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					                       DEA Licensing Transition Program


PART I. Instructions for Obtaining a DEA License
The Drug Enforcement Administration (DEA) is the principle Federal agency responsible
for the enforcement of regulations involving controlled substances, as defined by the
Controlled Substances Act of 1970. The DEA’s primary goal is to ensure that controlled
substances are available for medical use while preventing their abuse and illegal use. In
order to obtain controlled substances, an individual must first register with the DEA and
obtain a DEA license. There are two ways to obtain a DEA License – apply online or by
mail. Please follow these directions for applying:

A. ONLINE – The fastest way to obtain a DEA License is to register online.
       Registration requires a credit card. You will also need a Tax ID number and/or
       Social Security Number.

1. Log on to http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms_new.htm.

2. Click on Begin Application Process .

3. Read the directions in the new window, then select Form 225 under Select Your
   Business Category. Under Select One Business Activity, select RESEARCHER

   from the pop-up window. Click                         .

4. Fill out the information in the sections that follow. The online application is divided
   into six sections. Please have the following information available before you begin
   the application:

Section 1. Personal Information - Name, address, social security number or tax ID, and

       phone number. Complete page 1. Click                         . Complete page 2,

       then again click                       ,
               NOTE – on page 2 of this section, you will be given an option to
               apply for Fee Exemption. This Exemption only applies to federal,
               state, or local institutions or officials and requires a Certifying
               Official to verify the status of the applicant. Most researchers will
               not qualify for Fee Exemption.
Section 2. Activity - Business Activity and Drug Schedule information. Check what
       drug schedule(s) you will be working under. If you will be using a Schedule II
       drug, for example pentobarbital (Nembutal), you will also need to check the box
       requesting order forms (more information about order forms in Part C). Click

                           .
               NOTE – The Controlled Substances Schedules are available online
               at http://www.deadiversion.usdoj.gov/schedules/schedules.htm. A



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                         DEA Licensing Transition Program

               list of DCM’s most commonly requested controlled substances is
               in Part I.C following these application instructions
Section 3. State License(s) - Information pertaining to current and pending state
       controlled substance licenses/registrations. Oregon currently does not require a
       state controlled substance license, so most researchers can click

                           and go on to the next section.
Section 4. Background Information - Information pertaining to controlled substances in
       the applicant's background. Answer the following 4 questions, then click

                          . The next page prompts you to select Drug Codes for the
       Schedules you selected in Section2. Researchers requesting Schedule II-V are
       only required to report drug codes for Schedule II substances which they

       manufacture or import, so most can click                      and go on to the next
       section.
Section 5. Payment - Payment, via this on- line application, must be made with a Visa or
       MasterCard, American Express, or Discover. Complete the credit card
       information. Note that a non-refundable fee of $184 will be charged to your

       credit card upon submission of this application. Click                     .
Section 6. Confirmation - Confirm the entered information, make corrections if needed,
       and electronically submit the application and a submission confirmation will be
       presented. Applicants will be able to print copies for their records. When




       finished, click                to complete the application process.


B. BY MAIL – You may apply by mail if you wish to pay by check or if you do not
   want to apply online.

1. Download the Application from the DEA Applications website at
   http://www.deadiversion.usdoj.gov/drugreg/reg_apps/pdf_apps.htm. Under New
   Applications select Download DEA Form 225.

2. Print and complete Form 225.

Section 1. Applicant Identification – Complete this section, including Tax ID number
       or Social Security number.
Section 2. Business Activity – Most researchers should check “Researcher w/Sched II – V.”
Section 3. A. Drug Schedules – Check what drug schedule(s) you will be working
       under. If you will be using a Schedule II drug, for example pentobarbital
       (Nembutal), you will also need to check the box requesting order forms (more
       information about order forms in Part C).


