| 43 | | - | |
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| 65 | + | An Act relating to prescription drug pricing; |
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| 66 | + | amending 36 O.S. 2021, Section 6960, as amended by |
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| 67 | + | Section 1, Chapter 38, O.S.L. 2022, 6962, as last |
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| 68 | + | amended by Section 1, Chapter 293, O.S.L. 2023, and |
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| 69 | + | Section 3, Chapter 38, O.S.L. 2022, as amended by |
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| 70 | + | Section 3, Chapter 293, O.S.L. 2023 (36 O.S. Supp. |
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| 71 | + | 2023, Sections 6960, 6962, and 6966.1 ), which relate |
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| 72 | + | to the Patient’s Right to Pharmacy Choi ce Act; |
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| 73 | + | defining terms; increasing actions to be prohibited |
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| 74 | + | by pharmacy benefits manager; adding requirements to |
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| 75 | + | pharmacy benefits manager contracts; providing |
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| 76 | + | certain claims be deemed final upon adjudication; |
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| 77 | + | amending 59 O.S. 2021, Section 353.1, as amend ed by |
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| 78 | + | Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp. |
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| 79 | + | 2023, Section 353.1), which relates to the Oklahoma |
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| 80 | + | Pharmacy Act; defining terms; prohibiting |
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| 81 | + | prescription drug manufacturers from taking certain |
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| 82 | + | actions against certain entities; providing for |
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| 83 | + | codification; and providing an effective date . |
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| 53 | | - | 1. “Health insurer” means any corporation, association, benefit |
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| 54 | | - | society, exchange, partnership or individual licensed by the |
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| 55 | | - | Oklahoma Insurance Code; |
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| 56 | | - | 2. “Health insurer payor” means a health insurance company, |
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| 57 | | - | health maintenance organizatio n, union, hospital and medical |
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| 58 | | - | services organization or any entity providing or admin istering a |
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| 59 | | - | self-funded health benefit plan; |
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| 144 | + | 1. “Health insurer” means any corporation, association, benefit |
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| 145 | + | society, exchange, partnership or individual licensed by the |
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| 146 | + | Oklahoma Insurance Code; |
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| 147 | + | 2. “Health insurer payor” means a health insurance company, |
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| 148 | + | health maintenance organization, union, hospital and medical |
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| 149 | + | services organization or any entity providing or admin istering a |
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| 150 | + | self-funded health benefit plan; |
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| 87 | 151 | | 3. “Mail-order pharmacy” means a pharmacy licensed by this |
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| 88 | 152 | | state that primarily dispenses and delivers covered drugs via common |
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| 89 | 153 | | carrier; |
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| 90 | 154 | | 4. “Pharmacy benefits manager ” or “PBM” means a person that |
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| 91 | 155 | | performs pharmacy benefits man agement and any other person acting |
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| 92 | 156 | | for such person under a contractual or employm ent relationship in |
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| 93 | 157 | | the performance of pharmacy benefits management for a managed -care |
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| 94 | 158 | | company, nonprofit hospital, medi cal service organization, insurance |
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| 95 | 159 | | company, third-party payor or a health program administered by a |
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| 96 | 160 | | department of this state; |
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| 97 | 161 | | 5. “Provider” means a pharmacy, as defined in Section 353.1 of |
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| 98 | 162 | | Title 59 of the Oklahoma Statutes or an agent or representative of a |
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| 99 | 163 | | pharmacy; |
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| 100 | 164 | | 6. “Retail pharmacy network ” means retail pharmacy providers |
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| 101 | 165 | | contracted with a PBM in whi ch the pharmacy primari ly fills and |
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| 102 | 166 | | sells prescriptions via a retail, storefron t location; |
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| 138 | 226 | | 9. “Suburban service area ” means a five-digit ZIP code in which |
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| 139 | 227 | | the population density is between one thousan d (1,000) and three |
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| 140 | 228 | | thousand (3,000) individuals per square mile ; and |
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| 141 | 229 | | 10. “Urban service area” means a five-digit ZIP code in which |
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| 142 | 230 | | the population density is greater than three thousand (3,000) |
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| 143 | 231 | | individuals per square mile ; |
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| 144 | 232 | | 11. “340B drug pricing” means the pricing agreement established |
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| 145 | 233 | | under Section 602 of the Veterans Health Care Act of 1992, Pub. L. |
