Maryland 2022 Regular Session

Maryland Senate Bill SB305 Compare Versions

Only one version of the bill is available at this time.

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	5	sb0305
6	6
7	7	SENATE BILL 305
8	8	J2 2lr1750
9	9	CF HB 260
10	10	By: Senator Lam
11	11	Introduced and read first time: January 20, 2022
12	12	Assigned to: Education, Health, and Environmental Affairs
13	13
14	14	A BILL ENTITLED
15	15
16	16	AN ACT concerning 1
17	17
18	18	State Board of Physicians – Dispensing Permits 2
19	19
20	20	FOR the purpose of transferring oversight of the inspection of the offices of dispensing 3
21	21	physicians from the Office of Controlled Substances Administration to the State 4
22	22	Board of Physicians; altering the circumstances under which a physician may 5
23	23	dispense drugs or devices; and generally relating to the dispensing of drugs or 6
24	24	devices by licensed physicians. 7
25	25
26	26	BY repealing and reenacting, with amendments, 8
27	27	Article – Health Occupations 9
28	28	Section 12–102(a) and (c), 12–102.1, 12–102.2, and 14–509 10
29	29	Annotated Code of Maryland 11
30	30	(2021 Replacement Volume) 12
31	31
32	32	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 13
33	33	That the Laws of Maryland read as follows: 14
34	34
35	35	Article – Health Occupations 15
36	36
37	37	12–102. 16
38	38
39	39	(a) (1) In this section the following [terms] WORDS have the meanings 17
40	40	indicated. 18
41	41
42	42	(2) “In the public interest” means the dispensing of drugs or devices by a 19
43	43	licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 20
44	44	available to the patient. 21
45	45
46	46	(3) “Personally preparing and dispensing” means that the licensed 22
47	47	dentist[, physician,] or podiatrist: 23 2 SENATE BILL 305
48	48
49	49
50	50
51	51	(i) Is physically present on the premises where the prescription is 1
52	52	filled; and 2
53	53
54	54	(ii) Performs a final check of the prescription before it is provided to 3
55	55	the patient. 4
56	56
57	57	(c) (1) This subsection does not apply to a licensed dentist who obtains a 5
58	58	permit from the State Board of Dental Examiners under subsection (h) of this section. 6
59	59
60	60	(2) This title does not prohibit: 7
61	61
62	62	(i) A licensed veterinarian from: 8
63	63
64	64	1. Personally preparing and dispensing the veterinarian’s 9
65	65	prescriptions; or 10
66	66
67	67	2. Dispensing, in accordance with § 2–313(c) of the 11
68	68	Agriculture Article, compounded nonsterile preparations or compounded sterile 12
69	69	preparations provided by a pharmacy; 13
70	70
71	71	(II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 14
72	72	AND DISPENSING PRESC RIPTIONS IF THE PHYS ICIAN HAS OBT AINED A PERMIT 15
73	73	UNDER § 14–509 OF THIS ARTICLE; 16
74	74
75	75	[(ii)] (III) A licensed dentist[, physician,] or podiatrist from 17
76	76	personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 18
77	77	prescriptions when: 19
78	78
79	79	1. The dentist[, physician,] or podiatrist: 20
80	80
81	81	A. Has applied to the board of licensure in this State which 21
82	82	licensed the dentist[, physician,] or podiatrist; 22
83	83
84	84	B. Has demonstrated to the satisfaction of that board that the 23
85	85	dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 24
86	86	the public interest; 25
87	87
88	88	C. Has received a written permit from that board to dispense 26
89	89	prescription drugs or devices except that a written permit is not required in order to 27
90	90	dispense starter dosages or samples without charge; and 28
91	91
92	92	D. Posts a sign conspicuously positioned and readable 29
93	93	regarding the process for resolving incorrectly filled prescriptions or includes written 30
94	94	information regarding the process with each prescription dispensed; 31
