DEA Pharmacist's Manual Flashcards

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?

Pseudoephedrine (correct)

Phenylpropanolamine (correct)

Ephedrine (correct)

Aspirin

Describe the 5 schedules of controlled substances.

I - high potential for abuse + no currently accepted medical use in the US; II - high potential for abuse with accepted medical use; III - less potential for abuse and may lead to moderate/lower physical dependence; IV - low potential for abuse compared to III; V - low potential for abuse with limited quantities of certain narcotics. Signup and view all the answers

What form must be completed in order for a pharmacy to register with the DEA?

DEA form 224 Signup and view all the answers

Which statement is correct regarding pharmacy registrations?

If a person owns and operates more than one pharmacy, each must be registered with the DEA through form 224. Signup and view all the answers

What form is used to request a duplicate certificate of registration with the DEA?

DEA Form 223 Signup and view all the answers

According to federal law, a pharmacy registration must be renewed with the DEA every _ years utilizing DEA Form _

3 years, 224a Signup and view all the answers

When is the earliest a registrant can renew a pharmacy's existing registration with the DEA?

No more than 60 days prior to the current expiration date. Signup and view all the answers

A corporation that owns/operates a chain of pharmacies may submit a single DEA form for renewal.

True Signup and view all the answers

A pharmacy is moving to a new location. What is your responsibility in regards to the DEA?

Contact the DEA registration specialist in writing or request modification of registration online. Signup and view all the answers

After termination of DEA registration, how long must controlled substance records be kept/stored?

2 years Signup and view all the answers

What must be returned if terminating DEA registration for a pharmacy?

Certificate of registration and DEA forms. Signup and view all the answers

What must be submitted to the DEA agent in the area when transferring business operations to another pharmacy registrant?

Name, address, registration number and authorized business activity of both registrants, location details, and the date of controlled substance transfer. Signup and view all the answers

DEA Form _____ is used to transfer schedule II controlled substances.

222 Signup and view all the answers

What must be submitted or carried out if transferring controlled substances to the original supplier or manufacturer?

DEA Form 222 or electronic equivalent. Signup and view all the answers

How can controlled substances be disposed?

Pharmacy may transfer to a DEA-registered reverse distributor for disposal. Signup and view all the answers

What form must be submitted to DEA if destroying controlled substances?

DEA Form 41 Signup and view all the answers

What types of employees may be denied access to controlled substances?

<ol> <li>Convicted of felony related to controlled substances; 2. DEA registration denied, revoked or surrendered.</li> </ol> Signup and view all the answers

What procedures must be implemented if controlled substance theft or significant loss occurs?

Notify DEA in writing within one business day and complete DEA Form 106. Signup and view all the answers

What is considered a 'significant loss' according to the CSA regulations?

There is no definition; it's the registrant's responsibility to use best judgment. Signup and view all the answers

Who is responsible if all or part of a shipment of controlled substances is lost?

Supplier must report to DEA if it does not reach intended destination; purchaser if loss occurs after signed for. Signup and view all the answers

What should be done if a breakage or spillage of controlled substances occurs?

Dispose of recoverable controlled substances and report to DEA on Form 41. Signup and view all the answers

How long must records concerning controlled substances be maintained according to federal law?

At least 2 years for inspection and copying by duly authorized DEA officials. Signup and view all the answers

What are the required controlled substance records that must be maintained by the pharmacy?

Executed/unexecuted order forms (222), POA, Receipts for schedule III-V, inventory records, records of controls distributed, dispensed records, theft/loss reports, inventory of surrendered drugs, transfers. Signup and view all the answers

May a registrant maintain records at a location other than the registered location?

True Signup and view all the answers

What are the 3 options for filing prescription records?

<ol> <li>One separate file for schedule II, a file for schedules III-V, and a file for noncontrolled drugs; 2. One file for schedule II and another for all other drugs (red 'C'); 3. Electronic records must be retrievable.</li> </ol> Signup and view all the answers

Describe how accurate the physical count must be for schedule II and other controlled substances.

CII - must determine actual physical count; CIII-V - may be estimated if container holds. Signup and view all the answers

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.