FL Stat § 397.427 (2021)
2021 Florida Statutes|Title XXIX - Public Health|Chapter 397 - Substance Abuse Services|Part II - Service Providers (Ss. 397.401-397.4873)|397.427 - Medication-assisted treatment service providers; rehabilitation program; needs assessment and provision of services; persons authorized to issue takeout medication; unlawful operation; penalty.

397.427 Medication-assisted treatment service providers; rehabilitation program; needs assessment and provision of services; persons authorized to issue takeout medication; unlawful operation; penalty.—(1) Providers of medication-assisted treatment services for opiate addiction may not be licensed unless they provide supportive rehabilitation programs. Supportive rehabilitation programs include, but are not limited to, counseling, therapy, and vocational rehabilitation.(2) The department shall determine the need for establishing providers of medication-assisted treatment services for opiate addiction.(a) Providers of medication-assisted treatment services for opiate addiction may be established only in response to the department’s determination and publication of need for additional medication treatment services.(b) If needs assessment is required, the department shall annually conduct the assessment and publish a statement of findings which identifies each substate entity’s need.(c) Notwithstanding paragraphs (a) and (b), the license for medication-assisted treatment programs for opiate addiction licensed before October 1, 1990, may not be revoked solely because of the department’s determination concerning the need for medication-assisted treatment services for opiate addiction.(3) A service provider operating in violation of this section is subject to proceedings in accordance with this chapter to enjoin that unlawful operation.(4) Notwithstanding s. 465.019(2), a physician assistant, a registered nurse, an advanced practice registered nurse, or a licensed practical nurse working for a licensed service provider may deliver takeout medication for opiate treatment to persons enrolled in a maintenance treatment program for medication-assisted treatment for opiate addiction if:(a) The medication-assisted treatment program for opiate addiction has an appropriate valid permit issued pursuant to rules adopted by the Board of Pharmacy;(b) The medication for treatment of opiate addiction has been delivered pursuant to a valid prescription written by the program’s physician licensed pursuant to chapter 458 or chapter 459;(c) The medication for treatment of opiate addiction which is ordered appears on a formulary and is prepackaged and prelabeled with dosage instructions and distributed from a source authorized under chapter 499;(d) Each licensed provider adopts written protocols which provide for supervision of the physician assistant, registered nurse, advanced practice registered nurse, or licensed practical nurse by a physician licensed pursuant to chapter 458 or chapter 459 and for the procedures by which patients’ medications may be delivered by the physician assistant, registered nurse, advanced practice registered nurse, or licensed practical nurse. Such protocols shall be signed by the supervising physician and either the administering registered nurse, the advanced practice registered nurse, or the licensed practical nurse.(e) Each licensed service provider maintains and has available for inspection by representatives of the Board of Pharmacy all medical records and patient care protocols, including records of medications delivered to patients, in accordance with the board.(5) The department shall also determine the need for establishing medication-assisted treatment for substance use disorders other than opiate dependence. Service providers within the publicly funded system shall be funded for provision of these services based on the availability of funds.(6) Service providers that provide medication-assisted treatment for substance abuse other than opiate dependence shall provide counseling services in conjunction with medication-assisted treatment.(7) A physician assistant, a registered nurse, an advanced practice registered nurse, or a licensed practical nurse working for a licensed service provider may deliver medication as prescribed by rule if:(a) The service provider is authorized to provide medication-assisted treatment;(b) The medication has been administered pursuant to a valid prescription written by the program’s physician who is licensed under chapter 458 or chapter 459; and(c) The medication ordered appears on a formulary or meets federal requirements for medication-assisted treatment.(8) Each licensed service provider that provides medication-assisted treatment must adopt written protocols as specified by the department and in accordance with federally required rules, regulations, or procedures. The protocol shall provide for the supervision of the physician assistant, registered nurse, advanced practice registered nurse, or licensed practical nurse working under the supervision of a physician who is licensed under chapter 458 or chapter 459. The protocol must specify how the medication will be used in conjunction with counseling or psychosocial treatment and that the services provided will be included on the treatment plan. The protocol must specify the procedures by which medication-assisted treatment may be administered by the physician assistant, registered nurse, advanced practice registered nurse, or licensed practical nurse. These protocols shall be signed by the supervising physician and the administering physician assistant, registered nurse, advanced practice registered nurse, or licensed practical nurse.(9) Each licensed service provider shall maintain and have available for inspection by representatives of the Board of Pharmacy all medical records and protocols, including records of medications delivered to individuals in accordance with rules of the board.History.—s. 3, ch. 93-39; s. 7, ch. 98-152; s. 21, ch. 2009-132; s. 10, ch. 2015-4; s. 26, ch. 2018-106.