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pdfRENEWAL APPLICATION FOR REGISTRATION
Form-225A
Renewal
Under the Controlled Substances Act
INSTRUCTIONS
Save time - renew on-line at www.deadiversion.usdoj.gov
1. To renew by mail complete this application. Keep a copy for your records.
2. Mail this form to the address provided in Section 6 or use enclosed envelope.
3. The "MAIL-TO ADDRESS" can be different than your "PLACE OF BUSINESS" address.
4. If you have any questions call 800-882-9539 prior to submitting your application.
IMPORTANT: DO NOT SEND THIS APPLICATION AND RENEW ON-LINE.
MAIL-TO ADDRESS
SECTION 1
APPROVED OMB NO 1117-0012
FORM DEA-225A (09-11)
FORM EXPIRES: 3/31/2012
REGISTRATION INFORMATION:
DEA #
REGISTRATION EXPIRES
FEE IS NON-REFUNDABLE
Please print mailing address changes to the right of the address in this box.
UPDATE REGISTRATION INFORMATION - Please fill in missing information and make corrections if needed to any data we have on record for your registration.
Name 1 :
Name 2 :
PLACE OF
BUSINESS
Street
Address
Line 1 :
PLACE OF
BUSINESS
Address
Line 2 :
City
State :
Zip
Business
Phone
Number :
Business
Fax
Number :
Point of
Contact :
EMAIL
Address :
DEBT COLLECTION
INFORMATION
Tax Identification Number (if registration is for business)
Mandatory pursuant
to Debt Collection
Improvements Act
SECTION 2
A.
SCHEDULES
Social Security Number (if registration is for individual)
Provide SSN or TIN.
See additional information
note #3 on page 4.
Check this box if you wish to register for the same schedule(s):
Check this box if you require official order forms:
For purchase of schedule 2 controlled substances
NO CHANGE
-OR
CHANGE
Enter specific drug
codes on page 2.
B.
MANUFACTURER
ONLY
Mark each box with
an 'X' to indicate
which schedule is
handled in each
manufacturing stage.
If you want to make a change, check all the schedules that you are requesting for this registration:
List 1 (L1) manufacturers
&
importers ONLY
Schedule 2 Narcotic
Schedule 3 Narcotic
Schedule 4
Schedule 1
Schedule 2 Non-Narcotic (2N)
Schedule 3 Non-Narcotic (3N)
Schedule 5
2 NON 3 3 NON 4 5
L1 1 2 narcotic
narcotic
STAGE 1
Bulk synthesis/extraction
2 NON 3 3 NON 4 5
L1 1 2 narcotic
narcotic
STAGE 3
Package / Repackage
Label
/ Relabel
2 NON 3 3 NON 4 5
L1 1 2 narcotic
narcotic
STAGE 2
Dosage form manufacture
2 NON 3 3 NON 4 5
L1 1 2 narcotic
narcotic
STAGE 4
Non-human consumption
225A RENEWAL - Page 1
SECTION 3
You MUST be currently authorized to prescribe, distribute, dispense, conduct research, or otherwise handle the controlled substances
in the schedules for which you are applying under the laws of the state or jurisdiction in which you are operating or propose to operate.
STATE LICENSE(S)
Be sure to include both
state license numbers
if applicable
Expiration
Date
State License Number
(REQUIRED)
(REQUIRED)
What state issued this license ?
State Controlled Substance
License Number
Expiration
Date
(if required)
(if required)
What state issued this license ?
SECTION 4
/
/
Date(s) of incident MM-DD-YYYY:
IMPORTANT
2. Has the applicant ever surrendered (for cause) or had a federal controlled substance registration revoked, suspended,
restricted, or denied, or is any such action pending?
All questions in
this section must
be answered.
Date(s) of incident MM-DD-YYYY:
3. Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?
Date(s) of incident MM-DD-YYYY:
4. If the applicant is a corporation (other than a corporation whose stock is owned and traded by the public), association,
partnership, or pharmacy, has any officer, partner, stockholder, or proprietor been convicted of a crime in connection with
controlled substance(s) under state or federal law, or ever surrendered, for cause, or had a federal controlled substance
registration revoked, suspended, restricted, denied, or ever had a state professional license or controlled substance
registration revoked, suspended, denied, restricted or placed on probation, or is any such action pending?
Date(s) of incident MM-DD-YYYY:
EXPLANATION OF
"YES" ANSWERS
Applicants who have
answered "YES" to
any of the four questions
above must provide
a statement to explain
each "YES" answer.
Use this space or attach
a separate sheet and
return with application
SECTION 5
Liability question #
/
MM - DD - YYYY
1. Has the applicant ever been convicted of a crime in connection with controlled substance(s) under state or federal law,
or been excluded or directed to be excluded from participation in a medicare or state health care program, or is any such
action pending?
