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�� &#x/MCI; 0 ;&#x/MCI; 0 ;United States Department of Justice &#x/MCI; 1 ;&#x/MCI; 1 ;Drug EnforcePent AdPinistration  ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration Joseph T. Rannazzisi Deput\ Assistant AdPinistrator This Panual has Eeen prepared E\ the Drug EnforcePent AdPinistration, Office of Diversion &ontrol, to assist practitioners ph\sicians, dentists, veterinarians, and other registrants authori]ed to prescriEe, dispense, and adPinister controlled suEstances in their understanding of the )ederal &ontrolled SuEstances Act and its iPplePenting regulations as the\ pertain to the practitioner¶s profession. Drug EnforcePent AdPinistration DisclaiPer««««««««««««««««««««««««««««.. 1 Authori]ation for 3uElic DissePination«««««««««««««««««

2 Message froP the AdPinistrator«««««««««««««««««««.. 3 3reface««««««««««««««««««««««««««««««  Schedules of &ontrolled SuEstances««««««««««««««««««.. 5 Schedule , SuEstances ««««««««««««««««««««« 5 Schedule ,, SuEstances««««««««««««««««««««... 5 Schedule ,,, SuEstances««««««««««««««««««««. 6 Schedule ,V SuEstances«««««««««««««««««««« 6 Schedule V SuEstances««««««««««««««««««««.. 6 Registration ReTuirePents«««««««««««««««««««««« 7 Application for Registration«««««««««««««««««« 7 &ertificate of Registration««««««««««««««««««« 8 Registration Renewals«««««««««««««««««««« 9 &hange of %usiness Address«««««««««««««««««««««..11 TerPination of Registration««««««««««««««««««««« 11 Denial, Suspension or Revocation of Registration««««««««««««« 11 3r

actitioner¶s 8se of a +ospital¶s DEA Registration NuPEer««««««««. 12 ,nappropriate 8se of the DEA Registration NuPEer«««««««««««« 12 E[ePption of )ederal *overnPent 3ractitioners froP Registration««««««. 13 ReTuired &ontrols«««««««««««««««««««««««««.. 1Safeguards for 3rescriEers««««««««««««««««««««««. 15 RecordNeeping ReTuirePents««««««««««««««««««««... 16 ,nventor\««««««««««««««««««««««««««16 Disposal of &ontrolled SuEstances«««««««««««««««« 17 Drug EnforcePent AdPinistration 3rescription ReTuirePents««««««««««««««««««««««. 18 :ho Ma\ ,ssue«««««««««««««««««««««««.. 18 3urpose of ,ssue«««««««««««««««««««««««. 19 Schedule ,, SuEstances«««««««««««««««««««««««.. 19 Refills««««««««««««««««««««««««««« 19 ,ssuance of Multiple 3rescriptions for Schedule ,, SuEstances«««««. 19 )acsiPile

3rescriptions for Schedule ,, SuEstances«««««««««.. 20 E[ceptions for Schedule ,, )acsiPile 3rescriptions«««««««««.. 21 Schedule ,,,-V SuEstances«««««««««««««««««««««« 21 Refills««««««««««««««««««««««««««« 21 )acsiPile 3rescriptions for Schedule ,,,-V SuEstances«««««««« Telephone Authori]ation for Schedule ,,,-V 3rescriptions««««««.. 228.S«««««««.. 22 Opioid Narcotic Addiction TreatPent 3rograPs«««««««««««««.23 Appendi[ A &SA and &)R Definitions««««««««««««««««. 26 Appendi[ % 4uestions and Answers«««««««««««««««««. 28 Appendi[ & SuPPar\ of &ontrolled SuEstances Act ReTuirePents«««««. 32 Appendi[ D ,nternet Resources«««««««««««««««««««..33 Appendi[ E DEA Diversion )ield Office /ocations«««««««««««..3 Appendi[ ) SPall %usiness and Agriculture Regulator\ EnforcePent OPEudsPan«««««««««««««««««««««.. 0 Appendi[ * Additional Assi

stance and 3lain /anguage StatePents«««««. 1 Appendi[ + DEA )orPs«««««««««««««««««««««« 2 «««««.. 3««7«««««««. 52 ............................................ 56 ......................................... 60 Drug EnforcePent AdPinistration This practitioner¶s Panual is intended to suPPari]e and e[plain the Easic reTuirePents for prescriEing, adPinistering, and dispensing controlled suEstances under the &ontrolled &)R , 3arts 1300 to 1316. 3ertinent citations to the law and regulations are included in this Panual. 3rinted copies of the &)R and the coPplete regulations iPplePenting the &SA Pa\ Ee oEtained froP: Superintendent of DocuPents *overnPent 3rinting Office :ashington, D.&. 2002 which includes proposed and final regulations iPplePenting the &SA are availaEle on the ,nternet through the 8.S. *overnPent 3rinting Office *3O weEsite. This weEsite, which provides inforPation E\ section, citation and Ne\words

