| 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 | *hb0260* | |
| 9 | 6 | ||
| 10 | 7 | HOUSE BILL 260 | |
| 11 | 8 | J2 2lr0069 | |
| 12 | - | CF | |
| 9 | + | CF 2lr1750 | |
| 13 | 10 | By: Delegate Carr | |
| 14 | 11 | Introduced and read first time: January 13, 2022 | |
| 15 | 12 | Assigned to: Health and Government Operations | |
| 16 | - | Committee Report: Favorable with amendments | |
| 17 | - | House action: Adopted | |
| 18 | - | Read second time: February 25, 2022 | |
| 19 | 13 | ||
| 20 | - | ||
| 14 | + | A BILL ENTITLED | |
| 21 | 15 | ||
| 22 | 16 | AN ACT concerning 1 | |
| 23 | 17 | ||
| 24 | 18 | State Board of Physicians – Dispensing Permits 2 | |
| 25 | 19 | ||
| 26 | 20 | FOR the purpose of transferring oversight of the inspection of the offices of dispensing 3 | |
| 27 | 21 | physicians from the Office of Controlled Substances Administration to the State 4 | |
| 28 | 22 | Board of Physicians; altering the circumstances under which a physician may 5 | |
| 29 | - | dispense drugs or devices; requiring that certain appropriations be transferred to the 6 | |
| 30 | - | Board on a certain date; providing for the transfer of certain functions, powers, 7 | |
| 31 | - | duties, property, records, fixtures, credits, assets, liability, obligations, rights, and 8 | |
| 32 | - | privileges; requiring that certain employees of the Office be transferred to the Board 9 | |
| 33 | - | without diminution of their rights, benefits, employment, or retirement status; 10 | |
| 34 | - | requiring that certain positions at the Office be transferred to the Board; providing 11 | |
| 35 | - | for the continuity of certain transactions affected by or flowing from this Act; 12 | |
| 36 | - | providing for the continuity of certain laws, regulations, standards and guidelines, 13 | |
| 37 | - | policies, orders and other directives, forms, plans, membership, contracts, property, 14 | |
| 38 | - | investigations, administrative and judicial responsibilities, rights, and other duties 15 | |
| 39 | - | and responsibilities; and generally relating to the dispensing of drugs or devices by 16 | |
| 40 | - | licensed physicians. 17 | |
| 23 | + | dispense drugs or devices; and generally relating to the dispensing of drugs or 6 | |
| 24 | + | devices by licensed physicians. 7 | |
| 41 | 25 | ||
| 42 | - | BY repealing and reenacting, with amendments, 18 | |
| 43 | - | Article – Health Occupations 19 | |
| 44 | - | Section 12–102(a) and (c), 12–102.1, 12–102.2, and 14–509 20 | |
| 45 | - | Annotated Code of Maryland 21 | |
| 46 | - | (2021 Replacement Volume) 22 | |
| 47 | - | 2 HOUSE BILL 260 | |
| 26 | + | BY repealing and reenacting, with amendments, 8 | |
| 27 | + | Article – Health Occupations 9 | |
| 28 | + | Section 12–102(a) and (c), 12–102.1, 12–102.2, and 14–509 10 | |
| 29 | + | Annotated Code of Maryland 11 | |
| 30 | + | (2021 Replacement Volume) 12 | |
| 48 | 31 | ||
| 32 | + | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 13 | |
| 33 | + | That the Laws of Maryland read as follows: 14 | |
| 49 | 34 | ||
| 50 | - | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1 | |
| 51 | - | That the Laws of Maryland read as follows: 2 | |
| 35 | + | Article – Health Occupations 15 | |
| 52 | 36 | ||
| 53 | - | ||
| 37 | + | 12–102. 16 | |
| 54 | 38 | ||
| 55 | - | 12–102. 4 | |
| 39 | + | (a) (1) In this section the following [terms] WORDS have the meanings 17 | |
| 40 | + | indicated. 18 | |
| 56 | 41 | ||
| 57 | - | (a) (1) In this section the following [terms] WORDS have the meanings 5 | |
| 58 | - | indicated. 6 | |
| 42 | + | (2) “In the public interest” means the dispensing of drugs or devices by a 19 | |
| 43 | + | licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 20 | |
| 44 | + | available to the patient. 21 | |
| 59 | 45 | ||
| 60 | - | (2) “In the public interest” means the dispensing of drugs or devices by a 7 | |
| 61 | - | licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 8 | |
| 62 | - | available to the patient. 9 | |
| 63 | - | ||
| 64 | - | (3) “Personally preparing and dispensing” means that the licensed 10 | |
| 65 | - | dentist[, physician,] or podiatrist: 11 | |
| 66 | - | ||
| 67 | - | (i) Is physically present on the premises where the prescription is 12 | |
| 68 | - | filled; and 13 | |
| 69 | - | ||
| 70 | - | (ii) Performs a final check of the prescription before it is provided to 14 | |
| 71 | - | the patient. 15 | |
| 72 | - | ||
| 73 | - | (c) (1) This subsection does not apply to a licensed dentist who obtains a 16 | |
| 74 | - | permit from the State Board of Dental Examiners under subsection (h) of this section. 17 | |
| 75 | - | ||
| 76 | - | (2) This title does not prohibit: 18 | |
| 77 | - | ||
| 78 | - | (i) A licensed veterinarian from: 19 | |
| 79 | - | ||
| 80 | - | 1. Personally preparing and dispensing the veterinarian’s 20 | |
| 81 | - | prescriptions; or 21 | |
| 82 | - | ||
| 83 | - | 2. Dispensing, in accordance with § 2 –313(c) of the 22 | |
| 84 | - | Agriculture Article, compounded nonsterile preparations or compounded sterile 23 | |
| 85 | - | preparations provided by a pharmacy; 24 | |
| 86 | - | ||
| 87 | - | (II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 25 | |
| 88 | - | AND DISPENSING PRESC RIPTIONS IF THE PHYS ICIAN HAS OBTAINED A PERMIT 26 | |
| 89 | - | UNDER § 14–509 OF THIS ARTICLE; 27 | |
| 90 | - | ||
| 91 | - | [(ii)] (III) A licensed dentist[, physician,] or podiatrist from 28 | |
| 92 | - | personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 29 | |
| 93 | - | prescriptions when: 30 | |
| 94 | - | ||