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| 146 | 234 | | No. 102-585; and |
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| 147 | 235 | | 12. “340B entity” means a covered entity as that term is |
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| 148 | 236 | | defined in 42 U.S.C., Section 256b. |
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| 149 | 237 | | SECTION 2. AMENDATORY 36 O.S. 2021, Sect ion 6962, as |
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| 150 | 238 | | last amended by Section 1, Chapter 293, O.S.L. 2023 (36 O.S. Supp. |
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| 151 | 239 | | 2023, Section 6962), is amended to read as follows: |
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| 152 | | - | Section 6962. A. The Attorney General shall review and approve |
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| 153 | | - | retail pharmacy network access for all p harmacy benefits managers |
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| 154 | | - | (PBMs) to ensure compliance with Sec tion 6961 of this title. |
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| 155 | | - | B. A PBM, or an agent of a PBM, s hall not: |
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| 156 | | - | 1. Cause or knowingly permit the use of advertisement, |
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| 157 | | - | promotion, solicitation, representation, proposal or offer that is |
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| 158 | | - | untrue, deceptive or misleading; |
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| 159 | | - | 2. Charge a pharmacist or phar macy a fee related to the |
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| 160 | | - | adjudication of a claim including without limitation a fee for: |
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| 161 | | - | a. the submission of a claim, |
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| 291 | + | Section 6962. A. The Attorney General shall review and approve |
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| 292 | + | retail pharmacy network access for all p harmacy benefits managers |
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| 293 | + | (PBMs) to ensure compliance with Sec tion 6961 of this title. |
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| 294 | + | B. A PBM, or an agent of a PBM, shall not: |
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| 295 | + | 1. Cause or knowingly pe rmit the use of advertisement, |
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| 296 | + | promotion, solicitation, representation, proposal or offer that is |
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| 297 | + | untrue, deceptive or misleading; |
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| 298 | + | 2. Charge a pharmacist or phar macy a fee related to the |
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| 299 | + | adjudication of a claim including without limitation a fee for: |
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| 300 | + | a. the submission of a claim, |
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| 189 | 301 | | b. enrollment or participation in a retail pharmacy |
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| 190 | 302 | | network, or |
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| 191 | 303 | | c. the development or management of claims processing |
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| 192 | 304 | | services or claims payment services related to |
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| 193 | 305 | | participation in a retail pharmacy network; |
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| 194 | 306 | | 3. Reimburse a pharmacy or pharmacist in the state an amount |
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| 195 | 307 | | less than the amount that the PBM reimburses a pharm acy owned by or |
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| 196 | 308 | | under common ownership with a PBM for providing the s ame covered |
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| 197 | 309 | | services. The reimbursement amount paid to the pharmacy shall be |
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| 198 | 310 | | equal to the reimbursement amount calculated on a per-unit basis |
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| 199 | 311 | | using the same generic product identifier or generic code number |
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| 200 | 312 | | paid to the PBM-owned or PBM-affiliated pharmacy; |
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| 201 | 313 | | 4. Deny a provider the opportunity to participate in any |
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| 202 | 314 | | pharmacy network at preferred participation status if the provider |
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| 203 | | - | is willing to accept the terms and conditions that the PBM has |
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| 204 | | - | established for other providers as a condition of preferred networ k |
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| 205 | | - | participation status; |
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| 206 | | - | 5. Deny, limit or terminate a provider’s contract based on |
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| 207 | | - | employment status of a ny employee who has an active license to |
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| 208 | | - | dispense, despite probation status, wi th the State Board of |
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| 209 | | - | Pharmacy; |
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| 210 | | - | 6. Retroactively deny or reduce reimbu rsement for a covered |
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| 211 | | - | service claim after returning a paid claim response as part of the |
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| 212 | | - | adjudication of the claim, unless: |
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| 366 | + | is willing to accept the terms and conditions that the PBM has |
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| 367 | + | established for other providers as a condition of preferred networ k |
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| 368 | + | participation status; |
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| 369 | + | 5. Deny, limit or terminate a provider’s contract based on |
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| 370 | + | employment status of a ny employee who has an active license to |
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| 371 | + | dispense, despite probation status, wi th the State Board of |
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| 372 | + | Pharmacy; |
