Checklist for submitting new and renewing dc controlled

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CHECKLIST FOR SUBMITTING NEW AND RENEWING DC Controlled Substance Drug Registration Application (Manufacturers, Distributors, Wholesalers - Facilities)

IMPORTANT ? PLEASE READ

Every person who manufactures, distributes, dispenses, or conducts research with any controlled substance, or who proposes to engage in the manufacture, distribution, dispensing, or conducting of research with any controlled substance within the District of Columbia shall obtain (biennially) and maintain current registration. (?22-1002.1 - DCMR Chapter 10)

Mail completed application(s), nonrefundable fee(s) and required documents together to DC DOH - Pharmacy Division, P.O. Box 37803, Washington, DC 20013.

CHECKLIST FOR SUBMITTING THE DC CONTROLLED SUBSTANCE REGISTRATION APPLICATION FOR SCHEDULES II ? V DRUGS:

____ Controlled Substance Registration Application completed, dated and signed ____ $130.00 nonrefundable fee (check or money order), made payable to DC Treasurer ____ Copy of current U.S. Federal DEA Registration for the location (cannot be expired) ____ List of all controlled substance drug products applicant intends to ship into the District of

Columbia

IMPORTANT: A separate application, fee and required documentation are required to be submitted for Schedule I drug products. Requirements are listed below.

CHECKLIST FOR SUBMITTING THE DC CONTROLLED SUBSTANCE REGISTRATION APPLICATION FOR SCHEDULE I DRUGS:

____ Controlled Substance Registration Application completed dated and signed ____ $130.00 nonrefundable fee (check or money order), made payable to DC Treasurer ____ Copy of U.S. (Federal) DEA Registration for Schedule I for the location (cannot be expired) ____ List of Schedule I controlled substance drug products applicant intends to ship into the District ____ List of company names and complete addresses of customers to which the applicant intends

to ship Schedule I controlled substance drugs in the District of Columbia ____ Detailed explanation for intended use of Schedule I controlled substances drug products ____ An in state (Resident) applicant must also submit the IRB ? Safe with CRF Standards for

Schedule I controlled substance drugs

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899 North Capitol Street NE | 2nd Fl, Washington, DC 20002 | P 202-724-8800 | F 877-862-4252 |

CHECKLIST FOR SUBMITTING NEW AND RENEWING DC Controlled Substance Drug Registration Application (Manufacturers, Distributors, Wholesalers ? Facilities) _________________________________________________________________________________

RECORD KEEPING: Please make a copy of the completed application, payment(s) and all documents submitted with the application for your records. Mail to: DC HEALTH - PHARMACY DIVISION

P.O. Box 37803 Washington, DC 20013 LICENSE VERIFICATION: To verify the status of a DC controlled substance registration application, renewal, or license/registration, paste the web link below into your web browser:



SUBMITTING APPLICATION(S): When submitting multiple applications, it is the sole responsibility of the applicant to submit each application with the required fee(s) and document(s). The fee and documents must be securely attached to the respective application, as outlined in the checklist, and submitted in the order of the checklist.. FREQUENTLY ASKED QUESTIONS: A list of frequently asked questions can be located on the DC government website at .

DC WEBSITE: DC Applications, Forms, Checklists and Municipal Regulations are available online at .

IMPORTANT: The application, nonrefundable fee and all required documents must be submitted together. Incomplete applications or those submitted with missing, expired, or unreadable documents will be returned.

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899 North Capitol Street NE | 2nd Fl, Washington, DC 20002 | P 202-724-8800 | F 877-862-4252 |

CONTROLLED SUBSTANCE REGISTRATION APPLICATION FOR FACILITIES

Mail application, nonrefundable fee of $130, US (federal) DEA Registration, and all required documents to: DC HEALTH - PHARMACY DIVISION, P.O. Box 37803, Washington, DC 20013

Please print clearly in ink and in upper case letters only. Incomplete applications and those submitted with incorrect, missing, or expired documents will be returned via regular US mail

Application Type

Facility Location

New Change of Name Change of Ownership Change of Location Renewal (Provide Controlled Substance Registration number): ____________________

Out-of-State (Non-Resident) In State (Resident)

Profession Type

Pharmacy Distributor Wholesaler Substance Abuse Facility Researcher Veterinary Clinic Fire and EMS Other (specify below)

Choose Controlled Substance Schedules applicant is applying for:

Schedule II

Schedule IIN

Schedule III Schedule IIIN

Schedule IV

Schedule V

Applicant Information

___________________________________________________________________________________________________________________________

Name of Applicant (Legal Name of Business)

______________ Street No.

_______________________________________________________ __________________

Street Name

Suite No.

Provide Facility Location Address on this Page

_______________________________________________________

City

____________________________ __________________

State

Zip Code

___________________________________________

Cell Phone Number

_______________________________________________________________

E-Mail Address for Applicant

1 ______________________________________________________________________________________________________

899 North Capitol Street NE | 2nd Fl, Washington, DC 20002 | P 202-724-8800 | F 877-862-4252 |

Mailing Address (If Different) or DC Business Affiliation (Required for Researchers and Resident Health facilities)

_____________________

Street No.