| 95 | - | 1. The dentist[, physician,] or podiatrist: 31 HOUSE BILL 260 3 | |
| 46 | + | (3) “Personally preparing and dispensing” means that the licensed 22 | |
| 47 | + | dentist[, physician,] or podiatrist: 23 2 HOUSE BILL 260 | |
| 96 | 48 | ||
| 97 | 49 | ||
| 98 | 50 | ||
| 99 | - | | |
| 100 | - | ||
| 51 | + | (i) Is physically present on the premises where the prescription is 1 | |
| 52 | + | filled; and 2 | |
| 101 | 53 | ||
| 102 | - | B. Has demonstrated to the satisfaction of that board that the 3 | |
| 103 | - | dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 4 | |
| 104 | - | the public interest; 5 | |
| 54 | + | (ii) Performs a final check of the prescription before it is provided to 3 | |
| 55 | + | the patient. 4 | |
| 105 | 56 | ||
| 106 | - | C. Has received a written permit from that board to dispense 6 | |
| 107 | - | prescription drugs or devices except that a written permit is not required in order to 7 | |
| 108 | - | dispense starter dosages or samples without charge; and 8 | |
| 57 | + | (c) (1) This subsection does not apply to a licensed dentist who obtains a 5 | |
| 58 | + | permit from the State Board of Dental Examiners under subsection (h) of this section. 6 | |
| 109 | 59 | ||
| 110 | - | D. Posts a sign conspicuously positioned and readable 9 | |
| 111 | - | regarding the process for resolving incorrectly filled prescriptions or includes written 10 | |
| 112 | - | information regarding the process with each prescription dispensed; 11 | |
| 60 | + | (2) This title does not prohibit: 7 | |
| 113 | 61 | ||
| 114 | - | 2. The person for whom the drugs or devices are prescribed 12 | |
| 115 | - | is a patient of the prescribing dentist[, physician,] or podiatrist; 13 | |
| 62 | + | (i) A licensed veterinarian from: 8 | |
| 116 | 63 | ||
| 117 | - | | |
| 118 | - | ||
| 64 | + | 1. Personally preparing and dispensing the veterinarian’s 9 | |
| 65 | + | prescriptions; or 10 | |
| 119 | 66 | ||
| 120 | - | 4. The dentist[, physician,] or podiatrist: 16 | |
| 67 | + | 2. Dispensing, in accordance with § 2–313(c) of the 11 | |
| 68 | + | Agriculture Article, compounded nonsterile preparations or compounded sterile 12 | |
| 69 | + | preparations provided by a pharmacy; 13 | |
| 121 | 70 | ||
| 122 | - | A. Complies with the dispensing and labeling requirements 17 | |
| 123 | - | of this title; 18 | |
| 71 | + | (II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 14 | |
| 72 | + | AND DISPENSING PRESC RIPTIONS IF THE PHYSICIAN HAS OB TAINED A PERMIT 15 | |
| 73 | + | UNDER § 14–509 OF THIS ARTICLE; 16 | |
| 124 | 74 | ||
| 125 | - | B. Records the dispensing of the prescription drug or device 19 | |
| 126 | - | on the patient’s chart; 20 | |
| 75 | + | [(ii)] (III) A licensed dentist[, physician,] or podiatrist from 17 | |
| 76 | + | personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 18 | |
| 77 | + | prescriptions when: 19 | |
| 127 | 78 | ||
| 128 | - | C. Allows the Office of Controlled Substances Administration 21 | |
| 129 | - | to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 22 | |
| 130 | - | and in accordance with § 12–102.1 of this subtitle; 23 | |
| 79 | + | 1. The dentist[, physician,] or podiatrist: 20 | |
| 131 | 80 | ||
| 132 | - | D. On inspection by the Office of Controlled Substances 24 | |
| 133 | - | Administration, signs and dates an acknowledgment form provided by the Office of 25 | |
| 134 | - | Controlled Substances Administration relating to the requirements of this section; 26 | |
| 81 | + | A. Has applied to the board of licensure in this State which 21 | |
| 82 | + | licensed the dentist[, physician,] or podiatrist; 22 | |
| 135 | 83 | ||
| 136 | - | | |
| 137 | - | ||
| 138 | - | ||
| 84 | + | B. Has demonstrated to the satisfaction of that board that the 23 | |
| 85 | + | dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 24 | |
| 86 | + | the public interest; 25 | |
| 139 | 87 | ||
| 140 | - | F. Does not direct patients to a single pharmacist or 30 | |
| 141 | - | pharmacy in accordance with § 12–403(c)(8) of this title; 31 | |
| 88 | + | C. Has received a written permit from that board to dispense 26 | |
| 89 | + | prescription drugs or devices except that a written permit is not required in order to 27 | |
| 90 | + | dispense starter dosages or samples without charge; and 28 | |
| 91 | + | ||
| 92 | + | D. Posts a sign conspicuously positioned and readable 29 | |
| 93 | + | regarding the process for resolving incorrectly filled prescriptions or includes written 30 | |
| 94 | + | information regarding the process with each prescription dispensed; 31 | |
| 95 | + | HOUSE BILL 260 3 | |
| 96 | + | ||
| 97 | + | ||
| 98 | + | 2. The person for whom the drugs or devices are prescribed 1 | |
| 99 | + | is a patient of the prescribing dentist[, physician,] or podiatrist; 2 | |
| 100 | + | ||
| 101 | + | 3. The dentist[, physician,] or podiatrist does not have a 3 | |
| 102 | + | substantial financial interest in a pharmacy; and 4 | |
| 103 | + | ||
| 104 | + | 4. The dentist[, physician,] or podiatrist: 5 | |
| 105 | + | ||
| 106 | + | A. Complies with the dispensing and labeling requirements 6 | |
| 107 | + | of this title; 7 | |
| 108 | + | ||
| 109 | + | B. Records the dispensing of the prescription drug or device 8 | |
| 110 | + | on the patient’s chart; 9 | |
| 111 | + | ||
| 112 | + | C. Allows the Office of Controlled Substances Administration 10 | |
| 113 | + | to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 11 | |
| 114 | + | and in accordance with § 12–102.1 of this subtitle; 12 | |
| 115 | + | ||
| 116 | + | D. On inspection by the Office of Controlled Substances 13 | |
