According to a Drug Enforcement Administration (DEA) report since 2000 more than 30,000 Americans have lost their lives from an opioid overdose. Titles II and III of the Controlled Substances Act of 1970 (CSA), requires all registrants to register for DEA new registration or if their registration is about to expire a DEA registration renewal is a must. Registrants include those involved with manufacturing, distributing, dispensing, importing, exporting, healthcare practitioners handling controlled substances. The DEA’s Office of Diversion Control ensures that all transactions of controlled substances fall within a closed system. If the transaction falls outside, this can be termed as a diversion. Those violating the CSA or other regulations are subjected to DEA administrative enforcement action or can face civil penalties or criminal prosecution by the U.S. Department of Justice (Department).
What is DEA registration?
DEA registration is a number that anyone dealing with controlled substance distribution must have if they are applying for DEA new registration or DEA registration renewal. You will require the application form that varies according to your activity or intention of work. Looking through the registration category area will help form an idea of your applicability. All registration application forms should be obtained from the field office. You can telephone the Registration Section of the DEA headquarters. You can locate the nearest Diversion Field Office from the directory. The DEA Form 224 for new registration can also be availed online from https://www.deadiversion.usdoj.gov/drugreg/process.htm. Additionally, other new registration forms DEA 225,363 and 510 are available online. if you are mailing a paper form you can mail it to the:
Drug Enforcement Administration
P.O. Box 2639
Springfield, VA 22152-2639
- While filling the form you must be extra cautious when submitting the form to the DEA.
- You must carefully complete the application form filling in all the entries.
- All applications must be signed with dates.
- If you are physically mailing the form, enclose the applicable fee amount or enter the credit card information. The application must be mailed to the address printed on the form.
What is the purpose of DEA registration?
With a DEA registration, you are a screened worker and distributor approved by the DEA for procuring, storing, and distributing controlled substance drugs. However, healthcare providers will also require a DEA license. A healthcare worker can only prescribe and administer controlled substance drugs when you have a DEA license. Registration and licensing are important for your career as controlled substances are required by patients for controlling pain. Not just the DEA registration and license but compliance from federal laws is equally desirable. The DEA is the Drug Enforcement Administration under the jurisdiction of the U.S. Government. The work of this law enforcement body is to fight against drug trafficking, and stop the illegal cultivation, manufacturing, and distribution of controlled substance drugs. Screening processes ensure that healthcare workers are not participating in substance diversion and illegal distribution.
What is the process for acquiring a DEA registration number from the Drug Enforcement Administration?
If you are involved with administering, prescribing, or dispensing controlled substances you should be Drug Enforcement Administration (DEA) registered. You can procure a DEA new registration or a DEA registration renewal as necessary. All applications for the same can be made online from the https://www.deadiversion.usdoj.gov/drugreg/process.htm. You can call the DEA Headquarters Registration Unit toll free at 800-882-9539 or call your nearest DEA Registration Field Office if you wish to procure a physical copy of the form(s) you require.
If you are applying for a DEA new registration a new application must be procured. The application form is subject to your activity. You can refer to the registration category area to determine your category. All application forms including DEA Form 224 is available online.
DEA registration renewal forms are also available online. Some rules are applicable for reregistration. Registration form should be applied not before 60 days of the expiry date of the registration. Notifications for renewal are mailed to the official mailing addresses of the registrant 65 days before the date of expiry. Address changes demand written intimation to the DEA when the change occurs so that the notification of renewal if reaching by physical mail should be posted to the correct address. However, the DEA registration and intimations are now maintained online since January 2017.
One must ensure that the application for DEA registration renewal must be utilised in the above stated period to avoid operational interruption. Reinstatement of an application takes one calendar month after the date of expiration, which if not renewed, an application of the new DEA registration will be needed. After expiration DEA prohibits the handling of List 1 chemicals of controlled substances regardless of the status if of reinstated registration.
If your registered certificate is lost, damaged, or destroyed you can apply for a duplicate of the same for an additional cost. You need to get in touch with the Registration Call Center and fill the online duplicate certificate request. The DEA Registration certificate should arrive within eight working days.
How do I get a DEA number?
A DEA number is provided with a DEA registration. A DEA number is the key to allowing prescribers to write prescriptions involving controlled substance drugs. which include opioids, morphine, and steroids. With the use of a DEA number, the prescription falls under the scrutiny of the DEA that tracks the dispensing of controlled substances and the quantities prescribed and procured. The format follows two letters, six numbers, and one check digit pattern. The numbers not just reveal the validity of the registration but also allow greater insight into the prescriber.
