Recordkeeping in Pharmacy Practices

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Questions and Answers

Which records are specifically required to be maintained regarding the distribution of controlled substances?

Records of controlled substances destroyed (DEA Form 41)

Records of controlled substances distributed (correct)

Inventory records of controlled substances

Records of controlled substances dispensed

What is the primary purpose of the Suspicious Orders Report System (SORS)?

To issue registration certificates for DEA registrants

To track inventory discrepancies in controlled substances

To report suspicious orders of controlled substances (correct)

To manage prescriptions of controlled substances

Which of the following statements about the requirements under the SUPPORT Act is true?

Only manufacturers must report suspicious orders

Only reverse distributors need to report suspicious orders

Reporting is optional for registrants who distribute controlled substances

All DEA registrants that distribute controlled substances are required to report suspicious orders (correct)

Which document serves as a representation of compliance with the Combat Methamphetamine Epidemic Act of 2005?

Self-certification certificate and logbook Signup and view all the answers

Which forms are necessary for documenting the theft or significant loss of controlled substances?

DEA Form 106 Signup and view all the answers

What type of records must be maintained for controlled substances dispensed without prescriptions?

Dispensation record logbook Signup and view all the answers

What is the minimum duration for which records concerning controlled substances must be maintained?

Two years Signup and view all the answers

Which schedule of controlled substances must have its records maintained separately from all other records?

Schedule II Signup and view all the answers

What is the definition of 'readily retrievable' as per the regulations?

Records that can be retrieved within a reasonable time frame from other records Signup and view all the answers

What type of records must be kept by a pharmacy according to the requirements?

Executed official order forms or electronic equivalents Signup and view all the answers

What is required for a pharmacy to authorize someone to sign official order forms?

A Power of Attorney authorization Signup and view all the answers

Which of the following is NOT specifically mentioned as a required record for controlled substances?

Patient consent forms Signup and view all the answers

What must records for schedules III, IV, and V controlled substances be maintained in?

A manner that allows for easy retrieval from other records Signup and view all the answers

How can records be visually identified apart from other items in the records?

By marking them with asterisks or redlining Signup and view all the answers

Study Notes

Recordkeeping Requirements for Pharmacies

Pharmacies must maintain accurate and current records for all controlled substances received, sold, delivered, or disposed of.
Accountability of controlled substances must be tracked from manufacturing through dispensing to the end user.
Closed systems are mandated to minimize the risk of diversion of controlled substances.
Records must be kept for a minimum of two years and be available for inspection by DEA officials.

Record Maintenance for Controlled Substances

Schedule II substances must be kept in records separate from all other registrant records.
Schedules III, IV, and V records should be maintained separately or in a way that allows for easy retrieval from other business records.
"Readily retrievable" means records are organized via electronic systems or visual identifiers (like asterisks) for quick access.

Essential Records to Maintain

Executed official order forms (DEA Form 222) or electronic equivalents.
Power of Attorney documents authorizing signature on order forms.
Receipts and invoices for schedules III, IV, and V substances.
Inventory records, including initial and biennial counts, timed to the end of the business day.
Records of distribution of controlled substances, including sales and returns to vendors.

Reporting and Special Requirements

The Suspicious Orders Report System (SORS) is mandatory for all DEA registrants distributing controlled substances.
Reporting suspicious orders through SORS Online fulfills obligations under 21 U.S.C. 832.
Pharmacies must report theft or significant loss using DEA Form 106, if relevant.
Registrants are required to document any controlled substances destroyed on DEA Form 41, if applicable.
The DEA registration certificate and self-certification logs under the Combat Methamphetamine Epidemic Act must be maintained.

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Description

This quiz focuses on the essential recordkeeping requirements that pharmacies must adhere to regarding controlled substances. It covers accountability measures, record maintenance duration, and compliance with DEA regulations. Test your knowledge on proper documentation practices within pharmacy settings.