LIABILITY
/
MM - DD - YYYY
YES
NO
YES
NO
YES
NO
YES
NO
Note: If question 4 does not apply to you, be sure to mark 'NO'.
It will slow down processing of your application if you leave it blank.
Location(s) of incident:
Nature of incident:
Result of incident:
EXEMPTION FROM APPLICATION FEE
Check this box if the applicant is a federal, state, or local government official or institution. Does not apply to contractor-operated institutions.
Business or Facility Name of Fee Exempt Institution. Be sure to enter the address of this exempt institution in Section 1.
The undersigned hereby certifies that the applicant named hereon is a federal, state or local government official or institution,
and is exempt from payment of the application fee.
FEE EXEMPT
CERTIFIER
Provide the name and
phone number of the
certifying official
SECTION 6
METHOD OF
PAYMENT
Signature of certifying official (other than applicant)
Date
Print or type name and title of certifying official
Telephone No. (required for verification)
Check
Make check payable to: Drug Enforcement Administration
See page 4 of instructions for important information.
American Express
Check one form of
payment only
Credit Card Number
Sign if paying by
credit card
Signature of Card Holder
Discover
Master Card
Mail this form with payment to:
Visa
Expiration Date
DEA Headquarters
ATTN: Registration Section/ODR
P.O. Box 2639
Springfield, VA 22152-2639
FEE IS NON-REFUNDABLE
Printed Name of Card Holder
SECTION 7
APPLICANT'S
SIGNATURE
Sign in ink
I certify that the foregoing information furnished on this application is true and correct.
Signature of applicant (sign in ink)
Date
Print or type name and title of applicant
WARNING: 21 USC 843(d), states that any person who knowingly or intentionally furnishes false or fraudulent information in the application
is subject to a term of imprisonment of not more than 4 years, and a fine under Title 18 of not more than $250,000, or both.
225A RENEWAL - Page 2
C. SCHEDULE AND DRUG CODES
Listed below are examples of schedules 1-5 and List 1 codes. Check all drug codes you handle as required.
For more information, see our website at www.deadiversion.usdoj.gov, 21 CFR 1308, or call 1-800-882-9539.
Canine Handler
Exporter
Importer
Manufacturer
Distributor
Reverse Distributor
Researcher w/Sched 1
Researcher w/Sched 2-5
must mark schedule 1
must mark all schedule 1-5
must mark all schedule 1-5 & List 1 codes
must mark all schedule 1, 2 & List 1 codes
must mark all schedule 1, drug code 2012
must mark all schedule 1, drug code 2012
must mark schedule 1
must mark schedule 2 to be manufactured or imported
as part of research
If you bulk manufacture a substance, check the 'BULK?' column after the applicable class code.
SCHEDULE 1 NARCOTIC & NON-NARCOTIC
3,4-Methylenedioxyamphetamine (MDA)
3,4-Methylenedioxymethamphetamine (MDMA)
CODE
7400
7405
BULK?
SCHEDULE 2 NARCOTIC & NON-NARCOTIC
Amobarbital (Amytal, Tuinal)
Amphetamine (Dexedrine, Adderall)
CODE BULK?
2125
1100
4-Methyl - 2,5 - Dimethoxyamphetamine (DOM, STP)
4-Methylaminorex (cis isomer) (U4Euh, McN-422)
Alphacetylmethadol (except LAAM)
7395
1590
9603
Cocaine (Methyl benzoylecgonine)
Codeine (Morphine methyl ester)
Dextropropoxyphene (bulk)
9041
9050
9273
Bufotenine (Mappine)
Marihuana / Cannabidiol
Diethyltryptamine (DET) (
Difenoxin 1MG/25UG AtSO4 /DU (Motofen)
7433
7360/7372
7434
9167
Diphenoxylate
Fentanyl (Duragesic)
Hydrocodone (Dihydrocodeinone)
Hydromorphone (Diaudid)
9170
9801
9193
9150
Dimethyltryptamine (DMT)
Etorphine (except HCL)
Gamma Hydroxybutyric Acid (GHB)
7435
9056
2010
Levo-Alphacetylmethadol (LAAM)
Levorphanol (Levo-Dromoran)
Meperidine (Demerol, Mepergan)
9648
9220
9230
Heroin (Diamorphine)
Ibogaine
Lysergic acid diethylamide (LSD)
Mescaline
9200
7260
7315
7381
Methadone (Dolophine, Methadose)
Methamphetamine (Desoxyn)
Methylphenidate (Concerta, Ritalin)
Morphine (MS Contin, Roxanol)
9250
1105
1724
9300
Marihuana
Methaqualone (Quaalude)
Normorphine
Peyote
7360
2565
9313
7415
Opium, powdered
Oxycodone (Oxycontin, Percocet)
Oxymorphone (Numorphan)
Pentobarbital (bulk) (Nembutal)
9639
9143
9652
2270
Psilocybin
Tetrahydrocannabinols (THC)
SCHEDULE 3 NARCOTIC & NON-NARCOTIC
7437
7370
CODE
BULK?
