DEA Registration and Renewal Process

Questions and Answers

When receiving a transferred C-III through C-V Rx, what must the receiving pharmacist reduce to writing?

Various required elements

What must be recorded on the face of the transferred Rx?

Date Rx was issued, original number of refills, date of original first fill, number of refills left, location(s) of previous refill(s), transferring pharmacist's name, transferring pharmacy name, transferring pharmacy address, transferring pharmacy DEA registration number, original Rx number

What are the required elements of a controlled substance Rx label?

Date of fill, pharmacy name, pharmacy address, Rx number, name of patient, name of prescriber, directions for use (sig), cautionary statements required by law

What additional pieces of information are required on a controlled substance Rx label to indicate that it was filled in a central filling pharmacy?

Separate label showing the retail pharmacy name and address, central fill pharmacy's DEA registration number Signup and view all the answers

What is the warning that must be included on a controlled substance Rx?

CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. Signup and view all the answers

According to DEA and FDA regulations, an 'emergency situation' means that the prescriber has determined a C-II medication should be given within what time frame?

Immediately Signup and view all the answers

In an emergency situation, within what time frame must a prescriber deliver a written, signed Rx for the C-II after authorizing an oral Rx to the pharmacist?

Within 7 days Signup and view all the answers

To register as a new pharmacy, the DEA Form ___ must be completed.

224 Signup and view all the answers

The Certificate of Registration (DEA Form ___) must be maintained at the registered location and kept available for official inspection.

223 Signup and view all the answers

If a person owns and operates more than one pharmacy, each place of business must be separately registered with DEA.

True Signup and view all the answers

A pharmacy registration must be renewed every _ years utilizing a DEA Form _.

3; 224a Signup and view all the answers

How far in advance can a pharmacy renew their DEA registration?

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

In order to renew pharmacy registration, information from the old DEA Form 223 is not needed to initiate the renewal process.

False Signup and view all the answers

How often are electronic DEA reminders to renew sent?

At 60, 45, 30, 15, and 5 days prior to the expiration date. Signup and view all the answers

How long is the grace period to renew DEA registration after the expiration date?

30 days Signup and view all the answers

A pharmacy with a DEA registration that expired 15 days ago has submitted for their renewal within the grace period, and they are entitled to handle controlled substances during this time frame.

False Signup and view all the answers

The Retail Pharmacy Registration Affidavit for Chain Renewal is also known as a DEA Form ___.

224b Signup and view all the answers

How many retail pharmacies must a corporation have in order to enroll in the chain renewal program with the DEA?

50 or more Signup and view all the answers

Before moving to a new physical location, a pharmacy should first request a modification of registration.

True Signup and view all the answers

A pharmacy that discontinues business activities either completely, or only regarding controlled substances can destroy their remaining, unused official order forms (DEA Form 222).

False Signup and view all the answers

Controlled substance records must be kept for ___ years.

2 Signup and view all the answers

A pharmacy registrant that desires to transfer its business operations to another pharmacy registrant must submit in person or by registered or certified mail to whom?

Special Agent in Charge in his or her area Signup and view all the answers

How far in advance must a pharmacy registrant submit a transfer request to the DEA?

At least 14 days in advance Signup and view all the answers

When transferring pharmacies, when must a complete inventory of controlled substances be taken?

On the day the controlled substances are transferred Signup and view all the answers

Which of the following must be included in the controlled substance transfer inventory? (Select all that apply)

Quantity Signup and view all the answers

Match the following responsibilities regarding controlled substance records:

Transferor = Responsible for the accuracy of records prior to the transfer. Transferee = Responsible for custody and maintenance of the records. Signup and view all the answers

A pharmacy can register with the DEA to sell bulk quantities of scheduled listed chemical products (SLPCs).

True Signup and view all the answers

To obtain a DEA chemical distributor registration, a pharmacy may complete the DEA Form ___.

510 Signup and view all the answers

Which scheduled controlled substances are ordered with an official paper order form? (Select all that apply)

I & II Signup and view all the answers

A DEA Form ___ is required for each distribution or transfer of a C-I or C-II unless exempted.

222 Signup and view all the answers

If there are any errors on a DEA Form 222 regarding the registrant's name, address, or registration number, who must it be reported to?

DEA Diversion Field Office or Registration and Program Support Section Signup and view all the answers

When ordering controlled substances using a DEA Form 222, multiple items may be entered on each numbered line.

