Business Licensing Database
DRUG MANUFACTURING

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CONTROLLED SUBSTANCE	DRUG MANUFACTURING	DRUGS	MANUFACTURING
MEDICINE	METHADONE	PHARMACEUTICAL	RESEARCH

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Federal
U.S. Food & Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993 888-463-6332	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 12154 East Easter Ave Centennial , CO   80012-6740 (720)895-4040 (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 $551 for 3 years for dispensers/practitioners and $2,293 per year for manufacturers.
State
Colorado Division of Registrations Board of Pharmacy 1560 Broadway #1350 DENVER , CO   80202 (303)894-7800 Fax: (303)894-7692	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 $450 for license. Registration must be renewed yearly by October 31.

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NOTE:  If the cost is contingent upon weight, see WEIGHTS AND MEASURES

NOTE:  See MANUFACTURING regarding applicable environmental regulations.

page last updated 3/23/10

The Colorado Revised Statutes are available on line at http://www.state.co.us/gov_dir/leg_dir/olls/colorado_revised_statutes.htm. 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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