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§ 780-111. Professional prescription, administration, and dispensing

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: October 24, 2019

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 6. The Controlled Substance, Drug, Device and Cosmetic Act (Refs & Annos)
Effective: October 24, 2019
35 P.S. § 780-111
§ 780-111. Professional prescription, administration, and dispensing
Currentness
(a) Except when dispensed or administered directly to the patient by a practitioner or his authorized agent, other than a pharmacist, to an ultimate user, no controlled substance in Schedule II shall be dispensed without an electronic prescription of a practitioner, except in situations, as prescribed by the secretary by regulation. No prescription for a controlled substance in Schedule II may be refilled. All electronic prescription applications shall meet the requirements outlined in 21 CFR § 1311.120 (relating to electronic prescription application requirements). The electronic prescription requirement under this subsection shall not apply if the prescription is issued:
(1) by a veterinarian;
(2) under circumstances when an electronic prescription is not available to be issued or received due to a temporary technological or electrical failure, and, in the instance of a temporary technological failure, a practitioner shall, within seventy-two hours, seek to correct any cause for the failure that is reasonably within his or her control;
(3) by a practitioner and dispensed by a pharmacy located outside this Commonwealth;
(4) by a practitioner who or health care facility that does not have either of the following:
(i) Internet access; or
(ii) an electronic health record system;
(5) by a practitioner treating a patient in an emergency department or a health care facility under circumstances when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical for the patient to obtain the controlled substance prescribed by electronic prescription or would cause an untimely delay resulting in an adverse impact on the patient's medical condition;
(6) for a patient enrolled in a hospice program or for a patient residing in a nursing home or residential health care facility;
(7) for controlled substance compounded prescriptions and prescriptions containing certain elements required by the Federal Food and Drug Administration or any other governmental agency that are not able to be accomplished with electronic prescribing;
(8) pursuant to an established and valid collaborative practice agreement between a practitioner and a pharmacist, a standing order or a drug research protocol;
(9) in an emergency situation pursuant to Federal or State law and regulations of the department;
(10) under circumstances where the pharmacy that receives the prescription is not set up to process electronic prescriptions; or
(11) for controlled substances that are not required to be reported to the Prescription Drug Monitoring Program system administered by the department.
(b) Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in Schedule III, IV or V shall be dispensed without an electronic prescription of a practitioner, except in situations, as prescribed by the secretary by regulation. Such prescriptions shall not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner. All electronic prescription applications shall meet the requirements outlined in 21 CFR § 1311.120. The electronic prescription requirement under this subsection shall not apply if the prescription is issued:
(1) by a veterinarian;
(2) under circumstances when an electronic prescription is not available due to a temporary technological or electrical failure;
(3) by a practitioner and dispensed by a pharmacy located outside this Commonwealth;
(4) by a practitioner who or health care facility that does not have either of the following:
(i) Internet access; or
(ii) an electronic health record system;
(5) by a practitioner treating a patient in an emergency department or a health care facility under circumstances when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical for the patient to obtain the controlled substance prescribed by electronic prescription or would cause an untimely delay resulting in an adverse impact on the patient's medical condition;
(6) for a patient enrolled in a hospice program or for a patient residing in a nursing home or residential health care facility;
(7) for controlled substance compounded prescriptions and prescriptions containing certain elements required by the Federal Food and Drug Administration or any other governmental agency that are not able to be accomplished with electronic prescribing;
(8) for a prescription issued pursuant to an established and valid collaborative practice agreement between a practitioner and a pharmacist, a standing order or a drug research protocol;
(9) for a prescription issued in an emergency situation pursuant to Federal or State law and regulations of the board;
(10) under circumstances where the pharmacy that receives the prescription is not set up to process electronic prescriptions; or
(11) for controlled substances that are not required to be reported to the Prescription Drug Monitoring Program system administered by the department.
(b.1)(1) A practitioner, pharmacy or health care facility that does not meet an exception to the electronic prescribing requirements under subsection (a) or (b) and is unable to timely comply with the electronic prescribing requirements may petition the department for an exemption from the requirements based upon economic hardship, technical limitations or exceptional circumstances.
