D.C. Mun. Regs. tit. 22, r. 22-B1325

Current through Register Vol. 71, No. 52, December 27, 2024

Rule 22-B1325 - ISSUANCE OF NON-CONTROLLED SUBSTANCES

1325.1

A pharmacist shall dispense a non-controlled substance, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, or medical device pursuant to a valid written, oral, facsimile, or electronic prescription issued in compliance with this chapter by a licensed practitioner authorized to prescribe the substance or medical device.

1325.2

A prescription issued by a prescribing practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner only pursuant to the directions and order of the practitioner, and in conformance with applicable federal and District of Columbia laws and regulations and this chapter.

1325.3

A prescription order shall be issued or dispensed only for a legitimate medical purpose by a prescribing practitioner acting in the usual course of his or her professional practice.

1325.4

The prescribing practitioner and the pharmacist shall be jointly responsible for compliance with this chapter in prescribing and dispensing a prescribed substance or medical device.

1325.5

Any person issuing a prescription and any person knowingly filling a prescription which is not in conformity with this chapter shall be subject to the penalties provided for violations of the Act and this chapter.

1325.6

Non-controlled substance prescriptions shall have a label affixed to the package meeting the requirements as set forth in Chapter 19 of this title.

1325.7

The label required in § 1325.6 does not apply to a prescription for a non-controlled substance that is prescribed for administration to a patient who is institutionalized if the following limitations are observed:

(a) Not more than a thirty (30) day supply or one hundred (100) dosage units, whichever is less, of the prescription is dispensed at one time;

(b) The prescription controlled substance is not in the possession of the patient prior to administration;

(c) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the prescription substance; and

(d) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and sets forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

1325.8

A prescription for a non-controlled substance shall not be filled if presented for dispensing more than one (1) year after the date on which the prescription was issued.

1325.9

The total amount dispensed under one prescription order for a non-controlled substance, including refills, shall be limited to a one (1) year supply, not to exceed other applicable federal or District laws.

1325.10

Each refilling of a prescription shall be entered on the back of the prescription, or on another appropriate, uniformly maintained, readily retrievable record such as a medication record. The following information must be retrievable by the prescription number:

(a) The name of the drug or the name and manufacturer of the substituted drug if different than the originally prescribed or filled drug;

(b) The dosage form of the drug dispensed;

(c) The date of each refilling and the quantity dispensed;

(d) The identity or initials of the dispensing pharmacist for each refill; and

(e) The total number of refills for that prescription.

1325.11

If the pharmacist merely initials and dates the back of a prescription or in the electronic record, he or she shall be deemed to have dispensed a refill for the full face amount of the prescription.

1325.12

The prescribing practitioner may authorize additional refills of a non-controlled substance on the original prescription through an oral refill authorization transmitted to the pharmacist provided that the following conditions are met:

(a) The total quantity authorized, including the amount of the original prescription, does not extend beyond one year from the date of issuance of the original prescription;

(b) The pharmacist obtaining the oral authorization shall record the date, quantity of refill, and number of additional refills authorized, on the reverse of the original prescription and initial the prescription documenting that he or she received the authorization from the prescribing practitioner who issued the original prescription; and

(c) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.

1325.13

Additional quantities of prescription non-controlled substances beyond the one year limitation, shall only be authorized by a prescribing practitioner through the issuance of a new and separate prescription.

1325.14

As an alternative to the procedures provided under § 1325.10 of this chapter, an automated data processing system may be used for the storage and retrieval of refill information for prescription drug orders and prescription records.

1325.15

The partial filling of a prescription for a non-controlled substance is permissible, if the pharmacist is unable to supply the full quantity called for in the prescription, and he or she makes a notation of the quantity supplied on the face of the written or facsimile prescription (or written record of the oral prescription), provided that:

(a) Each partial filling is recorded in the same manner as a refilling;

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

(c) No dispensing occurs beyond one year after the date on which the prescription was issued.

1325.16

A pharmacist shall notify the prescribing physician if:

(a) The pharmacist is unable to dispense the remaining portion of a partially filled prescription for a prescription non-controlled substance within a reasonable period of time;

(b) The inability to do so lies with the pharmacy; and

(c) In the professional judgment of the pharmacist the delay may jeopardize or alter the drug therapy of the patient.

D.C. Mun. Regs. tit. 22, r. 22-B1325

Final Rulemaking published at 56 DCR 4742 (June 19, 2009)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980, (D.C. Law 3-98; D.C. Official Code § 47-2885.18.01(a)(3)); the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D. C. Law 4-29; D.C. Official Code § 48-901.01); Mayor's Order 98-48, dated April 15, 1998, Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731); Section 15 of the District of Columbia Drug Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a)); and Mayor's Order 98-88, dated May 29, 1998.