Maryland 2023 Regular Session

Maryland House Bill HB241 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1
2	2
3	3		EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
4	4		[Brackets] indicate matter deleted from existing law.
5		-	Underlining indicates amendments to bill.
6		-	Strike out indicates matter stricken from the bill by amendment or deleted from the law by
7		-	amendment.
8	5		hb0241
9	6
10	7		HOUSE BILL 241
11	8		J2 3lr1831
12	9		SB 305/22 – EHE CF SB 161
13		-	By: Delegate Bagnall Delegates Bagnall, Alston, Bhandari, Chisholm, Cullison,
14		-	Guzzone, Hill, Hutchinson, S. Johnson, Kaiser, Kerr, Kipke, R. Lewis,
15		-	Lopez, Martinez, M. Morgan, Pena–Melnyk, Reilly, Rosenberg, Szeliga,
16		-	Taveras, White, and Woods
	10	+	By: Delegate Bagnall
17	11		Introduced and read first time: January 23, 2023
18	12		Assigned to: Health and Government Operations
19		-	Committee Report: Favorable with amendments
20		-	House action: Adopted
21		-	Read second time: March 1, 2023
22	13
23		-	~~CHAPTER ______~~
	14	+	A BILL ENTITLED
24	15
25	16		AN ACT concerning 1
26	17
27	18		State Board of Physicians – Dispensing Permits 2
28	19
29	20		FOR the purpose of transferring oversight of the inspection of the offices of dispensing 3
30	21		physicians from the Office of Controlled Substances Administration to the State 4
31	22		Board of Physicians; altering the circumstances under which a physician may 5
32	23		dispense drugs or devices; requiring that certain appropriations be transferred to the 6
33	24		Board on a certain date; providing for the transfer of certain functions, powers, 7
34	25		duties, property, records, fixtures, credits, assets, liability, obligations, rights, and 8
35	26		privileges; requiring that certain employees of the Office be transferred to the Board 9
36	27		without diminution of their rights, benefits, employment, or retirement status; 10
37	28		requiring that certain positions at the Office be transferred to the Board; providing 11
38	29		for the continuity of certain transactions affected by or flowing from this Act; 12
39	30		providing for the continuity of certain laws, regulations, standards and guidelines, 13
40	31		policies, orders and other directives, forms, plans, membership, contracts, property, 14
41	32		investigations, administrative and judicial responsibilities, rights, and other duties 15
42	33		and responsibilities; and generally relating to the dispensing of drugs or devices by 16
43	34		licensed physicians. 17
44	35
45	36		BY repealing and reenacting, with amendments, 18
46	37		Article – Health Occupations 19
47	38		Section 12–102(a) and (c), 12–102.1, 12–102.2, and 14–509 20
48		-	Annotated Code of Maryland 21 2 HOUSE BILL 241
	39	+	Annotated Code of Maryland 21
	40	+	(2021 Replacement Volume and 2022 Supplement) 22
	41	+
	42	+	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 23
	43	+	That the Laws of Maryland read as follows: 24
	44	+
	45	+	Article – Health Occupations 25
	46	+
	47	+	12–102. 26
	48	+	2 HOUSE BILL 241
49	49
50	50
51		-	(2021 Replacement Volume and 2022 Supplement) 1
	51	+	(a) (1) In this section the following [terms] WORDS have the meanings 1
	52	+	indicated. 2
52	53
53		-	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 2
54		-	That the Laws of Maryland read as follows: 3
	54	+	(2) “In the public interest” means the dispensing of drugs or devices by a 3
	55	+	licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 4
	56	+	available to the patient. 5
55	57
56		-	Article – Health Occupations 4
	58	+	(3) “Personally preparing and dispensing” means that the licensed 6
	59	+	dentist[, physician,] or podiatrist: 7
57	60
58		-	12–102. 5
	61	+	(i) Is physically present on the premises where the prescription is 8
	62	+	filled; and 9
59	63
60		-	(a) ~~(1) In this section~~ the ~~following [terms] WORDS have the meanings 6~~
61		-	~~indicated~~. 7
	64	+	(ii) Performs a final check of the prescription before it is provided to 10
	65	+	the patient. 11
62	66
63		-	(2) “In the public interest” means the dispensing of drugs or devices by a 8
64		-	licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 9
65		-	available to the patient. 10
	67	+	(c) (1) This subsection does not apply to a licensed dentist who obtains a 12
	68	+	permit from the State Board of Dental Examiners under subsection (h) of this section. 13
66	69
67		-	(3) “Personally preparing and dispensing” means that the licensed 11
68		-	dentist[, physician,] or podiatrist: 12
	70	+	(2) This title does not prohibit: 14
69	71
70		-	(i) Is physically present on the premises where the prescription is 13
71		-	filled; and 14
	72	+	(i) A licensed veterinarian from: 15
72	73
73		-	~~(ii) Performs a final check of~~ the ~~prescription before it is provided to 15~~
74		-	~~the patient.~~ 16
	74	+	1. Personally preparing and dispensing the veterinarian’s 16
	75	+	prescriptions; or 17
75	76
76		-	(c) (1) This subsection does not apply to a licensed dentist who obtains a 17
77		-	permit from the State Board of Dental Examiners under subsection (h) of this section. 18
	77	+	2. Dispensing, in accordance with § 2 –313(c) of the 18
	78	+	Agriculture Article, compounded nonsterile preparations or compounded sterile 19
	79	+	preparations provided by a pharmacy; 20
78	80
79		-	(2) This title does not prohibit: 19
	81	+	(II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 21
	82	+	AND DISPEN SING PRESCRIPTIONS I F THE PHYSICIAN HAS OBTAINED A PERMIT 22
	83	+	UNDER § 14–509 OF THIS ARTICLE; 23
80	84
81		-	(i) A licensed veterinarian from: 20
	85	+	[(ii)] (III) A licensed dentist[, physician,] or podiatrist from 24