(2) The department shall adopt rules establishing the form and specific information to be included in a request for an exemption.
(3) The department may approve an exemption for a period of time determined by the department not to exceed one year from the date of approval and may be renewed annually upon request subject to department approval.
(4) The department may grant additional exemptions beyond the exemptions provided for in subsections (a) and (b) subject to the act of June 25, 1982 (P.L. 633, No. 181),1 known as the “Regulatory Review Act.”
(b.2) A prescription generated on an electronic system and printed or transmitted via facsimile is not an electronic prescription.
(b.3)(1) A pharmacist who receives a written, oral or faxed prescription shall not be required to verify that the prescription properly falls under one of the exceptions provided in subsections (a) and (b) from the requirement to electronically prescribe. A pharmacist may continue to dispense medications from the otherwise valid written, oral or faxed prescriptions that are consistent with current laws and regulations.
(2) If a pharmacist has a reasonable belief that a patient may be seeking a monitored prescription drug for a purpose other than the treatment of an existing medical condition, the pharmacist shall have the responsibility described in 21 CFR § 1306.04 (relating to purpose of issue of prescription).
(3) A practitioner shall be subject to the responsibilities described in 21 CFR § 1311.102 (relating to practitioner responsibilities).
(b.4) The department shall require the prescription origin to be submitted by dispensers under the authority of the department in compliance with the act of October 27, 2014 (P.L. 2911, No. 191),2 known as the “Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act.”
(b.5) A practitioner who violates subsection (a) or (b) is subject to an administrative penalty of one hundred dollars ($100) for the first through tenth violations and two hundred and fifty dollars ($250) for each subsequent violation after the tenth violation, up to a maximum of five thousand dollars ($5,000) per calendar year. Violations shall reset and shall not carry over to subsequent calendar years. The assessment of an administrative penalty pursuant to this subsection by the department to a practitioner alleged to have violated subsection (a) or (b) shall not be reported by the department to the practitioner's appropriate licensing board and shall not be considered a disciplinary action or need to be reported by the practitioner as a violation to the practitioner's appropriate licensing board. A practitioner may appeal the assessment of an administrative penalty pursuant to 2 Pa.C.S. (relating to administrative law and procedure).
(b.6) The department, within one hundred eighty days of the effective date of this subsection,3 shall promulgate regulations necessary to implement the requirements of this act.
(c) No controlled substance in Schedule V4 may be distributed or dispensed for other than a medicinal purpose.
(d) A practitioner may prescribe, administer, or dispense a controlled substance or other drug or device only (i) in good faith in the course of his professional practice, (ii) within the scope of the patient relationship, and (iii) in accordance with treatment principles accepted by a responsible segment of the medical profession. A practitioner may cause a controlled substance, other drug or device or drug to be administered by a professional assistant under his direction and supervision.
(d.1) A practitioner shall not prescribe, administer or dispense any anabolic steroid for the purpose of enhancing a person's performance in an exercise, sport or game. A practitioner may not prescribe, administer or dispense any anabolic steroid for the purpose of hormonal manipulation intended to increase muscle mass, strength or weight except when medically necessary.
(e) A veterinarian may prescribe, administer, or dispense a controlled substance, other drug or device only (i) in good faith in the course of his professional practice, and (ii) not for use by a human being. He may cause a controlled substance, other drug or device to be administered by a professional assistant under his direction and supervision.
(f) Any drug or device dispensed by a pharmacist pursuant to a prescription order shall bear a label showing (i) the name and address of the pharmacy and any registration number obtained pursuant to any applicable Federal laws, (ii) the name of the patient, or, if the patient is an animal, the name of the owner of the animal and the species of the animal, (iii) the name of the practitioner by whom the prescription order was written, and (iv) the serial number and date of filing of the prescription order. In addition, the following statement shall be required on the label of a controlled substance: “Transfer of this drug to anyone other than the patient for whom it was prescribed is illegal.”

Credits

1972, April 14, P.L. 233, No. 64, § 11, effective June 14, 1972. Amended 1989, Dec. 22, P.L. 750, No. 104, § 2, effective in 60 days; 1993, July 2, P.L. 377, No. 53, § 1, effective in 60 days; 2018, Oct. 24, P.L. 662, No. 96, § 3, effective in one year [Oct. 24, 2019].

Footnotes

1
71 P.S. § 745.1 et seq.
2
35 P.S. § 872.1 et seq.
3
Subsec. (b.6) added by 2018, Oct. 24, P.L. 662, No. 96, § 3, effective in one year [Oct. 24, 2019].
4
35 P.S. § 780-104.
35 P.S. § 780-111, PA ST 35 P.S. § 780-111
Current through Act 10 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
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