Current through Register Vol. 55, No. 1, January 4, 2025
Section 16.92 - Prescribing, administering and dispensing controlled substances(a) When prescribing, administering or dispensing controlled substances, a person licensed to practice medicine and surgery in this Commonwealth or otherwise licensed or regulated by the Board shall carry out, or cause to be carried out, the following minimum standards: (1)Initial medical history and physical examination. Except as provided in paragraph (9), an initial medical history shall be taken and an initial physical examination shall be conducted prior to prescribing controlled substances unless emergency circumstances justify otherwise. Medical history and physical examination information recorded by another licensed health care provider may be considered if the medical history was taken and the physical examination was conducted within the immediately preceding 30 days. The physical examination shall include an objective evaluation of the heart, lungs, blood pressure and body functions that relate to the patient-s specific complaint.(2)Reevaluations. Reevaluations of the patient-s condition and efficacy of the controlled substance shall be made consistent with the condition diagnosed, the controlled substance or substances involved, expected results and possible side effects.(3)Patient counseling. The patient shall be counseled regarding the condition diagnosed and the controlled substance prescribed, administered or dispensed. Unless the patient is in an inpatient care setting, the patient shall be specifically counseled about dosage levels, instructions for use, frequency and duration of use and possible side effects.(4)Medical records. Accurate and complete medical records must document the evaluation and care received by patients. The following apply: (i) On the initial occasion when a controlled substance is prescribed, administered or dispensed to a patient, the medical record must include the following: (A) A specification of the symptoms observed by the licensed health care provider and reported by the patient.(B) The diagnosis of the condition for which the controlled substance is being given.(C) The directions given to the patient for the use of the controlled substance.(D) The name, strength and quantity of the controlled substance and the date on which the controlled substance was prescribed, administered or dispensed.(ii) After the initial occasion when a controlled substance is prescribed, administered or dispensed, the medical record must include the information required in subsection (a)(4)(i)(D) and changes or additions to the information recorded under subsection (a)(4)(i)(A)-(C).(5)Emergency prescriptions. In the case of an emergency contact from a known patient, a prudent, short-term prescription for a controlled substance may be issued. Neither a refill nor a consecutive issuance of this emergency prescription may be given unless a physical examination and evaluation of the patient is first conducted by a licensed health care provider. The results of this examination and evaluation shall be recorded in the patient-s medical record together with the diagnosis of the condition for which the controlled substance is being prescribed. An emergency oral prescription for a Schedule II controlled substance shall be covered by a written prescription delivered to the pharmacist within 72 hours.(6)Compliance with other laws.(i) This section may not be construed as restricting or limiting the application of The Controlled Substance, Drug, Device and Cosmetic Act or statutes or regulations of the Department of Health and the Department of Public Welfare that govern the prescription, administration and dispensation of controlled substances and medical recordkeeping in certain health care facilities.(ii) This section may not be construed as restricting or limiting the application of Federal laws or regulations that govern the prescription, administration and dispensation of controlled substances and medical recordkeeping in certain health care facilities.(iii) This section does not relieve a person from complying with more stringent standards that may be imposed by another statute or regulation.(7)Compliance with facility policy. This section does not relieve a person from complying with more stringent standards that may be imposed by the health care facility in which the person practices or by the person-s employer.(8)Adherence to standards of practice. Compliance with this section will not be treated as compliance with the standards of acceptable and prevailing medical practice when medical circumstances require that the licensed health care provider exceed the requirements of this section.(9)Opioid Treatment Programs. For OTPs, the initial physical examination required under subsection (a)(1) may be conducted by means of telehealth for those patients being admitted for treatment of opioid use disorder in an OTP with either buprenorphine or metha-done provided that the provider determines that an adequate evaluation of the patient can be accomplished by telehealth and a full in-person physical examination is completed within 14 days after admission to the OTP. The initial telehealth examination must comply with the requirements of 42 CFR 8.12 (relating to Federal opioid use disorder treatment standards).(b) The following words and terms, when used in this section have the following meanings, unless the context clearly indicates otherwise: Controlled substance-A drug, substance or immediate precursor included in Schedules I through V of The Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. §§ 780-101-780-144) or that are controlled substances under Federal law as set forth at 21 U.S.C. § 812 (relating to schedules of controlled substances).
OTP-Opioid Treatment Program-A program engaged in opioid use disorder treatment of individuals with medications for opioid use disorder registered under the Controlled Substances Act at 21 U.S.C. § 823(h)(1)) (relating to registration requirements).
Telehealth-The delivery and facilitation of health care services by telecommunications and digital communication technologies, including Health Insurance Portability and Accountability Act (HIPPA)-compliant video and audio-only communication platforms.
The provisions of this § 16.92 amended June 21, 2013, effective 6/22/2013, 43 Pa.B. 3347.Amended by Pennsylvania Bulletin, Vol 54, No. 51. December 21, 2024, effective 12/21/2024The provisions of this § 16.92 amended under section 8 of the Medical Practice Act of 1985 (63 P. S. § 422.8).
This section cited in 49 Pa. Code § 18.6a (relating to prescribing, dispensing and administering drugs); 49 Pa. Code § 18.157 (relating to administration of controlled substances and whole blood and blood components); and 49 Pa. Code § 18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices).