- A pharmacy's DEA Certificate of Registration must be maintained where under DEA regulations?
Answer: At the registered location and readily retrievable for DEA inspection; the certificate must be kept at the physical address where controlled substances are dispensed.
DEA regulations require the Certificate of Registration to be maintained at the registered location and be readily retrievable for DEA inspection. A correctly identifies this requirement. B is incorrect because the state board does not maintain pharmacies' DEA certificates. C is incorrect because the certificate must be at the pharmacy location, not in personal records. D is incorrect because corporate headquarters are not the registered location where the certificate must be kept.
- A newly licensed pharmacist sets up an independent consulting practice advising physicians on pharmacotherapy but will not personally dispense controlled substances to patients. Does this pharmacist need an individual DEA registration?
Answer: No, DEA registration is not needed if the pharmacist does not handle controlled substances directly.
DEA registration is required for practitioners who actually dispense, prescribe, or administer controlled substances. A pharmacist who provides purely advisory consulting services without personally dispensing or prescribing controlled substances does not require an individual DEA registration. A correctly identifies this. B is incorrect because pharmacist licensure does not automatically require an individual DEA registration; the activity determines the need. C is incorrect because advising physicians on pharmacotherapy does not constitute dispensing, prescribing, or administering controlled substances. D is incorrect because DEA registration is not required of all healthcare professionals; it is required of those who engage in regulated controlled substance activities.
- A pharmacy has voluntarily agreed to surrender its DEA registration as part of a settlement agreement with the DEA. What happens to controlled substances remaining in the pharmacy's inventory at the time of surrender?
Answer: Controlled substances must be transferred to another DEA registrant or disposed of through DEA-authorized methods.
When a DEA registration is surrendered, remaining controlled substances must be transferred to another DEA registrant, returned to a distributor, or disposed of through a DEA-authorized method -- they cannot simply remain on the premises or be retained by the PIC. A final inventory must be conducted on the date of surrender and retained in the pharmacy's records; it is not generally required to be submitted to the DEA, but must be available for inspection. The DEA Certificate of Registration must be returned to the DEA. A correctly identifies these requirements. B is incorrect because the PIC cannot personally retain controlled substances for unofficial distribution. C is incorrect because the state board does not automatically take custody upon DEA surrender. D is incorrect because continuing to dispense controlled substances after agreeing to surrender the registration would violate the settlement terms and controlled substance laws.
- A pharmacy chain acquires a retail pharmacy from another company. The acquired pharmacy has an existing DEA registration. Which of the following best describes the DEA registration obligations following the acquisition?
Answer: The new owner must obtain a new DEA registration for the acquired location before dispensing controlled substances under the new ownership, because DEA registrations are not transferable between different legal entities.
DEA registrations are not transferable between legal entities. When ownership changes, the new owner must obtain its own DEA registration before dispensing controlled substances. B correctly identifies this requirement. A is incorrect because DEA registrations are not automatically transferable. C is incorrect because using another entity's registration is unauthorized and constitutes dispensing without a valid registration. D is incorrect because a simple notification does not transfer or authorize use of another entity's registration.
- A DEA registration application for a new pharmacy requires which of the following information about the proposed registrant?
Answer: The pharmacy's physical address, business activity, controlled substance schedules, applicant's name, and applicable fees.
A DEA registration application requires the applicant's name, the complete registered address, the activity to be registered, the schedules of controlled substances to be handled, and payment of applicable fees. A correctly identifies these elements. B is incorrect because state licensure does not satisfy the federal DEA registration requirement; they are separate processes. C is incorrect because the PIC's personal DEA number is not a substitute for the pharmacy's own registration. D is incorrect because a floor plan and social security number are not the primary required registration elements.
- Which DEA schedule authorizes a pharmacy to dispense the broadest range of controlled substances to patients?
Answer: A DEA registration for Schedules II-V allows dispensing of all controlled substances.
A DEA registration that includes Schedule II authority encompasses Schedules II through V, allowing the pharmacy to dispense across all of these schedules. D correctly describes the scope of a full pharmacy DEA registration. A is incorrect because a Schedule II-only registration does not exist in this way; pharmacies registering for Schedule II are generally authorized for III through V as well. B is incorrect because III-V only registration would not authorize Schedule II dispensing. C is incorrect because a state pharmacy license does not automatically grant DEA authority; a separate federal DEA registration is required.
- A DEA registration for a retail pharmacy must be renewed how frequently?
Answer: Every three years.
DEA registrations for retail pharmacies are valid for three years and must be renewed every three years under 21 CFR 1301.13. A correctly states this renewal period. B is incorrect because annual renewal is not the standard for retail pharmacy DEA registrations; three years is the applicable period. C is incorrect because five years exceeds the three-year renewal period. D is incorrect because ownership changes may require updating the registration but they are not the only trigger; periodic renewal is required regardless.
