Controlled Substances-DEA Title 21 CFR Part 1300 to end 1. Types of DEA licenses *Researcher *Manufacturer *Practitioner *Retail Pharmacy *Hospital/clinics *Teaching institutes *Analytical laboratory *Narcotic Treatment Program *Importer *Exporter *Distributor 2. Registration Procedure *Complete Registration application Form 225 (225a for renewal annually) Controlled substances listed in Schedule I to V. *A research protocol not needed for CS listed in Schedule I 3. Security requirement *No requirement of physical security controls for Research firms. 4. Employee Screening *Employer's comprehensive Employee Screening Program 5. Record Keeping and Inventory Requirements *Each registrant shall maintain the records and inventories and file reports. *Central record keeping *Inventory requirement: for each controlled substance in finished form, the inventory will include: Substance's name Each finished form # of units or volume # of containers Total Quantity Reason to maintain 6. Schedules of Controlled Substances *List of all classes or schedules (I, II, III, IV, V) of CS and their corresponding Administration Controlled Substances Code Number. |