95	95	SENATE BILL 305 3
96	96
97	97
98	98	2. The person for whom the drugs or devices are prescribed 1
99	99	is a patient of the prescribing dentist[, physician,] or podiatrist; 2
100	100
101	101	3. The dentist[, physician,] or podiatrist does not have a 3
102	102	substantial financial interest in a pharmacy; and 4
103	103
104	104	4. The dentist[, physician,] or podiatrist: 5
105	105
106	106	A. Complies with the dispensing and labeling requirements 6
107	107	of this title; 7
108	108
109	109	B. Records the dispensing of the prescription drug or device 8
110	110	on the patient’s chart; 9
111	111
112	112	C. Allows the Office of Controlled Substances Administration 10
113	113	to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 11
114	114	and in accordance with § 12–102.1 of this subtitle; 12
115	115
116	116	D. On inspection by the Office of Controlled Substances 13
117	117	Administration, signs and dates an acknowledgment form provided by the Office of 14
118	118	Controlled Substances Administration relating to the requirements of this section; 15
119	119
120	120	E. Except for starter dosages or samples without charge, 16
121	121	provides the patient with a written prescription, maintains prescription files in accordance 17
122	122	with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions; 18
123	123
124	124	F. Does not direct patients to a single pharmacist or 19
125	125	pharmacy in accordance with § 12–403(c)(8) of this title; 20
126	126
127	127	G. Does not receive remuneration for referring patients to a 21
128	128	pharmacist or pharmacy; 22
129	129
130	130	H. Complies with the child resistant packaging requirements 23
131	131	regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; 24
132	132
133	133	I. Complies with drug recalls; 25
134	134
135	135	J. Maintains biennial inventories and complies with any 26
136	136	other federal and State record–keeping requirements relating to controlled dangerous 27
137	137	substances; 28
138	138
139	139	K. Purchases prescription drugs from a pharmacy or 29
140	140	wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 30
141	141	the Board of Pharmacy; 31
142	142	4 SENATE BILL 305
143	143
144	144
145	145	L. Annually reports to the respective board of licensure 1
146	146	whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 2
147	147	prescription drugs within the previous year; and 3
148	148
149	149	M. Completes ten continuing education credits over a 5–year 4
150	150	period relating to the preparing and dispensing of prescription drugs, offered by the 5
151	151	Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 6
152	152	consultation with each respective board of licensure, as a condition of permit renewal; OR 7
153	153
154	154	[(iii) A licensed physician from dispensing a topical medication 8
155	155	without obtaining the permit required under item (ii)1C of this paragraph or completing 9
156	156	the continuing education required under item (ii)4M of this paragraph when the physician: 10
157	157
158	158	1. Otherwise complies with item (ii) of this paragraph; and 11
159	159
160	160	2. Has obtained a special written permit under § 14–509 of 12
161	161	this article; 13
162	162
163	163	(iv) A licensed physician who complies with the requirements of item 14
164	164	(ii) of this paragraph from personally preparing and dispensing a prescription written by: 15
165	165
166	166	1. A physician assistant in accordance with a delegation 16
167	167	agreement that complies with Title 15, Subtitle 3 of this article; or 17
168	168
169	169	2. A nurse practitioner who is authorized to practice under 18
170	170	Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 19
171	171	or] 20
172	172
173	173	[(v)] (IV) A hospital–based clinic from dispensing prescriptions to 21