| 117 | + | Administration, signs and dates an acknowledgment form provided by the Office of 14 | |
| 118 | + | Controlled Substances Administration relating to the requirements of this section; 15 | |
| 119 | + | ||
| 120 | + | E. Except for starter dosages or samples without charge, 16 | |
| 121 | + | provides the patient with a written prescription, maintains prescription files in accordance 17 | |
| 122 | + | with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions; 18 | |
| 123 | + | ||
| 124 | + | F. Does not direct patients to a single pharmacist or 19 | |
| 125 | + | pharmacy in accordance with § 12–403(c)(8) of this title; 20 | |
| 126 | + | ||
| 127 | + | G. Does not receive remuneration for referring patients to a 21 | |
| 128 | + | pharmacist or pharmacy; 22 | |
| 129 | + | ||
| 130 | + | H. Complies with the child resistant packaging requirements 23 | |
| 131 | + | regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; 24 | |
| 132 | + | ||
| 133 | + | I. Complies with drug recalls; 25 | |
| 134 | + | ||
| 135 | + | J. Maintains biennial inventories and complies with any 26 | |
| 136 | + | other federal and State record–keeping requirements relating to controlled dangerous 27 | |
| 137 | + | substances; 28 | |
| 138 | + | ||
| 139 | + | K. Purchases prescription drugs from a pharmacy or 29 | |
| 140 | + | wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 30 | |
| 141 | + | the Board of Pharmacy; 31 | |
| 142 | 142 | 4 HOUSE BILL 260 | |
| 143 | 143 | ||
| 144 | 144 | ||
| 145 | - | G. Does not receive remuneration for referring patients to a 1 | |
| 146 | - | pharmacist or pharmacy; 2 | |
| 145 | + | L. Annually reports to the respective board of licensure 1 | |
| 146 | + | whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 2 | |
| 147 | + | prescription drugs within the previous year; and 3 | |
| 147 | 148 | ||
| 148 | - | H. Complies with the child resistant packaging requirements 3 | |
| 149 | - | regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; 4 | |
| 149 | + | M. Completes ten continuing education credits over a 5–year 4 | |
| 150 | + | period relating to the preparing and dispensing of prescription drugs, offered by the 5 | |
| 151 | + | Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 6 | |
| 152 | + | consultation with each respective board of licensure, as a condition of permit renewal; OR 7 | |
| 150 | 153 | ||
| 151 | - | I. Complies with drug recalls; 5 | |
| 154 | + | [(iii) A licensed physician from dispensing a topical medication 8 | |
| 155 | + | without obtaining the permit required under item (ii)1C of this paragraph or completing 9 | |
| 156 | + | the continuing education required under item (ii)4M of this paragraph when the physician: 10 | |
| 152 | 157 | ||
| 153 | - | J. Maintains biennial inventories and complies with any 6 | |
| 154 | - | other federal and State record–keeping requirements relating to controlled dangerous 7 | |
| 155 | - | substances; 8 | |
| 158 | + | 1. Otherwise complies with item (ii) of this paragraph; and 11 | |
| 156 | 159 | ||
| 157 | - | K. Purchases prescription drugs from a pharmacy or 9 | |
| 158 | - | wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 10 | |
| 159 | - | the Board of Pharmacy; 11 | |
| 160 | + | 2. Has obtained a special written permit under § 14–509 of 12 | |
| 161 | + | this article; 13 | |
| 160 | 162 | ||
| 161 | - | L. Annually reports to the respective board of licensure 12 | |
| 162 | - | whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 13 | |
| 163 | - | prescription drugs within the previous year; and 14 | |
| 163 | + | (iv) A licensed physician who complies with the requirements of item 14 | |
| 164 | + | (ii) of this paragraph from personally preparing and dispensing a prescription written by: 15 | |
| 164 | 165 | ||
| 165 | - | M. Completes ten continuing education credits over a 5–year 15 | |
| 166 | - | period relating to the preparing and dispensing of prescription drugs, offered by the 16 | |
| 167 | - | Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 17 | |
| 168 | - | consultation with each respective board of licensure, as a condition of permit renewal; OR 18 | |
| 166 | + | 1. A physician assistant in accordance with a delegation 16 | |
| 167 | + | agreement that complies with Title 15, Subtitle 3 of this article; or 17 | |
| 169 | 168 | ||
| 170 | - | | |
| 171 | - | ||
| 172 | - | ||
| 169 | + | 2. A nurse practitioner who is authorized to practice under 18 | |
| 170 | + | Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 19 | |
| 171 | + | or] 20 | |
| 173 | 172 | ||
| 174 | - | 1. Otherwise complies with item (ii) of this paragraph; and 22 | |
| 173 | + | [(v)] (IV) A hospital–based clinic from dispensing prescriptions to 21 | |
| 174 | + | its patients. 22 | |
| 175 | 175 | ||
| 176 | - | 2. Has obtained a special written permit under § 14–509 of 23 | |
| 177 | - | this article; 24 | |
| 176 | + | 12–102.1. 23 | |
| 178 | 177 | ||
| 179 | - | (iv) A licensed physician who complies with the requirements of item 25 | |
| 180 | - | (ii) of this paragraph from personally preparing and dispensing a prescription written by: 26 | |
| 178 | + | (a) This section does not apply to [a]: 24 | |
| 181 | 179 | ||
| 182 | - | 1 | |
| 183 | - | ||
| 180 | + | (1) A licensed dentist who obtains a permit from the State Board of Dental 25 | |
| 181 | + | Examiners under § 12–102(h) of this subtitle; OR 26 | |
| 184 | 182 | ||
| 185 | - | 2. A nurse practitioner who is authorized to practice under 29 | |
| 186 | - | Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 30 | |
| 187 | - | or] 31 | |