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| 373 | + | 6. Retroactively deny or reduce reimbu rsement for a covered |
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| 374 | + | service claim after returning a paid claim response as part of the |
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| 375 | + | adjudication of the claim, unless: |
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| 240 | 376 | | a. the original claim was submitted fraudulently, or |
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| 241 | 377 | | b. to correct errors identified in an audit, so long as |
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| 242 | 378 | | the audit was conducted in compliance with Sections |
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| 243 | 379 | | 356.2 and 356.3 of Title 59 of the Oklahoma Statutes; |
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| 244 | 380 | | 7. Fail to make any payment due to a pharmacy or pharmacist for |
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| 245 | 381 | | covered services properly re ndered in the event a PBM terminates a |
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| 246 | 382 | | provider from a pharmacy benefits manager network; |
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| 247 | 383 | | 8. Conduct or practice spread pricing, as defined in Section 1 |
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| 248 | 384 | | of this act, in this state; or |
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| 249 | 385 | | 9. Charge a pharmacist or pharmacy a fee related to |
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| 250 | 386 | | participation in a re tail pharmacy network including but not limited |
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| 251 | 387 | | to the following: |
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| 252 | 388 | | a. an application fee, |
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| 253 | 389 | | b. an enrollment or participation fee, |
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| 254 | | - | c. a credentialing or re-credentialing fee, |
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| 255 | | - | d. a change of ownership fee, or |
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| 256 | | - | e. a fee for the development or management of claims |
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| 257 | | - | processing services or claims payment services; |
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| 258 | | - | 10. Discriminate, offer lower reimbursement, or impose any |
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| 259 | | - | separate terms upon a provider on the basis that a p rovider |
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| 260 | | - | participates in 340B drug pricing; |
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| 261 | | - | 11. Require a provider to reverse, resubmit, or clarify a 340B |
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| 262 | | - | drug pricing claim after the initial adjudication unless these |
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| 441 | + | c. a credentialing or re-credentialing fee, |
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| 442 | + | d. a change of ownership fee, or |
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| 443 | + | e. a fee for the development or management of claims |
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| 444 | + | processing services or claims payment services; |
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| 445 | + | 10. Discriminate, offer lower reimbursement, or impose any |
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| 446 | + | separate terms upon a provider on the basis that a p rovider |
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| 447 | + | participates in 340B drug pricing; |
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| 448 | + | 11. Require a provider to reverse, resubmit, or clarify a 340B |
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| 449 | + | drug pricing claim after the initial adjudication unless these |
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| 290 | 450 | | actions are in normal course of pharmacy business and not related to |
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| 291 | 451 | | 340B drug pricing; |
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| 292 | 452 | | 12. Require a billing modifier to indicate that the drug o r |
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| 293 | 453 | | claim is a 340B drug pricing claim, unless the drug or claim is |
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| 294 | 454 | | being billed to the Oklahoma Medicaid Program; |
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| 295 | 455 | | 13. Modify a patient copayment on the basis that the provider |
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| 296 | 456 | | of the patient participates in 340B drug pricing; |
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| 297 | 457 | | 14. Exclude a provider from a network on the basis that the |
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| 298 | 458 | | provider participates in 340B drug pricing ; |
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| 299 | 459 | | 15. Establish or set network adequacy req uirements based on |
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| 300 | 460 | | 340B drug pricing participation by a provider; |
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| 301 | 461 | | 16. Prohibit a 340B entity or a pharmacy under contract with a |
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| 302 | 462 | | 340B entity from participating in the network of the PBM on the |
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| 303 | 463 | | basis of participation in 340B drug pricing; or |
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| 304 | | - | 17. Base the drug formulary or drug coverage decisions upon the |
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| 305 | | - | 340B drug pricing status of a drug, including price or availability, |
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| 306 | | - | or whether a dispensing pharmacy participates in 340B drug pricing. |
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| 307 | | - | C. The prohibitions under this section shall apply to contracts |
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| 308 | | - | between pharmacy benefits managers and providers for participation |
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| 309 | | - | in retail pharmacy networks. |
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| 310 | | - | 1. A PBM contract shall: |
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| 311 | | - | a. not restrict, directly or indirectly, any pharmacy |
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| 312 | | - | that dispenses a presc ription drug from informing, or |
