Maryland 2024 Regular Session

Maryland House Bill HB1099 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	hb1099
6	6
7	7	HOUSE BILL 1099
8	8	M4, J2 4lr1728
9	9
10	10	By: Delegate Guyton
11	11	Introduced and read first time: February 7, 2024
12	12	Assigned to: Environment and Transportation
13	13
14	14	A BILL ENTITLED
15	15
16	16	AN ACT concerning 1
17	17
18	18	Veterinary Practitioners and Veterinary Technicians – Compounding 2
19	19	Prescription Drugs – Authorization and Requirements 3
20	20
21	21	FOR the purpose of authorizing certain veterinary practitioners and veterinary technicians 4
22	22	to compound prescription drugs under certain circumstances; requiring a veterinary 5
23	23	clinic or hospital that carries out compounding to establish certain policies and keep 6
24	24	certain records regarding certain compounded prescription drugs; authorizing an 7
25	25	office manager or veterinary assistant to maintain certain records in a certain 8
26	26	manner and update certain policies under certain circumstances; requiring a 9
27	27	veterinary clinic or hospital that compounds drugs on–site to take certain actions for 10
28	28	purposes of quality assurance; prohibiting a veterinary practitioner or veterinary 11
29	29	technician from compounding a drug under certain circumstances; authorizing a 12
30	30	veterinary practitioner to purchase, store, and distribute certain compounded drugs 13
31	31	under certain circumstances; requiring the State Board of Veterinary Medical 14
32	32	Examiners to establish certain safety standards and guidelines; and generally 15
33	33	relating to the compounding of prescription drugs by veterinary practitioners and 16
34	34	veterinary technicians. 17
35	35
36	36	BY repealing and reenacting, without amendments, 18
37	37	Article – Agriculture 19
38	38	Section 2–301(a), (i), and (j) 20
39	39	Annotated Code of Maryland 21
40	40	(2016 Replacement Volume and 2023 Supplement) 22
41	41
42	42	BY adding to 23
43	43	Article – Agriculture 24
44	44	Section 2–313.4 25
45	45	Annotated Code of Maryland 26
46	46	(2016 Replacement Volume and 2023 Supplement) 27
47	47	2 HOUSE BILL 1099
48	48
49	49
50	50	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1
51	51	That the Laws of Maryland read as follows: 2
52	52
53	53	Article – Agriculture 3
54	54
55	55	2–301. 4
56	56
57	57	(a) In this subtitle the following words have the meanings indicated. 5
58	58
59	59	(i) “Veterinary practitioner” means a licensed and registered veterinarian 6
60	60	engaged in the practice of veterinary medicine. 7
61	61
62	62	(j) “Veterinary technician” means a person who is registered with the Board as a 8
63	63	veterinary technician. 9
64	64
65	65	2–313.4. 10
66	66
67	67	(A) (1) IN THIS SECTION THE FOLLOWING WORDS HAVE THE MEANINGS 11
68	68	INDICATED. 12
69	69
70	70	(2) (I) “COMPOUNDING ” MEANS: 13
71	71
72	72	1. ALTERING THE DOSAGE F ORM OF A DRUG ; 14
73	73
74	74	2. ALTERING THE DELIVERY SYSTEM OF A DRUG ; 15
75	75
76	76	3. ALTERING THE STRENGTH OF A DRUG; 16
77	77
78	78	4. COMBINING INGREDIENTS OF DIFFERENT DRUGS ; OR 17
79	79
80	80	5. PREPARING A COMPOUNDE D DRUG PREPARATION 18
81	81	FROM CHEMICALS . 19
82	82
83	83	(II) “COMPOUNDING ” INCLUDES: 20
84	84
