DEPARTMENT OF HEALTH
Electronically Transmitted Prescriptions
[40 Pa.B. 7160]
[Saturday, December 11, 2010]
It has come to the Department of Health's (Department) attention that there is concern from members of the medical and pharmaceutical communities whether the electronic transmission of prescriptions to a pharmacy violates provisions of The Controlled Substance, Drug, Device and Cosmetic Act (DD&C Act) (35 P. S. §§ 780-101—780-144) and the regulations promulgated thereunder at 28 Pa. Code §§ 25.1 to 25.131. Through this notice, the Department seeks to clarify its position regarding whether this is an acceptable practice for the medical and pharmaceutical communities under the DD&C Act and its regulations, most notably 28 Pa. Code §§ 25.53(a) and (d) and 25.56(b) (relating to prescription orders; and prescription record keeping).
The Department recognizes the important technological advancements in the electronic prescribing of prescriptions. Therefore, subject to the limitations set forth as follows, the Department recognizes written prescriptions to include the electronic transmission of prescriptions by authorized members of the healing arts to a patient's pharmacy for processing and that this practice by itself will not constitute a violation of the DD&C Act or its regulations, when applicable.
A. 28 Pa. Code § 25.53(a)
Section 25.53(a) of 28 Pa. Code states that prescription orders may be written on prescription blanks or may be oral, if allowed by law. The electronic transmission of prescriptions shall be considered a written order on a prescription blank provided that the transmission complies with the remainder of 28 Pa. Code § 25.53 and any other requirements under Federal and other State laws or regulations, including, but not limited to, regulations promulgated by the State Board of Pharmacy at 49 Pa. Code Chapter 27, specifically 49 Pa. Code § 27.201 (relating to electronically transmitted prescriptions), and the Generic Equivalent Drugs Act (35 P. S. §§ 960.1— 960.7), specifically 35 P. S. § 960.3 regarding substitution for brand name drugs; oral prescription; notice to purchaser; refusal of substitution; prices; records; labels.
Prescriptions transmitted by means of facsimile shall be considered a written order on a prescription blank provided that the facsimile transmission meets the requirements of Federal and State laws and regulations, including, but not limited to, other requirements under the DD&C Act and its regulations and regulations promulgated by the State Board of Pharmacy at 49 Pa. Code Chapter 27, specifically 49 Pa. Code § 27.20 (relating to facsimile machines).
B. 28 Pa. Code § 25.53(d)
Section 25.53(d) of 28 Pa. Code states that prescriptions for controlled substances shall be written in indelible ink, indelible pencil or typewriter and shall include certain information. Electronically transmitted prescriptions shall be considered a typewritten order and shall satisfy the requirements of this section provided that these prescriptions comply with Federal and other State laws and regulations, including, but not limited to, the remainder of 28 Pa. Code § 25.53 and 49 Pa. Code Chapter 27.
C. 28 Pa. Code § 25.56(b)
A portion of 28 Pa. Code § 25.56(b) states that records for prescription orders for controlled substances in Schedules III, IV and V shall be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is marked in red ink in the lower right corner with the letter ''C,'' no less than 1 inch high and filed in the usual consecutively numbered prescription file for non-controlled substances.
Provided that a pharmacy can provide a hard copy or readily retrievable image of each electronically transmitted prescription for controlled substances in Schedules III, IV and V, and these hard copies or readily retrievable images meet the requirements for record keeping mandated by Federal and other State laws or regulations, including, but not limited to, 49 Pa. Code Chapter 27, the Department will deem the pharmacy to be in compliance with this section and the requirements for marking the electronic prescription in red ink with a letter ''C'' shall not be required.
Nothing in this notice shall be construed to waive any requirements or restrictions mandated under Federal and other State laws or regulations, including other requirements of the DD&C Act and its regulations or any other requirements issued by the appropriate State licensing boards.
This notice shall take effect immediately and remain in full force and effect until further notice by the Department.
STACY A. MITCHELL,
Deputy Secretary for Quality Assurance
[Pa.B. Doc. No. 10-2373. Filed for public inspection December 10, 2010, 9:00 a.m.]
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