, can Ee accessed at: www.gpoaccess.gov/cfr/inde[.htPl 8nofficial copies of pertinent &)R citations Pa\ Ee found at: This practitioner¶s Panual Pa\ also Ee found on the ,nternet at DEA¶s :eE Site under Should an\ pertinent provisions of the law or regulations Ee Podified in the future, DEA will issue a revised electronic version of this docuPent, which will Ee puElished on the DEA Diversion :eEsite. ,f \ou encounter errors in this docuPent, please notif\: Editor, DEA 3ractitioner¶s Manual /iaison and 3olic\ Section :ashington, D.&. 20537 ,nTuiries regarding topics within this docuPent Pa\ Ee addressed to \our local DEA field office listed in Appendi[ E or the address aEove. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration All Paterial in this puElication is in the puElic doPain and Pa\ Ee reproduced without the e[press perPission of the Drug EnforcePent AdPinistration. ��--------------------

---------------------------------------------------------------------------------------- Drug EnforcePent AdPinistration The Drug EnforcePent AdPinistration is pleased to provide this updated edition of the 1990 3ractitioner¶s Manual to assist \ou in understanding \our responsiEilities under the &ontrolled SuEstances Act &SA and its iPplePenting regulations. This Panual will help answer Tuestions that \ou Pa\ encounter in \our practice and provide guidance in coPpl\ing with federal reTuirePents. DEA rePains coPPitted to the 2001 %alanced 3olic\ of proPoting pain relief and preventing aEuse of pain Pedications. ,n enforcing the &SA, it is DEA¶s responsiEilit\ to ensure drugs are not diverted for illicit purposes. 8nfortunatel\, this countr\ is now e[periencing an alarPing prescription drug aEuse proEleP: Toda\, Pore than 6 Pillion APericans are aEusing prescription drugs²that is Pore than the nuPEer of APericans aEusing cocaine, heroin, hallucinogens, and inhalants, coPEined. Researchers froP the &enters for

Disease &ontrol and 3revention report that opioid prescription painNillers now cause Pore drug overdose deaths than cocaine and heroin coPEined. Toda\ Pore new drug users have Eegun aEusing pain relievers 2. Pillion than Parijuana 2.1 Pillion or cocaine 1.0 Pillion . ,t is Pore iPportant now than ever to Ee vigilant in preventing the diversion and aEuse of controlled suEstances. This Panual will help \ou do that E\ listing soPe safeguards \ou can taNe to prevent such diversion. ,t also e[plains registration, recordNeeping, and valid prescription reTuirePents. As a practitioner, \our role in the proper prescriEing, adPinistering, and dispensing of controlled suEstances is critical to patients¶ health and to safeguarding societ\ against the diversion of controlled suEstances. DEA is coPPitted to worNing jointl\ with the Pedical coPPunit\ to ensure that those in need are cared for and that legitiPate controlled suEstances are not Eeing diverted for illegal use. AdPinistrator SeptePEer 2006

��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration The Drug EnforcePent AdPinistration DEA was estaElished in 1973 to serve as the priPar\ federal agenc\ responsiEle for the enforcePent of the &ontrolled SuEstances Act &SA . The &SA sets forth the federal law regarding Eoth illicit and licit pharPaceutical controlled suEstances. :ith respect to pharPaceutical controlled suEstances, DEA¶s statutor\ responsiEilit\ is twofold: to prevent diversion and aEuse of these drugs while ensuring an adeTuate and uninterrupted suppl\ is availaEle to Peet the countr\¶s legitiPate Pedical, scientific, and research needs. ,n carr\ing out this Pission, DEA worNs in close cooperation with state and local authorities and other federal agencies. 8nder the fraPeworN of the &SA, the DEA is responsiEle for ensuring that all controlled suEstance transactions taNe place within the ³closed s\steP´ of distr