________________________________________________

Street Name

_____________________________

Suite No.

________________________________________________ _______________________

City

State

________________________

Zip Code

______________________________________

Work Phone Number

_____________________________________

Fax Number

_________________________________________

E-Mail Address

All Applicants must answer the following questions; Any question that does not apply to the applicant must be answered as N/A.

A. If the applicant is a corporation, association or partnership, has any officer, partner, stockholder or proprietor been convicted of a felony in connection with controlled substance under District of Columbia, State or Federal law? Yes No

B. Has the applicant been convicted of a felony in connection with controlled substance (CS) under DC, State or Federal Law? Yes No If the answer is Yes, submit a written explanation.

C. Has the applicant ever surrendered or had a controlled substance registration revoked, suspended or denied? Yes No If the answer is Yes, submit a written explanation.

I CERTIFY THAT, TO THE BEST OF MY KNOWLEDGE, ALL OF THE STATEMENTS MADE ARE TRUE, COMPLETE AND CORRECT.

_________________________________________________ Signature of Applicant/Authorized Individual

______________________________________ Print Name and Title

_______________________ Today's Date

Submit application, nonrefundable fee of $130 made payable to "DC TREASURER, U.S. (Federal) DEA Registration, and list of all controlled substance drug products the applicant intends to ship to or within the District of Columbia. Mail to: DC HEALTH - PHARMACY DIVISION

P.O.BOX 37803 WASHINGTON, DC 20013

Note: Applicants seeking fee waiver under 22DCMR Chapter 10, Section 1005.1 (a-d) complete the certification of fee exemption form attached.

2 ______________________________________________________________________________________________________

899 North Capitol Street NE | 2nd Fl, Washington, DC 20002 | P 202-724-8800 | F 877-862-4252 |

TO THE APPLICANT: (Please read and complete all fields below)

Please read carefully and completely before signing. A false statement on this certification requires that the Department proceed immediately to revoke the license or permit for which you are now applying and fine you $1000.00. This certificate is required by the "CLEAN HANDS BEFORE RECEIVING A LICENSE OR PERMIT ACT OF 1996". (Effective May 11, 1996, D.C. Law 11-118, D.C. Code ?47-2861 et seq.)

I,___________________________________, certify that as of _______________ , I do not owe more than $100.00 to the District of Columbia government

Print Name

Today's Date

as a result of: 1. Fines, penalties or interest assessed pursuant to the Litter Control Administration Action of 1985, effective March 25, 1986 (D.C. Code ? 6-2901 et seq.); 2. Fines, penalties or interest assessed pursuant to the Illegal Dumping Enforcement Act of 1994, effective May 20, 1994 (D.C. Law 10-117; D.C. Code ? 6- 2911 et seq.); 3. Fines, penalties or interest assessed pursuant to the Department of Consumer and Regulatory Affair Civil Infractions Act of 1985, effective October 5, 1986 (D.C. Law 6- 42; D.C. Code ? 6-2701 et seq.); or 4. Past due taxes.

I understand that if I knowingly falsify this Certification, the Department will move to revoke the license or permit for which I am applying, and to fine me $1,000.00. I further understand that the Department may conduct an investigation to ascertain the veracity of this certification. I understand that this Certification is now required as documentation to accompany my application for a license or permit, and that by completing this Certification, I am not guaranteed that my license or permit will be approved.

_____________________________________________________ Signature of Applicant

_____________________________________________ Position Title

__________________ Today's Date

3 ______________________________________________________________________________________________________

899 North Capitol Street NE | 2nd Fl, Washington, DC 20002 | P 202-724-8800 | F 877-862-4252 |

CERTIFICATION OF FEE EXEMPTION

Pursuant to 22DCMR Chapter 10, Section 1005.1 (a-d) states:

The Director shall exempt from payment of a fee for registration or reregistration, any official employee or agency of the District of Columbia (DC) who is authorized to do the following: (a) To purchase controlled substances; (b) To obtain the substances from official stocks; (c) To dispense or administer the substances; or (d) To conduct research, instructional activities, or chemical analysis with the substances, or any combination thereof, in the course of his or her official duties or employment.

CHECK IF INDIVIDUAL NAMED HEREON IS A DC OFFICIAL/ DC AGENCY

The undersigned hereby certifies that the applicant hereon is an officer or employee of a local DC agency who in the course of such employment, is authorized to obtain, dispense, prescribe, or otherwise handle controlled substances.

___________________________________________________________ Signature of Certifying Official

_______________________________ Today's Date

___________________________________________________ Certifying Official's Name

__________________________________________________ Position Title

________________________________________________________________________________________________________ Name of Governmental Institution and Agency

4 ______________________________________________________________________________________________________

899 North Capitol Street NE | 2nd Fl, Washington, DC 20002 | P 202-724-8800 | F 877-862-4252 |

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