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| 313 | | - | penalize such pharmacy for informing, an indivi dual of |
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| 515 | + | 17. Base the drug formulary or drug coverage decisions upon the |
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| 516 | + | 340B drug pricing status of a drug, including price or availa bility, |
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| 517 | + | or whether a dispensing pharmacy participates in 340B drug pricing. |
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| 518 | + | C. The prohibitions under this section shall apply to contracts |
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| 519 | + | between pharmacy benefits managers and providers for participation |
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| 520 | + | in retail pharmacy networks. |
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| 521 | + | 1. A PBM contract shall: |
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| 522 | + | a. not restrict, directly or indirectly, any pharmacy |
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| 523 | + | that dispenses a presc ription drug from informing, or |
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| 524 | + | penalize such pharmacy for informing, an indivi dual of |
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| 341 | 525 | | any differential between the individual’s out-of- |
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| 342 | 526 | | pocket cost or coverage with respect to acquisition of |
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| 343 | 527 | | the drug and the amount an individual would pay to |
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| 344 | 528 | | purchase the drug directly, and |
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| 345 | 529 | | b. ensure that any entity that provides pharmacy benefits |
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| 346 | 530 | | management services under a contract with any such |
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| 347 | 531 | | health plan or health insurance coverage does not, |
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| 348 | 532 | | with respect to such plan or coverage, restrict, |
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| 349 | 533 | | directly or indirectly, a ph armacy that dispenses a |
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| 350 | 534 | | prescription drug from inf orming, or penalize such |
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| 351 | 535 | | pharmacy for informing, a covered individual of any |
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| 352 | 536 | | differential between the individual ’s out-of-pocket |
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| 353 | 537 | | cost under the plan or coverage with respect to |
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| 354 | 538 | | acquisition of the drug and t he amount an individual |
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| 355 | | - | would pay for acquisition of the drug without using |
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| 356 | | - | any health plan or health insurance coverag e, and |
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| 357 | | - | c. eliminate discriminatory contracting as it relates to: |
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| 358 | | - | (1) transferring the benefit of 340B drug pricing |
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| 359 | | - | savings from a 340B entity to another entity, |
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| 360 | | - | including without limitation pharmacy bene fits |
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| 361 | | - | managers, private insurers, and managed care |
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| 362 | | - | organizations, |
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| 590 | + | would pay for acquisition of the drug without using |
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| 591 | + | any health plan or health insurance coverag e, and |
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| 592 | + | c. eliminate discriminatory contracting as it relates to: |
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| 593 | + | (1) transferring the benefit of 340B drug pricing |
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| 594 | + | savings from a 340B entity to another entity, |
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| 595 | + | including without limitation pharmacy bene fits |
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| 596 | + | managers, private insure rs, and managed care |
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| 597 | + | organizations, |
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| 390 | 598 | | (2) offering a lower reimbursement rate for drugs |
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| 391 | 599 | | purchased under 340B drug pricing than for the |
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| 392 | 600 | | same drug not purchased under 340B d rug pricing, |
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| 393 | 601 | | (3) refusal to cover drug purchases utilizing 340B |
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| 394 | 602 | | drug pricing, |
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| 395 | 603 | | (4) refusal to allow providers who utilize 340B drug |
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| 396 | 604 | | pricing to participate in netwo rks, and |
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| 397 | 605 | | (5) charging more than fair market value or seeking |
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| 398 | 606 | | profit sharing in exchange for servi ces involving |
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| 399 | 607 | | 340B drug pricing. |
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| 400 | 608 | | 2. A pharmacy benefits manager ’s contract with a provider shall |
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| 401 | 609 | | not prohibit, restrict or limit disclosure of information to the |
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| 402 | 610 | | Attorney General, law enforcement or state and federal governmental |
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| 403 | 611 | | officials investigating or examining a c omplaint or conducting a |
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| 404 | 612 | | review of a pharmacy benefits manager ’s compliance with the |
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| 405 | 613 | | requirements under the Patient’s Right to Pharmacy Choice Act. |
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| 440 | 672 | | prescription drug discounts, rebates rece ived from drug |
