REGISTRATION REQUIREMENTS

Question 1

Every pharmacy that dispenses a controlled substance must be registered what agency?

Answer 1

DEA

Question 2

Who does a pharmacy need to obtain a licence from?

Answer 2

Their state

Question 3

What agencies are exempt from the state license requirement?

Answer 3

Federal agencies

Question 4

To register as a new pharmacy, what form must be completed?

Answer 4

DEA Form 224

Question 5

The Certificate of Registration (DEA Form 223) must be maintained where?

Answer 5

at the registered location and kept available for official inspection.

Question 6

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

Answer 6

Yes, each place of business must be separately registered with DEA

Question 7

A pharmacy registration must be renewed how often and what is the fastest way renew a DEA?

Answer 7

every three years utilizing a DEA Form 224a.
21 CFR 1301.13(e)(1)(iv). The most expeditious method to renew a DEA registration is online, but it may be completed by paper application no earlier than 60 days prior to the current expiration date.

Question 8

Are pharmacies sent a renewal notification?

Answer 8

Pharmacies will receive a renewal notification at the mailing address associated with the current registration approximately 60 days prior to the expiration date in accordance with 21 CFR 1301.13(e)(3). DEA will subsequently send an electronic reminder to the email
address associated with DEA registration approximately 20 days prior to the expiration date if the renewal has not been received or completed.

Question 9

The following policy and procedures with respect to renewal and reinstatement of a DEA registration are as follows:

Answer 9

1. If a renewal application is submitted in a timely manner prior to expiration, the
   practitioner may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application. 21 CFR 1301.13(b),
   1301.36(i).
2. DEA policy allows the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that
   calendar month, an application for a new DEA registration is required.
3. Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances for any
   period of time under an expired registration. 21 CFR 1301.13(a),(e).

Question 10

How do corporations that own or operate a chain of pharmacies apply for registration?

Answer 10

Corporations that own or operate a chain of pharmacies may submit a single DEA Form 224b, Retail Pharmacy Registration Affidavit for Chain Renewal.

Question 11

Every registrant under shall be required to report any change of professional or business address in accordance with DEA regulations.

Before moving they must:

Answer 11

request a modification of registration with name, address, and registration number as printed on the Certificate of Registration; the new name or address; and a signature

If the change of address involves a change in state, the proper state issued license and, if
applicable, controlled substances registration must be obtained prior to the approval of modification of the federal registration. The registrant should maintain the new certificate with the old certificate until expiration

Question 12

A pharmacy that discontinues business activities either completely, or only regarding controlled substances, must do what?

Answer 12

return its DEA registration certificate and DEA Form 222 to the local DEA Registration Program Specialist

DEA may ask for the location where inventories, prescriptions, and other required controlled substance records will be stored during the requisite two-year retention period.

Unwanted controlled substances in the pharmacy’s possession must be disposed of in accordance with DEA regulations

Question 13

What information must a a pharmacy registrant that desires to transfer its
business operations to another pharmacy registrant submit?

How can they submit it?

When must they submit it by?

Answer 13

What

1. The name, address, registration number, and authorized business activity of registrant-transferor;
2. The name, address, registration number, and authorized business activity of registrant-transferee;
3. Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed);
4. The date on which the transfer of controlled substances will occur.

How?
in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge

When?
at least 14 days in advance of the date of the proposed transfer

Question 14

When a pharmacy goes out of business, on the day the controlled substances are transferred, a complete inventory must be taken in accordance with 21 CFR 1304.11 which documents what?

Answer 14

the drug name, dosage form, drug strength, quantity, and date transferred.

Question 15

On the day the controlled substances are transferred from the closing pharmacy to another pharmacy what form must be prepared and why?

Answer 15

DEA Form 222 or the electronic equivalent must be prepared to document the transfer of schedule II controlled substances

Question 16

The inventory of controlled substances taken when a pharmacy goes out of business what does the inventory serve as?

Answer 16

This inventory serves as the final inventory for the registrant going out of business and transferring the
controlled substances. It also serves as the initial inventory for the registrant acquiring the controlled substances.