Phencyclidine (PCP)
Secobarbital (Seconal, Tuinal)
SCHEDULE 4 NARCOTIC & NON-NARCOTIC
7471
2315
CODE BULK?
Anabolic Steroids
Barbituric acid derivative
Benzphetamine (Didrex, Inapetyl)
Buprenorphine (Buprenex, Temgesic)
4000
2100
1228
9064
Alprazolam (Xanax
Barbital (Veronal, Plexonal)
Chloral Hydrate (Noctec)
Chlordiazepoxide (Librium)
2882
2145
2465
2744
Butabarbital
Butalbital
Codeine combo product (Empirin)
2100/2175
2100/2165
9804
Clonazepam (Klonopin)
Clorazepate (Tranxene)
Diazepam (Valium)
2737
2768
2765
Dihydrocodeine combo product (Compal)
Dronabinol in sesame oil soft cap (Marinol)
Gamma-Hydroxybutyric Acid preparations (Zyrem)
Hydrocodone combo products (Lorcet, Vicodin)
9807
7369
2012
9806
Flurazepam (Dalmane)
Lorazepam (Ativan)
Meprobamate (Milltown, Equanil)
Midazolam (Versed)
2767
2885
2820
2884
Ketamine (Ketaset, Ketalar)
Morphine combo product
Nalorphine (Nalline)
Opium combo product (Paregoric)
7285
9810
9400
9809
Oxazepam (Serax, Serenid-D)
Phenobarbital (Fastin, Zantryl)
Phentermine
Temazepam (Restoril)
2835
2285
1640
2925
Pentobarbital suppository dosage (FP3)
Phendimetrazine (Plegine, Bontril)
Thiopental
2270
1615
2100/2329
SCHEDULE 5 NARCOTIC & NON-NARCOTIC
Codeine preparations (Robitussin A-C, Pediacof)
Pyrovalerone (Centroton, Thymergix)
WRITE IN ADDITIONAL CODES
CODE
9050
1485
Zolpidem (Ambien, Stilnox)
LIST 1 REGULATED CHEMICALS
** ONLY manufacturers & importers may select List 1
BULK?
Ephedrine
Phenylpropanolamine
Pseudoephedrine
2783
CODE BULK?
8113
1225
8112
You may write in additional drug codes in this section. Attach a separate sheet if needed.
225A RENEWAL --Page 2
Form-225A
RENEWAL APPLICATION FOR REGISTRATION
Supplementary Instructions and Information
SECTION 1. UPDATE REGISTRATION INFORMATION - Each data field displays the information we have on record for your registration. Fill in blanks, update and correct data in the
blocks provided. A physical address is required in address line 1; a post office box or continuation of address may be entered in address line 2. Fee exempt applicant must list the address
of the fee exempt institution. Applicant must enter a valid social security number (SSN), or a tax identification number (TIN) if applying as a business entity.
Debt collection information is mandatory pursuant to the Debt Collection Improvement Act of 1996.
SECTION 2A. SCHEDULES - Check the order form box only if you intend to purchase or to transfer schedule 1 and 2 controlled substances. Order forms will be mailed to the registered
address following issuance of a Certificate of Registration. All the schedules you were certified for on previous registration are displayed above the dotted line. If you are registering for the
same schedule(s) listed, CHECK THE "NO CHANGE" BOX. If you need to make a change, applicant should check all schedules to be handled from the list displayed below the dotted line.
However, applicant must still comply with state requirements, federal registration does not overrule state restrictions.
2B. MANUFACTURER ONLY - Mark the chemical/controlled substance schedule(s) handled in each manufacturing stage listed.
2C. SCHEDULE CODES - Report all chemical/drug codes as required for your business activity. Controlled substances manufacturers and importers must obtain a separate
chemical registration if they handle chemicals other than an FDA-approved drug product containing 1225, 8112, or 8113.
SECTION 3. STATE LICENSE(S) - Federal registration by DEA is based upon the applicant 's compliance with applicable state and local laws. Applicant should contact the local state
licensing authority prior to completing this application. If your state requires a license, provide that number on this application.
SECTION 4. LIABILITY - Applicant must answer all four questions for the application to be accepted for processing. If you answer "Yes" to a question, provide an explanation in the space
provided. If you answer "Yes" to several questions, then you must provide a separate explanation describing the date, location, nature, and result of each incident. If the "Yes" box is already
marked, then we have that data on record from a previous registration. If additional space is required, you may attach a separate page.