iEution estaElished E\ &ongress. 8nder this ³closed s\steP,´ all legitiPate handlers of controlled suEstances ± Panufacturers, distriEutors, ph\sicians, pharPacies, and researchers ± Pust Ee registered with DEA and Paintain strict accounting for all distriEutions. To carr\ out DEA¶s Pission effectivel\, this 2006 3ractitioner¶s Manual seeNs to aid DEA registrants in coPpl\ing with the &SA and its iPplePenting regulations. The DEA understands that it can Eest serve the puElic interest E\ worNing with practitioners to prevent diversion of legal pharPaceutical controlled suEstances into the illicit ParNet. The federal controlled suEstances laws are designed to worN in tandeP with state controlled suEstance laws. Toward this saPe goal, DEA worNs in close cooperation with state professional licensing Eoards and state and local law enforcePent officials to ensure that pharPaceutical controlled suEstances are prescriEed, adPinistered, and dispensed for legitiPate Pedical purposes in accordance with federal and state laws. :ithin this cooperativ

e fraPeworN, the Pajorit\ of investigations into possiEle violations of the controlled suEstances laws are carried out E\ state authorities. +owever, DEA also conducts investigations into possiEle violations of federal law as circuPstances warrant. ,n the event a state Eoard revoNes the license of a practitioner, the DEA will taNe action and reTuest a voluntar\ surrender of the practitioner¶s DEA registration. ,f the practitioner refuses to voluntaril\ surrender the registration, the DEA will pursue adPinistrative action to revoNe the DEA registration. The DEA Pa\ also pursue judicial action if there is sufficient evidence of illegal distriEution or significant recordNeeping violations. All such actions are intended to den\ the practitioner the Peans to continue to divert or aEuse controlled suEstances as well as to protect the health and safet\ of the puElic and the practitioner. The DEA is authori]ed under federal law to pursue legal action in order to prevent the diversion of controlled suEstances and protect the puElic safet\. A lacN of c

oPpliance Pa\ result in a need for corrective action, such as adPinistrative action that is, /etter of AdPonition, an inforPal hearing or ³order to show cause´ , or in e[trePe cases, civil, or criPinal action. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration The drugs and other suEstances that are considered controlled suEstances under the &SA are divided into five schedules. A coPplete list of the schedules is puElished annuall\ on an updated Easis in the DEA regulations, Title 21 of the &ode of )ederal Regulations, Sections 1308.11 through 1308.15. SuEstances are placed in their respective schedules Eased on whether the\ have a currentl\ accepted Pedical use in treatPent in the 8nited States and their relative aEuse potential and liNelihood of causing dependence when aEused. SoPe e[aPples of the drugs in each schedule are outlined Eelow. use. In contrast, drugs listed in Schedules II through V all ha

ve some accepted medical use SuEstances in this schedule have no currentl\ accepted Pedical use in treatPent in the 8nited States, a lacN of accepted safet\ for use under Pedical supervision, and a high potential for aEuse. SoPe e[aPples of suEstances listed in Schedule , are: heroin l\sergic acid dieth\laPide /SD  Parijuana cannaEis  pe\ote PethaTualone and Peth\lene-diPetho[\PethaPphetaPine ³ecstas\´ . The &SA allows for Eona fide research with controlled suEstances in Schedule ,, provided that the )DA has deterPined the researcher to Ee Tualified and coPpetent, and provided further that the )DA has deterPined the research protocol to Ee Peritorious. Researchers who Peet these criteria Pust oEtain a separate registration to conduct research with a Schedule , controlled suEstance. SuEstances in this schedule have a high potential for aEuse with severe ps\chological or ph\sical dependence. E[aPples of single entit\ Schedule ,, narcotics include Porphine, cod

eine, and opiuP. Other Schedule ,, narcotic suEstances and their coPPon naPe Erand products include: h\droPorphone DilaudidŠ , Pethadone DolophineŠ , Peperidine DePerolŠ , o[\codone O[\&ontinŠ , and fentan\l SuEliPa]eŠ or DuragesicŠ . ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration E[aPples of Schedule ,, stiPulants include aPphetaPine De[edrineŠ or AdderallŠ , PethaPphetaPine Deso[\nŠ , and Peth\lphenidate RitalinŠ . Other Schedule ,, suEstances include: cocaine, aPoEarEital, glutethiPide, and pentoEarEital. SuEstances in this schedule have a potential for aEuse less than suEstances in Schedules , or ,,. E[aPples of Schedule ,,, narcotics include coPEination products containing less than 15 PilligraPs of h\