	86	+	personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 25
	87	+	prescriptions when: 26
82	88
83		-	1. Personally preparing and dispensing the veterinarian’s 21
84		-	prescriptions; or 22
	89	+	1. The dentist[, physician,] or podiatrist: 27
85	90
86		-	2. Dispensing, in accordance with § 2–313(c) of the 23
87		-	Agriculture Article, compounded nonsterile preparations or compounded sterile 24
88		-	preparations provided by a pharmacy; 25
	91	+	A. Has applied to the board of licensure in this State which 28
	92	+	licensed the dentist[, physician,] or podiatrist; 29
89	93
90		-	(II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 26
91		-	AND DISPENSING PRESC RIPTIONS IF THE PHYS ICIAN HAS OBT AINED A PERMIT 27
92		-	UNDER § 14–509 OF THIS ARTICLE; 28
93		-
94		-	[(ii)] (III) A licensed dentist[, physician,] or podiatrist from 29
95		-	personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 30
96		-	prescriptions when: 31 HOUSE BILL 241 3
	94	+	B. Has demonstrated to the satisfaction of that board that the 30
	95	+	dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 31
	96	+	the public interest; 32 HOUSE BILL 241 3
97	97
98	98
99	99
100		-	1. The dentist[, physician,] or podiatrist: 1
	100	+	C. Has received a written permit from that board to dispense 1
	101	+	prescription drugs or devices except that a written permit is not required in order to 2
	102	+	dispense starter dosages or samples without charge; and 3
101	103
102		-	A. Has applied to the board of licensure in this State which 2
103		-	licensed the dentist[, physician,] or podiatrist; 3
	104	+	D. Posts a sign conspicuously positioned and readable 4
	105	+	regarding the process for resolving incorrectly filled prescriptions or includes written 5
	106	+	information regarding the process with each prescription dispensed; 6
104	107
105		-	B. Has demonstrated to the satisfaction of that board that the 4
106		-	dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 5
107		-	the public interest; 6
	108	+	2. The person for whom the drugs or devices are prescribed 7
	109	+	is a patient of the prescribing dentist[, physician,] or podiatrist; 8
108	110
109		-	C. Has received a written permit from that board to dispense 7
110		-	prescription drugs or devices except that a written permit is not required in order to 8
111		-	dispense starter dosages or samples without charge; and 9
	111	+	3. The dentist[, physician,] or podiatrist does not have a 9
	112	+	substantial financial interest in a pharmacy; and 10
112	113
113		-	D. Posts a sign conspicuously positioned and readable 10
114		-	regarding the process for resolving incorrectly filled prescriptions or includes written 11
115		-	information regarding the process with each prescription dispensed; 12
	114	+	4. The dentist[, physician,] or podiatrist: 11
116	115
117		-	2. The ~~person for whom the drugs or devices are prescribed 13~~
118		-	~~is a patient~~ of ~~the prescribing dentist[, physician,] or podiatrist~~; 14
	116	+	A. Complies with the dispensing and labeling requirements 12
	117	+	of this title; 13
119	118
120		-	3. The ~~dentist[, physician,]~~ or ~~podiatrist does not have a 15~~
121		-	~~substantial financial interest in a pharmacy~~; ~~and 16~~
	119	+	B. Records the dispensing of the prescription drug or device 14
	120	+	on the patient’s chart; 15
122	121
123		-	4. The dentist[, physician,] or podiatrist: 17
	122	+	C. Allows the Office of Controlled Substances Administration 16
	123	+	to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 17
	124	+	and in accordance with § 12–102.1 of this subtitle; 18
124	125
125		-	A. Complies with the dispensing and labeling requirements 18
126		-	of this title; 19
	126	+	D. On inspection by the Office of Controlled Substances 19
	127	+	Administration, signs and dates an acknowledgment form provided by the Office of 20
	128	+	Controlled Substances Administration relating to the requirements of this section; 21
127	129
128		-	B. Records the dispensing of the prescription drug or device 20
129		-	on the patient’s chart; 21
	130	+	E. Except for starter dosages or samples without charge, 22
	131	+	provides the patient with a written prescription, maintains prescription files in accordance 23
	132	+	with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions; 24
130	133
131		-	C. Allows the Office of Controlled Substances Administration 22
132		-	to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 23
133		-	and in accordance with § 12–102.1 of this subtitle; 24
	134	+	F. Does not direct patients to a single pharmacist or 25
	135	+	pharmacy in accordance with § 12–403(c)(8) of this title; 26
134	136
135		-	D. On inspection by the Office of Controlled Substances 25
136		-	Administration, signs and dates an acknowledgment form provided by the Office of 26
137		-	Controlled Substances Administration relating to the requirements of this section; 27
	137	+	G. Does not receive remuneration for referring patients to a 27
	138	+	pharmacist or pharmacy; 28
138	139
139		-	E. Except for starter dosages or samples without charge, 28
140		-	provides the patient with a written prescription, maintains prescription files in accordance 29
141		-	with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions; 30
	140	+	H. Complies with the child resistant packaging requirements 29
	141	+	regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; 30
142	142
143		-	F. Does not direct patients to a single pharmacist or 31
144		-	pharmacy in accordance with § 12–403(c)(8) of this title; 32 4 HOUSE BILL 241