SECTION 5. EXEMPTION -Exemption from payment of application fee is limited to federal, state or local government official or institution. The applicant's superior or agency officer must
certify exempt status. The signature, authority title, and telephone number of the certifying official (other than the applicant) must be provided. The address of the fee exempt institution must
appear in Section 1.
SECTION 6. METHOD OF PAYMENT -Indicate the desired method of payment. Make checks payable to "Drug Enforcement Administration". Third-party checks or checks drawn on
foreign banks will not be accepted. FEES ARE NON-REFUNDABLE.
SECTION 7. APPLICANT'S SIGNATURE - Applicant MUST sign in this section or application will be returned. Card holder signature in section 6 does not fulfill this requirement.
ATTACHMENTS: Researchers must attach 3 copies of protocol, including curriculum vitae, to conduct research with schedule 1 controlled substances. For clinical investigations,
researcher must first submit to FDA a "Notice of Claimed Investigational Exemption for New Drug (IND)". See DEA web site or CFR 1301.18 for details.
NOTICE TO REGISTRANTS MAKING PAYMENT BY CHECK
Authorization to Convert Your Check: If you send us a check to make your payment, your check will be converted into an electronic fund transfer. "Electronic fund transfer" is the term
used to refer to the process in which we electronically instruct your financial institution to transfer funds from your account to our account, rather than processing your check. By
sending your completed, signed check to us, you authorize us to copy your check and to use the account information from your check to make an electronic fund transfer from your
account for the same amount as the check. If the electronic fund transfer cannot be processed for technical reasons, you authorize us to process the copy of your check.
Insufficient Funds: The electronic funds transfer from your account will usually occur within 24 hours, which is faster than a check is normally processed. Therefore, make sure there
are sufficient funds available in your checking account when you send us your check. If the electronic funds transfer cannot be completed because of insufficient funds, we may try to
make the transfer up to two more times.
Transaction Information: The electronic fund transfer from your account will be on the account statement you receive from your financial institution. However, the transfer may be in a
different place on your statement than the place where your checks normally appear. For example, it may appear under "other withdrawals" or "other transactions". You will not receive
your original check back from your financial institution. For security reasons, we will destroy your original check, but we will keep a copy of the check for record-keeping purposes.
Your Rights: You should contact your financial institution immediately if you believe that the electronic fund transfer reported on your account statement was not properly authorized or
is otherwise incorrect. Consumers have protections under Federal law called the Electronic Fund Transfer Act for an unauthorized or incorrect electronic fund transfer.
ADDITIONAL INFORMATION
No registration will be issued unless a completed application form has been received (21 CFR 1301.13).
In accordance with the Paperwork Reduction Act of 1995, no person is required to respond to a collection of information unless it displays a valid OMB control number. The OMB
number for this collection is 1117-0012. Public reporting burden for this collection of information is estimated to average 12 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information.
The Debt Collection Improvements Act of 1996 (31 U.S.C. §7701) requires that you furnish your Taxpayer Identification Number (TIN) or Social Security Number (SSN) on this
application. This number is required for debt collection procedures if your fee is not collectible.
PRIVACY ACT NOTICE: Providing information other than your SSN or TIN is voluntary; however, failure to furnish it will preclude processing of the application. The authorities for
collection of this information are §§302 and 303 of the Controlled Substances Act (CSA) (21 U.S.C. §§822 and 823). The principle purpose for which the information will be used is to
register applicants pursuant to the CSA. The information may be disclosed to other Federal law enforcement and regulatory agencies for law enforcement and regulatory purposes,
State and local law enforcement and regulatory agencies for law enforcement and regulatory purposes, and person registered under the CSA for the purpose of verifying registration.
For further guidance regarding how your information may be used or disclosed, and a complete list of the routine uses of this collection, please see the DEA System of Records Notice
"Controlled Substances Act Registration Records" (DEA-005), 52 FR 47208, December 11, 1987, as modified.
Your Local
DEA Office
CONTACT INFORMATION
All offices are listed on web site
(800, 877, and 888 are toll-free
INTERNET:
www.deadiversion.usdoj.gov
TELEPHONE:
HQ Call Center (800) 882-9539
WRITTEN INQUIRIES:
DEA
Attn: Registration Section/ODR
P.O. Box 2639
Springfield, VA 22152-2639
225A RENEWAL - Page 4
File Type | application/pdf |
File Title | DEA Form-225A |
Subject | DEA Form-225A |
Author | DEA Office of Diversion Control |
File Modified | 2012-04-11 |
File Created | 2006-06-05 |