drocodone per dosage unit i.e., VicodinŠ and products containing not Pore than 90 PilligraPs of codeine per dosage unit i.e., T\lenol with codeineŠ . E[aPples of Schedule ,,, non-narcotics include Een]phetaPine Didre[Š , phendiPetra]ine, dronaEinol MarinolŠ , NetaPine, and anaEolic steroids such as o[androlone O[andrinŠ . SuEstances in this schedule have a lower potential for aEuse relative to suEstances in Schedule ,,,. E[aPples of a Schedule ,V narcotics include propo[\phene DarvonŠ and Other Schedule ,V suEstances include alpra]olaP ;ana[Š , clona]epaP .lonopinŠ , clora]epate Tran[eneŠ , dia]epaP ValiuPŠ , lora]epaP AtivanŠ , Pida]olaP VersedŠ , tePa]epaP RestorilŠ , and tria]olaP +alcionŠ . SuEstances in this schedule have a lower potential fo

r aEuse relative to suEstances listed in Schedule ,V and consist priParil\ of preparations containing liPited Tuantities of certain narcotic and stiPulant drugs. These are generall\ used for antitussive, antidiarrheal and analgesic purposes. E[aPples include cough preparations containing not Pore than 200 PilligraPs of codeine per 100 Pilliliters or per 100 graPs RoEitussin A&Š, and 3henergan with Drug EnforcePent AdPinistration 8nder the &SA, the terP ³practitioner´ is defined as a ph\sician, dentist, veterinarian, scientific investigator, pharPac\, hospital, or other person licensed, registered, or otherwise perPitted, E\ the 8nited States or the jurisdiction in which the practitioner practices or perforPs research, to distriEute, dispense, conduct research with respect to, adPinister, or use in teaching or chePical anal\sis, a controlled suEstance in the course of professional practice or research. Ever\ person or entit\ that handles controlled suEstances Pust Ee registered with DEA or Ee e[ePpt E\ regulation froP r

egistration. The DEA registration grants practitioners federal authorit\ to handle controlled suEstances. +owever, the DEA registered practitioner Pa\ onl\ engage in those activities that are authori]ed under state law for the jurisdiction in which the practice is located. :hen federal law or regulations differ froP state law or regulations, the practitioner is reTuired to aEide E\ the Pore stringent aspects of Eoth the federal and state reTuirePents. ,n Pan\ cases, state law is Pore stringent than federal law, and Pust Ee coPplied with in addition to federal law. 3ractitioners should Ee certain the\ understand their state as well as DEA controlled suEstance regulations. To oEtain a DEA registration, a practitioner Pust appl\ using a DEA )orP 22. Applicants Pa\ suEPit the forP E\ hard cop\ or on-line. &oPplete instructions accoPpan\ the forP. To oEtain the application, DEA Pa\ Ee contacted at: DEA Diversion ,nternet :eE Site an\ DEA field office see listing in Appendi[ E of this Panual DEA +eadTuarters¶

Registration Section in :ashington, D.&. at 1-800-882-9539 Registration &all &enter The DEA )orP-22 Pa\ Ee coPpleted on-line or in hard cop\ and Pailed to: A saPple DEA )orP 22 ± New Application foRegistration, is located at Appendi[ +, DEA )orPs. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration The DEA &ertificate of Registration DEA )orP 223 Pust Ee Paintained at the registered location in a readil\ retrievaEle Panner and Nept availaEle for official The &SA reTuires that a separate registration Ee oEtained for each principal place of Eusiness or professional practice where controlled suEstances are Panufactured, distriEuted, or dispensed. DEA has historicall\ provided an e[ception that a practitioner who is registered at one location, Eut also practices at other locations, is not reTuired to register separatel\ for an\ other location at which controlled suEstances are onl\ prescriEed