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                        DEA Licensing Transition Program

           B. To be completed by manufacturers only.
           C. Researchers requesting Schedule II-V are only required to report drug
       codes for Schedule II substances which they manufacture or import, so most can
       go on to the next section.
                NOTE – The Controlled Substances Schedules are available online
                at http://www.deadiversion.usdoj.gov/schedules/schedules.htm. A
                list of DCM’s most commonly requested controlled substances is
                in Part I.C following these application instructions.
Section 4. State License(s) – Information pertaining to current and pending state
       controlled substance licenses/registrations. Oregon currently does not require a
       state controlled substance license, so most researchers can go on to the next
       section.
Section 5. Liability – Answer all 4 questions in this section.
Section 6. Exe mption – This Exemption only applies to federal, state, or local
       institutions or officials and requires a Certifying Official to verify the status of the
       applicant. Most researchers will not qualify for Fee Exemption.
Section 7. Method of Payme nt – Indicate the method of payment. The $184 annual fee
       is non-refundable.

3. Mail Application with payment to:

                       U.S. Department of Justice
                       Drug Enforcement Administration
                       P.O. Box 28083
                       Washington, DC 20038-8083


C. Commonly Requested Controlled Substances
Substance                           DEA #      Sched.      Narcotic        Other Names
Buprenorphine                        9064        III          Y         Buprenex
Butorphanol                          9720        IV           N         Torbutrol
Codeine                              9804        III          Y         Codeine w/ Tylenol
Diazepam                             2765        IV           N         Valium
Ketamine                             7285        III          N
Midazolam                            2884        IV           N         Versed
Pentobarbital                        2270         II          N         Nembutal
Pentobarbital w/ noncontrolled       2271        III          N         Euthasol
Tiletamine/zolazepam                 7295        III          N         Telazol


           For more information, log on to http://www.deadiversion.usdoj.gov/.




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                      DEA Licensing Transition Program

       PART II. Instructions for Obtaining Controlled Substances
   Once you have obtained a DEA License, you may then purchase controlled
   substances. Many of the controlled substances used in animal research are drugs
   approved for use in humans. Some are specific to the veterinary field. Some
   anesthetic combinations are not commercially available and must be prepared.

A. SINGLE AGENTS – Researchers may purchase controlled substances from
several sources:

1. Central Pharmacy – Most controlled substances can be purchased through the
   OHSU Central Pharmacy. To obtain a Pharmacy Order Sheet, go to the Pharmacy
   Services webpage at http://pharmacy/cms/index.php?section=1, select Storeroom Request
   For m then Dow nload the form in pdf format. Be sure to complete the entire form,
   including Alias Acct# and FAID#. From the Central Pharmacy you will be able to
   order any human-approved controlled substance. For questions regarding orders, call
   4-0699.

2. Distributors – Some controlled substances, namely tiletamine/zolazepam
   combination (Telazol) and euthanasia solution (Euthasol) are not available through
   the Central Pharmacy. Researchers may purchase these and other controlled
   substances from veterinary distributors. DCM currently obtains controlled substances
   from Butler Animal Health Supply. In order to obtain controlled substances from
   Butler, researchers need two documents.

       First, the principal investigator must obtain a controlled substance registration as a
       researcher (i.e. DEA License).

       Second, the researcher needs to submit a letter to the Oregon Board of
       Pharmacy. The title of the letter should be: "Letter Requesting an Exemption of
       Licensing". The letter needs to explain who they are, the research they are
       performing etc. A copy of the letter, after approval by the State of Oregon must
       be submitted to Butler Animal Health Supply in lieu of a state veterinary license
       for the purchase of a controlled substance. To request a letter, contact:
                              Gary Schnabel
                              Executive Director
                              Oregon Board of Pharmacy
                              800 SE Oregon Street, Suite 150
                              97232
       Information on the Oregon Board of Pharmacy can be found at
       http://www.oregon.gov/Pharmacy/.

   After the researcher has the approved letter from the State of Oregon and a DEA
   License he/she may apply for an account with Butler Animal Health Supply.
   Researchers may only purchase controlled substances and no other legend (non-
   controlled substance). A copy of Butler’s Account Application Form is attached.