	143	+	I. Complies with drug recalls; 31
	144	+	4 HOUSE BILL 241
	145	+
	146	+
	147	+	J. Maintains biennial inventories and complies with any 1
	148	+	other federal and State record–keeping requirements relating to controlled dangerous 2
	149	+	substances; 3
	150	+
	151	+	K. Purchases prescription drugs from a pharmacy or 4
	152	+	wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 5
	153	+	the Board of Pharmacy; 6
	154	+
	155	+	L. Annually reports to the respective board of licensure 7
	156	+	whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 8
	157	+	prescription drugs within the previous year; and 9
	158	+
	159	+	M. Completes ten continuing education credits over a 5–year 10
	160	+	period relating to the preparing and dispensing of prescription drugs, offered by the 11
	161	+	Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 12
	162	+	consultation with each respective board of licensure, as a condition of permit renewal; OR 13
	163	+
	164	+	[(iii) A licensed physician from dispensing a topical medication 14
	165	+	without obtaining the permit required under item (ii)1C of this paragraph or completing 15
	166	+	the continuing education required under item (ii)4M of this paragraph when the physician: 16
	167	+
	168	+	1. Otherwise complies with item (ii) of this paragraph; and 17
	169	+
	170	+	2. Has obtained a special written permit under § 14–509 of 18
	171	+	this article; 19
	172	+
	173	+	(iv) A licensed physician who complies with the requirements of item 20
	174	+	(ii) of this paragraph from personally preparing and dispensing a prescription written by: 21
	175	+
	176	+	1. A physician assistant in accordance with a delegation 22
	177	+	agreement that complies with Title 15, Subtitle 3 of this article; or 23
	178	+
	179	+	2. A nurse practitioner who is authorized to practice under 24
	180	+	Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 25
	181	+	or] 26
	182	+
	183	+	[(v)] (IV) A hospital–based clinic from dispensing prescriptions to 27
	184	+	its patients. 28
	185	+
	186	+	12–102.1. 29
	187	+
	188	+	(a) This section does not apply to [a]: 30
	189	+
	190	+	(1) A licensed dentist who obtains a permit from the State Board of Dental 31
	191	+	Examiners under § 12–102(h) of this subtitle; OR 32
	192	+	HOUSE BILL 241 5
	193	+
	194	+
	195	+	(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FRO M THE 1
	196	+	STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 2
	197	+
	198	+	(b) The Office of Controlled Substances Administration shall enter and inspect 3
	199	+	the office of a dentist[, physician,] or podiatrist who holds: 4
	200	+
	201	+	(1) An initial dispensing permit: 5
	202	+
	203	+	(i) Within 6 months after receiving the report required under § 6
	204	+	12–102(l)(1) of this subtitle; and 7
	205	+
	206	+	(ii) At least one more time during the duration of the permit; and 8
	207	+
	208	+	(2) A renewed dispensing permit at least two times during the duration of 9
	209	+	the permit. 10
	210	+
	211	+	(c) The Office of Controlled Substances Administration promptly shall report the 11
	212	+	results of the inspections required under subsection (b) of this section to the respective 12
	213	+	board of licensure. 13
	214	+
	215	+	12–102.2. 14
	216	+
	217	+	(a) This section does not apply to [a]: 15
	218	+
	219	+	(1) A licensed dentist who obtains a permit from the State Board of Dental 16
	220	+	Examiners under § 12–102(h) of this subtitle; OR 17
	221	+
	222	+	(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 18
	223	+	STATE BOARD OF PHYSICIANS UND ER § 14–509 OF THIS ARTICLE . 19
	224	+
	225	+	(b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 20
	226	+	Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 21
	227	+	holds a dispensing permit in an amount that will produce funds to approximate but not 22
	228	+	exceed the documented costs to the Office of Controlled Substances Administration for 23
	229	+	inspection of dispensing permit holders. 24
	230	+
	231	+	(c) Revenues collected by the Board of Dental Examiners [, the Board of 25
	232	+	Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 26
	233	+	into the General Fund of the State. 27
	234	+
	235	+	14–509. 28
	236	+
	237	+	(a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 29
	238	+	INDICATED. 30
	239	+	6 HOUSE BILL 241
	240	+
	241	+
	242	+	(2) “ACCME” means the Accrediting Council for Continuing Medical 1
	243	+	Education. 2
	244	+
	245	+	(3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 3
	246	+	SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 4
	247	+	OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 5
	248	+
	249	+	(4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 6
	250	+	BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 7
	251	+	OR DEVICES TO A PATI ENT. 8
	252	+
	253	+	(5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 9
	254	+	OR DEVICES BY A LICENSED PHYSICIAN TO A PATIENT WHEN A PHARMACY IS NOT 10
	255	+	CONVENIENTLY AVAILAB LE TO THE PATIENT . 11
	256	+
	257	+	(6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 12
	258	+	LICENSED PHYSICIAN : 13
	259	+
	260	+	(I) IS PHYSICALLY PRESENT ON THE PREMISES WHER E THE 14
	261	+	PRESCRIPTION IS FILL ED; AND 15
	262	+
	263	+	(II) PERFORMS A FINAL CHEC K OF THE PRESCRIPTIO N BEFORE 16
	264	+	IT IS PROVIDED TO TH E PATIENT. 17
	265	+
	266	+	(7) “SAMPLE UNIT ” HAS THE MEANING STAT ED IN 21 C.F.R. § 18
	267	+	203.3(AA). 19
	268	+
	269	+	(8) “STARTER DOSAGE ” MEANS AN AMOUNT OF A DRUG OR A DEVICE 20
	270	+	SUFFICIENT TO BEGIN THERAPY: 21
	271	+
	272	+	(I) FOR A DURATION OF 72 HOURS OR LESS ; OR 22
	273	+