The code pattern is as follows:
The first letter of the code reveals the identity of the registrant, which also throws light on the registrant’s place of work, whether the registrant is working in a hospital, an independent practitioner, a researcher, manufacturer or involved with some other occupation.
The second letter reveals the first letter of the DEA registrant’s name.
After the two letters six digits follow.
The last digit in the code is the seventh digit and is a check digit of the formula that once reaches the pharmacy, or a provider can automatically identify the markup of the DEA number checking opioid abuse. Every practitioner must procure a DEA number and be present in the CSA database as a minimum eligibility credential for handling controlled substance drugs. Without a DEA number, a provider cannot prescribe controlled substances to patience. Each DEA registration number is unique and are given to those with proper certification and testing according to state and federal laws. A provider may practice without a DEA, number but cannot prescribe controlled substances. The National Provider Identifier (NPI)must not be confused with DEA numbers. NPI cannot be considered a substitute for DEA. NPI allows all providers to perform all types of HIPAA transactions. All providers with a DEA will have NPI, those with NPI will not qualify for a DEA number.
If your DEA number is compromised, you must immediately notify the DEA and local law enforcement authorities. The report must be lodged within 24 hours of discovery. The complaint can be registered online if you find controlled substance missing from your procurement in the DAE Theft and Loss Reporting (TRL) System where a complaint can be filed in a DEA Form 106 and/or a Form 107.
How do I renew my DEA registration?
You can fill a DEA 224 form online along with your attached protocol application.
The key information required are:
- Your business activity
- You address of operation where you store the controlled substance drugs or free samples and specimens, or another storage location where the controlled substance drugs are sold.
- The physical mailing address or the address of your operational location.
- Your DEA registration number
- You will be contacted by the DEA investigator to finalize the DEA registration renewal process. The procedure involves a questionnaire, which needs to be filled and submitted.
How often do I renew my DEA registration?
The DEA registration renewal is required after every three years. The date of DEA registration is correlated to the first issued DEA registration date. In some cases, the expiry date of the DEA registration, may not follow a full three-year course. Upon initial or DEA new registration the initial registration period is for a minimum of 28 months or a maximum of 39 months. However, when you are applying for a DEA registration renewal, you will be applicable for a three-year registration. When applying for DEA registration renewal you must fill the DEA Form 24, online. A renewal notice will appear in your mailbox. The DEA registration renewal is a four-week process.
The DEA registration renewal process has a fee attached to it depending on the registration category. Dispensing practitioner category fee is $888.
If applications for renewal of DEA registration are submitted promptly, the applicant can continue with their operation beyond the expiry date until the renewal action is finalized.
If the application, has failed to meet a timely submission, the DEA registration renewal is reinstated by the DEA within one month of the date of expiry, if the renewal is not successful the applicant will need to apply for a DEA new registration.
In case of an untimely or delayed application for DEA registration renewal, the applicant will need to suspend operations concerning controlled substances.
What is a DEA Form 224?
DEA form 224 must be filled by those dispensing controlled substances like a pharmacy and practitioners storing controlled substances for prescribing and distributing. The form is divided into 8 sections.
- The first section deals with address details, social security number (SSN), a tax identification number (TIN) if the application is for a business entity along with the Debt collection information. Other personal details are required such as the qualifications of the applicant.
- In the second section, the applicant must enter the name of the parent retail pharmacy/ hospital/care center with address, license number or permit date certified by the state to operate ADS at the named LTC facility. All the information must stand true and be attested by an authorized officer.
- Section 3 of the form deals with the controlled substance drug scheduling handled by the applicant that needs to be checked.
- The fourth section deals with the applicant’s compliance with state and local laws. Before filling the application, the applicant must be in contact with the local state and licensing authorities. If the state-controlled substance number is provided it should be mentioned in this form.
- In section 5 applicants must answer four questions provided with an explanation describing the location and nature of the result indicated.
- Section 6 deals with the exemption of fees which must be certified by a superior of the applicants. The title of the signature authority, along with the telephone number of the certifying officer must be provided.
- In section 7 the method of payment must be indicated a payable to the “Drug Enforcement Administration”.
- Section 8 the applicant signature is a must and should not be misread with the card holders’ signature in section 7. If the form is not filled fully the DEA registration renewal or DEA new registration will be refused by the DEA. The applicants must read the form carefully before filling it.