Last Updated: May 14, 2019
The Pennsylvania Medical Society (PAMED) often receives questions from member physicians regarding Drug Enforcement Administration (DEA) registration, renewal, and reporting.
Registration with the DEA is necessary for physicians and other health care practitioners to write prescriptions for controlled substances. Upon successful registration, a practitioner will be issued a DEA Registration Number. This DEA number is a personal identifier, which must thereafter be used by the practitioner in controlled substance prescriptions.
Here are answers to frequently asked questions.
How do I register with the DEA?
Registration with the DEA is based upon an applicant’s compliance with their respective state licensing and practice laws. Note that some states require a separate controlled substance number in addition to your medical license. Pennsylvania, however, does not require such separate registration.
To register with the DEA, applicants (who are individual practitioners, hospitals, teaching institutions, or retail pharmacies) must complete DEA Form 224. There are separate application forms required for entities such as manufacturers and narcotic treatment clinics. DEA Form 224 can be completed and accessed here.
The DEA advises applicants to allow four to six weeks for the processing of initial DEA registrations.
When is a separate DEA registration required?
Federal law, see 21 C.F.R. §1301.12, requires separate DEA registration for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed. Practitioners who register at one location in a state, but practice at other locations within that same state, are not required to register with the DEA at any other location in that state at which they only prescribe controlled substances.
If you prescribe controlled substances in more than one state, a separate DEA registration is required for each state where you administer, dispense, or prescribe controlled substances. Multiple registrations might also be needed within the same state dependent upon the details of your practice.
Modifications of registration must be requested when DEA registrants move to a new physical practice location. Modifications are handled in the same manner as new applications and must be approved by the DEA. Once such a modification is processed, a new certificate of registration will be issued.
When and how do I renew my DEA registration?
DEA registrations are renewed every three years. Unlike state medical licenses, your DEA registration renewal date is directly correlated to the date your registration was first issued.
There are situations where expiration dates may not be the full three-year period. When an individual is first registered with the DEA, they may receive an initial registration period of a minimum of 28 months or a maximum of 39 months. Subsequent renewal periods, however, will follow the three-year schedule.
To renew DEA registration, DEA Form 224a must be submitted. DEA Form 224a can be completed and accessed here.
A renewal notice will be mailed to the registrant’s mailing address of record about sixty-five days before their registration expires. A second renewal reminder will later be sent via email. Prior to 2017, the DEA mailed two renewal notices to each registrant’s mailing address of record.
The DEA advises registrants to allow approximately four weeks for renewal processing.
What if my DEA registration was not renewed before its expiration date?
The DEA has existing policy that allows registrants to continue operations beyond the expiration of their registration until final action is taken on their renewal, if their renewal application was submitted in a timely manner prior to expiration.
If a renewal was not timely submitted, an expired registration may be reinstated by the DEA within one calendar month after the expiration date. If registration is not renewed within that month, an application for new registration must be submitted.
If you did not timely submit a renewal application before your registration expired, controlled substances cannot be handled while your registration is expired.
How do I report a compromised DEA number or theft/loss?
DEA registrants are required to notify the DEA and local law enforcement of the theft or loss of controlled substances, including a compromised DEA registration number used to divert controlled substances. Registrants must report within twenty-four (24) hours of discovery.
DEA registrants are required to submit DEA Form 106 to report the theft or loss of controlled substances. DEA Form 107 is required to report the theft or loss of a listed chemical. The DEA has created an online Theft and Loss Reporting (TLR) System which provides the capability for a registrant to electronically submit a DEA Form 106 and/or a Form 107. DEA Forms 106 and 107 can be completed and accessed here.
DEA registrants are required to submit DEA Form 106 to report the theft or loss of controlled substances. DEA Form 106 can be completed and accessed here.
Federal regulations (21 C.F.R. §1301.76(b)) provide the following factors to consider in determining the significance of a specific controlled substance loss:
- The actual quantity of controlled substances lost in relation to the type of business;
- The specific controlled substances lost;
- Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
- A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
- Whether the specific controlled substances are likely candidates for diversion;
- Local trends and other indicators of the diversion potential of the missing controlled substance.
Additional information on the DEA reporting of controlled substance theft or loss can be accessed here.
How do I report DEA scam attempts?
Unfortunately, DEA registrants can be targets for extortion attempts and other scams. One recent scam involved telephone calls to registrants from individuals claiming to be DEA agents and demanding monetary payment for violations of controlled substances laws. The DEA has warned registrants to be cautious of these calls. The DEA will never contact registrants by telephone to demand money or any other forms of payment.
Scam attempts involving DEA registration or targeting DEA registrants should be reported. Suspected DEA scams can be reported on the DEA website.
Where can I find more information?
The DEA’s Practitioner’s Manual summarizes and explains the basic requirements for prescribing, administering, and dispensing controlled substances under the Federal Controlled Substances Act, its implementing regulations, and subsequent DEA rules. The manual can be accessed here.
Answers to frequently asked questions regarding DEA registration and renewal can be found here and more information on DEA registration and renewal procedures can be accessed here. Click here. for additional details on the fee categories associated with DEA registration and renewal.
You can also find and contact your DEA Field Office here.
PAMED's Legal Resource Center
PAMED's Legal Resource Center provides quality, timely legal advocacy and resources for member physicians who practice in Pennsylvania. You'll find:
- News on PAMED's strong legal advocacy in the courts, legislature, and state government agencies
- Resources about laws and regulations that impact the practice of medicine, in the form of frequently asked questions (FAQs), legal briefs, and more.
Get details at www.pamedsoc.org/LegalResourceCenter.