False Signup and view all the answers

In regards to a DEA Form 222, the purchaser does not have the option of obtaining the original copy.

True Signup and view all the answers

Who retains the original DEA Form 222? For how long?

The supplier must retain the original copy for 2 years. Signup and view all the answers

In regards to a DEA Form 222, who is the registrant? (Select one)

Pharmacy Signup and view all the answers

Who must sign the power of attorney to allow one or more individuals to obtain and execute a DEA Form 222?

The registrant, the person to whom the power of attorney is being granted, and two witnesses. Signup and view all the answers

A power of attorney for a DEA Form 222 is sent to the DEA after it is signed.

False Signup and view all the answers

How soon must a pharmacy report lost or stolen DEA Form 222 unused order forms?

Immediately Signup and view all the answers

What is the name of the electronic system used to order schedule II controlled substances?

Controlled Substance Ordering System (CSOS) Signup and view all the answers

A purchaser may correct a defective order.

False Signup and view all the answers

The supplier is not required to retain a record of orders that are not filled.

True Signup and view all the answers

When ordering C-III through C-V substances, which 5 things must be included on the receipts/invoices?

<ol> <li>Name of the substance, 2. Each finished form, 3. Number of units of finished forms and commercial containers acquired, 4. Number of commercial containers distributed, 5. Number of units of finished forms/commercial containers disposed of.</li> </ol> Signup and view all the answers

Inventories of C-II substances will be determined by an actual physical count.

True Signup and view all the answers

In regards to C-III through C-V substances, open bottles with tablet or capsule counts less than ___ may be estimated; anything above this number must be an exact count.

1000 Signup and view all the answers

Records for controlled substance inventory must be kept for at least ___ years.

2 Signup and view all the answers

A registrant is required to send a copy of their inventory to the DEA.

False Signup and view all the answers

After the initial controlled substance inventory, the registrant is required to take a new inventory at least every ___ years.

2 (biennially) Signup and view all the answers

When a drug not previously listed as a controlled substance is scheduled, when must the drug be inventoried?

On the effective date of scheduling Signup and view all the answers

DEA Form ___ is used to report theft or significant loss.

106 Signup and view all the answers

DEA Form ___ is used to record destruction of controlled substances.

41 Signup and view all the answers

Which 5 things regarding the patient and the prescriber must be included on a Rx for a controlled substance?

<ol> <li>Patient's name, 2. Patient's address, 3. Practitioner's name, 4. Practitioner's address, 5. Practitioner's DEA registration number.</li> </ol> Signup and view all the answers

Which 6 things must be included on a controlled substance Rx? (Not including patient or prescriber - things about the drug itself)

<ol> <li>Drug name, 2. Drug strength, 3. Dosage form, 4. Quantity prescribed, 5. Directions for use, 6. Number of refills authorized.</li> </ol> Signup and view all the answers

An individual (i.e. - secretary, RN) may prepare prescriptions under the practitioner's signature.

True Signup and view all the answers

Regarding purpose of issue, the practitioner is the sole responsible party for the proper prescribing and dispensing of controlled substances, including how the prescription is filled at the pharmacy.

False Signup and view all the answers

What does the first letter of a DEA registration number represent? (i.e. - A, B, F, M)

A - physicians, dentists, veterinarians, other practitioners Signup and view all the answers

What does the second letter of DEA registration number represent?

The practitioner's last name. Signup and view all the answers

What does an 'X' represent in a DEA registration number? Which Acts are associated with this?

Unique Identification Number (UIN) for qualified practitioners under various acts. Signup and view all the answers

Name examples of mid-level practitioners.

NPs, PAs, nurse midwives, nurse anesthetists, clinical nurse specialists. Signup and view all the answers

The federal time limit within which a C-II must be filled is 4 months.

False Signup and view all the answers

An oral Rx is permitted during an emergency.

True Signup and view all the answers

Within how many days after authorizing an emergency Rx must a prescriber deliver a written prescription to the pharmacist for dispensing?

7 days Signup and view all the answers

An agent may call in a C-II for a practitioner during an emergency.

False Signup and view all the answers

Refills on C-IIs are prohibited.

True Signup and view all the answers

An individual practitioner may issue multiple Rx's for up to ___ days.

