3 Controlled-Substance Handling and Pharmacy Operations Free Online FlashCards

How does Schedule I differ from Schedules II–V in pharmacy practice?

Schedule I substances are not considered to have an accepted medical use under federal law and are not part of routine community-pharmacy dispensing.

What is a REMS, and how does it relate to DEA schedules?

A REMS is an FDA drug-safety program, not a DEA schedule. Follow any product-specific pharmacy conditions in addition to ordinary controlled-substance requirements.

What DEA registration rule applies to pharmacy locations?

A separate DEA registration is generally required for each principal place of business where controlled substances are dispensed. The pharmacy may handle only the schedules and activities its registration authorizes.

How does a pharmacy generally order Schedule I and II substances?

Each Schedule I or II distribution generally requires a completed DEA Form 222 or an electronic order through CSOS. A digitally signed CSOS order replaces the paper form for electronic orders.

What records ordinarily document Schedule III–V receipts?

Form 222 is not ordinarily required. Retain invoices, packing slips, or equivalent records identifying the substance, dosage form and strength, quantity, receipt date, and supplier.

What should a pharmacy do when a controlled-substance shipment arrives?

Compare the shipment with the order and receiving documents, investigate discrepancies promptly, document their resolution, and ensure records show the actual quantity received.

When must a pharmacy take controlled-substance inventories?

Take a complete, accurate initial inventory when the pharmacy first begins handling controlled substances, then take a new inventory at least every two years. Record zero inventory if there is no stock.

How specifically should controlled substances be identified in an inventory?

Identify each drug and finished form, recording its quantity. Distinguish strengths and dosage forms rather than listing only the drug’s general name.

How long must required controlled-substance records generally be kept?

Maintain complete, accurate records on a current basis. Required records generally must be kept for at least two years and be available for inspection by authorized DEA officials.

How do record-filing rules differ for Schedule II versus Schedules III–V?

Keep Schedule II inventories and records separately from other pharmacy records. Schedule III–V records may be separate or kept in a format that makes them readily retrievable.

What storage options may a pharmacy use to secure controlled substances?

Use a securely locked, substantially constructed cabinet, or disperse Schedule II–V stock throughout noncontrolled stock in a way that obstructs theft or diversion. Restrict access to authorized personnel.

What are the federal reporting deadlines for theft or significant loss?

Notify the local DEA Field Division Office in writing within one business day after discovery, then submit DEA Form 106 through DEA’s secure reporting system within 45 days after discovery.