. ,f the practitioner Paintains supplies of controlled suEstances, adPinisters, or directl\ dispenses controlled suEstances at the separate location the practitioner Pust oEtain a separate DEA registration for that location. The e[ception applies onl\ to a secondar\ location within the saPe state in which the practitioner Paintains his/her registration. DEA individual practitioner registrations are Eased on state authorit\ to dispense or conduct research with respect to controlled suEstances. Since a DEA registration is Eased on a state license, it cannot authori]e controlled suEstance dispensing outside that state. +ence, the separate registration e[ception applies onl\ to locations within the saPe state in which practitioners have their DEA registrations. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration A duplicate &ertificate of Registration Pa\ Ee reTuested on-line. ,t appears on DEA¶s 3ractitioner registrations Pust Ee r

enewed ever\ three \ears. Renewal registrations use DEA )orP 22a, Renewal Application for DEA Registration see e[aPple at Appendi[ +, DEA )orPs . The cost of the registration is indicated on the application forP. A renewal application is sent to the registrant appro[iPatel\ 5 da\s Eefore the registration e[piration date. The renewal application is sent to the address listed on the current registration certificate. ,f the renewal forP is not received within 30 da\s Eefore the e[piration date of the current registration, the practitioner should contact the DEA registration office for their state, or DEA +eadTuarters at 1-800-882-9539, and reTuest a renewal registration forP. ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration The registration renewal application Pa\ Ee coPpleted on-line at , or in hard cop\ and Pailed to:   ��---------------------

--------------------------------------------------------------------------------------- Drug EnforcePent AdPinistration A practitioner who Poves to a new ph\sical location Pust reTuest a Podification of registration. A Podification of registration can Ee reTuested on-line at eld office responsiEle for that state. ,f the change in address involves a change in state, the proper state issued license and controlled suEstances registration Pust Ee oEtained prior to the approval of Podification of the federal registration. ,f the Podification is approved, DEA will issue a new certificate of registration and, if reTuested, new Schedule ,, order forPs DEA )orP-222, Official Order )orP . A Renewal Application for Registration DEA )orP-22a will onl\ Ee sent to the registered address on file with DEA. ,t will not Ee forwarded. An\ practitioner desiring to discontinue Eusiness activities with respect to controlled suEstances Pust notif\ the nearest DEA field of

fice see Appendi[ E in writing. Along with the notification of terPination of registration, the practitioner should send the DEA &ertificate of Registration and an\ unused Official Order )orPs DEA )orP-222 to the a finding that the registrant has: Materiall\ falsified an\ application filed %een convicted of a felon\ relating to a controlled suEstance or a /ist , chePical +ad their state license or registration suspended, revoNed, or denied &oPPitted an act which would render the DEA registration inconsistent with the puElic interest %een e[cluded froP participation in a Medicaid or Medicare prograP ,n deterPining the puElic interest, the &SA states the following factors are to Ee considered: The recoPPendation of the appropriate state licensing Eoard or professional disciplinar\ authorit\ The applicant¶s e[perience in dispensing or conducting research with respect to controlled suEstances The applicant¶s conviction record under federal or state laws relating to the Panufacture, distriEution, or dispensing of

controlled suEstances &oPpliance with applicaEle state, federal, or local laws relating to controlled Such other conduct which Pa\ threaten the puElic health and safet\ Drug EnforcePent AdPinistration 3ractitioners e.g., intern, resident, staff ph\sician, Pid-level practitioner who are agents or ePplo\ees of a hospital or other institution Pa\, when acting in the usual course of Eusiness or ePplo\Pent, adPinister, dispense, or prescriEe controlled suEstances under the registration of the hospital or other institution in which the\ are ePplo\ed, provided that: The dispensing, adPinistering, or prescriEing is in the usual course of professional practice 3ractitioners are authori]ed to do so E\ the state in which the\ practice The hospital or institution has verified that the practitioner is perPitted to dispense, adPinister or prescriEe controlled suEstances within the state The practitioner acts onl\ within the scope of ePplo\Pent in the hospital or The hospital or institution authori]es the practitioner to dispense

or prescriEe under its registration and assigns a specific internal code nuPEer for each practitioner so authori]ed See e[aPple of a specific internal code nuPEer +ospital A%123567-012 3h\sician¶sDEA Registration +ospital &ode NuPEer NuPEer A current list of internal codes and the corresponding individual practitioners is to Ee Paintained E\ the hospital or other institution. This list is to Ee Pade availaEle at all tiPes to other registrants and law enforcePent agencies upon reTuest for the purpose of verif\ing the authorit\ of the prescriEing individual practitioner. DEA strongl\ opposes the use of a DEA registration nuPEer for an\ purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled suEstances. The use of DEA registration nuPEers as an identification nuPEer is not an appropriate use and could lead to a weaNening of the registration s\steP. The &enters for Medicare and Medicaid Services has developed a National 3rovider ,dentification

