Questions and Answers
Who enforces the Controlled Substances Act (CSA)?
Drug Enforcement Administration (DEA)
What are the main responsibilities of the DEA?
- Prevent diversion and abuse of controlled substances 2. Ensure there is an adequate and uninterrupted supply of controlled substances to meet the country's needs.
Which 3 nonprescription products require ID, log of sales, purchase/sale limits, and must be placed out of customer reach? Under what law?
Describe the 5 schedules of controlled substances.
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What form must be completed in order for a pharmacy to register with the DEA?
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Which statement is correct regarding pharmacy registrations?
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What form is used to request a duplicate certificate of registration with the DEA?
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According to federal law, a pharmacy registration must be renewed with the DEA every _____ years utilizing DEA Form _____
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When is the earliest a registrant can renew a pharmacy's existing registration with the DEA?
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A corporation that owns/operates a chain of pharmacies may submit a single DEA form for renewal.
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A pharmacy is moving to a new location. What is your responsibility in regards to the DEA?
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After termination of DEA registration, how long must controlled substance records be kept/stored?
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What must be returned if terminating DEA registration for a pharmacy?
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What must be submitted to the DEA agent in the area when transferring business operations to another pharmacy registrant?
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DEA Form _____ is used to transfer schedule II controlled substances.
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What must be submitted or carried out if transferring controlled substances to the original supplier or manufacturer?
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How can controlled substances be disposed?
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What form must be submitted to DEA if destroying controlled substances?
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What types of employees may be denied access to controlled substances?
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What procedures must be implemented if controlled substance theft or significant loss occurs?
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What is considered a 'significant loss' according to the CSA regulations?
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Who is responsible if all or part of a shipment of controlled substances is lost?
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What should be done if a breakage or spillage of controlled substances occurs?
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How long must records concerning controlled substances be maintained according to federal law?
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What are the required controlled substance records that must be maintained by the pharmacy?
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May a registrant maintain records at a location other than the registered location?
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What are the 3 options for filing prescription records?
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Describe how accurate the physical count must be for schedule II and other controlled substances.
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Study Notes
DEA Overview
- The Drug Enforcement Administration (DEA) enforces the Controlled Substances Act (CSA).
- DEA's responsibilities include prevention of controlled substance diversion and abuse, and ensuring an adequate supply to meet national needs.
Nonprescription Products Regulations
- Ephedrine, Pseudoephedrine, and Phenylpropanolamine require ID, sales logs, purchase limits, and must be kept out of customer reach under the Combat Methamphetamine Epidemic Act of 2005.
Controlled Substances Schedules
- Schedule I: High potential for abuse, no accepted medical use.
- Schedule II: High potential for abuse, accepted medical use, possible severe dependence.
- Schedule III: Lower potential for abuse compared to I & II, moderate or low physical dependence.
- Schedule IV: Low potential for abuse relative to III.
- Schedule V: Minimal abuse potential, includes limited quantities of certain narcotics.
Registration and Renewal
- Pharmacies must register with the DEA using Form 224.
- Each pharmacy location must individually register; Form 224b allows corporations to renew multiple registrations.
- Registration must be renewed every three years (Form 224a).
Moving and Business Transfers
- Pharmacies changing location must notify the DEA and obtain approval, particularly if moving out of state.
- For business transfers, all relevant registration details and a complete inventory must be submitted 14 days prior to the transfer.
Disposal and Destruction of Controlled Substances
- Controlled substances can be disposed of through a DEA-registered reverse distributor or by following specific protocols with DEA Form 41.
- Records of controlled substance disposal must be maintained.
Theft and Loss Reporting
- Significant loss of controlled substances must be reported to the DEA within one business day using Form 106.
- There is no formal definition of "significant loss"; registrants should use judgment.
Record Keeping Requirements
- Records must be maintained for at least two years for DEA inspection.
- Schedule III-V records must be readily retrievable and separated from other records, identifiable via marking.
- Essential records include executed order forms, purchase receipts, inventory records, and theft/loss reports.
Filing Prescription Records
- three filing options are available for prescriptions based on schedules to ensure compliance.
Physical Count Accuracy
- Schedule II requires actual physical counts; CIII-V may be estimated if containers permit.
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Test your knowledge on the enforcement of the Controlled Substances Act and the responsibilities of the DEA with these flashcards. This quiz will help you understand key concepts vital for pharmacists dealing with controlled substances.