	274	+	(II) PRIOR TO OBTAINING A LARGER QUANTITY OF T HE DRUG 23
	275	+	OR DEVICE TO COMPLET E THE THERAPY . 24
	276	+
	277	+	(9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERM IT 25
	278	+	ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DISP ENSE TOPICAL 26
	279	+	MEDICATIONS THAT ARE APPROVED BY THE FEDE RAL FOOD AND DRUG 27
	280	+	ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 28
	281	+
	282	+	(b) [A physician may dispense a topical medication that is approved by the federal 29
	283	+	Food and Drug Administration for the treatment of hypotrichosis without obtaining a 30
	284	+	dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 31
	285	+	of this article if the physician: 32
	286	+	HOUSE BILL 241 7
	287	+
	288	+
	289	+	(1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 1
	290	+	article; and 2
	291	+
	292	+	(2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 3
	293	+
	294	+	(1) (I) Has received a [special class of written] TOPICAL MEDICATION 4
	295	+	permit from the Board[.]; 5
	296	+
	297	+	[(c) The Board may issue a special class of written permit to a physician under 6
	298	+	subsection (b) of this section if the physician: 7
	299	+
	300	+	(1)] (II) DISPENSES ONLY A TOPI CAL MEDICATION THAT IS 8
	301	+	APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 9
	302	+	TREATMENT OF HYPOTRI CHOSIS; 10
	303	+
	304	+	(III) Completes 1 hour of continuing medical education per year on 11
	305	+	the dispensing of topical medications developed by an ACCME–accredited Maryland 12
	306	+	nonprofit or governmental entity; and 13
	307	+
	308	+	[(2)] (IV) Pays to the Board a $100 permit fee; 14
	309	+
	310	+	(2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 15
	311	+	PATIENT IF: 16
	312	+
	313	+	(I) THE SAMPLE COMPLIES W ITH THE LABELING 17
	314	+	REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 18
	315	+
	316	+	(II) NO CHARGE IS MADE FOR THE SAMPLE; AND 19
	317	+
	318	+	(III) THE AUTHORIZED PRESCRIBER ENTERS AN APPROPRIAT E 20
	319	+	RECORD IN THE PATIEN T’S CHART; 21
	320	+
	321	+	(3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 22
	322	+	OF TREATING A PATIEN T; 23
	323	+
	324	+	(4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 24
	325	+	DRUG OR DEVICE TO A PATIENT IF: 25
	326	+
	327	+	(I) THE STARTER DOSAGE CO MPLIES WITH THE LABE LING 26
	328	+	REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 27
	329	+
	330	+	(II) NO CHARGE IS MADE FOR THE STARTER DOSAGE ; AND 28
	331	+
	332	+	(III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 29
	333	+	RECORD ON THE PATIEN T’S CHART; OR 30 8 HOUSE BILL 241
145	334
146	335
147	336
148		-	~~G. Does not receive remuneration for referring patients to~~ a 1
149		-	~~pharmacist or pharmacy;~~ 2
	337	+	(5) DISPENSES A PRESCRIPTION DRUG OR DEVICE IN THE COU RSE OF 1
	338	+	TREATING A PATIENT A T: 2
150	339
151		-	~~H. Complies with the child resistant packaging requirements~~ 3
152		-	~~regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article~~; 4
	340	+	(I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 3
	341	+	NONPROFIT BASIS ; 4
153	342
154		-	I. Complies with drug recalls; 5
	343	+	(II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 5
	344	+	INSTITUTION OF HIGHE R EDUCATION; OR 6
155	345
156		-	~~J. Maintains biennial inventories and complies with any 6~~
157		-	~~other federal and~~ State ~~record–keeping requirements relating to controlled dangerous 7~~
158		-	~~substances; 8~~
	346	+	(III) A PUBLIC HEALTH FACILITY , A MEDICAL FACILITY U NDER 7
	347	+	CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 8
	348	+	WITH PUBLIC FUNDS . 9
159	349
160		-	K. Purchases prescription drugs from a pharmacy or 9
161		-	wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 10
162		-	the Board of Pharmacy; 11
	350	+	(C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 10
	351	+	PRESCRIPTIONS ONLY I F: 11
163	352
164		-	L. Annually reports to the respective board of licensure 12
165		-	whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 13
166		-	prescription drugs within the previous year; and 14
	353	+	(1) THE PHYSICIAN: 12
167	354
168		-	M. Completes ten continuing education credits over a 5–year 15
169		-	period relating to the preparing and dispensing of prescription drugs, offered by the 16
170		-	Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 17
171		-	consultation with each respective board of licensure, as a condition of permit renewal; OR 18
	355	+	(I) HAS AN ACTIVE LICENSE IN GOOD STANDING ; 13
172	356
173		-	[(iii) A licensed physician from dispensing a topical medication 19
174		-	without obtaining the permit required under item (ii)1C of this paragraph or completing 20
175		-	the continuing education required under item (ii)4M of this paragraph when the physician: 21
	357	+	(II) HAS APPLIED TO THE BOARD FOR A DISPENSIN G PERMIT; 14
176	358
177		-	1. Otherwise complies with item (ii) of this paragraph; and 22
	359	+	(III) HAS PAID A FEE DETERM INED BY THE BOARD TO PRODUCE 15
	360	+	FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 16
	361	+	BOARD FOR CONDUCTING INSPECTIONS OF DISPE NSING PERMIT HOLDERS ; 17
178	362
179		-	2. Has obtained a special written permit under § 14–509 of 23
180		-	this article; 24
	363	+	(IV) HAS DEMONSTRATED TO T HE SATISFACTION OF T HE BOARD 18
	364	+	THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 19
	365	+	IN THE PUBLIC INTERE ST; 20
181	366
182		-	(iv) A ~~licensed physician who complies with~~ the ~~requirements of item 25~~
183		-	~~(ii) of this paragraph from personally preparing~~ and ~~dispensing a prescription written by: 26~~