90 Signup and view all the answers

A prescriber may send a C-II Rx via facsimile to a community pharmacy, but the pharmacist must wait for the patient to bring the original paper Rx.

True Signup and view all the answers

In the case of a patient at a nursing home, hospice, or LTCF, a prescriber (or their direct agent) may send a C-II Rx via facsimile, which serves as the original Rx.

True Signup and view all the answers

Name four (4) ways a pharmacist may accept a C-III through C-V prescription.

Electronic, Paper, Facsimile, Called in. Signup and view all the answers

How many refills (within how many months) are allowed on C-III and C-IV prescriptions?

5 refills within 6 months Signup and view all the answers

What is required on the back of the Rx (or documented electronically) each time a C-III or C-IV prescription is filled?

Dispensing pharmacist's initials, Date the Rx was refilled, Amount of drug dispensed on the refill Signup and view all the answers

A pharmacy is required to use an electronic recordkeeping system for C-III through C-IV.

False Signup and view all the answers

Name some features that an electronic recordkeeping system must track in regards to controlled substance Rx's.

Original Rx number, Date of issuance, Patient's full name, Patient's address, Prescriber's name, Prescriber's address. Signup and view all the answers

The pharmacist is not required to sign/date the hard copy printout of each day's controlled substance refills.

False Signup and view all the answers

The hard copy printout of each day's controlled substance refills must be uploaded or available electronically for other pharmacies to see within ___ of the date on which the refill was dispensed.

72 hours Signup and view all the answers

The printout of a refill-by-refill audit trail must be provided to the requesting pharmacy within ___.

48 hours Signup and view all the answers

For auditing purposes, what must be included on the refill-by-refill audit trail for controlled substance Rx's?

Prescriber's name, Patient's name, Patient's address, Original Rx number, Quantity dispensed on each refill, Date of each refill, Name/ID code of dispensing pharmacist. Signup and view all the answers

A pharmacy may use both paper and electronic methods for storage and retrieval of Rx order refill information of C-III and C-IV Rx's.

False Signup and view all the answers

A prescriber's agent may send a C-III through C-V Rx via facsimile to a community pharmacy as long as the prescriber has manually signed it.

True Signup and view all the answers

A pharmacist may dispense C-III through C-V pursuant to an oral prescription made by a prescriber or their authorized agent as long as it is reduced to writing and contains all information for a valid Rx except the signature of the prescriber.

True Signup and view all the answers

How many times may a C-III through C-V Rx be transferred to another pharmacy (that does not share a real-time electronic system)?

Once Signup and view all the answers

What 5 things must be recorded on the back of the C-III through C-V Rx being transferred? What must be recorded on the face of the Rx?

On the back: 1. Name of the pharmacy, 2. Address of the pharmacy, 3. DEA registration number, 4. Date of transfer, 5. Pharmacist making transfer. On the face: Any remaining refills left. Signup and view all the answers

Study Notes

DEA Registration and Renewals

Completing DEA Form 224 is necessary to register a new pharmacy.
The Certificate of Registration (DEA Form 223) must be displayed at the pharmacy for inspection.
Each pharmacy under a single ownership requires its own DEA registration.
Renewals for pharmacy registration occur every 3 years via DEA Form 224a.
Pharmacies can renew their DEA registration no earlier than 60 days before expiration.
Information from the previous DEA Form 223 is essential for the renewal process.
Electronic reminders for renewal are sent at 60, 45, 30, 15, and 5 days prior to expiration.
A 30-day grace period is granted for renewal after expiration, but no handling of controlled substances is allowed during this time.

Chain Pharmacies and Transfers

DEA Form 224b is used for chain pharmacy registrations with 50 or more retail pharmacies.
Modifications to registration must be requested before relocating the pharmacy.
Upon discontinuation of business, pharmacies must return DEA registration certificates and unused official order forms to the DEA.

Recordkeeping and Inventories

Controlled substance records must be maintained for 2 years.
A transfer request to the DEA requires submission 14 days before the transfer date.
A comprehensive inventory of controlled substances must be documented on the day of transfer.
Specific details like drug name, dosage form, strength, quantity, and transfer date must be included in transfer inventories.

Ordering and Handling Controlled Substances

Bulk purchases of scheduled listed chemical products require registration as a chemical distributor (DEA Form 510).
DEA Form 222 is essential for ordering C-I and C-II substances; it must have one item per line.
Errors on DEA Form 222 need to be reported to the DEA Diversion Field Office.
Lost or stolen DEA Form 222 order forms must be reported immediately, including serial numbers.

