405671 To clarify the responsibilities and reporting requirements for pharmacies with respect to thefts, suspected diversions, and significant losses of drug inventory.

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(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 § 48-903.01); 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 19, Pharmacies, of Subtitle B, Public Health and Medicine, of Title 22 of the District of Columbia Municipal Regulations (DCMR) in not less than thirty (30) days after the date of publication of this notice in the D.C. Register.

 

The purpose of these amendments is to clarify the responsibilities and reporting requirements for pharmacies with respect to thefts, suspected diversions, and significant losses of drug inventory. 

 

The following rulemaking action is proposed:

 

Chapter 19, PHARMACIES, of Subtitle B, PUBLIC HEALTH AND MEDICINE, of Title 22 of the DCMR is amended as follows:

 

Section 1901, GENERAL OPERATING STANDARDS, is amended as follows:

 

Subsection 1901.8 is amended to read as follows:

 

1901.8                          Burglaries, thefts, suspected diversions, significant losses of drug inventory or the inability to account for such inventory, and damage to a pharmacy or its inventory by fire, flood, or other causes shall be reported by the licensee or agent of the licensee to the Director within forty-eight (48) hours after discovery.

 

Section 1921, INSTITUTIONAL PHARMACIES, is amended as follows:

 

Subsection 1921.4 is amended as follows:

 

Paragraphs (u) and (v) are amended to read as follows:

 

(u)        Ensuring the making and maintaining of reports of suspected reactions to the FDA, to the manufacturer, and to the United States Pharmacopeia, and  reporting of drug product defects accordingly;

 

(v)        Developing or ensuring the establishment of procedures for an ongoing quality assurance program of pharmaceutical services that include a mechanism for reviewing and evaluating drug related patient care, as well as an appropriate response to findings;

 

New paragraphs (w) and (x) are added to read as follows:

 

(w)       Notifying the Director of the occurrence of any of the following:

 

(1)        Permanent closing of the pharmacy;

 

(2)        Change of proprietorship, management, location, or pharmacist-in-charge of the pharmacy;

 

(3)        Any theft or loss of prescription drugs or medical devices from the pharmacy;

 

(4)        Conviction of any employee of the pharmacy of any federal, state, or District of Columbia drug laws;

 

(5)        Disasters or accidents resulting in damage to the pharmacy facility, or

            inventory;

 

(6)        Any theft, destruction, or loss of records required to be maintained by

            federal or District of Columbia law or regulation;

 

(7)        Occurrences of significant adverse drug reactions; or

 

(8)        Illegal use or disclosure of protected patient health information; and

 

(x)        Ensuring the making or filing of any reports required by federal or District of  Columbia laws or regulations.

 

Section 1922, NUCLEAR PHARMACIES, is amended as follows:

 

Subsection 1922.9 is amended as follows:

 

Paragraphs (h) and (i) are amended to read as follows:

 

(h)        Ensuring that the pharmacy has a system to dispose of radioactive and cytotoxic waste in a manner so as not to endanger the public health;

 

(i)         Developing and implementing written policies and procedures to ensure compliance with the applicable provisions of federal and District of Columbia laws and regulations;

 

New paragraphs (j) and (k) are added to read as follows:

 

(j)         Notifying the Director of the occurrence of any of the following:

 

(1)        Permanent closing of the pharmacy;

 

(2)        Change of proprietorship, management, location, or pharmacist-in-charge of the pharmacy;

 

(3)        Any theft or loss of prescription drugs or medical devices from the pharmacy;

 

(4)        Conviction of any employee of the pharmacy of any federal, state, or District of Columbia drug laws;

 

(5)        Disasters or accidents resulting in damage to the pharmacy facility, or

            inventory;

 

(6)        Any theft, destruction, or loss of records required to be maintained by

            federal or District of Columbia law or regulation;

 

(7)        Occurrences of significant adverse drug reactions; or

 

(8)        Illegal use or disclosure of protected patient health information; and

 

(k)         Ensuring the making or filing of any reports required by federal or District of Columbia laws or regulations.

 

All persons desiring to comment on the subject matter of this proposed rulemaking action shall submit written comments, no 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.