D.C. Municipal Regulations (Last Updated: September 13, 2017) |
Title 22. HEALTH |
SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
Chapter 22-B10. CONTROLLED SUBSTANCE REGISTRATION FOR MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS |
Section 22-B1003. REGISTRATION
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1003.1Unless otherwise exempted by federal law or this chapter, a person shall register with the Department and obtain and maintain a registration certificate before the person:
(a)Manufactures, distributes, or dispenses controlled substances in the District;
(b)Conducts research or instructional activities with controlled substances listed in Schedules II through V in the District;
(c)Conducts research or instructional activities with a controlled substance listed in Schedule I in the District;
(d)Conducts a chemical analysis with controlled substances listed in any schedule in the District; or
(e)Engages in any other activity for which registration is required.
1003.2For practitioners, a District of Columbia controlled substances registration issued pursuant to this chapter shall expire simultaneously with the expiration of the practitioner's District of Columbia health professional license, certification, or occupation registration.
1003.3For non-practitioners, a District of Columbia controlled substance registration issued pursuant to this chapter shall expire at 12:00 midnight of December 31 of each even-numbered year.
1003.4Applications to renew a registration must be filed in a timely manner, not less than sixty (60) days prior to the expiration of the registration.
1003.5A registration certificate expires on the date shown on the certificate.
1003.6The Director shall mail a renewal application or a notice to renew to a registrant not less than thirty (30) days before the expiration date shown on the certificate.
1003.7If a person fails to apply for renewal of a registration before the expiration date of his or her registration, he or she shall thereafter apply for a new registration and the prior registration shall be deemed to have expired on the date specified on the registration.
1003.8Any person who is required to be registered and who is not so registered may apply for registration at any time and may obtain an application form by writing to the Department of Health's Pharmaceutical Control Division, 717 14th Street, NW., 6th Floor, Washington, D.C. 20005.
1003.9To apply for a controlled substances registration, an applicant shall:
(a)Submit a completed application to the Department on the required forms which shall be signed by the:
(1)Applicant, if an individual;
(2)General partner, if the applicant is a partnership; or
(3)Officer responsible for the applicant, if the applicant is a corporation or other entity; and
(b)Pay all applicable fees.
1003.10Applications submitted for filing shall be dated upon receipt. Applications which are complete shall be accepted for filing. Applications failing to comply with the requirements set forth in this chapter and the Act shall not be accepted for filing.
1003.11In the case of minor defects as to completeness, the Director may accept the application for filing with a request to the applicant for additional information.
1003.12A defective application shall be returned to the applicant within ten (10) days following its receipt with a statement of the reason for not accepting the application for filing.
1003.13A defective application may be corrected and resubmitted for filing at any time; the Director shall accept for review any application upon resubmission by the applicant.
1003.14Accepting an application for filing does not preclude any subsequent request for additional information pursuant to this chapter and has no bearing on whether the application will be granted.
1003.15If the information requested on the application is not applicable to the applicant, the applicant shall indicate such on the form.
1003.16The Director may require an applicant to submit additional documentation pertinent to the registration or written statements in support of an application to:
(a)Clarify application information; or
(b)Determine if the applicant meets the requirements of this chapter.
1003.17The Director may deny an application if the applicant fails to provide information within fifteen (15) days of receipt of the Director's request.
1003.18An application shall be considered withdrawn if the following occurs:
(a)The applicant requests its return; or
(b)The applicant fails to respond to a registered or certified letter regarding the application within fifteen (15) days of its delivery to the applicant.