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                       DEA Licensing Transition Program

   Completed applications can be faxed to 614-760-0639. You may contact Butler’s
   Credit Department at (800) 848-5983 with any questions regarding account
   applications.


B. COCKTAIL – Many researchers request controlled substances in the form of pre-
   mixed anesthetic “Cocktails.” As of January 1, 2008, you may obtain Cocktail in the
   following ways:

1. Do It Yourself - Researchers and labs may mix their own Cocktail. Below are the
   formulas currently used by DCM for mice and rats.

                       Drug                  Mouse      Mouse    Rat       Rat
                                                        mg/ml             mg/ml
            Ketamine (100 mg/ ml)            0.75 ml     7.5    2.5 ml     25

            Xylazine (20 mg/ ml)             0.75 ml     1.5    2.5 ml      5

            Acepromazine (10 mg/ ml)         0.25 ml     0.25   1.0 ml      1

            Water (sterile for inject ion)   8.25 ml            4.0 ml

            Total                            10.00 ml           10.0 ml



       Each 1 ml of Mouse Cocktail should provide ketamine (7.5 mg), xylazine
       (1.5 mg), and acepromazine (0.25 mg). The recommended dose is 0.1-0.2
       ml (SQ or IP) for a 25 g mouse.

       Each 1 ml of Rat Cocktail should provide ketamine (25 mg), xylazine (5
       mg), and acepromazine (1 mg). The recommended dose is 0.15 ml (SQ or
       IP) for 100 g of body weight.

       References:
       1. Hawk CT, Leary SL. 1999. Formulary for Laboratory Animals,
              second edition. Ames, IA: Iowa State University Press.
       2. Welberg LAM, et al. 2006. Ketamine-xylazine-acepromazine anesthesia
              and postoperative recovery in rats. JAALAS 45(2):13-20

   Other formulas are available from the following references:

   Wixson SK. 1994. Rabbits and Rodents: Anesthesia and Analgesia. In: Smith AC,
      Swindle MM, eds. Research Animal Anesthesia, Analgesia, and Surgery.
      Greenbelt, MD: Scientists Center for Animal Welfare. p 59-92.
   Wixson SK, Smiler KL. 1997. Anesthesia and Analgesia in Rodents. In: Kohn DF,
      Wixson SK, White WJ, Benson GJ, eds. Anesthesia and Analgesia in Laboratory
      Animals. San Diego, CA: Academy Press. p 165-203.



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                      DEA Licensing Transition Program

   For information about other anesthetic combinations and Cocktails, please contact the
   DCM veterinarians.

2. Research Pharmacy – DCM is working with the Research Pharmacy to explore the
   possibility of providing investigators with pre- mixed Cocktail. DCM will notify PIs
   if the Research Pharmacy will indeed be offering Cocktail to investigators.


C. SCHEDULE II DRUGS – The DEA requires a special form be submitted when
   ordering Schedule II controlled substances. This form is known as Form 222, and it
   is only available by request from the DEA.

1. Orde r Forms – To request order forms, go to the DEA Order Forms Request website
   at https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp and
   complete the online application. In addition, official Order Forms may be ordered by
   calling the DEA Headquarters Registration Unit toll free at 1-800-882-9539 or the
   nearest DEA Registration Field Office. The forms will be mailed within 10 working
   days. Official order forms may also be obtained by submitting a completed
   requisition form, DEA Form 222a, to DEA, Registration Unit, P.O. Box 28083,
   Washington, DC 20038-8083. There is no charge for Official Order Forms.

2. When ordering Schedule II drugs, you must present a completed Order Form when
   placing your order with Central Pharmacy or a distributor. Form 222 must be signed
   by the registrant of the DEA License or by a person authorized by a power of attorney
   to sign on behalf of the registrant. Follow the instructions on the reverse side of the
   Form.