| 183 | + | (2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 27 | |
| 184 | + | STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 28 | |
| 188 | 185 | ||
| 189 | - | [(v)] (IV) A hospital–based clinic from dispensing prescriptions to 32 | |
| 190 | - | its patients. 33 | |
| 186 | + | (b) The Office of Controlled Substances Administration shall enter and inspect 29 | |
| 187 | + | the office of a dentist[, physician,] or podiatrist who holds: 30 | |
| 188 | + | ||
| 189 | + | (1) An initial dispensing permit: 31 | |
| 191 | 190 | HOUSE BILL 260 5 | |
| 192 | 191 | ||
| 193 | 192 | ||
| 194 | - | 12–102.1. 1 | |
| 193 | + | (i) Within 6 months after receiving the report required under § 1 | |
| 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 | - | ||
| 199 | - | ||
| 198 | + | (2) A renewed dispensing permit at least two times during the duration of 4 | |
| 199 | + | the permit. 5 | |
| 200 | 200 | ||
| 201 | - | (2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 5 | |
| 202 | - | STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 6 | |
| 201 | + | (c) The Office of Controlled Substances Administration promptly shall report the 6 | |
| 202 | + | results of the inspections required under subsection (b) of this section to the respective 7 | |
| 203 | + | board of licensure. 8 | |
| 203 | 204 | ||
| 204 | - | (b) The Office of Controlled Substances Administration shall enter and inspect 7 | |
| 205 | - | the office of a dentist[, physician,] or podiatrist who holds: 8 | |
| 205 | + | 12–102.2. 9 | |
| 206 | 206 | ||
| 207 | - | ( | |
| 207 | + | (a) This section does not apply to [a]: 10 | |
| 208 | 208 | ||
| 209 | - | ( | |
| 210 | - | 12–102( | |
| 209 | + | (1) A licensed dentist who obtains a permit from the State Board of Dental 11 | |
| 210 | + | Examiners under § 12–102(h) of this subtitle; OR 12 | |
| 211 | 211 | ||
| 212 | - | (ii) At least one more time during the duration of the permit; and 12 | |
| 212 | + | (2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 13 | |
| 213 | + | STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 14 | |
| 213 | 214 | ||
| 214 | - | (2) A renewed dispensing permit at least two times during the duration of 13 | |
| 215 | - | the permit. 14 | |
| 215 | + | (b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 15 | |
| 216 | + | Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 16 | |
| 217 | + | holds a dispensing permit in an amount that will produce funds to approximate but not 17 | |
| 218 | + | exceed the documented costs to the Office of Controlled Substances Administration for 18 | |
| 219 | + | inspection of dispensing permit holders. 19 | |
| 216 | 220 | ||
| 217 | - | (c) The | |
| 218 | - | ||
| 219 | - | ||
| 221 | + | (c) Revenues collected by the Board of Dental Examiners [, the Board of 20 | |
| 222 | + | Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 21 | |
| 223 | + | into the General Fund of the State. 22 | |
| 220 | 224 | ||
| 221 | - | ||
| 225 | + | 14–509. 23 | |
| 222 | 226 | ||
| 223 | - | (a) This section does not apply to [a]: 19 | |
| 227 | + | (a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 24 | |
| 228 | + | INDICATED. 25 | |
| 224 | 229 | ||
| 225 | - | ||
| 226 | - | ||
| 230 | + | (2) “ACCME” means the Accrediting Council for Continuing Medical 26 | |
| 231 | + | Education. 27 | |
| 227 | 232 | ||
| 228 | - | (2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 22 | |
| 229 | - | STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 23 | |
| 233 | + | (3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 28 | |
| 234 | + | SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 29 | |
| 235 | + | OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 30 | |
| 236 | + | 6 HOUSE BILL 260 | |
| 230 | 237 | ||
| 231 | - | (b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 24 | |
| 232 | - | Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 25 | |
| 233 | - | holds a dispensing permit in an amount that will produce funds to approximate but not 26 | |
| 234 | - | exceed the documented costs to the Office of Controlled Substances Administration for 27 | |
| 235 | - | inspection of dispensing permit holders. 28 | |
| 236 | 238 | ||
| 237 | - | (c) Revenues collected by the Board of Dental Examiners [, the Board of 29 | |
| 238 | - | Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 30 | |
| 239 | - | into the General Fund of the State. 31 6 HOUSE BILL 260 | |
| 239 | + | (4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 1 | |
| 240 | + | BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 2 | |
| 241 | + | OR DEVICES TO A PATI ENT. 3 | |
| 242 | + | ||
| 243 | + | (5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 4 | |
| 244 | + | OR DEVICES BY A LICE NSED PHYSICIAN TO A PATIENT WHEN A PHARM ACY IS NOT 5 | |
| 245 | + | CONVENIENTLY AVAILAB LE TO THE PATIENT. 6 | |
| 246 | + | ||
| 247 | + | (6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 7 | |
| 248 | + | LICENSED PHYSICIAN : 8 | |
| 249 | + | ||
| 250 | + | (I) IS PHYSICALLY PRESENT ON THE PREMISES WHER E THE 9 | |
| 251 | + | PRESCRIPTION IS FILL ED; AND 10 | |
| 252 | + | ||
| 253 | + | (II) PERFORMS A FINAL CHEC K OF THE PRESCRIPTIO N BEFORE 11 | |
| 254 | + | IT IS PROVIDED TO TH E PATIENT. 12 | |
| 255 | + | ||
| 256 | + | (7) “SAMPLE UNIT ” HAS THE MEANING STAT ED IN 21 C.F.R. § 13 | |
| 257 | + | 203.3(AA). 14 | |
| 258 | + | ||
| 259 | + | (8) “STARTER DOSAGE ” MEANS AN AMOUNT OF D RUG OR DEVICE 15 | |
| 260 | + | SUFFICIENT TO BEGIN THERAPY: 16 | |
| 261 | + | ||
| 262 | + | (I) FOR A SHORT DURATION OF 72 HOURS OR LESS ; OR 17 | |
