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Office of Economic Development and International Trade

Business Licensing Database
DRUG MANUFACTURING

CONTROLLED SUBSTANCE DRUG MANUFACTURING DRUGS MANUFACTURING
MEDICINE METHADONE PHARMACEUTICAL RESEARCH

Federal

U.S. Food & Drug Administration
7920 Elmbrook Dr. #102
DALLAS , TX   75247
(214)253-4952
(214)655-8100
Need FDA (Washington Office) approval to manufacture drugs. Apply for new drug approval, inspection of facilities required. Approval will depend on the drug that is being manufactured.
Register with FDA office as drug manufacturer establishment. No fee.
Register all drugs manufactured (specify dosage, # of tablets per bottle, etc.) with FDA office.

Federal

U.S. Drug Enforcement Administration
Drug Registration
Denver Field Division
115 Inverness Drive, East
Englewood , CO   80012
(303)705-7300
(800)882-9539
Fax: (303)705-7423
All individuals and firms that handle controlled substances must be registered by the DEA. They are required to maintain complete and accurate inventories and records of all transactions involving controlled substances, as well as security for the storage of controlled substances.
Must have state license first.
Fee is $210 for 3 years.

State

Colorado Division of Registrations
Board of Pharmacy
1560 Broadway #1310
DENVER , CO   80202
(303)894-7750
Fax: (303)894-7764
A manufacturer with a facility in this state must be separately registered to manufacture any prescription drug or controlled substance.
A manufacturer with a facility located outside of this state must register to manufacture any controlled substance which it distributes into this state.
Each facility must be separately and appropriately registered.
A manufacturer must register as a distributor to distribute a prescription drug and/or a controlled substance which it does not manufacture itself. For example, a manufacturer of both prescription drugs and controlled substances which also buys both prescription drugs and controlled substance from another source for further distribution must register in all four categories (Rx drug mfr; CS mfr; Rx drug dist’r; and CS dist’r.)
Fee is $250 for EACH license. Registration must be renewed yearly by October 31.
NOTE:  If the cost is contingent upon weight, see WEIGHTS AND MEASURES
NOTE:  See MANUFACTURING regarding applicable environmental regulations.

page last updated 6/13/03

The Colorado Revised Statutes are available on line at http://198.187.128.12/colorado/lpext.dll?f=templates&fn=fs-main.htm&2.0. You can locate a statute of interest by searching either on the citation given in the database (e.g., 18-5-307) or on a keyword or phrase.

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