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| 441 | 673 | | manufacturers and pharmacy audit recoupments; |
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| 442 | 674 | | 3. Provide the Attorney General, insurers, self-funded employer |
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| 443 | 675 | | plans and unions unrestricted audi t rights of and access to the |
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| 444 | 676 | | respective PBM pharmaceutical manufacturer and provider contracts, |
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| 445 | 677 | | plan utilization data, plan pricing data, pharmacy utilization dat a |
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| 446 | 678 | | and pharmacy pricing data; |
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| 447 | 679 | | 4. Maintain, for no less than three (3) years, documentation of |
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| 448 | 680 | | all network development activities including but not limited to |
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| 449 | 681 | | contract negotiations and any denials to providers to join networks. |
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| 450 | 682 | | This documentation shall be made available to th e Attorney General |
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| 451 | 683 | | upon request; |
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| 452 | 684 | | 5. Report to the Attorney General, on a quarterly basis for |
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| 453 | 685 | | each health insurer payor, on the following information: |
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| 454 | 686 | | a. the aggregate amount of rebates received by t he PBM, |
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| 455 | 687 | | b. the aggregate amount of rebates distributed to the |
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| 456 | 688 | | appropriate health in surer payor, |
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| 491 | 747 | | itemized by pharmacy, drug product and service |
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| 492 | 748 | | provided, and |
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| 493 | 749 | | e. the individual and aggregate amount a PBM paid a |
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| 494 | 750 | | provider for pharmac y services itemized by pharmacy, |
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| 495 | 751 | | drug product and service provide d; and |
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| 496 | 752 | | 6. Make drug formulary and coverage decisions based on the |
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| 497 | 753 | | normal course of business of the PBM. |
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| 498 | 754 | | SECTION 3. AMENDATORY Section 3, Chapter 38, O.S.L. |
|---|
| 499 | 755 | | 2022, as amended by Section 3, Chapter 293, O.S.L. 2023 (36 O.S. |
|---|
| 500 | 756 | | Supp. 2023, Section 6966.1), is am ended to read as fol lows: |
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| 501 | 757 | | Section 6966.1. A. The Insurance Commissioner may censure, |
|---|
| 502 | 758 | | suspend, revoke or refuse to issue or renew a license of or levy a |
|---|
| 503 | 759 | | civil penalty against any person licensed under the insurance laws |
|---|
| 504 | 760 | | of this state for any violation of the Patient’s Right to Pharmacy |
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| 505 | 761 | | Choice Act, Section 6958 et seq. o f this title. |
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| 506 | 762 | | B. 1. If the Attorney General finds, after notice and |
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| 507 | 763 | | opportunity for hearing, that a pharmacy benefits manager (PBM) |
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| 541 | 821 | | makes such recommendation, the Commissioner shall take the |
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| 542 | 822 | | recommended action. |
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| 543 | 823 | | 2. In addition to or in lieu of any censure, suspension or |
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| 544 | 824 | | revocation of a license, a PBM may be subject to a civil fine o f not |
|---|
| 545 | 825 | | less than One Hundred Dollars ($100.00) and not greater tha n Ten |
|---|
| 546 | 826 | | Thousand Dollars ($10,000.00) for each violation of the provisions |
|---|
| 547 | 827 | | of the Patient’s Right to Pharmacy Choice Act, the Pharmacy Audit |
|---|
| 548 | 828 | | Integrity Act or the provi sions of Sections 357 throug h 360 of Title |
|---|
| 549 | 829 | | 59 of the Oklahoma Statues, following notic e and an opportunity for |
|---|
| 550 | 830 | | a hearing. |
|---|
| 551 | 831 | | C. Notwithstanding whether the license of a PBM has been |
|---|
| 552 | 832 | | issued, suspended, revoke d, surrendered or lapsed by operation of |
|---|
| 553 | 833 | | law, the Attorney General is hereby authorized to enforce the |
|---|
| 554 | 834 | | provisions of the Patient ’s Right to Pharmacy Cho ice Act and impose |
|---|
| 555 | 835 | | any penalty or remedy authorized under the act against a PBM under |
|---|
| 556 | 836 | | investigation for or charg ed with a violation of the Pati ent’s Right |
|---|
| 557 | 837 | | to Pharmacy Choice Act, the Pharmacy Audit Integrity Act, the |
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| 590 | 894 | | E. 1. All hearings conducted by the Office of the Attorney |
|---|
| 591 | 895 | | General pursuant to this section shall be public and held in |
|---|
| 592 | 896 | | accordance with the Administrative Procedures Act. |
|---|
| 593 | 897 | | 2. Hearings shall be held at the office of the Attorney General |
|---|
| 594 | 898 | | or any other place the Attorney General may deem convenient. |
|---|
| 595 | 899 | | 3. The Attorney General, upon written request from a PBM |
|---|
| 596 | 900 | | affected by the hearing, shall cause a f ull stenographic record of |
|---|
| 597 | 901 | | the proceedings to be made by a competent court reporter . This |
|---|
| 598 | 902 | | record shall be at the expense of the PBM. |
|---|
| 599 | 903 | | 4. The ordinary fees and cost s of the hearing examiner |
|---|
| 600 | 904 | | appointed pursuant to Section 319 of this title may be assessed by |
|---|
| 601 | 905 | | the hearing examiner against the respondent unless the respondent is |
|---|
| 602 | 906 | | the prevailing party. |
|---|
| 603 | 907 | | F. Any PBM whose license has been censured, susp ended, revoked |
|---|
| 604 | 908 | | or denied renewal or who has had a fine levied against him or her |
|---|
| 605 | 909 | | shall have the right of appeal from the final order of the Attorney |
|---|
| 606 | 910 | | General, pursuant to Section 318 et seq. of Title 75 of the Oklahoma |
