Ordering Rules - Mpje

1. Which DEA form (or electronic equivalent) must a pharmacy use to order Schedule II controlled substances from a distributor?
   Answer: DEA Form 222 or CSOS Schedule I and II controlled substances must be ordered using DEA Form 222 (a triplicate paper order form) or through the Controlled Substances Ordering System (CSOS), which is the electronic equivalent authorized under 21 CFR Part 1305. DEA Form 224 is for pharmacy registration; DEA Form 41 is for destruction; DEA Form 106 is for reporting theft or significant loss.
2. A pharmacy's DEA registration expires and it fails to renew before the expiration date. What is the consequence for controlled substance ordering?
   Answer: The pharmacy may not order, receive, or dispense controlled substances until the registration is reinstated or renewed A lapsed DEA registration suspends all controlled substance activities, including ordering, receiving, and dispensing. There is no grace period once the registration expires unless the renewal application was submitted before expiration (in which case the existing registration may continue while the DEA processes the renewal). Schedule restrictions do not apply - a lapsed registration affects all schedules equally.
3. When a pharmacy completes a CSOS electronic order for Schedule II substances, what replaces the handwritten signature required on a paper DEA Form 222?
   Answer: A DEA-issued digital certificate applied by the authorized registrant. Under 21 CFR Part 1305, CSOS electronic orders must be signed using a DEA-issued digital certificate (based on Public Key Infrastructure - PKI) held by the authorized registrant or their properly executed Power of Attorney. This digital signature provides the legal equivalent of a handwritten signature on DEA Form 222. A typed statement, license number, or PIN alone does not satisfy the CSOS authentication requirement.
4. A retail pharmacy wants to order a Schedule IV controlled substance from a wholesale distributor. The pharmacy's DEA registration is current. What documentation is required for this order?
   Answer: A purchase order or invoice reflecting both parties' DEA registration numbers Schedules III, IV, and V controlled substances may be ordered via ordinary commercial channels, using purchase orders or invoices. Both the purchaser and the supplier must be DEA-registered, and the order records must reflect the DEA registration numbers and be retained for 2 years. DEA Form 222 and CSOS are required only for Schedule I and II ordering. DEA Form 224 is the registration application, not an ordering tool.
5. A hospital pharmacy receives a Schedule II controlled substance shipment. When must the pharmacy record receipt of the shipment in its controlled substance records?
   Answer: Upon receipt, typically the same business day. DEA regulations require that receipt of Schedule II controlled substances be documented in the pharmacy's controlled substance records promptly upon receipt - generally the same business day. Timely recording is essential for accurate inventory tracking and to maintain accountability. The 72-hour window applies to follow-up written orders for emergency oral Schedule II prescriptions, not to receipt recording. Biennial inventory and audits are separate obligations.
6. Under DEA regulations, how long must a pharmacy retain completed DEA Form 222s and associated Schedule II records?
   Answer: 2 years from the date of the transaction DEA regulations require that all controlled substance records, including DEA Form 222s and Schedule II receiving records, be retained for a minimum of 2 years from the date of the transaction and be readily retrievable for DEA inspection. The 6-year retention requirement applies to DSCSA transaction records under federal drug supply chain law, not DEA controlled substance records.
7. A pharmacist-in-charge (PIC) authorizes a staff pharmacist to sign DEA Form 222 orders. What must the PIC do to delegate this authority?
   Answer: Execute a DEA Power of Attorney (POA) naming the staff pharmacist as an authorized agent to sign DEA Form 222 DEA regulations allow a registrant to delegate Schedule II ordering authority to another individual through a formal Power of Attorney (POA). The POA must be signed by the registrant, include the delegate's specimen signature, and be kept on file at the pharmacy. State board notification and DEA registration amendments are not required for POA delegation. Per-order letters do not satisfy DEA requirements.
8. A DEA Form 222 is prepared and sent to a distributor. The distributor ships the order partially and later ships the remainder. How many DEA Form 222s are required for this transaction?
   Answer: One - the original form covers the entire order, including partial shipments. A single DEA Form 222 covers the entire order. When a distributor ships in partial quantities, they record each partial shipment on the same form, noting the quantity and date for each delivery. The form is not considered complete until all items are shipped or the 60-day window expires. There is no requirement to issue a separate form for each partial shipment.