- A pharmacy's DEA registration has been revoked by the DEA following a diversion investigation. The state board of pharmacy has not yet taken action. May the pharmacy continue to dispense controlled substances under its state pharmacy license?
Answer: No, a valid DEA registration is required to dispense controlled substances, regardless of the state pharmacy license status.
A valid DEA registration is a federal prerequisite for dispensing controlled substances. State pharmacy licensure and DEA registration are both required and each is independent. DEA revocation terminates the pharmacy's federal authority to dispense controlled substances regardless of state license status. B correctly identifies this dual requirement. A is incorrect because while the state license is independent, both are required; one cannot substitute for the other. C is incorrect because all schedule dispensing requires a valid DEA registration. D is incorrect because pending appeal does not automatically stay the effect of a DEA revocation allowing continued dispensing.
- Under the DEA registration framework, which of the following best describes a mid-level practitioner (MLP) such as a nurse practitioner or physician assistant obtaining controlled substance prescribing authority?
Answer: Mid-level practitioners must obtain their own DEA registration to prescribe controlled substances if state law allows it.
Mid-level practitioners authorized by their state to prescribe controlled substances must obtain individual DEA registrations in their own names. They may not use a supervising physician's DEA registration number. C correctly identifies this requirement. A is incorrect because using a supervising physician's DEA number is a federal violation. B is incorrect because many states authorize mid-level practitioners to prescribe controlled substances. D is incorrect because a state license alone does not substitute for a federal DEA registration requirement.
- A pharmacy operating in one state wishes to expand by opening a mail-order operation that will ship controlled substance prescriptions to patients in multiple other states. Which of the following best describes the DEA registration implications?
Answer: The pharmacy needs one DEA registration but must comply with each state's laws on mailing controlled substances.
A pharmacy's DEA registration covers its dispensing activities at the registered location, and a mail-order pharmacy with one DEA registration at its physical location may generally ship to patients in other states. However, state pharmacy practice acts in recipient states may impose additional licensure requirements. D correctly identifies both the DEA sufficiency and the state law compliance obligation. A is not the most complete answer because it omits the state law compliance dimension. B is incorrect because obtaining a separate DEA registration in each recipient state is not required for the dispensing pharmacy's DEA compliance. C is incorrect because while federally a single registration may be sufficient, state law compliance must also be addressed.
- A hospital that operates both an inpatient pharmacy and a separate outpatient retail pharmacy in adjacent buildings asks whether it may use a single DEA registration for both locations. Which of the following applies?
Answer: Each pharmacy must hold a separate DEA registration; a single registration cannot cover two distinct physical locations even if operated by the same entity.
DEA registrations are location-specific. Each physically distinct pharmacy location must have its own registration regardless of common ownership. D correctly identifies this requirement. A is incorrect because common ownership does not allow a single registration to cover multiple locations. B is incorrect because having adjacent addresses does not allow a single registration for physically distinct pharmacy operations. C is incorrect because sharing a PIC does not allow a single registration to cover multiple separate physical locations.
- A pharmacy that is moving to a new address within the same city must do which of the following regarding its DEA registration?
Answer: The pharmacy must notify the DEA in advance and receive authorization before moving controlled substances to the new location.
DEA regulations require pharmacies to notify the DEA before changing the registered address. A pharmacy may not move controlled substances to a new location without prior DEA notification and authorization of the address change. C correctly identifies this requirement. A is incorrect because DEA registrations do not automatically transfer; advance notification is required. B is incorrect because notification must occur in advance, not after the move. D is incorrect because an entirely new registration application is generally not required; the address change is handled through a modification process with advance notification.
- A pharmacy is submitting a new DEA registration application. Under DEA regulations, who is authorized to sign the application on behalf of the pharmacy?
Answer: A proprietor, partner, or officer of the registrant organization, or the pharmacist-in-charge, is authorized to sign the DEA registration application.
Under 21 CFR 1301.13, a DEA registration application must be signed by a proprietor, partner, or officer of the registrant organization, or the pharmacist-in-charge. These are the expressly authorized signatories under federal regulation. C correctly identifies this framework. A is incorrect because general employment as a pharmacist does not authorize signing the registration application; the signatory must be a proprietor, partner, officer, or pharmacist-in-charge. B is incorrect because it is too narrow; partners, officers, and the pharmacist-in-charge are also authorized signatories in addition to the sole owner. D is incorrect because no DEA-designated state board compliance representative category exists for this purpose.
- A DEA registration may be denied, revoked, or suspended on which of the following grounds?
Answer: If the registrant's conduct is inconsistent with the public interest.
