1. (a) Prescription orders may be written on prescription blanks or may be oral, if allowed by law.

2. (b) If prescriptions are issued in writing, the bottom of every prescription blank shall be imprinted with the words ‘‘substitution permissible’’ and shall contain one signature line for the physician’s or other authorized prescriber’s signature. The prescriber’s signature shall validate the prescription, and unless the prescriber handwrites ‘‘brand necessary’’ or ‘‘brand medically necessary’’ shall designate approval of substitution of a drug by a pharmacist, pursuant to the act. Imprinted conspicuously on the prescription blanks shall be the words: IN ORDER FOR A BRAND NAME PRODUCT TO BE DISPENSED, THE PRESCRIBER MUST HANDWRITE ‘‘BRAND NECESSARY’’ OR ‘‘BRAND MEDICALLY NECESSARY’’ IN THE SPACE BELOW.’’ Information printed on the prescription blank shall be in 8 point, upper-case print. The following example would be acceptable: SUBSTITUTION PERMISSIBLE

   M.D.* IN ORDER FOR A BRAND NAME PRODUCT TO BE DISPENSED, THE PRESCRIBER MUST HANDWRITE ‘‘BRAND NECESSARY’’ OR ‘‘BRAND MEDICALLY NECESSARY’’ IN THE SPACE BELOW. *as appropriate

3. (c) If prescription orders are given orally, substitution is permissible unless the prescriber expressly indicates to the pharmacist that the brand name drug is necessary and that substitution is not allowed.

4. (d) Prescriptions for controlled substances shall be written in indelible ink, indelible pencil or typewriter and shall include the following information:

   1. (1) The date of issue.
   2. (2) The name and address of the patient, or if the patient is an animal, the name and address of the owner and the species of the animal.
   3. (3) Directions for administration.
   4. (4) The name, address and Federal Drug Enforcement Administration registration number of the prescribing practitioner.
   5. (5) The signature of the prescribing practitioner in the manner described in subsection (b).
5. (e) The Federal Drug Enforcement Administration registration number cannot be preprinted on the prescription form.

Authority

The provisions of this § 25.53 issued under section 5(a) of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. § 960.5); amended under section 3 of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. § 960.5); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

Source

The provisions of this § 25.53 amended through June 24, 1977, 7 Pa.B. 1815; amended October 26, 1990, effective October 27, 1990, 20 Pa.B. 5426. Immediately preceding text appears at serial pages (116446) to (116447).

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relating to prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices); 49 Pa. Code § 25.177 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs).