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DRUG ENFORCEMENT ADMINISTRATION

DRUG ENFORCEMENT ADMINISTRATION. DALLAS FIELD DIVISION FORT WORTH RESIDENT OFFICE. DEA RESEARCHER PRE-REGISTRATION INVESTIGATION. DEA Fort Worth Resident Office 801 Cherry St., Suite 700 Fort Worth, TX 76102 Tel. No. 817-639-2000 www.deadiversion.usdoj.gov. Title 21.

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DRUG ENFORCEMENT ADMINISTRATION

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  1. DRUG ENFORCEMENT ADMINISTRATION DALLAS FIELD DIVISION FORT WORTH RESIDENT OFFICE

  2. DEA RESEARCHER PRE-REGISTRATION INVESTIGATION DEA Fort Worth Resident Office801 Cherry St., Suite 700 Fort Worth, TX 76102 Tel. No. 817-639-2000www.deadiversion.usdoj.gov

  3. Title 21 CODE OF FEDERAL REGULATIONS Part 1300 to End

  4. RESEARCHER New Application- DEA Form 225 Renewal Application- DEA Form 225a Registration Period- One Year

  5. Coincident Activities Allowed§1301.13 • May conduct chemical analysis with controlled substances in those schedules for which registration was issued; • Manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration or reregistration and provided that the manufacture is not for the purpose of dosage form development;

  6. Import such substances for research purposes; • Distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities or research with such substances, and to persons exempt from registration pursuant to §1301.24; • Conduct instructional activities with controlled substances.

  7. RECORD KEEPING Maintenance of Records and Inventories §1304.04 (a)Except as provided in paragraphs (a)(1) and (a)(2) of this section, every inventory and other records required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Administration.

  8. Inventory Requirements§1304.11(a) General requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location.

  9. Initial Inventory Date §1304.11(b) Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with paragraph (e) of this section as applicable. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.

  10. Biennial Inventory Date §1304.11(c) After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.

  11. General Requirements for Continuing Records§1304.21 (a) Every registrant required to keep records pursuant to §1304.03 shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported , received, sold delivered, exported, or otherwise disposed of by him/her, except that no registrant shall be required to maintain a perpetual inventory. (d) In recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution of any documents of transfer (e.g., invoices or packing slips.

  12. Records for Dispensers and Researchers §1304.22 (c) Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and (ix) of this section. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.

  13. Distributions Requiring a Form 222 §1305.03Either a DEA Form 222 or its electronic equivalent as set forth in sub-part C of this part and Part 1311 of this chapter is required for each distribution of a Schedule I or II controlled substances.

  14. Persons Entitled to Order Schedule I and II Controlled Substances§1305.04 (a) Only persons who are registered with DEA under section 303 of the Act (21 U.S.C. 823) to handle Schedule I or II controlled substances, and persons who are registered with DEA under section 1008 of the Act (21 U.S.C. 958) to export these substances may obtain and use DEA Form 222 (order forms) or issue electronic orders for those substances.

  15. Persons Entitled to Fill Orders for Schedule I and II Controlled Substances§1305.06(d) A person registered or authorized to conduct chemical analysis or research with controlled substances may distribute a Schedule I or II controlled substance to another person registered or authorized to conduct chemical analysis, instructional activities, or research with the substances with either a DEA Form 222 or an electronic order, if the distribution is for the purpose of furthering the chemical analysis, instructional activities, or research.

  16. Procedure for Executing DEA Forms 222 §1305.12 (a) A purchaser must prepare and execute a DEA Form 222 simultaneously in triplicate by means of interleaved carbon sheets that are part of the DEA Form 222. DEA Form 222 must be prepared by use of a typewriter, pen, or indelible pencil. (b) Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided. DEA Forms 222 for carfentanil, etorphine hydrochloride, and diprenorphine must contain only theses substances.

  17. c) The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form. (d) Each DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a Form 222 under §1305.05. The name of the purchaser, if different from the individual signing the DEA Form 222, must also be inserted in the signature space.

  18. (e) Unexecuted DEA Forms 222 may be kept and may be executed at a location other than the registered location printed on the form, provided that all unexecuted forms are delivered promptly to the registered location upon an inspection of the location by any officer authorized to make inspections, or to enforce, any Federal, State, or local law regarding controlled substances.

  19. Procedure for Filling DEA Forms 222 §1305.13 (a) A purchaser must submit Copy 1 and Copy 2 of the DEA Form 222 to the supplier and retain Copy 3 in the purchaser’s files.(e) The purchaser must record on Copy 3 of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser.

  20. Preservation of DEA Forms 222 §1305.17 (a) The purchaser must retain Copy 3 of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached.(c) DEA Forms 222 must be maintained separately from all other records of the registrant. DEA Forms 222 are required to be kept available for inspection for a period of two years.

  21. Power of Attorney § 1305.05 (a) A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant’s behalf by executing a power of attorney for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with other order records.

  22. Security Requirements Generally § 1301.71 (a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Administrator shall use the security requirements set forth in §§ 1301.72-1301.76 as standards for the physical security controls and operating procedures necessary to prevent diversion. §1301.72(1) Where small quantities permit, a safe or steel cabinet.

  23. Other Security Controls for Practitioners §1301.76 (b) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft of significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft.

  24. DEA Form 106

  25. Procedure for Disposing of Controlled Substances §1307.21 (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.

  26. Reverse Distributor List

  27. Modification in Registration §1301.51 Any registrant may apply to modify his/her registration to authorize the handling of additional controlled substances or to change his/her name or address, by submitting a letter of request to the Registration Unit, Drug Enforcement Administration. If the registrant is seeking to handle additional controlled substances listed in schedule I for the purpose of research or instructional activities, he/she shall attach three copies of a research protocol describing each research project involving the additional substances, or two copies of a statement describing the nature, extent, and duration of such instructional activities, as appropriate.

  28. QUESTIONS

  29. Thank You DEA Fort worth resident office DIVERSION INVESTIGATOR CHRIS HULL 817-639-2021 Christopher.l.hull@usdoj.gov

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