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MPJE

MPJE - FEDERAL CONTROLLED SUBSTANCE LAW - RECORDKEEPING REQUIREMENTS

TermDefinition
All records concerning controlled substances must be maintained for at least ___ years 2 years for inspection and copying by duly authorized DEA officials. Records and inventories of Schedule II controlled substances must be maintained separately from all other records of the registrant.
All records and inventories of Schedule III, IV and V controlled substances must be maintained either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business records
Readily retrievable means that: 1. Certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time.
Readily retrievable means that: 2. And/or records are kept on which certain items are asterisked, redlined or in some other manner visually identifiable apart from other items appearing on the records.
Records that Must be Maintained Official Order Forms (DEA Form-222) (both executed and unexecuted forms ) OR electronic equivalents 2. Power of Attorney authorization to sign Order Forms. 3. Receipts and invoices for Schedule III, IV, and V controlled substances
Records that Must be Maintained All inventory records of controlled substances, including the initial and biennial inventories, dated as of beginning or close of business
Records that Must be Maintained 5. Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors).
Records that Must be Maintained 6. Records of controlled substances dispensed (i.e., prescriptions, schedule V logbook) 7. Report of Theft or Loss (DEA Form-106), if applicable. 8. Inventory of Drugs Surrendered for Disposal (DEA Form-41), if applicable.
Records that Must be Maintained 9. Records of transfers of controlled substances between pharmacies. 10. DEA registration certificate.
Records that Must be Maintained 11. Self-certification certificate and logbook (or electronic equivalent) as required under the Combat Methamphetamine Epidemic Act of 2005.
Prescription Records Paper Prescription Records Option 1 (Three separate files)  A file for Schedule II drugs dispensed,  A file for Schedule III, IV and V drugs dispensed, and  A file for prescription orders for all noncontrolled drugs dispensed
Prescription Records Paper Prescription Records Option 2 (Two separate files)  A file for all Schedule II drugs dispensed,  A file for all other drugs dispensed must be made readily retrievable by use of a red “C” stamp not less than one inch high.
Prescription Records Electronic Prescription Records Electronic records must be maintained electronically for two years from the date of their creation or receipt.
Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled.
Created by: LilTren
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