   NOTE – Form 222 is only necessary for ordering Schedule II controlled substances.
   The only commonly used controlled substance is pentobarbital (Nembutal). For
   drugs under Schedules III-V, Form 222 is not necessary. For a complete list of
   controlled substances, visit
   http://www.deadiversion.usdoj.gov/schedules/schedules.htm.

3. Frequently Asked Questions – The DEA maintains a website for frequently asked
   questions about Form 222 at http://www.deadiversion.usdoj.gov/faq/dea222.htm.




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                      DEA Licensing Transition Program

              PART III. Responsibilities of the DEA Registrant
In addition to regulating their manufacture and purchasing, Federal law and the DEA
have strict regulations governing the secure storage, recordkeeping, and disposal of
controlled substances. Please refer to the DEA Diversion Website at
http://www.deadiversion.usdoj.gov/ for the most current information.

A. STORAGE – DEA registrants are required to keep controlled substances in a
   locked cabinet or other secure storage container with limited access by personnel.
   DCM recommends the following tips for storing controlled substances:

1. Keep controlled substances in a cabinet, safe, or other lockable container. Secure the
   safe to the floor, counter, or wall.
2. Keep the cabinet in a room with a door that locks. Keep the room locked after hours
   or at other times when no one is around.
3. Keep the cabinet locked at all times, unlocking it only to retrieve or store the drugs.
4. Limit access to the controlled substances cabinet. Issue keys to as few people as
   possible. Alternatively, keep one key in a secure location and limit access to the key
   to as few people as possible.


B. RECORDKEEPING – Researchers are required to maintain records of their
   controlled substances in accordance to Federal law as mandated by Title 21 CFR,
   section 1304.22, paragraph (c). The law requires that researchers maintain records
   including the following information:

1. When acquiring controlled substances:
     a. Name of the substance (e.g. Ketamine)
     b. Form and quantity per container (e.g. 100 mg/ml, 10 ml vials)
     c. Number of containers acquired
     d. The date the controlled substance was acquired
     e. The name and address from where the substance was acquired

2. When dispensing controlled substances:
     a. Name of individual who whom it was dispensed
     b. Date of dispensing
     c. Volume or quantity dispensed
     d. Name or initials of dispenser

3. Controlled substances not dispensed or used – Controlled substances that are lost,
   stolen, spilled, arrive in damaged container, or are otherwise unusable must be
   documented and reported. See Section D. General Questions and Answers for more
   information




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                      DEA Licensing Transition Program

4. Biennial inventory – DEA registrants are required to conduct an inventory of any
   controlled substances they have on hand. This inventory must be conducted at least
   every two years. The following information should be included in the inventory:
       a. Name of the substance (e.g. Ketamine)
       b. Form and quantity per container (e.g. 100 mg/ml, 10 ml vials)
       c. Number of containers on hand
   If any impure or unusable substances are on hand (e.g. cocktail or expired drugs),
   they should also be included in the inventory. List the name of the substance, the
   quantity, the reason it is being kept, and whether the substance could be used in the
   manufacture of any controlled substance.

5. Tips – DCM recommends the following tips for maintaining records of controlled
   substances
      a. Invoices of drug purchases can serve as records of acquiring controlled
          substances. Keep them in a readily retrievable location.
      b. If you are ordering Schedule II drugs, Form 222 can also serve as a record.
      c. Keep a log of your controlled drug use. Below is an example controlled
          substance dispensing record.

   Drug                 Bottle #         Bottle Size    Concentration       Exp. Date


       Date      Patient ID Protocol #   Amount                 Balance       Initials
    Administered or Species* or Purpose Used (mL)                (mL)         of User




   *Species – It is adequate to record common name of species if Mouse, Rat, or Bird.
   Otherwise, please record individual animal identification number.

       d. Maintain records on any substances not dispensed. Document any significant
          losses, thefts, spills, authorized destruction, etc.