|---|
| 607 | 911 | | Statutes. |
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| 641 | 969 | | report at any periodic interval the Attorney General deems |
|---|
| 642 | 970 | | necessary. |
|---|
| 643 | 971 | | H. All claims processed by a PBM on behalf of a provider that |
|---|
| 644 | 972 | | participates in 340B drug pricing or on behalf of a 340B entity |
|---|
| 645 | 973 | | shall be deemed final at the point of adjudication. |
|---|
| 646 | 974 | | SECTION 4. AMENDATORY 59 O.S. 2021, Section 353.1, as |
|---|
| 647 | 975 | | amended by Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp. 2023, |
|---|
| 648 | 976 | | Section 353.1), is amended to read as follows: |
|---|
| 649 | 977 | | Section 353.1. For the purposes of the Ok lahoma Pharmacy Act: |
|---|
| 650 | 978 | | 1. “Accredited program” means those seminars, classes, |
|---|
| 651 | 979 | | meetings, work projects, and oth er educational courses approved by |
|---|
| 652 | 980 | | the Board for purposes of continuing professional education; |
|---|
| 653 | 981 | | 2. “Act” means the Oklahoma Pharmacy Act; |
|---|
| 654 | 982 | | 3. “Administer” means the direct application of a drug, whether |
|---|
| 655 | 983 | | by injection, inhalation, ingestion or any other m eans, to the body |
|---|
| 656 | 984 | | of a patient; |
|---|
| 657 | 985 | | 4. “Assistant pharmacist” means any person presently licensed |
|---|
| 658 | 986 | | as an assistant pharmacist in the State of Oklahoma by the Board |
|---|
| 692 | 1044 | | licensed practitioner with dispensing authority to confirm that the |
|---|
| 693 | 1045 | | medication, labeling an d packaging of the filled prescription are |
|---|
| 694 | 1046 | | accurate and meet all requirem ents prescribed by state and federa l |
|---|
| 695 | 1047 | | law. For the purposes of this paragraph, “licensed practitioner” |
|---|
| 696 | 1048 | | shall not include optometrists with dispensing authority; |
|---|
| 697 | 1049 | | 7. “Chemical” means any medicinal substance, whether simple or |
|---|
| 698 | 1050 | | compound or obtained through the process of the science and art of |
|---|
| 699 | 1051 | | chemistry, whether of organic or inorganic ori gin; |
|---|
| 700 | 1052 | | 8. “Compounding” means the combining, admixing, mixing, |
|---|
| 701 | 1053 | | diluting, pooling, reconstituting or ot herwise altering of a drug or |
|---|
| 702 | 1054 | | bulk drug substance to create a drug. Compounding includes the |
|---|
| 703 | 1055 | | preparation of drugs or devices in anticipation of prescript ion drug |
|---|
| 704 | 1056 | | orders based on routine, regularly observed prescribing patterns; |
|---|
| 705 | 1057 | | 9. “Continuing professiona l education” means professional, |
|---|
| 706 | 1058 | | pharmaceutical education in the general areas of the socioeconomic |
|---|
| 707 | 1059 | | and legal aspects of health care; the properties and actions of |
|---|
| 708 | 1060 | | drugs and dosage forms; and the etiology, characteristics and |
|---|
| 709 | 1061 | | therapeutics of the diseased s tate; |
|---|
| 742 | 1118 | | this drug except for use by or on the order of a |
|---|
| 743 | 1119 | | licensed veterinarian.”; |
|---|
| 744 | 1120 | | 11. “Director” means the Executive Director of the State Board |
|---|
| 745 | 1121 | | of Pharmacy unless context clearly indicates otherwise; |
|---|
| 746 | 1122 | | 12. “Dispense” or “dispensing” means the interpretation, |
|---|
| 747 | 1123 | | evaluation, and implementation of a prescription drug order |
|---|
| 748 | 1124 | | including the prepar ation and delivery of a drug or dev ice to a |
|---|
| 749 | 1125 | | patient or a patient ’s agent in a suitable container appropria tely |
|---|
| 750 | 1126 | | labeled for subsequent administration to, or use by, a patient . |
|---|
| 751 | 1127 | | Dispense includes sell, distribute, leave with, give away, dispose |
|---|
| 752 | 1128 | | of, deliver or supply; |
|---|
| 753 | 1129 | | 13. “Dispenser” means a retail pharmacy, hospital pharmacy, a |
|---|
| 754 | 1130 | | group of chain pharmacies under c ommon ownership and control that do |
|---|
| 755 | 1131 | | not act as a wholesale distributor, or any other person authorized |
|---|
| 756 | 1132 | | by law to dispense or adm inister prescription d rugs, and the |
|---|
| 757 | 1133 | | affiliated warehouses or distributions of such entities und er common |
|---|
| 758 | 1134 | | ownership and control t hat do not act as a wholesale distributor. |
|---|
| 759 | 1135 | | For the purposes of this parag raph, “dispenser” does not mean a |
|---|
| 760 | | - | person who dispenses only products to be used in animals in |
|---|
| 761 | | - | accordance with 21 U.S.C. 360b(a)(5); |
|---|
| 762 | | - | 14. “Distribute” or “distribution” means the sale, purchase, |
|---|
| 763 | | - | trade, delivery, handling, storage, or receipt of a product, and |
|---|
| 764 | | - | does not include the dispensing of a product pursuant to a |
|---|
| 765 | | - | prescription executed in accordance with 21 U.S.C . 353(b)(1) or the |
|---|
| 1187 | + | person who dispenses only products to be used in animals in |
|---|
| 1188 | + | accordance with 21 U.S.C. 360b(a)(5); |
|---|
| 1189 | + | 14. “Distribute” or “distribution” means the sale, purchase, |
|---|
| 1190 | + | trade, delivery, handling, storage, or receipt of a product, and |
|---|
| 1191 | + | does not include the dispensing of a product pursua nt to a |
|---|
| 1192 | + | prescription executed in accordance with 21 U.S.C . 353(b)(1) or the |
|---|
| 793 | 1193 | | dispensing of a product approved under 21 U.S.C. 360 b(b); provided, |
|---|
| 794 | 1194 | | taking actual physical possession of a product or title s hall not be |
|---|
| 795 | 1195 | | required; |
|---|
| 796 | 1196 | | 15. “Doctor of Pharmacy” means a person licensed by the Board |
|---|
| 797 | 1197 | | to engage in the practice of pharmacy . The terms “pharmacist”, |
|---|
| 798 | 1198 | | “D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and shall |
|---|
| 799 | 1199 | | have the same meaning wherever they a ppear in the Oklahoma Statutes |
|---|
| 800 | 1200 | | and the rules promulgated by the Board; |
|---|
| 801 | 1201 | | 16. “Drug outlet” means all manufacturers , repackagers, |
|---|
| 802 | 1202 | | outsourcing faciliti es, wholesale distributors, third -party |
|---|
| 803 | 1203 | | logistics providers, pharmacies, and all other facilities which are |
|---|
| 804 | 1204 | | engaged in dispensing, delivery, distribution or storage of |
|---|
| 805 | 1205 | | dangerous drugs; |
|---|
| 806 | 1206 | | 17. “Drugs” means all medicinal substances and preparations |
|---|
| 807 | 1207 | | recognized by the United States Pharmacopoeia and National |
|---|
| 808 | 1208 | | Formulary, or any revision thereof, and all substances an d |
|---|
| 809 | 1209 | | preparations intended for external and/or internal use i n the cure, |
|---|
