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How to Survive a DEA Inspection Series - For Manufacturers and Distributors
The training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
Question And Answers
1. What is the meaning of Readily Retrievable?
- The term readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized record-keeping systems in such a manner that they can be separated out from all other records in a reasonable time 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.
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2. What comes under Biennial Inventory?
- Bulk Products, In-Process Products, Finished Form Products, Damage/Defective Products, Products Awaiting Disposal, and Products Held for QC.
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3. What is the Procedure for filling DEA Form 222 for purchaser according to Title 21 CFR 1305.13?
- "(e) The purchaser must record on Copy 3 of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the date on which the containers are received by the purchaser."
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4. How to preserve DEA Forms 222 by purchaser according to Title 21 CFR 1305.17?
- "(a) A purchaser must retain Copy 3 of each executed DEA Form 222 and all 1opies of unacceptable or defective forms with each statement attached."
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5. How to cancel or void DEA Forms 222 by a purchaser according to Title 21 CFR 1305.19?
- "(a) The purchaser may cancel part or all of an order on a DEA Form 222 by notifying the supplier in writing of the cancellation. The supplier must indicate the cancellation on Copies 1 and 2 of the DEA Form 222 by drawing a line through the canceled items and printing “canceled” in the space provided for number of items shipped."
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6. How to cancel or void DEA Forms 222 by a supplier according to Title 21 CFR 1305.19?
- The supplier may void part or all of an order on a DEA Form 222 by notifying the purchaser in writing (email is acceptable) of the voiding. The supplier must indicate the voiding in the manner prescribed for cancellation for purchaser.
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7. What is the use of electronic Controlled Substances Ordering System (CSOS)?
- CSOS is similar Record-Keeping Requirements for the Use of a Paper DEA Form 222 but customers are less likely to understand.
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8. What do you mean by Power of Attorney?
- A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant's behalf by executing a power of attorney for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with other order records.
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9. What are the Security Compliances that an applicant should provide?
- All applicants and registrants shall provide effective controls and procedures to guard against thefts and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Administration shall use the security requirements set forth in Sections 1301.72 to 1301.76 as standards for the physical security controls and operating procedures necessary to prevent diversion.
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