Section 25.177. Prescribing and dispensing drugs, pharmaceutical aids and devices

(a) Prescribing, dispensing and administration of drugs.

(1) The supervising physician may delegate to the physician assistant the prescribing, dispensing and administering of drugs and therapeutic devices.

(2) A physician assistant may not prescribe or dispense Schedule I controlled substances as defined under section 4 of The Controlled Substances, Drug, Device and Cosmetic Act (35 P. S. § 780-104).

(3) A physician assistant may prescribe a Schedule II controlled substance for initial therapy, up to a 72-hour dose. The physician assistant shall notify the supervising physician of the prescription as soon as possible, but in no event longer than 24 hours from the issuance of the prescription. The physician assistant shall have no authority to prescribe a Schedule II controlled substance after the initial therapy of up to a 72-hour dose, until the patient has been examined by the supervising physician and the supervising physician has reviewed and approved the prescription of a Schedule II controlled substance by the physician assistant for up to a 30-day supply.

(i) If the supervising physician determines and documents that the patient is chronically ill, the physician assistant may write a prescription for a Schedule II controlled substance for up to a 30-day supply of the Schedule II controlled substance, only if the prescription of a Schedule II controlled substance by the physician assistant is reviewed and approved by the supervising physician at least every 30 days.

(ii) If the supervising physician determines and documents that the patient is terminally ill, the physician assistant may write a prescription for a Schedule II controlled substance for up to a 30-day supply if the prescription of a Schedule II controlled substance by the physician assistant is reviewed and approved by the supervising physician at least every 120 days.

(iii) The prescription must clearly state on its face that it is for initial or ongoing therapy.

(4) A physician assistant may only prescribe or dispense a drug for a patient who is under the care of the physician responsible for the supervision of the physician assistant and only in accordance with the supervising physician’s instructions and written agreement.

(5) A physician assistant may request, receive and sign for professional samples and may distribute professional samples to patients.

(6) A physician assistant authorized to prescribe or dispense, or both, controlled substances shall register with the Drug Enforcement Administration (DEA).

(b) Prescription blanks. The requirements for prescription blanks are as follows:

(1) Prescription blanks must bear the license number of the physician assistant and the name of the physician assistant in printed format at the heading of the blank. The supervising physician’s name and license number must also be printed or preprinted on the prescription.

(2) The signature of a physician assistant must be followed by the initials ‘‘PA-C’’ or similar designation to identify the signer as a physician assistant. When appropriate, the physician assistant’s DEA registration number must appear on the prescription.

(3) The supervising physician is prohibited from presigning prescription blanks.

(4) The physician assistant may use a prescription blank generated by a hospital provided the information in paragraph (1) appears on the blank.

(c) Inappropriate prescription. The supervising physician shall immediately advise the patient, notify the physician assistant and, in the case of a written or oral prescription, advise the pharmacy if the physician assistant is prescribing or dispensing a drug inappropriately. The supervising physician shall advise the patient and notify the physician assistant to discontinue using the drug and, in the case of a written or oral prescription, notify the pharmacy to discontinue the prescription. The order to discontinue use of the drug or prescription shall be noted in the patient’s medical record by the supervising physician.

(d) Recordkeeping requirements. Recordkeeping requirements are as follows:

(1) When prescribing a drug, the physician assistant shall keep a copy of the prescription, including the number of refills, in a ready reference file, or record the name, amount, directions for use and doses of the drug prescribed, the number of refills, the date of the prescription and the physician assistant’s name in the patient’s medical records.

(2) When dispensing a drug, the physician assistant shall record the physician assistant’s name, the name of the medication dispensed, the amount of medication dispensed, the dose of the medication dispensed and the date dispensed in the patient’s medical records.

(3) The physician assistant shall report, orally or in writing, to the supervising physician within 36 hours, a drug prescribed or medication dispensed by the physician assistant while the supervising physician was not physically present, and the basis for each decision to prescribe or dispense in accordance with the written agreement.

(4) The supervising physician shall countersign the patient record at least weekly in accordance with § 25.178 (relating to medical records).

(5) The physician assistant and the supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the physician assistant’s authority to prescribe or dispense a drug. The written agreement must list the categories of drugs which the physician assistant is not permitted to prescribe.

(e) Compliance with regulations relating to prescribing, administering, dispensing, packaging and labeling of drugs. A physician assistant shall comply with this section and with the regulations of the Department of Health in 28 Pa. Code § § 25.51—25.58 and 25.91—25.95 (relating to prescriptions; and labeling of drugs, devices and cosmetics).

The provisions of this § 25.177 adopted August 7, 2009, effective August 8, 2009, 39 Pa.B. 4754.