C. UNUSED CONTROLLED SUBSTANCES – Controlled substances
   obtained by DEA registrants may not always be consumed. They sometimes reach
   their expiration date before they can be consumed, or they are purchased for specific
   projects and are no longer needed after project completion. Federal law and the DEA
   have strict regulations governing the disposal of controlled substances. Do not
   dispose of any unused controlled s ubstances without authorization from the
   DEA! If you have any controlled substances that you wish to get rid of, you must
   complete DEA Form 41 and submit it to the Special Agent in Charge in our area. See
   Contact Information in PART IV of this packet for the DEA Portland District Office.



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                          DEA Licensing Transition Program

   Form 41 can be found at
   http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/index.html.


D. GENERAL QUESTIONS AND ANSWERS – The following questions and
   answers were taken from the DEA webpage
   http://www.deadiversion.usdoj.gov/faq/general.htm. They deal with issues of
   recordkeeping, drug security, theft, losses, and spillage.

   Question: What receiving records must a practitioner/physician maintain if the y plan on
   maintaining a stock of controlled substances for dispensing and administering to their
   patients?

   Answer: If the controlled substance is in Schedule II, procurement must be accomplished by using
   the DEA Form 222. If the drug preparation is in Schedule III through V, then a readily retrievable
   invoice is sufficient. These records should contain the date, drug type, dosage form, etc. The
   prescriber should also maintain an inventory of the drugs received and dispensed or administered.

   Question: Are there any special security requirements that a practitioner/physician should
   take if they plan on maintaining a stock of controlled substances in their office for
   dispensing and administering?

   Answer: All controlled substances should be stored in a locked cabinet or other secure storage
   container with limited access by the office staff.

   Question: What reports must be filed if a practitioner/physician experiences a theft or
   significant loss of controlled substances?

   Answer: All thefts and any significant losses must be reported to the DEA immediately upon
   discovery of the theft or loss. Notification must be accomplished by completing and filing a DEA
   Form 106, Report of Loss or Theft. The form my be found on the Internet at
   www.DEAdiversion.usdoj.gov or may be obtained from your local DEA office. If th e circumstances
   regarding the theft or loss need clarification before the form can be completed, the registrant can
   make an initial report via telephone or some other means and file the completed form as soon as
   the circumstances are known.

   Question: As a DEA registrant, how do I report breakage or spillage of controlled
   substances?

   Answer: Breakage of controlled substances does not constitute a "loss" of controlled substances.
   When there is breakage, damage, spillage or some other form of destruction, any recoverable
   controlled substances must be disposed of according to DEA requirements. Damaged goods may
   be disposed of through shipment to a "reverse distributor" or by a DEA approved process. The DEA
   recommends that any registrant seeking to dispose of controlled substances first contact the
   nearest DEA Diversion Field Office for disposal instructions. In no case should drugs be forwarded
   to the DEA unless the registrant has received prior approval from the DEA.

   If the breakage or spillage is not recoverable, the registrant must document the circumstances of
   the breakage in their inventory records. Two individuals who witnessed the breakage must sign the
   inventory records indicating what they witnessed. The submission of a DEA Form 41, Registrants
   Inventory of Drugs Surrendered is not required for non-recoverable controlled substances.

   The DEA procedures established for the destruction of controlled substances shall not be
   construed as altering in any way the state laws or regulations for the disposal of controlled
   substances. When this disposal occurs, it must be reported to the DEA on a DEA Form 41 .




                                                                                                         9
                 DEA Licensing Transition Program

                    PART IV: Helpful Documents
1. Contact Information
2. Summary of requirements for obtaining various controlled substances
3. DEA Application for Registration (Form 225)
4. OHSU Pharmacy Order Sheet
5. Account Application form for Butler Animal Health Supply (for veterinary-
   specific controlled drugs)
6. Questions and Answers regarding DEA Form 222 (order form for Schedule II
   controlled substances)
7. Procedure for disposing of controlled substances.