| 263 | + | ||
| 264 | + | (II) PRIOR TO OBTAINING A LARGER QUANTITY OF T HE DRUG 18 | |
| 265 | + | OR DEVICE TO COMPLET E THE THERAPY . 19 | |
| 266 | + | ||
| 267 | + | (9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERM IT 20 | |
| 268 | + | ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DISPENSE TOPICAL 21 | |
| 269 | + | MEDICATIONS THAT ARE APPROVED BY THE FEDERAL FOOD AND DRUG 22 | |
| 270 | + | ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 23 | |
| 271 | + | ||
| 272 | + | (b) [A physician may dispense a topical medication that is approved by the federal 24 | |
| 273 | + | Food and Drug Administration for the treatment of hypotrichosis without obtaining a 25 | |
| 274 | + | dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 26 | |
| 275 | + | of this article if the physician: 27 | |
| 276 | + | ||
| 277 | + | (1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 28 | |
| 278 | + | article; and 29 | |
| 279 | + | ||
| 280 | + | (2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 30 | |
| 281 | + | ||
| 282 | + | (1) (I) Has received a [special class of written] TOPICAL MEDICATION 31 | |
| 283 | + | permit from the Board[.]; 32 HOUSE BILL 260 7 | |
| 240 | 284 | ||
| 241 | 285 | ||
| 242 | 286 | ||
| 243 | - | 14–509. 1 | |
| 287 | + | [(c) The Board may issue a special class of written permit to a physician under 1 | |
| 288 | + | subsection (b) of this section if the physician: 2 | |
| 244 | 289 | ||
| 245 | - | (a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 2 | |
| 246 | - | INDICATED. 3 | |
| 290 | + | (1)] (II) DISPENSES ONLY A TOPICAL MEDICATION THAT IS 3 | |
| 291 | + | APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 4 | |
| 292 | + | TREATMENT OF HYPOTRICHOSIS ; 5 | |
| 247 | 293 | ||
| 248 | - | (2) “ACCME” means the Accrediting Council for Continuing Medical 4 | |
| 249 | - | Education. 5 | |
| 294 | + | (III) Completes 1 hour of continuing medical education per year on 6 | |
| 295 | + | the dispensing of topical medications developed by an ACCME–accredited Maryland 7 | |
| 296 | + | nonprofit or governmental entity; and 8 | |
| 250 | 297 | ||
| 251 | - | (3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 6 | |
| 252 | - | SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 7 | |
| 253 | - | OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 8 | |
| 298 | + | [(2)] (IV) Pays to the Board a $100 permit fee[.]; 9 | |
| 254 | 299 | ||
| 255 | - | (4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 9 | |
| 256 | - | BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 10 | |
| 257 | - | OR DEVICES TO A PATI ENT. 11 | |
| 300 | + | (2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 10 | |
| 301 | + | PATIENT IF: 11 | |
| 258 | 302 | ||
| 259 | - | (5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 12 | |
| 260 | - | OR DEVICES BY A LICE NSED PHYSICIAN TO A PATIENT WHEN A PHARM ACY IS NOT 13 | |
| 261 | - | CONVENIENTLY AVAILAB LE TO THE PATIENT . 14 | |
| 303 | + | (I) THE SAMPLE COMPLIES W ITH THE LABELING 12 | |
| 304 | + | REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 13 | |
| 262 | 305 | ||
| 263 | - | (6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 15 | |
| 264 | - | LICENSED PHYSICIAN : 16 | |
| 306 | + | (II) NO CHARGE IS MADE FOR THE SAMPLE; AND 14 | |
| 265 | 307 | ||
| 266 | - | ( | |
| 267 | - | ||
| 308 | + | (III) THE AUTHORIZED PRESCR IBER ENTERS AN APPROPRIATE 15 | |
| 309 | + | RECORD IN THE PATIEN T’S CHART; 16 | |
| 268 | 310 | ||
| 269 | - | ( | |
| 270 | - | ||
| 311 | + | (3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 17 | |
| 312 | + | OF TREATING A PATIEN T; 18 | |
| 271 | 313 | ||
| 272 | - | ( | |
| 273 | - | ||
| 314 | + | (4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 19 | |
| 315 | + | DRUG OR DEVICE TO A PATIENT IF: 20 | |
| 274 | 316 | ||
| 275 | - | ( | |
| 276 | - | ||
| 317 | + | (I) THE STARTER DOSAGE CO MPLIES WITH THE LABELIN G 21 | |
| 318 | + | REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 22 | |
| 277 | 319 | ||
| 278 | - | ( | |
| 320 | + | (II) NO CHARGE IS MADE FOR THE STARTER DOSAGE ; AND 23 | |
| 279 | 321 | ||
| 280 | - | ( | |
| 281 | - | ||
| 322 | + | (III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 24 | |
| 323 | + | RECORD ON THE PATIEN T’S CHART; OR 25 | |
| 282 | 324 | ||
| 283 | - | (9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERMIT 28 | |
| 284 | - | ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DISPENSE TOPICAL 29 | |
| 285 | - | MEDICATIONS THAT ARE APPROVED BY THE FEDE RAL FOOD AND DRUG 30 | |
| 286 | - | ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 31 HOUSE BILL 260 7 | |
| 325 | + | (5) DISPENSES A PRESCRIPT ION DRUG OR DEVICE IN THE COURSE OF 26 | |
| 326 | + | TREATING A PATIENT AT: 27 | |
| 327 | + | ||
| 328 | + | (I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 28 | |
| 329 | + | NONPROFIT BASIS ; 29 | |
| 330 | + | 8 HOUSE BILL 260 | |
| 331 | + | ||
| 332 | + | ||
| 333 | + | (II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 1 | |
| 334 | + | INSTITUTION OF HIGHE R EDUCATION; OR 2 | |
| 335 | + | ||
| 336 | + | (III) A PUBLIC HEALTH FACILI TY, A MEDICAL FACILITY U NDER 3 | |
| 337 | + | CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 4 | |
| 338 | + | WITH PUBLIC FUNDS . 5 | |
| 339 | + | ||
| 340 | + | (C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 6 | |
| 341 | + | PRESCRIPTIONS ONLY IF: 7 | |
| 342 | + | ||
| 343 | + | (1) THE PHYSICIAN: 8 | |
| 344 | + | ||
| 345 | + | (I) HAS AN ACTIVE LICENSE IN GOOD STANDING ; 9 | |
| 346 | + | ||
