How to Survive a DEA Inspection Series: Compounding Controlled Substances
Published by International Academy of Compounding Pharmacists and Texas Pharmacy Association
Summary
Part Four of a Four-Part Series.
The responsibilities to enforced federal laws and regulations on the compounding of controlled substances by a pharmacy are placed on the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion).
Since the focus of any DEA compliance inspection is record-keeping, a compounding pharmacy will need to be prepared for that unannounced inspection that will focus on the purpose for compounding medications containing controlled substances and records required by DEA to be maintained by the pharmacy.
Attendees will familiarize themselves with the types of actions taken by DEA Diversion personnel at a compounding pharmacy. The focus of any compounding pharmacy is whether the pharmacy is compounding for a specific patient or group of patients needing a medication or the manufacturing of a controlled substance medication.
Learning Objectives:
At the conclusion of this program, the pharmacist and technician attendee will be able to:
The responsibilities to enforced federal laws and regulations on the compounding of controlled substances by a pharmacy are placed on the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion).
Since the focus of any DEA compliance inspection is record-keeping, a compounding pharmacy will need to be prepared for that unannounced inspection that will focus on the purpose for compounding medications containing controlled substances and records required by DEA to be maintained by the pharmacy.
Attendees will familiarize themselves with the types of actions taken by DEA Diversion personnel at a compounding pharmacy. The focus of any compounding pharmacy is whether the pharmacy is compounding for a specific patient or group of patients needing a medication or the manufacturing of a controlled substance medication.
Learning Objectives:
At the conclusion of this program, the pharmacist and technician attendee will be able to:
- Identify the authority of Drug Enforcement Administration (DEA) Office of Diversion Control (Diversion) personnel to conduct an unannounced inspection at a compounding pharmacy and records that will be inspected or copied by their personnel.
- Discuss administrative or civil actions taken by DEA for failure of a pharmacy to maintain compounding records for Schedules II through V prescriptions filled or compounded by the pharmacy.
- Identify DEA record-keeping violations pertaining to: Inventory of Controlled Substances, Batch Records, Power of Attorney forms and other records required to be maintained by the compounding pharmacy.
- Discuss the failure of specific DEA Diversion offices to understand the difference between anticipatory compounding versus manufacturing and how a compounding pharmacy can handle such issue when DEA enters the pharmacy.
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