	367	+	(V) HAS RECEIVED A DISPEN SING PERMIT FROM THE BOARD; 21
	368	+	AND 22
184	369
185		-	1. A physician assistant in accordance with a delegation 27
186		-	agreement that complies with Title 15, Subtitle 3 of this article; or 28
	370	+	(VI) HAS A SIGN CONSPICUOU SLY POSITIONED AND R EADABLE 23
	371	+	REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PR ESCRIPTIONS 24
	372	+	OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 25
	373	+	PRESCRIPTION DISPENS ED; 26
187	374
188		-	2. A nurse practitioner who is authorized to practice under 29
189		-	Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 30
190		-	or] 31
	375	+	(2) THE INDIVIDUAL FOR WH OM THE DRUG OR DEVIC E IS 27
	376	+	PRESCRIBED IS A PATI ENT OF: 28
191	377
192		-	[(v)] (IV) A hospital–based clinic from dispensing prescriptions to 32
193		-	its patients. 33 HOUSE BILL 241 5
	378	+	(I) THE PRESCRIBING PHYSI CIAN; 29
	379	+	HOUSE BILL 241 9
	380	+
	381	+
	382	+	(II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 1
	383	+	DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 2
	384	+	ARTICLE; OR 3
	385	+
	386	+	(III) A NURSE PRACTITIONER W HO IS AUTHORIZED TO PRACTICE 4
	387	+	UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 5
	388	+	PHYSICIAN IN THE SAM E OFFICE SETTING; 6
	389	+
	390	+	(3) THE PHYSICIAN DOES NO T HAVE A SUBSTANTIAL FINANCIAL 7
	391	+	INTEREST IN A PHARMA CY; AND 8
	392	+
	393	+	(4) THE PHYSICIAN: 9
	394	+
	395	+	(I) COMPLIES WITH THE DIS PENSING AND LABELING 10
	396	+	REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE , AND THE BOARD’S 11
	397	+	REGULATIONS ; 12
	398	+
	399	+	(II) RECORDS THE DISPENSIN G OF THE PRESCRIPTIO N DRUG 13
	400	+	OR DEVICE ON THE PAT IENT’S CHART; 14
	401	+
	402	+	(III) PROVIDES THE PATIENT WITH A WRITTEN PRESC RIPTION, 15
	403	+	MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 16
	404	+	ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 17
	405	+
	406	+	(IV) DOES NOT DIRECT PATIE NTS TO A SINGLE PHAR MACIST OR 18
	407	+	PHARMACY IN ACCORDAN CE WITH § 12–403(C)(8) OF THIS ARTICLE; 19
	408	+
	409	+	(V) DOES NOT RECEIVE REMU NERATION FOR REFERRI NG 20
	410	+	PATIENTS TO A PHARMA CIST OR PHARMACY ; 21
	411	+
	412	+	(VI) COMPLIES WITH THE CHI LD RESISTANT PACKAGI NG 22
	413	+	REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 23
	414	+	OF THE HEALTH – GENERAL ARTICLE; 24
	415	+
	416	+	(VII) COMPLIES WITH DRUG RE CALLS; 25
	417	+
	418	+	(VIII) MAINTAINS BIENNIAL IN VENTORIES AND COMPLI ES WITH 26
	419	+	ANY OTHER FEDERAL AND STATE RECORD –KEEPING REQUIREMENTS RELATING TO 27
	420	+	CONTROLLED DANGEROUS SUBSTANCES; 28
	421	+
	422	+	(IX) PURCHASES PRESCRIPTIO N DRUGS FROM A PHARM ACY OR 29
	423	+	WHOLESALE DISTRIBUTO R THAT HOLDS A PERMI T ISSUED BY THE STATE BOARD OF 30
	424	+	PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 31
	425	+	10 HOUSE BILL 241
	426	+
	427	+
	428	+	(X) COMPLIES WITH CONTINU ING EDUCATION REQUIR EMENTS 1
	429	+	RELATING TO THE PREP ARING AND DISPENSING OF PRESCRIPTION DRUG S AS 2
	430	+	PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 3
	431	+
	432	+	(D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS O F THIS 4
	433	+	SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 5
	434	+	SHALL: 6
	435	+
	436	+	(1) HAVE THE DISPENSING P ERMIT REVOKED ; AND 7
	437	+
	438	+	(2) BE SUBJECT TO DISCIPL INARY ACTION BY THE BOARD. 8
	439	+
	440	+	(E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITI AL 9
	441	+	DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 10
	442	+	INSPECT THE OFFICE O F THE PHYSICIAN. 11
	443	+
	444	+	(II) IF THE BOARD RENEWS A DISPEN SING PERMIT TO A 12
	445	+	LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 13
	446	+	PHYSICIAN AT LEAST O NE TIME DURING THE D URATION OF THE RENEW ED PERMIT. 14
	447	+
	448	+	(2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 15
	449	+	SUBSTANCES ADMINISTRATION ANY VI OLATION RELATED TO C ONTROLLED 16
	450	+	DANGEROUS SUBSTANCES FOUND DURING A N INSPECTION REQUIRE D UNDER 17
	451	+	PARAGRAPH (1) OF THIS SUBSECTION . 18
	452	+
	453	+	SECTION 2. AND BE IT FURTHER ENACTED, That, on the effective date of this 19
	454	+	Act, the following shall be transferred to the State Board of Physicians: 20
	455	+
	456	+	(1) all appropriations, including State and federal funds, held by the Office 21
	457	+	of Controlled Substances Administration for the purposes of conducting inspections of 22
	458	+	offices of physicians who hold dispensing permits under § 14–509 of the Health Occupations 23
	459	+	Article on the effective date of this Act; and 24
	460	+
	461	+	(2) all books and records including electronic records, real and personal 25
	462	+	property, equipment, fixtures, assets, liabilities, obligations, credits, rights, and privileges 26
	463	+	held by the Office of Controlled Substances Administration for the purposes of conducting 27
	464	+	inspections of offices of physicians who hold dispensing permits under § 14–509 of the 28
	465	+	Health Occupations Article on the effective date of this Act. 29
	466	+
	467	+	SECTION 3. AND BE IT FURTHER ENACTED, That all employees of the Office of 30
	468	+	Controlled Substances Administration who are assigned more than 50% of the time to a 31
	469	+	function related to conducting inspections of offices of physicians who hold dispensing 32
	470	+	permits under § 14–509 of the Health Occupations Article on the effective date of this Act 33
	471	+	shall be transferred to the State Board of Physicians without diminution of their rights, 34
	472	+	benefits, employment, or retirement status. 35 HOUSE BILL 241 11