85	85	1. THE PREPARATION OF A COMPOUNDED DRUG FROM 21
86	86	BULK SUBSTANCES ; AND 22
87	87
88	88	2. THE PREPARATION OF OFFICE –USE PRODUCTS 23
89	89	APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION THAT HAVE BEEN 24
90	90	CREATED IN: 25
91	91	HOUSE BILL 1099 3
92	92
93	93
94	94	A. A PHARMACY EQUIPPED WI TH A CLASS A 1
95	95	PRESCRIPTION BALANCE AND WEIGHTS , OR A PRESCRIPTION BA LANCE WITH 2
96	96	EQUIVALENT OR SUPERI OR SENSITIVITY TO A CLASS A PRESCRIPTION BALANCE ; OR 3
97	97
98	98	B. AN OUTSOURC ING FACILITY REGISTE RED WITH THE 4
99	99	U.S. FOOD AND DRUG ADMINISTRATION . 5
100	100
101	101	(3) “OFFICE USE” MEANS PATIENT TREATM ENT CARRIED OUT BY A 6
102	102	VETERINARY PRACTITIO NER OR A VETERINARY TECHNICIAN UNDER THE DIRECT OR 7
103	103	INDIRECT SUPERVISION OF A VETERINARY PRAC TITIONER. 8
104	104
105	105	(4) “PATIENT TREATMENT” INCLUDES: 9
106	106
107	107	(I) TREATMENT PROVIDED DU RING A PATIENT ’S OFFICE OR 10
108	108	HOSPITAL VISIT; 11
109	109
110	110	(II) TREATMENT PROVIDED DU RING SURGERY ; 12
111	111
112	112	(III) EMERGENCY TREATMENT ; AND 13
113	113
114	114	(IV) PRESCRIBED AT–HOME TREATMENT . 14
115	115
116	116	(B) COMPOUNDING MAY BE CARRIED OUT BY: 15
117	117
118	118	(1) A VETERINARY PRACTITIO NER WHO HAS AN ESTAB LISHED 16
119	119	RELATIONSHIP WITH TH E CLIENT; OR 17
120	120
121	121	(2) A VETERINARY TECHNICIA N UNDER THE DIRECT S UPERVISION OF 18
122	122	A VETERINARY PRACTIT IONER WHO HAS AN ESTABLISH ED RELATIONSHIP WITH THE 19
123	123	CLIENT. 20
124	124
125	125	(C) A VETERINARY CLINIC OR HOSPITAL THAT CARRIE S OUT COMPOUNDING 21
126	126	SHALL: 22
127	127
128	128	(1) ESTABLISH POLICIES AN D CREATE A MANUAL ON COMPOUND ING 23
129	129	THAT INCLUDE : 24
130	130
131	131	(I) HOW EACH COMPOUNDED D RUG WAS CREATED , 25
132	132	INCLUDING: 26
133	133
134	134	1. THE MANUFACTURER ’S NAME; 27
135	135
136	136	2. THE ORIGINAL DOSAGE; 28 4 HOUSE BILL 1099
137	137
138	138
139	139
140	140	3. THE LOT NUMBER ; 1
141	141
142	142	4. THE EXPIRATION DATE ; AND 2
143	143
144	144	5. THE PURCHASE DATE ; AND 3
145	145
146	146	(II) HOW VETERINARY TECHNI CIANS SHALL BE TRAIN ED AT 4
147	147	COMPOUNDING ; 5
148	148
149	149	(2) MAINTAIN A RECORD OF : 6
150	150
151	151	(I) THE FORMULA USED WHEN COMPOUNDING ; 7
152	152
153	153	(II) ALL ACTIVE AND INACTIVE INGREDI ENTS; 8
154	154
155	155	(III) ANY EQUIPMENT USED ; 9
156	156
157	157	(IV) THE EXPIRATION DATE O F: 10
158	158
159	159	1. THE COMPOUNDED DRUG; AND 11
160	160
161	161	2. ANY INGREDIENTS USED ; 12
162	162
163	163	(V) THE SPECIFIC STEPS TA KEN WHILE COMPOUNDIN G; 13
164	164
165	165	(VI) INSTRUCTIONS ON PROPE R STORAGE , HANDLING, 14
166	166	ADMINISTRATION , AND DISPOSAL OF THE COMPOUNDED DRUG; AND 15
167	167
168	168	(VII) THE NAME OF THE INDIVIDUAL WHO PREPARED THE DRUG 16
169	169	AND THE DATE OF PREPARATION ; 17
170	170
171	171	(3) MAINTAIN THE FOLLOWING INFORMATIO N IN A PATIENT RECORD : 18
172	172
173	173	(I) THE NAME OF THE VETER INARY PRACTITIONER W HO 19
174	174	COMPOUNDED , OR SUPERVISED THE CO MPOUNDING OF , THE DRUG, AND THE NAME 20
175	175	OF THE VETERINARY TE CHNICIAN, IF APPLICABLE; 21
176	176
177	177	(II) THE EXPIRATION DATE O F THE COMPOUNDED DRU G; 22
178	178
179	179	(III) INSTRUCTIONS ON PROPE R STORAGE , HANDLING, 23