Prescription Handling

Controlled substances prescriptions require comprehensive information like patient and prescriber details, drug name, strength, dosage form, and directions for use.
C-III and C-IV prescriptions allow 5 refills within 6 months, while C-IIs cannot be refilled.
Transferring C-III through C-V prescriptions to another pharmacy is limited to one transfer unless using a real-time electronic system.
Faxed prescriptions for C-IIs are permissible for certain facilities, such as nursing homes, without needing the original prescription.

Compliance and Regulations

A pharmacist must keep a hard copy of daily controlled substance refills and must sign and date this printout.
DEA Form 106 is used to report theft or significant loss, while DEA Form 41 records the destruction of controlled substances.
The pharmacy is responsible for upholding accurate records of controlled substances and conducting biennial inventories.

Emergency Provisions

C-II prescriptions can be authorized orally during emergencies; however, a written prescription must be provided within 7 days.
The emergency situation definition includes immediate provision of C-II medications as deemed necessary by the prescriber.

Special Designations and Requirements

"X" in a DEA registration indicates a Unique Identification Number for practitioners prescribing narcotic controlled substances for treatment.
Mid-level practitioners, such as Nurse Practitioners and Physician Assistants, can prescribe controlled substances under specific regulations.

Pharmacy Responsibilities

The practitioner is responsible for the proper prescribing of controlled substances, but pharmacists share this responsibility regarding dispensing.
When filling prescriptions, complete and accurate record-keeping is fundamental to maintaining compliance with DEA regulations.

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Description

This quiz covers the essential aspects of DEA registration and renewal processes for pharmacies. It includes information on completing necessary forms, the requirements for registrations, and details on renewal timings and procedures. Understanding these elements is critical for pharmacy compliance and operations.

DEA Registration and Renewal Process

Questions and Answers

When receiving a transferred C-III through C-V Rx, what must the receiving pharmacist reduce to writing?

What must be recorded on the face of the transferred Rx?

What are the required elements of a controlled substance Rx label?

What additional pieces of information are required on a controlled substance Rx label to indicate that it was filled in a central filling pharmacy?

What is the warning that must be included on a controlled substance Rx?

According to DEA and FDA regulations, an 'emergency situation' means that the prescriber has determined a C-II medication should be given within what time frame?

In an emergency situation, within what time frame must a prescriber deliver a written, signed Rx for the C-II after authorizing an oral Rx to the pharmacist?

To register as a new pharmacy, the DEA Form ___ must be completed.

The Certificate of Registration (DEA Form ___) must be maintained at the registered location and kept available for official inspection.

If a person owns and operates more than one pharmacy, each place of business must be separately registered with DEA.

A pharmacy registration must be renewed every ___ years utilizing a DEA Form ___.

How far in advance can a pharmacy renew their DEA registration?

In order to renew pharmacy registration, information from the old DEA Form 223 is not needed to initiate the renewal process.

How often are electronic DEA reminders to renew sent?

How long is the grace period to renew DEA registration after the expiration date?

A pharmacy with a DEA registration that expired 15 days ago has submitted for their renewal within the grace period, and they are entitled to handle controlled substances during this time frame.

The Retail Pharmacy Registration Affidavit for Chain Renewal is also known as a DEA Form ___.

How many retail pharmacies must a corporation have in order to enroll in the chain renewal program with the DEA?

Before moving to a new physical location, a pharmacy should first request a modification of registration.

A pharmacy that discontinues business activities either completely, or only regarding controlled substances can destroy their remaining, unused official order forms (DEA Form 222).

Controlled substance records must be kept for ___ years.

A pharmacy registrant that desires to transfer its business operations to another pharmacy registrant must submit in person or by registered or certified mail to whom?

How far in advance must a pharmacy registrant submit a transfer request to the DEA?

When transferring pharmacies, when must a complete inventory of controlled substances be taken?

Which of the following must be included in the controlled substance transfer inventory? (Select all that apply)

Match the following responsibilities regarding controlled substance records:

A pharmacy can register with the DEA to sell bulk quantities of scheduled listed chemical products (SLPCs).

To obtain a DEA chemical distributor registration, a pharmacy may complete the DEA Form ___.

