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Questions and Answers
What is the frequency for preparing and maintaining an inventory of controlled substances as mandated for various licensed entities?
What is the frequency for preparing and maintaining an inventory of controlled substances as mandated for various licensed entities?
- Annually
- Every five years
- Every two years (correct)
- Every month
Which of the following is NOT included as a party required to maintain an inventory of controlled substances?
Which of the following is NOT included as a party required to maintain an inventory of controlled substances?
- Pharmaceutical sales agents (correct)
- Veterinarians
- Distributors
- Physicians
What specific information must be recorded for each controlled substance in the inventory?
What specific information must be recorded for each controlled substance in the inventory?
- Name, quantity, size of individual package, and total content (correct)
- Name, quantity, category, and purchase date
- Name, quantity, content, and administration route
- Name, quantity, content, and expiration date
For how long must the inventory records be kept available for inspection after they are prepared?
For how long must the inventory records be kept available for inspection after they are prepared?
A manufacturer is unsure about the compliance of their inventory management with federal regulations. How is compliance determined?
A manufacturer is unsure about the compliance of their inventory management with federal regulations. How is compliance determined?
Which entities are required to prepare an inventory of controlled substances starting from May 1, 1975?
Which entities are required to prepare an inventory of controlled substances starting from May 1, 1975?
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Study Notes
Inventory Requirements for Controlled Substances
- Entities required to maintain inventory include manufacturers, distributors, importers, exporters, institutional dispensers, research and educational facilities, and licensed medical practitioners such as physicians, dentists, podiatrists, and veterinarians.
- Pharmacies handling controlled substances must comply with inventory regulations as well.
- The inventory must be prepared and maintained every two years, starting from May 1, 1975, in accordance with state regulations.
- Each type of controlled substance or preparation requires a separate entry in the inventory.
- Entries must detail:
- Name of the controlled substance
- Quantity and content per unit of the substance
- Size of each individual package
- Total number of packages
- Aggregate content across all packages
- Maintaining the inventory in alignment with federal statutes and regulations satisfies state compliance requirements.
Record Retention
- A copy of the inventory must be kept on file alongside other controlled substances records.
- Records should be available for inspection for a minimum duration of five years to ensure compliance and accountability.
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