174	174	its patients. 22
175	175
176	176	12–102.1. 23
177	177
178	178	(a) This section does not apply to [a]: 24
179	179
180	180	(1) A licensed dentist who obtains a permit from the State Board of Dental 25
181	181	Examiners under § 12–102(h) of this subtitle; OR 26
182	182
183	183	(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 27
184	184	STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 28
185	185
186	186	(b) The Office of Controlled Substances Administration shall enter and inspect 29
187	187	the office of a dentist[, physician,] or podiatrist who holds: 30
188	188
189	189	(1) An initial dispensing permit: 31
190	190	SENATE BILL 305 5
191	191
192	192
193	193	(i) Within 6 months after receiving the report required under § 1
194	194	12–102(l)(1) of this subtitle; and 2
195	195
196	196	(ii) At least one more time during the duration of the permit; and 3
197	197
198	198	(2) A renewed dispensing permit at least two times during the duration of 4
199	199	the permit. 5
200	200
201	201	(c) The Office of Controlled Substances Administration promptly shall report the 6
202	202	results of the inspections required under subsection (b) of this section to the respective 7
203	203	board of licensure. 8
204	204
205	205	12–102.2. 9
206	206
207	207	(a) This section does not apply to [a]: 10
208	208
209	209	(1) A licensed dentist who obtains a permit from the State Board of Dental 11
210	210	Examiners under § 12–102(h) of this subtitle; OR 12
211	211
212	212	(2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 13
213	213	STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 14
214	214
215	215	(b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 15
216	216	Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 16
217	217	holds a dispensing permit in an amount that will produce funds to approximate but not 17
218	218	exceed the documented costs to the Office of Controlled Substances Administration for 18
219	219	inspection of dispensing permit holders. 19
220	220
221	221	(c) Revenues collected by the Board of Dental Examiners [, the Board of 20
222	222	Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 21
223	223	into the General Fund of the State. 22
224	224
225	225	14–509. 23
226	226
227	227	(a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 24
228	228	INDICATED. 25
229	229
230	230	(2) “ACCME” means the Accrediting Council for Continuing Medical 26
231	231	Education. 27
232	232
233	233	(3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 28
234	234	SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 29
235	235	OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 30
236	236	6 SENATE BILL 305
237	237
238	238
239	239	(4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 1
240	240	BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 2
241	241	OR DEVICES TO A PATI ENT. 3
242	242
243	243	(5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 4
244	244	OR DEVICES BY A LICENSED PHYSICIAN TO A PATIENT WHEN A PHARMACY IS NOT 5
245	245	CONVENIENTLY AVAILAB LE TO THE PATIENT . 6
246	246
247	247	(6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 7
248	248	LICENSED PHYSICIAN : 8
249	249
250	250	(I) IS PHYSICALLY PRESENT ON THE PREMISES WHER E THE 9
251	251	PRESCRIPTION IS FILL ED; AND 10
252	252
253	253	(II) PERFORMS A FINAL CHEC K OF THE PRESCRIPTIO N BEFORE 11
254	254	IT IS PROVIDED TO TH E PATIENT. 12
255	255
256	256	(7) “SAMPLE UNIT ” HAS THE MEANING STAT ED IN 21 C.F.R. § 13
257	257	203.3(AA). 14
258	258
259	259	(8) “STARTER DOSAGE ” MEANS AN AMOUNT OF D RUG OR DEVICE 15
260	260	SUFFICIENT TO BEGIN THERAPY: 16
261	261
262	262	(I) FOR A SHORT DURATION OF 72 HOURS OR LESS ; OR 17
263	263
264	264	(II) PRIOR TO OBTAINING A LARGER QUANTITY OF T HE DRUG 18
265	265	OR DEVICE TO COMPLET E THE THERAPY . 19
266	266