Which scheduled controlled substances are ordered with an official paper order form? (Select all that apply)

A DEA Form ___ is required for each distribution or transfer of a C-I or C-II unless exempted.

If there are any errors on a DEA Form 222 regarding the registrant's name, address, or registration number, who must it be reported to?

When ordering controlled substances using a DEA Form 222, multiple items may be entered on each numbered line.

In regards to a DEA Form 222, the purchaser does not have the option of obtaining the original copy.

Who retains the original DEA Form 222? For how long?

In regards to a DEA Form 222, who is the registrant? (Select one)

Who must sign the power of attorney to allow one or more individuals to obtain and execute a DEA Form 222?

A power of attorney for a DEA Form 222 is sent to the DEA after it is signed.

How soon must a pharmacy report lost or stolen DEA Form 222 unused order forms?

What is the name of the electronic system used to order schedule II controlled substances?

A purchaser may correct a defective order.

The supplier is not required to retain a record of orders that are not filled.

When ordering C-III through C-V substances, which 5 things must be included on the receipts/invoices?

Inventories of C-II substances will be determined by an actual physical count.

In regards to C-III through C-V substances, open bottles with tablet or capsule counts less than ___ may be estimated; anything above this number must be an exact count.

Records for controlled substance inventory must be kept for at least ___ years.

A registrant is required to send a copy of their inventory to the DEA.

After the initial controlled substance inventory, the registrant is required to take a new inventory at least every ___ years.

When a drug not previously listed as a controlled substance is scheduled, when must the drug be inventoried?

DEA Form ___ is used to report theft or significant loss.

DEA Form ___ is used to record destruction of controlled substances.

Which 5 things regarding the patient and the prescriber must be included on a Rx for a controlled substance?

Which 6 things must be included on a controlled substance Rx? (Not including patient or prescriber - things about the drug itself)

An individual (i.e. - secretary, RN) may prepare prescriptions under the practitioner's signature.

Regarding purpose of issue, the practitioner is the sole responsible party for the proper prescribing and dispensing of controlled substances, including how the prescription is filled at the pharmacy.

What does the first letter of a DEA registration number represent? (i.e. - A, B, F, M)

What does the second letter of DEA registration number represent?

What does an 'X' represent in a DEA registration number? Which Acts are associated with this?

Name examples of mid-level practitioners.

The federal time limit within which a C-II must be filled is 4 months.

An oral Rx is permitted during an emergency.

Within how many days after authorizing an emergency Rx must a prescriber deliver a written prescription to the pharmacist for dispensing?

An agent may call in a C-II for a practitioner during an emergency.

Refills on C-IIs are prohibited.

An individual practitioner may issue multiple Rx's for up to ___ days.

A prescriber may send a C-II Rx via facsimile to a community pharmacy, but the pharmacist must wait for the patient to bring the original paper Rx.

In the case of a patient at a nursing home, hospice, or LTCF, a prescriber (or their direct agent) may send a C-II Rx via facsimile, which serves as the original Rx.

Name four (4) ways a pharmacist may accept a C-III through C-V prescription.

How many refills (within how many months) are allowed on C-III and C-IV prescriptions?

What is required on the back of the Rx (or documented electronically) each time a C-III or C-IV prescription is filled?

A pharmacy is required to use an electronic recordkeeping system for C-III through C-IV.

Name some features that an electronic recordkeeping system must track in regards to controlled substance Rx's.

The pharmacist is not required to sign/date the hard copy printout of each day's controlled substance refills.

The hard copy printout of each day's controlled substance refills must be uploaded or available electronically for other pharmacies to see within ___ of the date on which the refill was dispensed.

The printout of a refill-by-refill audit trail must be provided to the requesting pharmacy within ___.

For auditing purposes, what must be included on the refill-by-refill audit trail for controlled substance Rx's?

A pharmacy may use both paper and electronic methods for storage and retrieval of Rx order refill information of C-III and C-IV Rx's.

A prescriber's agent may send a C-III through C-V Rx via facsimile to a community pharmacy as long as the prescriber has manually signed it.

A pharmacist may dispense C-III through C-V pursuant to an oral prescription made by a prescriber or their authorized agent as long as it is reduced to writing and contains all information for a valid Rx except the signature of the prescriber.

A pharmacy registration must be renewed every _ years utilizing a DEA Form _.