194	473
195	474
196	475
197		-	12–102.1. 1
	476	+	SECTION 4. AND BE IT FURTHER ENACTED, That all positions of the Office of 1
	477	+	Controlled Substances Administration who are assigned more than 50% of the time to a 2
	478	+	function related to conducting inspections of offices of physicians who hold dispensing 3
	479	+	permits under § 14–509 of the Health Occupations Article on the effective date of this Act 4
	480	+	shall be transferred to the State Board of Physicians. 5
198	481
199		-	(a) This section does not apply to [a]: 2
	482	+	SECTION 5. AND BE IT FURTHER ENACTED, That any transaction affected by 6
	483	+	the transfer of oversight of the conducting of inspections of offices of physicians who hold 7
	484	+	dispensing permits under § 14–509 of the Health Occupations Article and validly entered 8
	485	+	into before the effective date of this Act, and every right, duty, or interest flowing from it 9
	486	+	remains valid after the effective date of this Act and may be terminated, completed, 10
	487	+	consummated, or enforced under the law. 11
200	488
201		-	(1) A licensed dentist who obtains a permit from the State Board of Dental 3
202		-	Examiners under § 12–102(h) of this subtitle; OR 4
	489	+	SECTION 6. AND BE IT FURTHER ENACTED, That all existing laws, regulations, 12
	490	+	proposed regulations, standards and guidelines, policies, orders and other directives, forms, 13
	491	+	plans, memberships, contracts, property, investigations, administrative and judicial 14
	492	+	responsibilities, rights to sue and be sued, and all other duties and responsibilities 15
	493	+	associated with the oversight of the conducting of inspections of offices of physicians who 16
	494	+	hold dispensing permits under § 14–509 of the Health Occupations Article prior to the 17
	495	+	effective date of this Act shall continue and, as appropriate, are legal and binding on the 18
	496	+	State Board of Physicians until completed, withdrawn, canceled, modified, or otherwise 19
	497	+	changed under the law. 20
203	498
204		-	(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 5
205		-	STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 6
206		-
207		-	(b) The Office of Controlled Substances Administration shall enter and inspect 7
208		-	the office of a dentist[, physician,] or podiatrist who holds: 8
209		-
210		-	(1) An initial dispensing permit: 9
211		-
212		-	(i) Within 6 months after receiving the report required under § 10
213		-	12–102(l)(1) of this subtitle; and 11
214		-
215		-	(ii) At least one more time during the duration of the permit; and 12
216		-
217		-	(2) A renewed dispensing permit at least two times during the duration of 13
218		-	the permit. 14
219		-
220		-	(c) The Office of Controlled Substances Administration promptly shall report the 15
221		-	results of the inspections required under subsection (b) of this section to the respective 16
222		-	board of licensure. 17
223		-
224		-	12–102.2. 18
225		-
226		-	(a) This section does not apply to [a]: 19
227		-
228		-	(1) A licensed dentist who obtains a permit from the State Board of Dental 20
229		-	Examiners under § 12–102(h) of this subtitle; OR 21
230		-
231		-	(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 22
232		-	STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 23
233		-
234		-	(b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 24
235		-	Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 25
236		-	holds a dispensing permit in an amount that will produce funds to approximate but not 26
237		-	exceed the documented costs to the Office of Controlled Substances Administration for 27
238		-	inspection of dispensing permit holders. 28
239		-	6 HOUSE BILL 241
240		-
241		-
242		-	(c) Revenues collected by the Board of Dental Examiners [, the Board of 1
243		-	Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 2
244		-	into the General Fund of the State. 3
245		-
246		-	14–509. 4
247		-
248		-	(a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 5
249		-	INDICATED. 6
250		-
251		-	(2) “ACCME” means the Accrediting Council for Continuing Medical 7
252		-	Education. 8
253		-
254		-	(3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 9
255		-	SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 10
256		-	OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 11
257		-
258		-	(4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 12
259		-	BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 13
260		-	OR DEVICES TO A PATI ENT. 14
261		-
262		-	(5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 15
263		-	OR DEVICES BY A LICE NSED PHYSICIAN TO A PATIENT WHEN A PHARM ACY IS NOT 16
264		-	CONVENIENTLY AVAILAB LE TO THE PATIENT. 17
265		-
266		-	(6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 18
267		-	LICENSED PHYSICIAN : 19
268		-
269		-	(I) IS PHYSICALLY PRESENT ON THE PREMISES WHER E THE 20
270		-	PRESCRIPTION IS FILL ED; AND 21
271		-
272		-	(II) PERFORMS A FINAL CHEC K OF THE PRESCRIPTIO N BEFORE 22
273		-	IT IS PROVIDED TO TH E PATIENT. 23
274		-
275		-	(7) “SAMPLE UNIT ” HAS THE MEANING STAT ED IN 21 C.F.R. § 24
276		-	203.3(AA). 25
277		-
278		-	(8) “STARTER DOSAGE ” MEANS AN AMOUNT OF A DRUG OR A DEVICE 26
279		-	SUFFICIENT TO BEGIN THERAPY: 27
280		-
281		-	(I) FOR A DURATION OF 72 HOURS OR LESS ; OR 28
282		-
283		-	(II) PRIOR TO OBTAINING A LARGER QUANTITY OF T HE DRUG 29
284		-	OR DEVICE TO COMPLET E THE THERAPY . 30
285		-	HOUSE BILL 241 7
286		-
287		-
288		-	(9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERM IT 1
289		-	ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DISPENSE TOPICAL 2
