54628 To allow practitioners to issue multiple prescriptions for Schedule II controlled substances to authorize the patient to receive up to a 90-day supply.

DEPARTMENT OF HEALTH

                                            _____________________________________

 

                                            NOTICE OF PROPOSED RULEMAKING                                   

                                            ______________________________________

 

The Director of the Department of Health, pursuant to the authority set forth in 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; hereby gives notice of his intent to take final rulemaking action to adopt the following amendments to Chapter 13 (Prescriptions and Distribution) of Title 22 of the District of Columbia Municipal Regulations (DCMR) in not less than thirty (30) days from the date of publication of this notice in the D.C. Register. 

 

The purpose of this amendment is to allow the District’s regulations to coincide with its Federal counterpart as set forth in 21 CFR § 1306.12, which allows practitioners to issue multiple prescriptions for Schedule II controlled substances to authorize the patient to receive up to a 90-day supply. 

 

These rules were previously published as proposed rulemaking on July 10, 2009 at 56 DCR 5620.  Written comments were received from the National Association of Chain Drug Stores. Based on these comments, the Board voted to amend § 1302.6 to change the requirement from seventy (70) days to ninety (90) days.  Therefore, the revised rulemaking is being republished for another 30-day comment period.  

 

The following rulemaking action is proposed:

 

CHAPTER 13 (PRESCRIPTIONS AND DISTRIBUTION) is amended as follows:

 

Section 1306.2 is amended to read as follows:

 

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 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.

All persons desiring to comment on the subject matter of this proposed rulemaking action shall submit written comments, not later than thirty (30) days after the date of publication of this notice in the D.C. Register, to Kenneth Campbell, General Counsel, the Department of Health, Office of the General Counsel, 825 North Capitol Street, N.E., 4^th Floor, Washington, D.C. 20002.  Copies of the proposed rules may be obtained between the hours of 9:00 a.m. and 5:00 p.m. at the address listed above.