| 810 | 1210 | | diagnosis, mitigation, treatment or preventio n of disease in humans |
|---|
| 843 | 1267 | | not intended to be sold and is intended to promote the sale of the |
|---|
| 844 | 1268 | | drug; |
|---|
| 845 | 1269 | | 19. “Durable medical equipment” has the same meaning as |
|---|
| 846 | 1270 | | provided by Section 2 of this act; |
|---|
| 847 | 1271 | | 20. “Filled prescription” means a packaged prescription |
|---|
| 848 | 1272 | | medication to which a label has been affixed which contain s such |
|---|
| 849 | 1273 | | information as is required by the Oklahoma Pharmacy Act; |
|---|
| 850 | 1274 | | 21. “Hospital” means any institution licensed as a hospital by |
|---|
| 851 | 1275 | | this state for the care and treatment of patients, or a pharmacy |
|---|
| 852 | 1276 | | operated by the Oklahoma Department of Veterans Affairs; |
|---|
| 853 | 1277 | | 22. “Licensed practitioner” means an allopathic physician, |
|---|
| 854 | 1278 | | osteopathic physician, podiatric physician, dentist, veterinarian or |
|---|
| 855 | 1279 | | optometrist licensed to pra ctice and authorized to prescribe |
|---|
| 856 | 1280 | | dangerous drugs within the scope of practice of such practitione r; |
|---|
| 857 | 1281 | | 23. “Manufacturer” or “virtual manufacturer” means with respect |
|---|
| 858 | 1282 | | to a product: |
|---|
| 859 | 1283 | | a. a person that holds an application approved under 21 |
|---|
| 860 | 1284 | | U.S.C. 355 or a license issued under 42 U.S.C. 262 for |
|---|
| 861 | 1285 | | such product, or if such product is not the subject of |
|---|
| 893 | 1341 | | a person described in this subparagraph or |
|---|
| 894 | 1342 | | subparagraph a of this paragraph, |
|---|
| 895 | 1343 | | c. an affiliate of a person described in subparagraph a |
|---|
| 896 | 1344 | | or b who receives the product directly from a person |
|---|
| 897 | 1345 | | described in this subparagraph or in subparagraph a or |
|---|
| 898 | 1346 | | b of this paragraph, or |
|---|
| 899 | 1347 | | d. a person who contracts with another to manufacture a |
|---|
| 900 | 1348 | | product; |
|---|
| 901 | 1349 | | 24. “Manufacturing” means the production, preparation, |
|---|
| 902 | 1350 | | propagation, compounding, conversion or processing of a device or a |
|---|
| 903 | 1351 | | drug, either directly or indirectly by extraction from substances of |
|---|
| 904 | 1352 | | natural origin or independently by means of chemic al or biological |
|---|
| 905 | 1353 | | synthesis and includes any pa ckaging or repackaging of the |
|---|
| 906 | 1354 | | substances or labeling or relabeling of its container, and the |
|---|
| 907 | 1355 | | promotion and marketing of such drug s or devices. The term |
|---|
| 908 | 1356 | | “manufacturing” also includes the preparation and promoti on of |
|---|
| 909 | 1357 | | commercially available products from bul k compounds for resale by |
|---|
| 910 | 1358 | | licensed pharmacies, licensed practitioners or other persons; |
|---|
| 943 | 1415 | | 27. “Medical gas distributor ” means a person licensed to |
|---|
| 944 | 1416 | | distribute, transfer, wholesale, deliver or sell medical gases on |
|---|
| 945 | 1417 | | drug orders to suppliers or other entities licensed to use, |
|---|
| 946 | 1418 | | administer or distribute medical gas and may also include a patient |
|---|
| 947 | 1419 | | or ultimate user; |
|---|
| 948 | 1420 | | 28. “Medical gas supplier” means a person who dispenses medical |
|---|
| 949 | 1421 | | gases on drug orders only to a patient or ultimate user; |
|---|
| 950 | 1422 | | 29. “Medicine” means any drug or combination of drugs whic h has |
|---|
| 951 | 1423 | | the property of curing, preventing, treating , diagnosing or |
|---|
| 952 | 1424 | | mitigating diseases, or which is used for that purpose; |
|---|
| 953 | 1425 | | 30. “Nonprescription drugs ” means medicines or drug s which are |
|---|
| 954 | 1426 | | sold without a prescription and which are prepackaged for use by the |
|---|
| 955 | 1427 | | consumer and labeled in accordance with the req uirements of the |
|---|
| 956 | 1428 | | statutes and regulations of this state and th e federal government. |
|---|
| 957 | 1429 | | Such items shall also include medical and d ental supplies and |
|---|
| 958 | 1430 | | bottled or nonbulk chemicals which are sold or offered for sale to |
|---|
| 959 | 1431 | | the general public if such articles or pre parations meet the |
|---|
| 960 | 1432 | | requirements of the Federal Food, Drug and Cosmetic Act, 21 |
|---|
| 961 | 1433 | | U.S.C.A., Section 321 et seq.; |
|---|
| 993 | 1489 | | b. has elected to register as an outsourcing facility, |
|---|
| 994 | 1490 | | and |
|---|
| 995 | 1491 | | c. complies with all requirem ents of 21 U.S.C. 353b; |
|---|
| 996 | 1492 | | 32. “Package” means the smallest individual saleable unit of |
|---|
| 997 | 1493 | | product for distribution by a manufacturer or repackager that is |
|---|
| 998 | 1494 | | intended by the manufacturer for ultimate s ale to the dispenser of |
|---|
| 999 | 1495 | | such product. For the purposes of this paragraph, “individual |
|---|
| 1000 | 1496 | | saleable unit” means the smallest container of a product intro duced |
|---|
| 1001 | 1497 | | into commerce by the manufactur er or repackager that is intended by |
|---|
| 1002 | 1498 | | the manufacturer or repackager fo r individual sale to a dispenser; |
|---|
| 1003 | 1499 | | 33. “Person” means an individual, partnership, li mited |
|---|
| 1004 | 1500 | | liability company, corporation or association, unless the c ontext |
|---|
| 1005 | 1501 | | otherwise requires; |
|---|
| 1006 | 1502 | | 34. “Pharmacist-in-charge” or “PIC” means the pharmacist |
|---|
| 1007 | 1503 | | licensed in this state responsible for th e management control of a |
|---|
| 1008 | 1504 | | pharmacy and all other aspects of t he practice of pharmacy in a |
|---|
| 1009 | 1505 | | licensed pharmacy as defined by Section 353.18 of this title; |
|---|
| 1010 | 1506 | | 35. “Pharmacy” means a place regularly licensed by the Board of |
|---|
| 1011 | 1507 | | Pharmacy in which prescriptions, drugs, medicines, chemicals and |
|---|
| 1012 | 1508 | | poisons are compounded or dispe nsed or such place where pharmacists |
|---|
| 1044 | 1564 | | Pharmacy to assist the pharmacist and perform nonjudgment al, |
|---|
| 1045 | 1565 | | technical, manipulative, non-discretionary functions in the |
|---|
| 1046 | 1566 | | prescription department under the immediate and direct supervision |
|---|
| 1047 | 1567 | | of a pharmacist; |
|---|
| 1048 | 1568 | | 37. “Poison” means any substance which when introduced into the |
|---|
| 1049 | 1569 | | body, either directly or by absorption, pro duces violent, morbid or |
|---|
| 1050 | 1570 | | fatal changes, or wh ich destroys living tissue with which such |
|---|
| 1051 | 1571 | | substance comes into contact; |
|---|
| 1052 | 1572 | | 38. “Practice of pharmacy” means: |