9. A pharmacy is closing permanently. The PIC needs to return remaining Schedule II controlled substance inventory to the manufacturer. What is required?
   Answer: The manufacturer must issue a DEA Form 222 to the pharmacy to receive the returned Schedule II drugs A DEA Form 222 must be used when Schedule II drugs are transferred from one DEA registrant to another - including returns to manufacturers. The manufacturer (as the receiving registrant) must issue a DEA Form 222 to the pharmacy to document the transfer. DEA Form 41 is for on-site destruction, not return to a manufacturer. State board notification does not substitute for DEA transfer documentation.
10. A state law requires pharmacies to report all Schedule II purchases to the state's prescription drug monitoring program (PDMP). A pharmacy argues that DEA Form 222 compliance is sufficient and the state reporting is redundant. Which analysis BEST addresses this argument?
    Answer: States can impose additional reporting requirements for Schedule II orders if not conflicting with federal law. The Supremacy Clause allows federal law to preempt state law only when there is a direct conflict or Congress expressly preempts state regulation. DEA ordering requirements do not preempt state law requirements to report purchases to PDMPs. States retain authority to impose additional reporting and monitoring requirements as part of their police powers, even when federal obligations are also met. The pharmacy must comply with both.
11. A pharmacy discovers that a shipment of Schedule II opioids was delivered without a corresponding DEA Form 222 on file. The distributor claims the form was lost in transit. Which analysis BEST describes the pharmacy's obligation?
    Answer: Refuse the shipment until a valid DEA Form 222 or CSOS record is obtained for the Schedule II opioids. Every receipt of Schedule II controlled substances must be supported by a DEA Form 222 or CSOS transaction. Accepting and retaining a Schedule II shipment without proper documentation violates DEA regulations and the pharmacy's recordkeeping obligations. The pharmacy bears responsibility for ensuring proper documentation exists, regardless of the distributor's claim. DEA Form 106 is for theft or significant loss, not recordkeeping deficiencies.
12. A hospital pharmacy receives a large Schedule II shipment and the receiving pharmacist is not available. A pharmacy technician accepts delivery. Which statement is most accurate?
    Answer: Pharmacist must verify Schedule II receipt and documentation, even if a technician physically accepts the delivery. While DEA regulations and state pharmacy laws vary on the specific tasks technicians may perform during controlled substance delivery acceptance, the pharmacist bears ultimate responsibility for verifying the shipment's accuracy against the DEA Form 222 and completing required receipt documentation in the controlled substance records. A technician may assist with or physically receive the delivery in many settings, but the pharmacist's oversight and accountability for final documentation is a consistent regulatory expectation. A correctly identifies this framework. B is incorrect because technicians may be present and involved in the delivery process in many settings; blanket exclusion is not the universal rule. C is incorrect because DEA regulations do not require a pharmacist to be physically present for every delivery; what is required is pharmacist accountability for accurate receipt documentation. D is incorrect because technician acceptance alone does not satisfy all documentation requirements; pharmacist review and accountability for the DEA Form 222 receipt record is required.
13. A DEA Form 222 is prepared but not used within 60 days. What happens to the unfilled order?
    Answer: The order is void; the pharmacy must prepare a new DEA Form 222 to place the order Under DEA regulations, a DEA Form 222 that has not been filled within 60 days of its execution date becomes void. The pharmacy must prepare a new form to place the order. The void form should be retained on file. Updating the date on a stale form or obtaining verbal DEA approval are not acceptable procedures.
14. A pharmacy uses paper DEA Form 222 to order Schedule II opioids. The pharmacist makes an error on one line of the form. What is the correct procedure?
    Answer: Void the form and start a new DEA Form 222; do not attempt to correct errors on an executed form DEA Form 222 does not permit erasures or alterations. Any error requires the form to be voided. The pharmacist should write 'VOID' on the spoiled form, retain the copy, and prepare a new form. Crossing out and initialing or attaching correction memos are not acceptable for DEA Form 222. Distributors cannot alter the purchaser's order form.
