Section 22-B1306. PRESCRIPTIONS FOR CONTROLLED SUBSTANCES LISTED IN SCHEDULE II  


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    1306.1Except as otherwise authorized in this section, a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, shall only be dispensed pursuant to a valid written prescription signed by the prescribing practitioner, unless otherwise authorized by federal law.

     

    1306.2 A prescription for a controlled substance listed in Schedule II shall not be filled if submitted more than thirty (30) days after the date on which the prescription is written; except as follows:

     

    (a) A pharmacist may fill a prescription for a controlled substance listed in Schedule II that was submitted to the pharmacy more than thirty (30) days after the date on which it was written, if it is clear on the face of the prescription that the individual practitioner issued multiple prescriptions authorizing the patient to receive a total of up to a ninety (90)-day supply of the Schedule II controlled substance and:

     

    (i) Each separate prescription was issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;

     

    (ii) The individual practitioner provided written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription; and

     

    (iii) The prescription is presented to the pharmacy for filling not more than ninety (90) days after the date on which the prescription was written.

     

    1306.3A prescription for a controlled substance listed in Schedule II shall not be refilled and shall be cancelled out by a line drawn through the entire prescription order, with the date dispensed and initials of the person that dispensed the drug.

     

    1306.4A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via telephone facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to issuance of the controlled substance to the patient or the patient's representative. The original prescription shall be maintained in accordance with the requirements of this chapter and as required under federal and District law.

     

    1306.5In emergency situations, as defined under § 1306.6 of this chapter, a pharmacist may dispense Schedule II drugs upon the oral prescription of a practitioner. The pharmacist shall comply with the following requirements as set forth in 21 C.F.R. § 1306.11(d) and failure to do so may result in suspension or revocation of a pharmacy registration:

     

    (a)The quantity prescribed and dispensed is limited to no more than a seven (7) day supply to treat the patient during the emergency period (dispensing beyond the emergency period shall be pursuant to a written prescription signed by the prescribing individual practitioner);

     

    (b)The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required by District and federal law;

     

    (c)If the prescribing practitioner is not known to the pharmacist, the pharmacist shall make a reasonable effort to determine that the oral authorization came from a registered practitioner, which may include a call back to the prescribing practitioner using the practitioner's phone number as listed in the telephone directory or other good faith efforts to insure the practitioner's identity; and

     

    (d)Within seven (7) days after authorizing an emergency oral prescription, the practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of § 1301 of this chapter, the prescription shall:

     

    (1)Have written on its face "Authorization for Emergency Dispensing," and the date of the oral order; and

     

    (2)The written prescription shall be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven (7) day period. Upon receipt, the dispensing pharmacist shall attach the written prescription to the oral emergency prescription which was previously reduced to writing. The pharmacist shall notify, in writing, the Director if the prescribing individual practitioner fails to deliver a written prescription to him or her. Failure of the pharmacist to notify the Director shall void the authority conferred by this section to dispense without a written prescription of a prescribing practitioner.

     

    1306.6As used in this section "emergency situation" means those situations in which the prescribing practitioner determines the following:

     

    (a)That immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user;

     

    (b)That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II; and

     

    (c)That it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing.

     

    1306.7A prescription for a Schedule II controlled substance to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the institutional or home health care pharmacy by telephone facsimile. The telephone facsimile shall serve as the original written prescription and shall be maintained in accordance with the requirements of this Title and federal and District law.

     

    1306.8A prescription for a Schedule II controlled substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by telephone facsimile. The telephone facsimile shall serve as the original written prescription and shall be maintained in accordance with the requirements of this Title and federal and District law.

     

    1306.9A prescription for a Schedule II controlled substance for a patient enrolled in a hospice care program certified or paid for by Medicare under Title XVIII or a hospice program which is licensed by the District may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by telephone facsimile. The practitioner or the practitioner's agent shall note on the prescription that the patient is a hospice patient. The telephone facsimile shall serve as the original written prescription and shall be maintained in accordance with the requirement of this Title and federal and District law.

     

    1306.10An individual practitioner may administer or dispense directly to a patient a Schedule II controlled substance in the course of his or her professional practice without a prescription, subject to the conditions set forth in 21 C.F.R. § 1306.07.

     

    1306.11An institutional practitioner may administer or dispense directly, (but not prescribe) a controlled substance listed in Schedule II only pursuant to:

     

    (a)A valid written prescription signed by the prescribing individual practitioner; or

     

    (b)An order for medication made by an individual practitioner which is dispensed for immediate administration to the patient, subject to 21 C.F.R. § 1306.07.

     

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)); section 301 of 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

source

Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009); as amended by Final Rulemaking published at 57 DCR 1240 (February 5, 2010).