290		-	MEDICATIONS THAT ARE AP PROVED BY THE FEDERA L FOOD AND DRUG 3
291		-	ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 4
292		-
293		-	(b) [A physician may dispense a topical medication that is approved by the federal 5
294		-	Food and Drug Administration for the treatment of hypotrichosis without obtaining a 6
295		-	dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 7
296		-	of this article if the physician: 8
297		-
298		-	(1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 9
299		-	article; and 10
300		-
301		-	(2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 11
302		-
303		-	(1) (I) Has received a [special class of written] TOPICAL MEDICATION 12
304		-	permit from the Board[.]; 13
305		-
306		-	[(c) The Board may issue a special class of written permit to a physician under 14
307		-	subsection (b) of this section if the physician: 15
308		-
309		-	(1)] (II) DISPENSES ONLY A TOPI CAL MEDICATION THAT IS 16
310		-	APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 17
311		-	TREATMENT OF HYPOTRI CHOSIS; 18
312		-
313		-	(III) Completes 1 hour of continuing medical education per year on 19
314		-	the dispensing of topical medications developed by an ACCME–accredited Maryland 20
315		-	nonprofit or governmental entity; and 21
316		-
317		-	[(2)] (IV) Pays to the Board a $100 permit fee; 22
318		-
319		-	(2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 23
320		-	PATIENT IF: 24
321		-
322		-	(I) THE SAMPLE COMPLIES W ITH THE LABELING 25
323		-	REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 26
324		-
325		-	(II) NO CHARGE IS MADE FOR THE SAMPLE; AND 27
326		-
327		-	(III) THE AUTHORIZED PRESCRIBE R ENTERS AN APPROPRI ATE 28
328		-	RECORD IN THE PATIEN T’S CHART; 29
329		-
330		-	(3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 30
331		-	OF TREATING A PATIEN T; 31
332		-	8 HOUSE BILL 241
333		-
334		-
335		-	(4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 1
336		-	DRUG OR DEVICE TO A PATIENT IF: 2
337		-
338		-	(I) THE STARTER DOSAGE CO MPLIES WITH THE LABE LING 3
339		-	REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 4
340		-
341		-	(II) NO CHARGE IS MADE FOR THE STARTER DOSAGE ; AND 5
342		-
343		-	(III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 6
344		-	RECORD ON THE PATIEN T’S CHART; OR 7
345		-
346		-	(5) DISPENSES A PRESCRIPTION DRUG OR DEVICE IN THE COU RSE OF 8
347		-	TREATING A PATIENT A T: 9
348		-
349		-	(I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 10
350		-	NONPROFIT BASIS ; 11
351		-
352		-	(II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 12
353		-	INSTITUTION OF HIGHE R EDUCATION; OR 13
354		-
355		-	(III) A PUBLIC HEALTH FACILITY , A MEDICAL FACILITY U NDER 14
356		-	CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 15
357		-	WITH PUBLIC FUNDS . 16
358		-
359		-	(C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 17
360		-	PRESCRIPTIONS ONLY I F: 18
361		-
362		-	(1) THE PHYSICIAN: 19
363		-
364		-	(I) HAS AN ACTIVE LICENSE IN GOOD STANDING ; 20
365		-
366		-	(II) HAS APPLIED TO THE BOARD FOR A DISPENSIN G PERMIT; 21
367		-
368		-	(III) HAS PAID A FEE DETERM INED BY THE BOARD TO PRODUCE 22
369		-	FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 23
370		-	BOARD FOR CONDUCTING INSPECTION S OF DISPENSING PERM IT HOLDERS; 24
371		-
372		-	(IV) HAS DEMONSTRATED TO T HE SATISFACTION OF T HE BOARD 25
373		-	THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 26
374		-	IN THE PUBLIC INTERE ST; 27
375		-
376		-	(V) HAS RECEIVED A DISPEN SING PERMIT FROM THE BOARD; 28
377		-	AND 29
378		-	HOUSE BILL 241 9
379		-
380		-
381		-	(VI) HAS A SIGN CONSPICUOU SLY POSITIONED AND R EADABLE 1
382		-	REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PRESC RIPTIONS 2
383		-	OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 3
384		-	PRESCRIPTION DISPENS ED; 4
385		-
386		-	(2) THE INDIVIDUAL FOR WH OM THE DRUG OR DEVIC E IS 5
387		-	PRESCRIBED IS A PATI ENT OF: 6
388		-
389		-	(I) THE PRESCRIBING PHYSI CIAN; 7
390		-
391		-	(II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 8
392		-	DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 9
393		-	ARTICLE; OR 10
394		-
395		-	(III) A NURSE PRACTITIONER W HO IS AUTHORIZED TO PRACTICE 11
396		-	UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 12
397		-	PHYSICIAN IN THE SAM E OFFICE SETTING ; 13
398		-
399		-	(3) THE PHYSICIAN DOES NO T HAVE A SUBSTANTIAL FINANCIAL 14
400		-	INTEREST IN A PHARMA CY; AND 15
401		-
402		-	(4) THE PHYSICIAN: 16
403		-
404		-	(I) COMPLIES WITH THE DIS PENSING AND LABELING 17
405		-	REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE , AND THE BOARD’S 18
406		-	REGULATIONS ; 19
407		-
408		-	(II) RECORDS THE DISPENSIN G OF THE PRESCRIPTIO N DRUG 20
409		-	OR DEVICE ON THE PAT IENT’S CHART; 21
410		-
411		-	(III) PROVIDES THE PATIENT WIT H A WRITTEN PRESCRIP TION, 22
412		-	MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 23
413		-	ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 24
414		-
415		-	(IV) DOES NOT DIRECT PATIE NTS TO A SINGLE PHAR MACIST OR 25
416		-	PHARMAC Y IN ACCORDANCE WITH § 12–403(C)(8) OF THIS ARTICLE; 26
417		-
418		-	(V) DOES NOT RECEIVE REMU NERATION FOR REFERRI NG 27
419		-	PATIENTS TO A PHARMA CIST OR PHARMACY ; 28
420		-
421		-	(VI) COMPLIES WITH THE CHI LD RESISTANT PACKAGI NG 29
422		-	REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 30
423		-	OF THE HEALTH – GENERAL ARTICLE; 31
424		-	10 HOUSE BILL 241
425		-
426		-
427		-	(VII) COMPLIES WITH DRUG RE CALLS; 1
428		-
429		-	(VIII) MAINTAINS BIENNIAL IN VENTORIES AND COMPLI ES WITH 2