Under 21 USC 824, the DEA may deny, revoke, or suspend a registration on multiple grounds: drug-related felony conviction, material falsification of the application, state license revocation or suspension, failure to maintain effective diversion controls, or conduct inconsistent with the public interest. D correctly identifies this broad range. A is incorrect because drug-related felony conviction is only one of several grounds. B is incorrect because state board action is one ground but not the only one. C is incorrect because fee failure is not listed as a substantive ground for revocation in 21 USC 824.
- A pharmacy has applied for DEA registration renewal and the application is pending. The current registration expires while the renewal is still being processed. May the pharmacy continue to dispense controlled substances during this period?
Answer: Yes, if the renewal application was submitted before expiration, the pharmacy may continue dispensing controlled substances.
Under 21 CFR 1301.36, if a registrant has timely submitted a renewal application before the current registration expired, the existing registration remains in effect until the DEA acts on the renewal application. B correctly describes this continuation provision. A is incorrect because a timely-filed renewal application extends the operational authority while the DEA processes the application. C is incorrect because state board notification is not required for a registration continuation during pending renewal. D is incorrect because a temporary state board permit is not required during DEA renewal processing when the application was timely submitted.
- A pharmacy that closed two years ago and surrendered its DEA registration at that time now wishes to reopen and resume controlled substance dispensing. Which of the following best describes the DEA registration requirement?
Answer: The pharmacy must apply for a new DEA registration to lawfully dispense controlled substances.
A surrendered DEA registration cannot be simply reactivated. The pharmacy must apply for a new registration and go through the full application process, including meeting all DEA requirements for a new registrant. D correctly identifies this requirement. A is incorrect because there is no reactivation letter process for surrendered registrations. B is incorrect because a former PIC's personal registration does not authorize a pharmacy location to operate. C is incorrect because the state board is not the mechanism for reactivating or obtaining a federal DEA registration.
- Which of the following practitioner types must obtain a separate, individual DEA registration to prescribe controlled substances?
Answer: Physicians, dentists, veterinarians, and other authorized practitioners who prescribe, administer, or dispense controlled substances in the usual course of their professional practice.
Practitioners who prescribe, administer, or dispense controlled substances in the usual course of professional practice must obtain individual DEA registrations. This includes physicians, dentists, veterinarians, and other authorized mid-level practitioners. C correctly identifies this requirement. A is incorrect because a physician who does not prescribe controlled substances does not need a DEA registration. B is incorrect because pharmacy technicians performing compounding functions under a pharmacist do not require individual DEA registrations. D is incorrect because DEA registration is required for any schedule of controlled substance activity.
- When a pharmacy permanently closes and surrenders its DEA registration, which of the following must occur?
Answer: The pharmacy must return its DEA registration certificate and final inventory to the DEA.
When a pharmacy closes and surrenders its DEA registration, it must complete a final inventory, arrange DEA-compliant transfer or disposal of remaining controlled substances, and return the Certificate of Registration with the final inventory. D correctly identifies these closing obligations. A is incorrect because transfer of controlled substances must follow DEA regulations, not simply be given to any pharmacist. B is incorrect because controlled substances do not automatically become state board property. C is incorrect because on-site destruction requires DEA authorization and must follow prescribed disposal requirements.
- A hospital notices that its DEA registration will expire in 60 days. When should the hospital submit its renewal application?
Answer: The renewal application should be submitted at least 45 days before the expiration date to allow sufficient processing time; DEA recommends submitting 60 days before expiration.
DEA recommends submitting renewal applications at least 60 days before expiration to allow sufficient processing time, though the minimum requirement for benefit of the continuation provision is submitting before the expiration date. A correctly identifies the recommended practice. B is incorrect because submitting after expiration loses the benefit of the continuation provision that allows continued operations while renewal is pending. C is incorrect because waiting until the exact expiration date creates the risk that operations must cease if the DEA does not process the application before expiration. D is incorrect because 6 months is not required for hospital registrations.
- A pharmacy's DEA registration is currently under federal investigation for potential diversion. The DEA seeks to immediately suspend the registration pending the outcome of the investigation. Under what authority may the DEA take this action?
Answer: The DEA may issue an Immediate Suspension Order if continued registration poses an imminent public health threat.
Under 21 USC 824(d), the DEA may issue an Immediate Suspension Order without a prior hearing when continued registration poses an imminent danger to public health or safety. The registrant is entitled to an expedited hearing after the suspension. C correctly describes this authority. A is incorrect because the CSA specifically provides for immediate suspension without a prior hearing in emergency situations. B is incorrect because state board approval is not required for the DEA to exercise its independent federal suspension authority. D is incorrect because a federal court order is not required for the DEA to exercise its Immediate Suspension Order authority.