N3, nuPEer uniTue to each healthcare provider. The )inal Rule for estaElishPent of the N3, s\steP was puElished in the )ederal Register )R 33, Vol. 69, No. 15 E\ the DepartPent of +ealth and +uPan Services on -anuar\ 23, 200. The effective date of this )inal Rule was Ma\ 23, 2005 all covered entities Pust Eegin using the N3, in standard transactions E\ Ma\ 23, 2007. ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration The reTuirePent of registration is waived for an\ official of the 8.S. ArP\, Nav\, Marine authori]ed to prescriEe, dispense, or adPinister, Eut not to procure or purchase controlled suEstances in the course of his/her official duties. Such officials shall follow procedures set forth in Title 21, &)R † 1306 regarding prescriptions, Eut shall state the Eranch of service or agenc\ e.g., 8.S. ArP\ or �

5;3uElic +ealth Service and the service identification nuPEer of the issuing official in lieu of the registration nuPEer reTuired on prescription forPs. The service identification nuPEer for a 3uElic +ealth Service ePplo\ee is his/her Social Securit\ identification nuPEer. ,f )ederal *overnPent practitioners wish to Paintain a DEA registration for a private practice, which would include prescriEing for private patients, the\ Pust Ee full\ licensed to handle controlled suEstances E\ the state in which the\ are located. 8nder these circuPstances, the )ederal *overnPent practitioner will not Ee eligiEle for the fee e[ePption and Pust pa\ a fee for the registration. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration Title 21, &)R Section 1301.71 a , reTuires that all registrants provide effective controls and procedures to guard against theft and diversion of controlled s

uEstances. A list of factors is used to deterPine the adeTuac\ of these securit\ controls. )actors affecting practitioners The location of the prePises and the relationship such location Eears on securit\ The t\pe and Tuantit\ of controlled suEstances stored on the prePises The t\pe of storage PediuP safe, vault, or steel caEinet The control of puElic access to the facilit\ The adeTuac\ of registrant¶s Ponitoring s\steP alarPs and detection s\stePs The availaEilit\ of local police protection 3ractitioners are reTuired to store stocNs of Schedule ,, through V controlled suEstances in a securel\ locNed, suEstantiall\ constructed caEinet. 3ractitioners authori]ed to possess carfentanil, etorphine h\drochloride and/or diprenorphine, Pust store these controlled suEstances in a safe or steel caEinet eTuivalent to a 8.S. *overnPent &lass V securit\ Registrants should not ePplo\ as an agent or ePplo\ee who has access to controlled An\ person who has surrendered a DEA registration for cause /astl\, practitioners should

notif\ the DEA, upon discover\, of an\ thefts or significant losses of controlled suEstances and coPplete a DEA )orP 106 regarding such theft or loss. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration ,n addition to the reTuired securit\ controls, practitioners can utili]e additional Peasures to ensure securit\. These include: .eep all prescription ElanNs in a safe place where the\ cannot Ee stolen PiniPi]e the nuPEer of prescription pads in use. :rite out the actual aPount prescriEed in addition to giving a nuPEer to discourage alterations of the prescription order. 8se prescription ElanNs onl\ for writing a prescription order and not Never sign prescription ElanNs in advance. Assist the pharPacist when the\ telephone to verif\ inforPation aEout a prescription order a corresponding responsiEilit\ rests with the pharPacist who dispenses the prescription order to ensure the accurac\ of the prescript

ion. &ontact the nearest DEA field office see Appendi[ E to oEtain or to furnish inforPation regarding suspicious prescription activities. 8se taPper-resistant prescription pads. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration Each practitioner Pust Paintain inventories and records of controlled suEstances listed in Schedules , and ,, separatel\ froP all other records Paintained E\ the registrant. /iNewise, inventories and records of controlled suEstances in Schedules ,,,, ,V, and V Pust Ee Paintained separatel\ or in such a forP that the\ are readil\ retrievaEle froP the ordinar\ Eusiness records of the practitioner. All records related to controlled suEstances Pust Ee Paintained and Ee availaEle for inspection for a PiniPuP of two \ears. A registered practitioner is reTuired to Neep records of controlled suEstances that are dispensed to the patient, other than E\ prescriEing or adPin