267	267	(9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERM IT 20
268	268	ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DI SPENSE TOPICAL 21
269	269	MEDICATIONS THAT ARE APPROVED BY THE FEDE RAL FOOD AND DRUG 22
270	270	ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 23
271	271
272	272	(b) [A physician may dispense a topical medication that is approved by the federal 24
273	273	Food and Drug Administration for the treatment of hypotrichosis without obtaining a 25
274	274	dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 26
275	275	of this article if the physician: 27
276	276
277	277	(1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 28
278	278	article; and 29
279	279
280	280	(2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 30
281	281
282	282	(1) (I) Has received a [special class of written] TOPICAL MEDICATION 31
283	283	permit from the Board[.]; 32 SENATE BILL 305 7
284	284
285	285
286	286
287	287	[(c) The Board may issue a special class of written permit to a physician under 1
288	288	subsection (b) of this section if the physician: 2
289	289
290	290	(1)] (II) DISPENSES ONLY A TOPI CAL MEDICATION THAT IS 3
291	291	APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 4
292	292	TREATMENT OF HYPOTRICHOSIS ; 5
293	293
294	294	(III) Completes 1 hour of continuing medical education per year on 6
295	295	the dispensing of topical medications developed by an ACCME–accredited Maryland 7
296	296	nonprofit or governmental entity; and 8
297	297
298	298	[(2)] (IV) Pays to the Board a $100 permit fee[.]; 9
299	299
300	300	(2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 10
301	301	PATIENT IF: 11
302	302
303	303	(I) THE SAMPLE COMPLIES W ITH THE LABELING 12
304	304	REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 13
305	305
306	306	(II) NO CHARGE IS MADE FOR THE SAMPLE; AND 14
307	307
308	308	(III) THE AUTHORIZED PRESCR IBER ENTERS AN APPROPRIATE 15
309	309	RECORD IN THE PATIEN T’S CHART; 16
310	310
311	311	(3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 17
312	312	OF TREATING A PATIEN T; 18
313	313
314	314	(4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 19
315	315	DRUG OR DEVICE TO A PATIENT IF: 20
316	316
317	317	(I) THE STARTER DOSAGE CO MPLIES WITH THE LABELIN G 21
318	318	REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 22
319	319
320	320	(II) NO CHARGE IS MADE FOR THE STARTER DOSAGE ; AND 23
321	321
322	322	(III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 24
323	323	RECORD ON THE PATIEN T’S CHART; OR 25
324	324
325	325	(5) DISPENSES A PRESCRIPT ION DRUG OR DEVICE IN THE COURSE OF 26
326	326	TREATING A PATIENT A T: 27
327	327
328	328	(I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 28
329	329	NONPROFIT BASIS ; 29
330	330	8 SENATE BILL 305
331	331
332	332
333	333	(II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 1
334	334	INSTITUTION OF HIGHE R EDUCATION; OR 2
335	335
336	336	(III) A PUBLIC HEALTH FACILI TY, A MEDICAL F ACILITY UNDER 3
337	337	CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 4
338	338	WITH PUBLIC FUNDS . 5
339	339
340	340	(C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 6
341	341	PRESCRIPTIONS ONLY I F: 7
342	342
343	343	(1) THE PHYSICIAN: 8
344	344
345	345	(I) HAS AN ACTIVE LICENSE IN GOOD STANDING; 9
346	346
347	347	(II) HAS APPLIED TO THE BOARD FOR A DISPENSIN G PERMIT; 10
348	348
349	349	(III) HAS PAID A FEE DETERM INED BY THE BOARD TO PRODUCE 11
350	350	FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 12
351	351	BOARD FOR CONDUCTING INSPECTIONS OF DISPE NSING PERMIT HOLDERS ; 13
352	352
353	353	(IV) HAS DEMONSTRATED TO T HE SATISFACTION OF T HE BOARD 14
354	354	THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 15
355	355	IN THE PUBLIC INTERE ST; 16
356	356