| 347 | + | (II) HAS APPLIED TO THE BOARD FOR A DISPENSING PER MIT; 10 | |
| 348 | + | ||
| 349 | + | (III) HAS PAID A FEE DETERMINE D BY THE BOARD TO PRODUCE 11 | |
| 350 | + | FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 12 | |
| 351 | + | BOARD FOR CONDUCTING INSPECTIONS OF DISPE NSING PERMIT HOLDERS ; 13 | |
| 352 | + | ||
| 353 | + | (IV) HAS DEMONSTRATED TO THE SATISFACTION OF THE BOARD 14 | |
| 354 | + | THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 15 | |
| 355 | + | IN THE PUBLIC INTERE ST; 16 | |
| 356 | + | ||
| 357 | + | (V) HAS RECEIVED A DISPENSING PERMIT FROM THE BOARD; 17 | |
| 358 | + | AND 18 | |
| 359 | + | ||
| 360 | + | (VI) HAS A SIGN CONSPICUOUSLY POSITIONED AND READA BLE 19 | |
| 361 | + | REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PRESC RIPTIONS 20 | |
| 362 | + | OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 21 | |
| 363 | + | PRESCRIPTION DISPENS ED; 22 | |
| 364 | + | ||
| 365 | + | (2) THE INDIVIDUAL FOR WHOM THE DRUG OR DEVICE IS23 | |
| 366 | + | PRESCRIBED IS A PATI ENT OF: 24 | |
| 367 | + | ||
| 368 | + | (I) THE PRESCRIBING PHYSICIA N; 25 | |
| 369 | + | ||
| 370 | + | (II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 26 | |
| 371 | + | DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 27 | |
| 372 | + | ARTICLE; OR 28 | |
| 373 | + | ||
| 374 | + | (III) A NURSE PRACTITIONER W HO IS AUTHORIZED TO PRACTICE 29 | |
| 375 | + | UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 30 | |
| 376 | + | PHYSICIAN IN THE SAM E OFFICE SETTING ; 31 HOUSE BILL 260 9 | |
| 287 | 377 | ||
| 288 | 378 | ||
| 289 | 379 | ||
| 290 | - | (b) [A physician may dispense a topical medication that is approved by the federal 1 | |
| 291 | - | Food and Drug Administration for the treatment of hypotrichosis without obtaining a 2 | |
| 292 | - | dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 3 | |
| 293 | - | of this article if the physician: 4 | |
| 380 | + | (3) THE PHYSICIAN DOES NOT H AVE A SUBSTANTIAL FI NANCIAL 1 | |
| 381 | + | INTEREST IN A PHARMA CY; AND 2 | |
| 294 | 382 | ||
| 295 | - | (1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 5 | |
| 296 | - | article; and 6 | |
| 383 | + | (4) THE PHYSICIAN: 3 | |
| 297 | 384 | ||
| 298 | - | (2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 7 | |
| 385 | + | (I) COMPLIES WITH THE DISPENSING AND LABELING 4 | |
| 386 | + | REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE, AND THE BOARD’S 5 | |
| 387 | + | REGULATIONS ; 6 | |
| 299 | 388 | ||
| 300 | - | ( | |
| 301 | - | ||
| 389 | + | (II) RECORDS THE DISPENSING OF TH E PRESCRIPTION DRUG 7 | |
| 390 | + | OR DEVICE ON THE PAT IENT’S CHART; 8 | |
| 302 | 391 | ||
| 303 | - | [(c) The Board may issue a special class of written permit to a physician under 10 | |
| 304 | - | subsection (b) of this section if the physician: 11 | |
| 392 | + | (III) PROVIDES THE PATIENT WITH A W RITTEN PRESCRIPTION , 9 | |
| 393 | + | MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 10 | |
| 394 | + | ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 11 | |
| 305 | 395 | ||
| 306 | - | (1)] (II) DISPENSES ONLY A TOPI CAL MEDICATION THAT IS 12 | |
| 307 | - | APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 13 | |
| 308 | - | TREATMENT OF HYPOTRI CHOSIS; 14 | |
| 396 | + | (IV) DOES NOT DIRECT PATIENTS TO A SINGLE PHARMACI ST OR 12 | |
| 397 | + | PHARMACY IN ACCORDANCE WITH § 12–403(C)(8) OF THIS ARTICLE; 13 | |
| 309 | 398 | ||
| 310 | - | (III) Completes 1 hour of continuing medical education per year on 15 | |
| 311 | - | the dispensing of topical medications developed by an ACCME–accredited Maryland 16 | |
| 312 | - | nonprofit or governmental entity; and 17 | |
| 399 | + | (V) DOES NOT RECEIVE REMUNERA TION FOR REFERRING 14 | |
| 400 | + | PATIENTS TO A PHARMA CIST OR PHARMACY ; 15 | |
| 313 | 401 | ||
| 314 | - | [(2)] (IV) Pays to the Board a $100 permit fee[.]; 18 | |
| 402 | + | (VI) COMPLIES WITH THE CHILD RESIS TANT PACKAGING 16 | |
| 403 | + | REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 17 | |
| 404 | + | OF THE HEALTH – GENERAL ARTICLE; 18 | |
| 315 | 405 | ||
| 316 | - | (2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 19 | |
| 317 | - | PATIENT IF: 20 | |
| 406 | + | (VII) COMPLIES WITH DRUG RECALLS ; 19 | |
| 318 | 407 | ||
| 319 | - | (I) THE SAMPLE COMPLIES W ITH THE LABELING 21 | |
| 320 | - | REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 22 | |
| 408 | + | (VIII) MAINTAINS BIENNIAL INVENTORIES AND COMPLIES WITH 20 | |
| 409 | + | ANY OTHER FEDERAL AN D STATE RECORD–KEEPING REQUIREMENTS RELATING TO 21 | |
| 410 | + | CONTROLLED DANGEROUS SUBSTANCES; 22 | |
| 321 | 411 | ||
| 322 | - | (II) NO CHARGE IS MADE FOR THE SAMPLE; AND 23 | |
| 412 | + | (IX) PURCHASES PRESCRIPTION DRUGS F ROM A PHARMACY OR 23 | |
| 413 | + | WHOLESALE DISTRIBUTO R THAT HOLDS A PERMIT ISSUE D BY THE STATE BOARD OF 24 | |
| 414 | + | PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 25 | |
| 323 | 415 | ||
| 324 | - | (III) THE AUTHORIZED PRESCR IBER ENTERS AN APPRO PRIATE 24 | |
| 325 | - | RECORD IN THE PATIEN T’S CHART; 25 | |
| 416 | + | (X) COMPLIES WITH CONTINUING EDUC ATION REQUIREMENTS 26 | |
| 417 | + | RELATING TO THE PREPARING AND DISPEN SING OF PRESCRIPTION DRUGS AS 27 | |
| 418 | + | PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 28 | |
| 326 | 419 | ||
| 327 | - | (3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 26 | |
| 328 | - | OF TREATING A PATIEN T; 27 | |
| 329 | - | ||
| 330 | - | (4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 28 | |
| 331 | - | DRUG OR DEVICE TO A PATIENT IF: 29 | |
| 332 | - | 8 HOUSE BILL 260 | |