430		-	ANY OTHER FEDERAL AN D STATE RECORD –KEEPING REQUIREMENTS RELATING TO 3
431		-	CONTROLLED DANGEROUS SUBSTANCES; 4
432		-
433		-	(IX) PURCHASES PRESCRIPTIO N DRUGS FROM A PHARM ACY OR 5
434		-	WHOLESALE DISTRIBUTO R THAT HOLDS A PERMI T ISSUED BY THE STATE BOARD OF 6
435		-	PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 7
436		-
437		-	(X) COMPLIES WITH CONTINU ING EDUCATION REQUIR EMENTS 8
438		-	RELATING TO THE PREP ARING AND DISPENSING O F PRESCRIPTION DRUGS AS 9
439		-	PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 10
440		-
441		-	(D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS OF THIS 11
442		-	SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 12
443		-	SHALL: 13
444		-
445		-	(1) HAVE THE DISPEN SING PERMIT REVOKED ; AND 14
446		-
447		-	(2) BE SUBJECT TO DISCIPL INARY ACTION BY THE BOARD. 15
448		-
449		-	(E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITI AL 16
450		-	DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 17
451		-	INSPECT THE OFFICE O F THE PHYSICIAN. 18
452		-
453		-	(II) IF THE BOARD RENEWS A DISPEN SING PERMIT TO A 19
454		-	LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 20
455		-	PHYSICIAN AT LEAST O NE TIME DURING THE D URATION OF THE RENEW ED PERMIT. 21
456		-
457		-	(2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 22
458		-	SUBSTANCES ADMINISTRATION AND THE OFFICE OF THE ATTORNEY GENERAL ANY 23
459		-	VIOLATION RELATED TO CONTROLLED DANGEROUS SUBSTANCES FOUND DUR ING 24
460		-	AN INSPECTION REQUIR ED UNDER PARAGRAPH (1) OF THIS SUBSECTION . 25
461		-
462		-	SECTION 2. AND BE IT FURTHER ENACTED, That , on: 26
463		-
464		-	(a) On the effective date of this Act, the following shall be transferred to the State 27
465		-	Board of Physicians: 28
466		-
467		-	(1) all appropriations, including State and federal funds, held by the Office 29
468		-	of Controlled Substances Administration for the purposes of conducting inspections of 30
469		-	offices of physicians who hold dispensing permits under § 14–509 of the Health Occupations 31
470		-	Article on the effective date of this Act; and 32
471		-	HOUSE BILL 241 11
472		-
473		-
474		-	(2) subject to subsection (b) of this section, all books and records including 1
475		-	electronic records, real and personal property, equipment, fixtures, assets, liabilities, 2
476		-	obligations, credits, rights, and privileges held by the Office of Controlled Substances 3
477		-	Administration for the purposes of conducting inspections of offices of physicians who hold 4
478		-	dispensing permits under § 14–509 of the Health Occupations Article on the effective date 5
479		-	of this Act. 6
480		-
481		-	(b) If the record relates to a pending or ongoing investigation that was initiated 7
482		-	by the Office of Controlled Substances Administration before the effective date of this Act, 8
483		-	the Office may provide the State Board of Physicians with a copy of the record in lieu of the 9
484		-	original record. 10
485		-
486		-	SECTION 3. AND BE IT FURTHER ENACTED, That all employees of the Office of 11
487		-	Controlled Substances Administration who are assigned more than 50% of the time to a 12
488		-	function related to conducting inspections of offices of physicians who hold dispensing 13
489		-	permits under § 14–509 of the Health Occupations Article on the effective date of this Act 14
490		-	shall be transferred to the State Board of Physicians without diminution of their rights, 15
491		-	benefits, employment, or retirement status. 16
492		-
493		-	SECTION 4. AND BE IT FURTHER ENACTED, That all positions of the Office of 17
494		-	Controlled Substances Administration who are assigned more than 50% of the time to a 18
495		-	function related to conducting inspections of offices of physicians who hold dispensing 19
496		-	permits under § 14–509 of the Health Occupations Article on the effective date of this Act 20
497		-	shall be transferred to the State Board of Physicians. 21
498		-
499		-	SECTION 5. AND BE IT FURTHER ENACTED, That any transaction affected by 22
500		-	the transfer of oversight of the conducting of inspections of offices of physicians who hold 23
501		-	dispensing permits under § 14–509 of the Health Occupations Article and validly entered 24
502		-	into before the effective date of this Act, and every right, duty, or interest flowing from it 25
503		-	remains valid after the effective date of this Act and may be terminated, completed, 26
504		-	consummated, or enforced under the law. 27
505		-
506		-	SECTION 6. AND BE IT FURTHER ENACTED, That all existing laws , regulations, 28
507		-	proposed regulations, standards and guidelines, policies, orders and other directives, forms, 29
508		-	plans, memberships, contracts, property, investigations, administrative and judicial 30
509		-	responsibilities, rights to sue and be sued, and all other duties and responsibilities 31
510		-	associated with the oversight of the conducting of inspections of offices of physicians who 32
511		-	hold dispensing permits under § 14–509 of the Health Occupations Article prior to the 33
512		-	effective date of this Act shall continue and, as appropriate, are legal and binding on the 34
513		-	State Board of Physicians until completed, withdrawn, canceled, modified, or otherwise 35
514		-	changed under the law. 36
515		-
516		-	SECTION 7. AND BE IT FURTHER ENACTED, That this Act shall take effect 37
517		-	October 1, 2023. 38
518		-
	499	+	SECTION 7. AND BE IT FURTHER ENACTED, That this Act shall take effect 21
	500	+	October 1, 2023. 22