULATIONS ; 6
(II) RECORDS THE DISPENSIN G OF THE PRESCRIPTIO N DRUG 7
OR DEVICE ON THE PAT IENT’S CHART; 8
(III) PROVIDES THE PATIENT WITH A WRITTEN PRESCRIPTION , 9
MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 10
ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 11
(IV) DOES NOT DIRECT PATIE NTS TO A SINGLE PHAR MACIST OR 12
PHARMACY IN ACCORDAN CE WITH § 12–403(C)(8) OF THIS ARTICLE; 13
(V) DOES NOT RECEIVE REMU NERATION FOR REFERRI NG 14
PATIENTS TO A PHARMA CIST OR PHARMACY ; 15
(VI) COMPLIES WITH THE CHI LD RESISTANT PACKAGI NG 16
REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 17
OF THE HEALTH – GENERAL ARTICLE; 18
(VII) COMPLIES WITH DRUG RE CALLS; 19
(VIII) MAINTAINS BIENNIAL IN VENTORIES AND COMPLI ES WITH 20
ANY OTHER FEDERAL AN D STATE RECORD –KEEPING REQUIREMENTS RELATING TO 21
CONTROLLED DANGEROUS SUBSTANCES; 22
(IX) PURCHASES PRESCRIPTIO N DRUGS FROM A PHARMACY OR 23
WHOLESALE DISTRIBUTO R THAT HOLDS A PERMI T ISSUED BY THE STATE BOARD OF 24
PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 25
(X) COMPLIES WITH CONTINU ING EDUCATION REQUIR EMENTS 26
RELATING TO THE PREP ARING AND DISPENSING OF PRESCRIPTION DRUGS AS 27
PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 28
(D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS OF THIS 29
SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 30
SHALL: 31 10 SENATE BILL 305
(1) HAVE THE DISPENSING P ERMIT REVOKED ; AND 1
(2) BE SUBJECT TO DISCIPL INARY ACTION BY THE BOARD. 2
(E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITI AL 3
DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 4
INSPECT THE OFFICE O F THE PHYSICIAN. 5
(II) IF THE BOARD RENEWS A DISPENSING PERMIT TO A 6
LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 7
PHYSICIAN AT LEAST O NE TIME DURING THE D URATION OF THE RENEW ED PERMIT. 8
(2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 9
SUBSTANCES ADMINISTRATION ANY VIOLATION RELATE D TO CONTROLLED 10
DANGEROUS SUBSTANCES FOUND DURING AN INSP ECTION REQUIRED UNDE R 11
PARAGRAPH (1) OF THIS SUBSECTION . 12
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 13
October 1, 2022. 14