| 420 | + | (D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS OF THIS 29 | |
| 421 | + | SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 30 | |
| 422 | + | SHALL: 31 10 HOUSE BILL 260 | |
| 333 | 423 | ||
| 334 | 424 | ||
| 335 | - | (I) THE STARTER DOSAGE CO MPLIES WITH THE LABE LING 1 | |
| 336 | - | REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 2 | |
| 337 | 425 | ||
| 338 | - | ( | |
| 426 | + | (1) HAVE THE DISPENSING PERMIT RE VOKED; AND 1 | |
| 339 | 427 | ||
| 340 | - | (III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 4 | |
| 341 | - | RECORD ON THE PATIEN T’S CHART; OR 5 | |
| 428 | + | (2) BE SUBJECT TO DISCIPLIN ARY ACTION BY THE BOARD. 2 | |
| 342 | 429 | ||
| 343 | - | (5) DISPENSES A PRESCRIPT ION DRUG OR DEVICE I N THE COURSE OF 6 | |
| 344 | - | TREATING A PATIENT A T: 7 | |
| 430 | + | (E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITIAL 3 | |
| 431 | + | DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 4 | |
| 432 | + | INSPECT THE OFFICE O F THE PHYSICIAN. 5 | |
| 345 | 433 | ||
| 346 | - | (I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 8 | |
| 347 | - | NONPROFIT BASIS ; 9 | |
| 434 | + | (II) IF THE BOARD RENEWS A DISPEN SING PERMIT TO A 6 | |
| 435 | + | LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 7 | |
| 436 | + | PHYSICIAN AT LEAST ONE TIME DU RING THE DURATION OF THE RENEWED PERMIT. 8 | |
| 348 | 437 | ||
| 349 | - | (II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 10 | |
| 350 | - | INSTITUTION OF HIGHE R EDUCATION; OR 11 | |
| 438 | + | (2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 9 | |
| 439 | + | SUBSTANCES ADMINISTRATION ANY VIOLATION RELATE D TO CONTROLLED 10 | |
| 440 | + | DANGEROUS SUBSTANCES FOUND DURING AN INSPECTION REQUIRED UNDER 11 | |
| 441 | + | PARAGRAPH (1) OF THIS SUBSECTION. 12 | |
| 351 | 442 | ||
| 352 | - | (III) A PUBLIC HEALTH FACILI TY, A MEDICAL FACILITY U NDER 12 | |
| 353 | - | CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 13 | |
| 354 | - | WITH PUBLIC FUNDS . 14 | |
| 355 | - | ||
| 356 | - | (C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 15 | |
| 357 | - | PRESCRIPTIONS ONLY I F: 16 | |
| 358 | - | ||
| 359 | - | (1) THE PHYSICIAN: 17 | |
| 360 | - | ||
| 361 | - | (I) HAS AN ACTIVE LICENSE IN GOOD STANDING ; 18 | |
| 362 | - | ||
| 363 | - | (II) HAS APPLIED TO THE BOARD FOR A DISPENSIN G PERMIT; 19 | |
| 364 | - | ||
| 365 | - | (III) HAS PAID A FEE DETERM INED BY THE BOARD TO PRODUCE 20 | |
| 366 | - | FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 21 | |
| 367 | - | BOARD FOR CONDUCTING INSPECTIONS OF DISPE NSING PERMIT HOLDERS ; 22 | |
| 368 | - | ||
| 369 | - | (IV) HAS DEMONSTRATED TO T HE SATISFACTION OF T HE BOARD 23 | |
| 370 | - | THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 24 | |
| 371 | - | IN THE PUBLIC INTERE ST; 25 | |
| 372 | - | ||
| 373 | - | (V) HAS RECEIVED A DISPEN SING PERMIT FROM THE BOARD; 26 | |
| 374 | - | AND 27 | |
| 375 | - | ||
| 376 | - | (VI) HAS A SIGN CONSPICUOU SLY POSITIONED AND R EADABLE 28 | |
| 377 | - | REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PRESCRIPTIONS 29 HOUSE BILL 260 9 | |
| 378 | - | ||
| 379 | - | ||
| 380 | - | OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 1 | |
| 381 | - | PRESCRIPTION DISPENS ED; 2 | |
| 382 | - | ||
| 383 | - | (2) THE INDIVIDUAL FOR WH OM THE DRUG OR DEVIC E IS 3 | |
| 384 | - | PRESCRIBED IS A PATI ENT OF: 4 | |
| 385 | - | ||
| 386 | - | (I) THE PRESCRIBING PHYSI CIAN; 5 | |
| 387 | - | ||
| 388 | - | (II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 6 | |
| 389 | - | DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 7 | |
| 390 | - | ARTICLE; OR 8 | |
| 391 | - | ||
| 392 | - | (III) A NURSE PRACTITIONER W HO IS AUTHORIZED TO PRACTICE 9 | |
| 393 | - | UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 10 | |
| 394 | - | PHYSICIAN IN THE SAM E OFFICE SETTING; 11 | |
| 395 | - | ||
| 396 | - | (3) THE PHYSICIAN DOES NO T HAVE A SUBSTANTIAL FINANCIAL 12 | |
| 397 | - | INTEREST IN A PHARMA CY; AND 13 | |
| 398 | - | ||
| 399 | - | (4) THE PHYSICIAN: 14 | |
| 400 | - | ||
| 401 | - | (I) COMPLIES WITH THE DIS PENSING AND LABELING 15 | |
| 402 | - | REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE , AND THE BOARD’S 16 | |
| 403 | - | REGULATIONS ; 17 | |
| 404 | - | ||
| 405 | - | (II) RECORDS THE DISPENSIN G OF THE PRESCRIPTIO N DRUG 18 | |
| 406 | - | OR DEVICE ON THE PAT IENT’S CHART; 19 | |
| 407 | - | ||
| 408 | - | (III) PROVIDES THE PATIENT WITH A WRITTEN PRESC RIPTION, 20 | |
| 409 | - | MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 21 | |
| 410 | - | ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 22 | |
| 411 | - | ||
| 412 | - | (IV) DOES NOT DIRECT PATIE NTS TO A SINGLE PHAR MACIST OR 23 | |
| 413 | - | PHARMACY IN ACCORDAN CE WITH § 12–403(C)(8) OF THIS ARTICLE; 24 | |
| 414 | - | ||
| 415 | - | (V) DOES NOT RECEIVE REMU NERATION FOR REFERRI NG 25 | |
| 416 | - | PATIENTS TO A PHARMA CIST OR PHARMACY ; 26 | |
| 417 | - | ||
| 418 | - | (VI) COMPLIES WITH THE CHI LD RESISTANT PACKAGI NG 27 | |
| 419 | - | REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 28 | |
| 420 | - | OF THE HEALTH – GENERAL ARTICLE; 29 | |
| 421 | - | ||
| 422 | - | (VII) COMPLIES WITH DRUG RE CALLS; 30 | |
| 423 | - | 10 HOUSE BILL 260 | |
| 424 | - | ||
| 425 | - | ||
| 426 | - | (VIII) MAINTAINS BIENNIAL IN VENTORIES AND COMPLI ES WITH 1 | |
| 427 | - | ANY OTHER FEDERAL AN D STATE RECORD –KEEPING REQUIREMENTS RELATING TO 2 | |
| 428 | - | CONTROLLED DANGEROUS SUBSTANCES; 3 | |
| 429 | - | ||