                                                                               10
                     DEA Licensing Transition Program

                               Contact Information
Drug Enforcement Administration
      Portland District Office
      1220 SW 3rd Avenue, Room 1525
      Portland, OR 97204
      503-326-2447
      1-800-882-9539 for Registration Support
      http://www.deadiversion.usdoj.gov/

OHSU Departme nt of Comparative Medicine Veterinarians
     B1 level, Biomedical Research Building, Room B110
     Extension 4-8425
     http://www.ohsu.edu/research/rda/cm/index.shtml

       Victor Monterroso MV, MS, PhD
       Associate Director
       monterro@ohsu.edu

       Tom Chatkupt, DVM
       Clinical Veterinarian
       chatkupt@ohsu.edu

OHSU Central Pharmacy
     9th floor, Hatfield Research Center, room 9D20
     Extension 4-0699
     http://pharmacy/cms/index.php?section=1

Butle r Animal Health Supply
        Corporate Office
        5600 Blazer Parkway
        Dublin, Ohio 43017-7545
        614-761-9095
        (800) 848-5983 for account information
        https://www.accessbutler.com

Oregon Board of Pharmacy
      800 NE Oregon St., Suite 150
      Portland, OR 97232-2162
      971-673-0001
      http://www.pharmacy.state.or.us/Pharmacy/




                                                         11
                      DEA Licensing Transition Program

 Summary of requirements for obtaining various controlled substances

You can get…     AKA…             From…           If you have…     And…           Plus…
Buprenorphine    Buprenex         Central         DEA License      Pharmacy
                                  Pharmacy                         order sheet
Codeine w/                        Central         DEA License      Pharmacy
Tylenol                           Pharmacy                         order sheet
Diazepam         Valium           Central         DEA License      Pharmacy
                                  Pharmacy                         order sheet
Euthasol                          Butler          DEA License      Letter from    Butler
                                                                   OBP*           Account
Ketamine                          Central         DEA License      Pharmacy
                                  pharmacy                         order sheet
Midazolam        Versed           Central         DEA License      Pharmacy
                                  pharmacy                         order sheet
                 ketamine/        DO IT
Mouse cocktail   xylazine/        YOURSELF        DEA License      A Recipe
                 acepromazine
Pentobarbital    Nembutal         Central         DEA License      Pharmacy       Form
                                  Pharmacy                         order sheet    222
                 ketamine/        DO IT
Rat Cocktail     xylazine/        YOURSELF        DEA License      A Recipe
                 acepromazine
Tiletamine/      Telazol          Butler          DEA License   Letter from Butler
zolazepam                                                       OBP*          Account
                                                    *OBP = Oregon Board of Pharmacy

For other controlled substances or anesthetic combinations, contact a DCM veterinarian.




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           DEA Licensing Transition Program

      DEA Application for Registration (Form 225)
                     (In PDF format)




             OHSU Pharmacy Order Sheet
                       (In PDF format)




Account Application form for Butler Animal Health Supply
                     (In PDF format)




                                                           13
                     DEA Licensing Transition Program

                        Questions & Answers


                   DEA Form 222 - Official Order Forms

      How do I obtain additional Official Order Forms, DEA Form 222?

      Can a distributor accept a DEA Form 222 that contains minor
       misspellings?

      Can a distributor fill in sections omitted by the registrant on a DEA Form
       222?

          o   Date of the form
          o   Size of the package
          o   Strength of the drug
          o   Last line completed

      Can a distributor accept a DEA Form 222 if the size and strength of a
       product have been placed incorrectly on the form?



Question: How do I obtain additional Official Order Forms, DEA Form 222?

Answer: Official Order Forms may be ordered by calling the DEA Headquarters
Registration Unit toll free at 1-800-882-9539 or the nearest DEA Registration
Field Office. The forms will be mailed within 10 working days. Official order forms
may also be obtained by submitting a completed requisition form, DEA Form
222a, to DEA, Registration Unit, PO Box 28083, Washington, DC 20038-8083.
There is no charge for Official Order Forms

                                     Back to Top




Question: Can a distributor accept a DEA Form 222 that contains minor
misspellings in the registrant’s name, address, or drug name?