180	180	ADMINISTRATION , AND DISPOSAL OF THE COMPOUNDED DRUG ; 24
181	181	HOUSE BILL 1099 5
182	182
183	183
184	184	(IV) THE NAME , STRENGTH, AND QUANTITY OF THE 1
185	185	COMPOUNDED DRUG ; AND 2
186	186
187	187	(V) THE DATE THE DRUG WAS COMPOUNDED ; AND 3
188	188
189	189	(4) MAINTAIN PROPER STORA GE FOR COMPOUNDED DR UGS. 4
190	190
191	191	(D) AN OFFICE MANAGER OR VETERINARY ASSIST ANT, UNDER THE 5
192	192	SUPERVISION OF A VET ERINARY PRACTITIONER , MAY: 6
193	193
194	194	(1) MAINTAIN THE RECORDS REQUIRED UNDER SUBSE CTION (C) OF 7
195	195	THIS SECTION IN WRIT TEN OR ELECTRONIC FO RMAT; AND 8
196	196
197	197	(2) UPDATE THE POLICIES AND MAN UAL REQUIRED UNDER 9
198	198	SUBSECTION (C) OF THIS SECTION. 10
199	199
200	200	(E) A VETERINARY PRACTITIONER S HALL PROVIDE TRAINING FOR A 11
201	201	VETERINARY TECHNICIA N WHO IS COMPOUNDING DRUGS OR HANDLING 12
202	202	COMPOUNDED DRUGS UNDER THE SUPERVISIO N OF THE VETERINARY 13
203	203	PRACTITIONER . 14
204	204
205	205	(F) A VETERINARY CLINIC OR HOSPITAL THAT COMPOUNDS DRUGS ON–SITE 15
206	206	SHALL: 16
207	207
208	208	(1) CREATE A QUALITY ASSU RANCE PROGRAM THAT D OCUMENTS 17
209	209	AND ASSESSES MEDICAT ION ERRORS; 18
210	210
211	211	(2) DOCUMENT ANY CAUSES , REACTIONS, AND TREATMENTS 19
212	212	RESULTING FROM MEDIC ATION ERRORS ; 20
213	213
214	214	(3) CONTACT A CLIENT AS SOON AS POSSIBLE TO NOTIFY THE M OF 21
215	215	ANY ERRORS AND THE STEPS REQUIR ED TO FIX THE ERROR AND TO AVOID INJURY 22
216	216	OR ILLNESS; AND 23
217	217
218	218	(4) BE SUBJECT TO QUESTIO NS AND REVIEW FROM T HE BOARD AND 24
219	219	THE STATE BOARD OF PHARMACY. 25
220	220
221	221	(G) A VETERINARY PRACTITIO NER OR VETERINARY TECHNICIAN MAY NOT 26
222	222	COMPOUND A DRUG IF T HE COMPLEXITY OF COM POUNDING THE DRUG IS BEYOND 27
223	223	THE VETERINARY PRACT ITIONER’S OR VETERINARY TECHNI CIAN’S KNOWLEDGE , 28
224	224	SKILL, EXPERTISE, OR AVAILABLE FACILIT IES OR EQUIPMENT . 29
225	225	6 HOUSE BILL 1099
226	226
227	227
228	228	(H) A VETERINARY PRACTITIO NER MAY PURCHASE COMPOUN DED DRUGS 1
229	229	FOR OFFICE USE IF TH E DRUGS WERE COMPOUN DED AT A LICENSED PH ARMACY IN 2
230	230	THE STATE OR AT AN OUTSOU RCING FACILITY. 3
231	231
232	232	(I) A VETERINARY PRACTITIO NER MAY STORE COMPOU NDED DRUGS FOR 4
233	233	IN–OFFICE OR HOSPITAL USE: 5
234	234
235	235	(1) IF COMPOUNDED AT A LICENSED PHARMACY IN THE STATE OR AT 6
236	236	AN OUTSOURCING FACIL ITY, FOR A PERIOD OF 21 DAYS; AND 7
237	237
238	238	(2) IF COMPOUNDED IN THE VETERINARY PRACTITIO NER’S OFFICE 8
239	239	OR HOSPITAL, FOR A PERIOD OF 14 DAYS. 9
240	240
241	241	(J) A VETERINARY PRACTITIO NER MAY DISPENSE COM POUNDED DRUGS 10
242	242	IN–OFFICE: 11
243	243
244	244	(1) FOR IMMEDIATE MEDICAL NEED; 12
245	245
246	246	(2) WHEN THERE ARE LIMITE D OR NO RETAIL OPTIO NS AVAILABLE 13
247	247	TO THE PATIENT; AND 14
248	248
249	249	(3) WHEN THERE IS A POTEN TIAL RISK OF HARM TO THE PATIENT IF 15
250	250	THE COMPOUNDED DRUGS ARE NOT DISPENSED . 16
251	251
252	252	(K) THE BOARD SHALL EST ABLISH STANDARDS AND GUIDELINES FOR 17
253	253	VETERINARY PRACTITIO NERS AND VETERINARY TECHNICIANS TO ENSURE THE 18
254	254	SAFETY OF COMPOUNDED DRUGS. 19
255	255
256	256	SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 20
257	257	October 1, 2024. 21