| 430 | - | (IX) PURCHASES PRESCRIPTIO N DRUGS FROM A PHARM ACY OR 4 | |
| 431 | - | WHOLESALE DISTRIBUTO R THAT HOLDS A PERMI T ISSUED BY THE STATE BOARD OF 5 | |
| 432 | - | PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 6 | |
| 433 | - | ||
| 434 | - | (X) COMPLIES WITH CONTINU ING EDUCATION REQUIR EMENTS 7 | |
| 435 | - | RELATING TO THE PREP ARING AND DISPENSING OF PRESCRIPTION DRUG S AS 8 | |
| 436 | - | PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 9 | |
| 437 | - | ||
| 438 | - | (D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS OF THIS 10 | |
| 439 | - | SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 11 | |
| 440 | - | SHALL: 12 | |
| 441 | - | ||
| 442 | - | (1) HAVE THE DISPENSING P ERMIT REVOKED ; AND 13 | |
| 443 | - | ||
| 444 | - | (2) BE SUBJECT TO DISCIPL INARY ACTION BY THE BOARD. 14 | |
| 445 | - | ||
| 446 | - | (E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITI AL 15 | |
| 447 | - | DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 16 | |
| 448 | - | INSPECT THE OFFICE O F THE PHYSICIAN. 17 | |
| 449 | - | ||
| 450 | - | (II) IF THE BOARD RENEWS A DISPEN SING PERMIT TO A 18 | |
| 451 | - | LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 19 | |
| 452 | - | PHYSICIAN AT LEAST O NE TIME DURING THE D URATION OF THE RENEW ED PERMIT. 20 | |
| 453 | - | ||
| 454 | - | (2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 21 | |
| 455 | - | SUBSTANCES ADMINISTRATION ANY VI OLATION RELATED TO C ONTROLLED 22 | |
| 456 | - | DANGEROUS SUBSTANCES FOUND DURING AN INSPECTION REQUIRED UNDER 23 | |
| 457 | - | PARAGRAPH (1) OF THIS SUBSECTION . 24 | |
| 458 | - | ||
| 459 | - | SECTION 2. AND BE IT FURTHER ENACTED, That, on the effective date of this 25 | |
| 460 | - | Act, the following shall be transferred to the State Board of Physicians: 26 | |
| 461 | - | ||
| 462 | - | (1) all appropriations, including State and federal funds, held by the Office 27 | |
| 463 | - | of Controlled Substances Administration for the purposes of conducting inspections of 28 | |
| 464 | - | offices of physicians who hold dispensing permits under § 14–509 of the Health Occupations 29 | |
| 465 | - | Article on the effective date of this Act; and 30 | |
| 466 | - | ||
| 467 | - | (2) all books and records including electronic records, real and personal 31 | |
| 468 | - | property, equipment, fixtures, assets, liabilities, obligations, credits, rights, and privileges 32 | |
| 469 | - | held by the Office of Controlled Substances Administration for the purposes of conducting 33 HOUSE BILL 260 11 | |
| 470 | - | ||
| 471 | - | ||
| 472 | - | inspections of offices of physicians who hold dispensing permits under § 14–509 of the 1 | |
| 473 | - | Health Occupations Article on the effective date of this Act. 2 | |
| 474 | - | ||
| 475 | - | SECTION 3. AND BE IT FURTHER ENACTED, That all employees of the Office of 3 | |
| 476 | - | Controlled Substances Administration who are assigned more than 50% of the time to a 4 | |
| 477 | - | function related to conducting inspections of offices of physicians who hold dispensing 5 | |
| 478 | - | permits under § 14–509 of the Health Occupations Article on the effective date of this Act 6 | |
| 479 | - | shall be transferred to the State Board of Physicians without diminution of their rights, 7 | |
| 480 | - | benefits, employment, or retirement status. 8 | |
| 481 | - | ||
| 482 | - | SECTION 4. AND BE IT FURTHER ENACTED, That all positions of the Office of 9 | |
| 483 | - | Controlled Substances Administration who are assigned more than 50% of the time to a 10 | |
| 484 | - | function related to conducting inspections of offices of physicians who hold dispensing 11 | |
| 485 | - | permits under § 14–509 of the Health Occupations Article on the effective date of this Act 12 | |
| 486 | - | shall be transferred to the State Board of Physicians. 13 | |
| 487 | - | ||
| 488 | - | SECTION 5. AND BE IT FURTHER ENACTED, That any transaction affected by 14 | |
| 489 | - | the transfer of oversight of the conducting of inspections of offices of physicians who hold 15 | |
| 490 | - | dispensing permits under § 14–509 of the Health Occupations Article and validly entered 16 | |
| 491 | - | into before the effective date of this Act, and every right, duty, or interest flowing from it 17 | |
| 492 | - | remains valid after the effective date of this Act and may be terminated, completed, 18 | |
| 493 | - | consummated, or enforced under the law. 19 | |
| 494 | - | ||
| 495 | - | SECTION 6. AND BE IT FURTHER ENACTED, That all existing laws, regulations, 20 | |
| 496 | - | proposed regulations, standards and guidelines, policies, orders and other directives, forms, 21 | |
| 497 | - | plans, memberships, contracts, property, investigations, administrative and judicial 22 | |
| 498 | - | responsibilities, rights to sue and be sued, and all other duties and responsibilities 23 | |
| 499 | - | associated with the oversight of the conducting of inspections of offices of physicians who 24 | |
| 500 | - | hold dispensing permits under § 14–509 of the Health Occupations Article prior to the 25 | |
| 501 | - | effective date of this Act shall continue and, as appropriate, are legal and binding on the 26 | |
| 502 | - | State Board of Physicians until completed, withdrawn, canceled, modified, or otherwise 27 | |
| 503 | - | changed under the law. 28 | |
| 504 | - | ||
| 505 | - | SECTION 2. 7. AND BE IT FURTHER ENACTED, That this Act shall take effect 29 | |
| 506 | - | October 1, 2022. 30 | |
| 507 | - | ||
| 443 | + | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effe ct 13 | |
| 444 | + | October 1, 2022. 14 |