Answer: Yes, the DEA Form 222 is acceptable if the registrant’s name or
address contains minor misspellings. The registrant should request corrected
official order forms and if necessary a corrected registration certificate from DEA.
If the drug name has been misspelled and there is no question as to what
product has been ordered then the DEA Form 222 is acceptable.



                                                                                    14
                     DEA Licensing Transition Program

                                    Back to Top




Question: Can a distributor fill in sections omitted by a registrant on a DEA Form
222?

Answer: Date of the form - The distributor may place the date on the form.
        When possible, the date ascertained from the delivery document
        should be used as the issue date. The form is acceptable unless the
        ascertained date of issue is greater than 60 days from the date of
        receipt.

          Size of the package - The size of the package must be completed by
          the purchaser unless the product is only manufactured in one size. If
          more than one package size is manufactured and no package size is
          indicated, then the package size may not be added by the supplier.
          The line item with the missing package size must be voided by the
          supplier and the purchaser notified.

          Strength of the drug - If the product is only manufactured in one
          strength, then it is not necessary to indicate the strength in the section
          "Name of Drug". If the product is available in more than one strength,
          then the strength may not be added by the distributor. The line should
          be voided on the DEA Form 222 by the supplier a nd the purchaser
          notified.

          Last Line Completed - A distributor may not fill in the "Last Line
          Completed" area of the DEA Form 222. This section must be
          completed by the purchaser. If the purchaser enters an incorrect
          number, such as the total number of packages ordered instead of the
          last line completed, then the DEA Form 222 is not valid.

                                    Back to Top




Question: Can a distributor accept a DEA Form 222 if the size and strength of a
product have been placed incorrectly on the form?

Answer: Yes, the DEA Form 222 is acceptable as long as there is no question
as to what product has been ordered.




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                     DEA Licensing Transition Program

                  Code of Federal Regulations

                 DISPOSAL OF CONTROLLED SUBSTANCES

Section 1307.21 Procedure for disposing of controlled substances.

(a) Any person in possession of any controlled substance and desiring or
required to dispose of such substance may request assistance from the Special
Agent in Charge of the Administration in the area in which the person is located
for authority and instructions to dispose of such substance. The request should
be made as follows:

(1) If the person is a registrant, he/she shall list the controlled substance or
substances which he/she desires to dispose of on DEA Form 41, and submit
three copies of that form to the Special Agent in Charge in his/her area; or
(2) If the person is not a registrant, he/she shall submit to the Special Agent in
Charge a letter stating:
(i) The name and address of the person;
(ii) The name and quantity of each controlled substance to be disposed of;
(iii) How the applicant obtained the substance, if known; and
(iv) The name, address, and registration number, if known, of the person who
possessed the controlled substances prior to the applicant, if known.

(b) The Special Agent in Charge shall authorize and instruct the applicant to
dispose of the controlled substance in one of the following manners:

(1) By transfer to person registered under the Act and authorized to possess the
substance;
(2) By delivery to an agent of the Administration or to the nearest office of the
Administration;
(3) By destruction in the presence of an agent of the Administration or other
authorized person; or
(4) By such other means as the Special Agent in Charge may determine to
assure that the substance does not become available to unauthorized persons.

(c) In the event that a registrant is required regularly to dispose of controlled
substances, the Special Agent in Charge may authorize the registrant to dispose
of such substances, in accordance with paragraph (b) of this section, without
prior approval of the Administration in each instance, on the condition that the
registrant keep records of such disposals and file periodic reports with the
Special Agent in Charge summarizing the disposals made by the registrant. In
granting such authority, the Special Agent in Charge may place such conditions
as he deems proper on the disposal of controlled substances, including the
method of disposal and the frequency and detail of reports.



                                                                                     16
                     DEA Licensing Transition Program

(d) This section shall not be construed as affecting or altering in any way the
disposal of controlled substances through procedures provided in laws and
regulations adopted by any State.

[36 FR 7801, Apr. 24, 1971, as amended at 37 FR 15922, Aug. 8, 1972.
Re designated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735,
Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997]




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