Question 17

A copy of the inventory of controlled substance going from the closing pharmacy to another pharmacy must be included in the records of

Answer 17

each pharmacy

Question 18

Is not necessary to send a copy of the inventory to DEA?

Answer 18

It is not necessary to send a copy of the inventory to DEA unless requested by the Special Agent in Charge

Question 19

How long must the pharmacy acquiring the controlled substances from a closing pharmacy maintain all records involved in the transfer of the controlled substances

Answer 19

for two years.

Question 20

When transferring controlled substances from a closing pharmacy to another pharmacy where are all controlled substance records required to be kept?

Answer 20

All controlled substance records required by the registrant-transferor shall be transferred to the registrant-transferee

Question 21

When transferring controlled substances form a closing pharmacy to another pharmacy who has responsibility for the accuracy of the records prior to date of transfer?

Answer 21

transferor

Question 22

When transferring controlled substances form a closing pharmacy to another pharmacy who has responsibility for custody and maintenance of records?

Answer 22

the transferee.

Question 23

If the registrant acquiring the pharmacy from the closing pharmacy owns at least one other pharmacy licensed in the same state as the pharmacy being transferred, the registrant may do what?

Answer 23

apply for a new DEA registration prior to the date of transfer

DEA may issue a registration which will authorize the registrant to obtain controlled substances at the time of transfer, but the registrant may not dispense controlled substances until the pharmacy has been issued a valid state pharmacy license.

Question 24

A DEA registration application to transfer ownership of an existing pharmacy can be facilitated if

Answer 24

the applicant includes an affidavit verifying that the pharmacy has been registered by the state licensing agency.

The affidavit verifying the existence of the state license should be attached to the initial application for registration.

Question 25

A pharmacy may be denied DEA registration why

Answer 25

upon a finding that such registration is inconsistent with the public interest

Question 26

In determine public interest the CSA provides that the 5 factors are to be considered:

Answer 26

1. The recommendation of the appropriate state licensing board or professional disciplinary authority.
2. The applicant’s experience in dispensing controlled substances.
3. The applicant’s conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances.
4. Compliance with applicable state, federal, or local laws relating to controlled substances.
5. Such other conduct which may threaten the public health and safety.

Question 27

Under 21 U.S.C. 824(a), DEA has the authority to suspend or revoke a DEA registration upon a finding that the registrant:

Answer 27

1. Has materially falsified the application;
2. Has been convicted of a felony relating to a controlled substance or a List I chemical;
3. Had a state license or registration suspended, revoked, or denied by a competent state authority
4. Has committed such acts as would render its registration inconsistent with the public interest
5. Has been excluded (or directed to be excluded) from participation in a program

Question 28

Is registration required for regulated sellers of scheduled listed chemical products

Answer 28

No, however, a regulated seller must self-certify with DEA pursuant to federal law

Question 29

What is a regulated seller of scheduled listed chemicals?

Answer 29

A regulated seller is a retail distributor (including a pharmacy or a mobile retail vendor) of SLCPs,
except that the term does not include an employee or agent of the distributor.

Question 30

Examples of regulated sellers of scheduled listed chemicals include

Answer 30

grocery stores, general merchandise stores, drug stores, or other entities engaged in over-the counter sales of ephedrine (both single entity and combination products),
pseudoephedrine, or phenylpropanolamine products, directly to walk-in customers or in face-to-face transactions by direct sales.

Question 31

If a pharmacy desires to engage in the distribution of bulk quantities of SLCPs what must they do?

Answer 31

the pharmacy is required to register with DEA as a chemical distributor because these activities fall outside the definition of a regulated seller.

Question 32

If a pharmacy desires to engage in the distribution of bulk quantities of SLCPs what registration requirements will they be subject to?

Answer 32

the pharmacy would be subject to the registration requirements that apply to chemical distributors for those distribution activities, and subject to the pharmacy
requirements for its pharmacy activities. To obtain a DEA chemical distributor registration, a pharmacy may complete the DEA Form 510 online.