357	357	(V) HAS RECEIVED A DISPEN SING PERMIT FROM THE BOARD; 17
358	358	AND 18
359	359
360	360	(VI) HAS A SIGN CONSPICUOU SLY POSITIONED AND R EADABLE 19
361	361	REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PR ESCRIPTIONS 20
362	362	OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 21
363	363	PRESCRIPTION DISPENS ED; 22
364	364
365	365	(2) THE INDIVIDUAL FOR WH OM THE DRUG OR DEVIC E IS23
366	366	PRESCRIBED IS A PATI ENT OF: 24
367	367
368	368	(I) THE PRESCRIBING PHYSI CIAN; 25
369	369
370	370	(II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 26
371	371	DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 27
372	372	ARTICLE; OR 28
373	373
374	374	(III) A NURSE PRACTITIONER W HO IS AUTHORIZED TO PRACTICE 29
375	375	UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 30
376	376	PHYSICIAN IN THE SAME OF FICE SETTING; 31 SENATE BILL 305 9
377	377
378	378
379	379
380	380	(3) THE PHYSICIAN DOES NO T HAVE A SUBSTANTIAL FINANCIAL 1
381	381	INTEREST IN A PHARMA CY; AND 2
382	382
383	383	(4) THE PHYSICIAN: 3
384	384
385	385	(I) COMPLIES WITH THE DIS PENSING AND LABELING 4
386	386	REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE , AND THE BOARD’S 5
387	387	REGULATIONS ; 6
388	388
389	389	(II) RECORDS THE DISPENSIN G OF THE PRESCRIPTIO N DRUG 7
390	390	OR DEVICE ON THE PAT IENT’S CHART; 8
391	391
392	392	(III) PROVIDES THE PATIENT WITH A WRITTEN PRESCRIPTION , 9
393	393	MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 10
394	394	ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 11
395	395
396	396	(IV) DOES NOT DIRECT PATIE NTS TO A SINGLE PHAR MACIST OR 12
397	397	PHARMACY IN ACCORDAN CE WITH § 12–403(C)(8) OF THIS ARTICLE; 13
398	398
399	399	(V) DOES NOT RECEIVE REMU NERATION FOR REFERRI NG 14
400	400	PATIENTS TO A PHARMA CIST OR PHARMACY ; 15
401	401
402	402	(VI) COMPLIES WITH THE CHI LD RESISTANT PACKAGI NG 16
403	403	REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 17
404	404	OF THE HEALTH – GENERAL ARTICLE; 18
405	405
406	406	(VII) COMPLIES WITH DRUG RE CALLS; 19
407	407
408	408	(VIII) MAINTAINS BIENNIAL IN VENTORIES AND COMPLI ES WITH 20
409	409	ANY OTHER FEDERAL AN D STATE RECORD –KEEPING REQUIREMENTS RELATING TO 21
410	410	CONTROLLED DANGEROUS SUBSTANCES; 22
411	411
412	412	(IX) PURCHASES PRESCRIPTIO N DRUGS FROM A PHARMACY OR 23
413	413	WHOLESALE DISTRIBUTO R THAT HOLDS A PERMI T ISSUED BY THE STATE BOARD OF 24
414	414	PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 25
415	415
416	416	(X) COMPLIES WITH CONTINU ING EDUCATION REQUIR EMENTS 26
417	417	RELATING TO THE PREP ARING AND DISPENSING OF PRESCRIPTION DRUGS AS 27
418	418	PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 28
419	419
420	420	(D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS OF THIS 29
421	421	SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 30
422	422	SHALL: 31 10 SENATE BILL 305
423	423
424	424
425	425
426	426	(1) HAVE THE DISPENSING P ERMIT REVOKED ; AND 1
427	427
428	428	(2) BE SUBJECT TO DISCIPL INARY ACTION BY THE BOARD. 2
429	429
430	430	(E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITI AL 3
431	431	DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 4
432	432	INSPECT THE OFFICE O F THE PHYSICIAN. 5
433	433
434	434	(II) IF THE BOARD RENEWS A DISPENSING PERMIT TO A 6
435	435	LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 7
436	436	PHYSICIAN AT LEAST O NE TIME DURING THE D URATION OF THE RENEW ED PERMIT. 8
437	437
438	438	(2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 9
439	439	SUBSTANCES ADMINISTRATION ANY VIOLATION RELATE D TO CONTROLLED 10
440	440	DANGEROUS SUBSTANCES FOUND DURING AN INSP ECTION REQUIRED UNDE R 11
441	441	PARAGRAPH (1) OF THIS SUBSECTION . 12
442	442
443	443	SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 13
444	444	October 1, 2022. 14
445	445