15. A pharmacist-in-charge at a retail pharmacy retires. A new PIC is appointed. What must occur regarding the existing DEA Power of Attorney for ordering?
    Answer: The existing POA must be revoked and a new one executed by the new authorized signer. Under DEA regulations, a power of attorney for ordering Schedule II controlled substances is granted by the registrant, or by a partner or officer authorized to sign on the registrant's behalf. The POA is tied to the specific grantor, not to the PIC title as such. When the PIC who served as grantor leaves, the POA granted by that person should be revoked, and if ordering authority is still needed, a new POA must be executed by whoever now holds the authorization to sign on behalf of the registrant. A is incorrect because POAs do not automatically transfer when a PIC changes; they are executed documents tied to specific individuals. C is incorrect because the DEA does not issue new Form 222 booklets in response to a PIC change; the registrant's Form 222 authority is tied to the registered location. D is incorrect because no automatic 90-day transition period for POAs exists in DEA regulations.
16. During a DEA inspection, an agent notes that the pharmacy cannot produce DEA Form 222s for several Schedule II purchases made 18 months ago. The PIC claims the forms were filed but cannot be located. Which analysis BEST describes the pharmacy's compliance status?
    Answer: A recordkeeping violation exists due to failure to produce DEA Form 222s for inspection. DEA regulations require that controlled substance records - including DEA Form 222s - be retained for at least 2 years and be readily retrievable upon DEA request. Forms from 18 months ago fall within the required retention window. Inability to produce them during a DEA inspection constitutes a recordkeeping violation regardless of whether the purchases actually occurred. Bank statements do not substitute for DEA-required documentation.
17. A pharmacy receives a Schedule II order but the shipment contains fewer units than were ordered. How should this discrepancy be handled on the DEA Form 222?
    Answer: Record the quantity received on Copy 3; the distributor can supply the balance within 60 days. When a Schedule II shipment is short, the pharmacy records only the actual quantity received on Copy 3 of DEA Form 222. Under DEA regulations, the unfilled balance of a line item may still be supplied by the distributor under the same Form 222 within 60 days of the date the form was executed; the balance is not automatically canceled by a partial delivery, but it does become void if not supplied within that 60-day window. A is incorrect because DEA Form 106 is for theft or significant loss, not routine partial shipment shortages. B is incorrect because the distributor does not issue a new Form 222 to fill the shortage balance; the existing form covers it within 60 days. D is incorrect because the pharmacy is not required to return the partial shipment and reorder; the existing form remains valid to cover the balance.
18. A pharmacy orders Schedule III controlled substances from a wholesale distributor. Which of the following is required for this transaction?
    Answer: A standard purchase order or invoice reflecting the pharmacy's DEA registration number Schedule III, IV, and V controlled substances do not require DEA Form 222 or CSOS for ordering. They may be ordered using ordinary business channels - purchase orders or invoices - as long as both the purchaser and seller are DEA-registered. The records of these transactions must be maintained for 2 years. DEA Form 222/CSOS is required only for Schedule I and II ordering.
19. A pharmacy wants to transfer its entire Schedule II inventory to a sister pharmacy during a system-wide renovation. What documentation is required?
    Answer: A DEA Form 222 issued by the receiving pharmacy to document the Schedule II transfer between DEA registrants Any transfer of Schedule II controlled substances between DEA registrants - including sister pharmacies - requires a DEA Form 222 (or CSOS transaction) issued by the receiving registrant. The same rules that govern ordering from a distributor apply to transfers between registrants. DEA Form 41 is for destruction; DEA Form 106 is for theft/significant loss; a standard invoice is insufficient for Schedule II transfers.
20. A pharmacy auditor discovers that the pharmacy's Schedule II ordering records contain multiple DEA Form 222s with the same serial number. What is the MOST likely compliance concern?
    Answer: Duplicate serial numbers indicate a potential DEA violation and require immediate investigation. DEA Form 222 serial numbers are unique identifiers; duplicate serial numbers in a pharmacy's records signal a serious problem - either recordkeeping errors, forgery, or controlled substance diversion. This finding requires immediate investigation, corrective action, and potentially a report to the DEA. The DEA does not assign duplicate numbers; duplicate numbers across distributors would still be a red flag requiring resolution.

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