|---|
| 1053 | 1573 | | a. the interpretation and evaluation of prescription |
|---|
| 1054 | 1574 | | orders, |
|---|
| 1055 | 1575 | | b. the compounding, dispensing, administer ing and |
|---|
| 1056 | 1576 | | labeling of drugs and devices, except labeling by a |
|---|
| 1057 | 1577 | | manufacturer, repackager or distributor of |
|---|
| 1058 | 1578 | | nonprescription drugs and commercially packaged legend |
|---|
| 1059 | 1579 | | drugs and devices, |
|---|
| 1060 | 1580 | | c. the participation in drug selection and drug |
|---|
| 1061 | 1581 | | utilization reviews, |
|---|
| 1062 | 1582 | | d. the proper and safe storage of drugs and devices and |
|---|
| 1063 | 1583 | | the maintenance of proper r ecords thereof, |
|---|
| 1095 | 1639 | | f. the offering or performing of those ac ts, services, |
|---|
| 1096 | 1640 | | operations or transacti ons necessary in the conduct, |
|---|
| 1097 | 1641 | | operation, management and control of a pharmacy, or |
|---|
| 1098 | 1642 | | g. the provision of those acts or services that are |
|---|
| 1099 | 1643 | | necessary to provide pharmaceutical care; |
|---|
| 1100 | 1644 | | 39. “Preparation” means an article which may or may not contain |
|---|
| 1101 | 1645 | | sterile products compounded in a licensed pharmacy pursuant to the |
|---|
| 1102 | 1646 | | order of a licensed prescriber; |
|---|
| 1103 | 1647 | | 40. “Prescriber” means a person licensed in this state who is |
|---|
| 1104 | 1648 | | authorized to prescribe dangerous drugs within the scope of p ractice |
|---|
| 1105 | 1649 | | of the person’s profession; |
|---|
| 1106 | 1650 | | 41. “Prescription” means and includes any order for drug or |
|---|
| 1107 | 1651 | | medical supplies written or signed, or transmitted by word of mouth, |
|---|
| 1108 | 1652 | | telephone or other means of co mmunication: |
|---|
| 1109 | 1653 | | a. by a licensed prescriber, |
|---|
| 1110 | 1654 | | b. under the supervision of an Oklahoma licensed |
|---|
| 1111 | 1655 | | practitioner, an Oklahoma licensed advanced practice |
|---|
| 1112 | 1656 | | registered nurse or an Oklahoma licensed physician |
|---|
| 1113 | 1657 | | assistant, or |
|---|
| 1146 | 1714 | | before reconstitution. “Product” does not include blo od components |
|---|
| 1147 | 1715 | | intended for transfusion, radioactive drugs or biologics and med ical |
|---|
| 1148 | 1716 | | gas; |
|---|
| 1149 | 1717 | | 43. “Repackager”, including “virtual repackager”, means a |
|---|
| 1150 | 1718 | | person who owns or operates an establishment that repac ks and |
|---|
| 1151 | 1719 | | relabels a product or package for further sale or distribution |
|---|
| 1152 | 1720 | | without further transaction; |
|---|
| 1153 | 1721 | | 44. “Sterile drug” means a drug that is intended for p arenteral |
|---|
| 1154 | 1722 | | administration, an ophthalmic or oral inhalation drug in aqueous |
|---|
| 1155 | 1723 | | format, or a drug that is required to be sterile under state and |
|---|
| 1156 | 1724 | | federal law; |
|---|
| 1157 | 1725 | | 45. “Supervising physician ” means an individual holding a |
|---|
| 1158 | 1726 | | current license to practice as a physician from the State Board of |
|---|
| 1159 | 1727 | | Medical Licensure and Supervision, pursuant to the provisions of the |
|---|
| 1160 | 1728 | | Oklahoma Allopathic Medical and Surgical Licensur e and Supervision |
|---|
| 1161 | 1729 | | Act, or the State Board of Osteopathic Examiners, pursuant to the |
|---|
| 1162 | 1730 | | provisions of the Oklahoma Osteopathic Medicine Act, who supervises |
|---|
| 1163 | 1731 | | an advanced practice registered nurse as defined in Secti on 567.3a |
|---|
| 1164 | 1732 | | of this title, and who is not in training as an intern, resident, or |
|---|
| 1196 | 1788 | | 46. “Supportive personnel” means technicians and auxi liary |
|---|
| 1197 | 1789 | | supportive persons who are regularly paid employees of a pharma cy |
|---|
| 1198 | 1790 | | who work and perform tasks in the pharmacy as authorized by Section |
|---|
| 1199 | 1791 | | 353.18A of this title; |
|---|
| 1200 | 1792 | | 47. “Third-party logistics provider ” including “virtual third- |
|---|
| 1201 | 1793 | | party logistics provider ” means an entity that provides or |
|---|
| 1202 | 1794 | | coordinates warehousing, or other logi stics services of a pr oduct in |
|---|
| 1203 | 1795 | | interstate commerce on beh alf of a manufacturer, wholesale |
|---|
| 1204 | 1796 | | distributor, or dispenser of a product but does not take ownersh ip |
|---|
| 1205 | 1797 | | of the product, nor have res ponsibility to direct the sale or |
|---|
| 1206 | 1798 | | disposition of the product. For the purposes of this parag raph, |
|---|
| 1207 | 1799 | | “third-party logistics provid er” does not include shippers and the |
|---|
| 1208 | 1800 | | United States Postal Service; |
|---|
| 1209 | 1801 | | 48. “Wholesale distributor ” including “virtual wholesale |
|---|
| 1210 | 1802 | | distributor” means a person other than a manufacturer, a |
|---|
| 1211 | 1803 | | manufacturer’s co-licensed partner, a third-party logistics |
|---|
| 1212 | 1804 | | provider, or repackager engaged in wh olesale distribution as defined |
|---|
| 1213 | 1805 | | by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security |
|---|
| 1214 | 1806 | | Act; |
|---|
| 1246 | 1862 | | 50. “State correctional facility ” means a facility or |
|---|
| 1247 | 1863 | | institution that houses a p risoner population under the jurisdiction |
|---|
| 1248 | 1864 | | of the Department of Corrections; |
|---|
| 1249 | 1865 | | 51. “Unit dose package” means a package that contains a single |
|---|
| 1250 | 1866 | | dose drug with the n ame, strength, control number, and expiration |
|---|
| 1251 | 1867 | | date of that drug on the label; and |
|---|
| 1252 | 1868 | | 52. “Unit of issue package” means a package that provides |
|---|
| 1253 | 1869 | | multiple doses of the same drug, but each drug is individually |
|---|
| 1254 | 1870 | | separated and includes the name, lot number, and expiration da te; |
|---|
| 1255 | 1871 | | 53. “340B drug pricing” means the pricing agreement established |
|---|
| 1256 | 1872 | | under Section 602 of the Veterans Health Care Act of 1992, Pub. L. |
|---|
| 1257 | 1873 | | No. 102-585; and |
|---|
| 1258 | 1874 | | 54. “340B entity” means a covered entity as that term is |
|---|
| 1259 | 1875 | | defined in 42 U.S.C., Section 256b. |
|---|
| 1260 | 1876 | | SECTION 5. NEW LAW A new secti on of law to be codified |
|---|
| 1261 | 1877 | | in the Oklahoma Statutes as Section 355.5 of Title 59, unless there |
|---|
| 1262 | 1878 | | is created a duplication in numbering, reads as follows : |
|---|
| 1263 | 1879 | | A manufacturer shall not: |
|---|
| 1264 | 1880 | | 1. Deny, prohibit, condition, discriminate against, refuse, or |
|---|
| 1265 | 1881 | | withhold 340B drug pricing for, or otherwise limit the dispensing , |
|---|