1. A. A prescription for a controlled substance listed in Schedule II may not be refilled.

2. B. A prescription for a controlled substance listed in Schedule III, IV, or V:

   1. (1) May not be refilled more than 6 months after the date on which the prescription was issued;
   2. (2) May not be refilled more than five times; and
   3. (3) Shall require a new and separate prescription to be issued if additional quantities are deemed necessary by the authorized prescribing provider.

3. C. The prescribing provider may authorize additional refills of Schedule III, IV, or V substances on the original prescription through an oral refill authorization transmitted to the pharmacist if the following conditions are met:

   1. (1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills or extend beyond 6 months from the date of issue of the original prescription;
   2. (2) The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, and number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription;
   3. (3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription; and
   4. (4) The prescribing practitioner executes a new and separate prescription for any additional quantities beyond the five-refill, 6-month limitation.

4. D. Required Documentation.

   1. (1) Each refilling of a prescription shall be documented on the:

      1. (a) Back of the prescription;
      2. (b) With Department approval, on another appropriate uniformly maintained, readily retrievable record, such as medication records; or
      3. (c) electronic prescription record.

   2. (2) The documentation shall indicate the:

      1. (a) Number of the prescription;
      2. (b) Name of the controlled substance;
      3. (c) Dosage form of the controlled substance;
      4. (d) Date of each refilling;
      5. (e) Quantity dispensed;
      6. (f) Identity or initials of the dispensing pharmacist in each refilling;
      7. (g) Total number of refills for that prescription;
      8. (h) Pharmacist’s initials; and
      9. (i) Date by the pharmacist as of the date of dispensing.

   3. (3) Each refilling of a prescription shall:

      1. (a) State the amount dispensed; or
      2. (b) If the amount dispensed is not specifically stated, be deemed to have been dispensed for the full face amount of the prescription.

Authority: Criminal Law Article, Title 5; Health-General Article, §21-220; Annotated Code of Maryland

Effective date: January 19, 1977 (4:2 Md. R. 87)

Regulation .03A amended effective December 17, 1984 (11:25 Md. R. 2134); February 17, 1992 (19:3 Md. R. 304); December 24, 2001 (28:25 Md. R. 2190)

Regulation .07E and J amended effective August 17, 1992 (19:16 Md. R. 1474)

Regulation .07H amended effective July 12, 1998 (25:14 Md. R. 1132)

Regulations .07N, R and .10B amended effective February 10, 1978 (5:3 Md. R. 138)

Regulation .08G amended effective March 30, 1992 (19:6 Md. R. 673)

Regulation .09A amended effective April 18, 1980 (7:8 Md. R. 771)

Chapter revised effective April 26, 2004 (31:8 Md. R. 646)

Regulation .03 repealed and new Regulation .03 adopted effective April 24, 2006 (33:8 Md. R. 732)

Regulation .03 amended effective January 1, 2016 (42:22 Md. R. 1377)

Regulation .13 adopted as an emergency provision effective October 18, 2011 (38:24 Md. R. 1495); adopted permanently effective December 26, 2011 (38:26 Md. R. 1697)

Regulations .01—.13 repealed and new Regulations .01—.20 adopted effective October 14, 2024 (51:20 Md. R. 899)