istering, in the lawful course of professional practice. A registered practitioner is not reTuired to Neep records of controlled suEstances that are prescriEed in the lawful course of professional practice, unless such suEstances are prescriEed in the course of Paintenance or deto[ification treatPent. A registered practitioner is not reTuired to Neep records of controlled suEstances that are adPinistered in the lawful course of professional practice unless the practitioner regularl\ engages in the dispensing or adPinistering of controlled suEstances and charges patients, either separatel\ or together with charges for other professional services, for suEstances so dispensed or adPinistered. A registered practitioner is also reTuired to Neep records of controlled suEstances adPinistered in the course of Paintenance or deto[ification treatPent of an individual. Each registrant who Paintains an inventor\ of controlled suEstances Pust Paintain a coPplete and accurate record of the controlled suEstances on hand and the date that the inventor\ was co

nducted. This record Pust Ee in written, t\pewritten, or printed forP and Ee Paintained at the registered location for at least two \ears froP the date that the inventor\ was conducted. After an initial inventor\ is taNen, the registrant shall taNe a new inventor\ of all controlled suEstances on hand at least ever\ two Each inventor\ Pust contain the following inforPation: :hether the inventor\ was taNen at the Eeginning or close of Eusiness NaPes of controlled suEstances Each finished forP of the suEstances e.g., 100 PilligraP taElet The nuPEer of dosage units of each finished forP in the coPPercial container e.g., 100 taElet Eottle The nuPEer of coPPercial containers of each finished forP e.g., four 100 taElet Eottles ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration Disposition of the controlled suEstances ,t is iPportant to note that inventor\ reTuirePents e[tend to controlled su

Estance saPples provided to practitioners E\ pharPaceutical coPpanies. A practitioner Pa\ dispose of out-of-date, daPaged, or otherwise unusaEle or unwanted controlled suEstances, including saPples, E\ transferring theP to a registrant who is authori]ed to receive such Paterials. These registrants are referred to as ³Reverse DistriEutors.´ The practitioner should contact the local DEA field office See Appendi[ E for a list of authori]ed Reverse DistriEutors. Schedule , and ,, controlled suEstances should Ee transferred via the DEA )orP 222, while Schedule ,,,±V coPpounds Pa\ Ee transferred via invoice. The practitioner should Paintain copies of the records docuPenting the transfer and disposal of controlled suEstances ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration prescription is an order for Pedication which is dispensed to or for an ultiPate user. A is not an order for Pedica

tion which is dispensed for iPPediate adPinistration to the ultiPate user for e[aPple, an order to dispense a drug to an inpatient for iPPediate adPinistration in a hospital is not a prescription . A prescription for a controlled suEstance Pust Ee dated and signed on the date when issued. The prescription Pust include the patient¶s full naPe and address, and the practitioner¶s full naPe, address, and DEA registration nuPEer. The prescription Pust also include: drug naPe Tuantit\ prescriEed directions for use nuPEer of refills if an\ authori]ed A prescription for a controlled suEstance Pust Ee written in inN or indeliEle pencil or t\pewritten and Pust Ee Panuall\ signed E\ the practitioner on the date when issued. An individual secretar\ or nurse Pa\ Ee designated E\ the practitioner to prepare prescriptions for the practitioner¶s signature. The practitioner is responsiEle for ensuring that the prescription conforPs to all reTuirePents of the law and regulations, Eoth federal and state. A prescr

iption for a controlled suEstance Pa\ onl\ Ee issued E\ a ph\sician, dentist, podiatrist, veterinarian, Pid-level practitioner, or other registered practitioner who is: Authori]ed to prescriEe controlled suEstances E\ the jurisdiction in which the practitioner is licensed to practice Registered with DEA or e[ePpted froP registration that is, 3uElic +ealth Service, )ederal %ureau of 3risons, or Pilitar\ practitioners An agent or ePplo\ee of a hospital or other institution acting in the norPal course of Eusiness or ePplo\Pent under the registration of the hospital or other institution which is registered in lieu of the individual practitioner Eeing registered provided that additional reTuirePents as set forth in the &)R are Pet. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration To Ee valid, a prescription for a controlled suEstance Pust Ee issued for a legitiPate Pedical purpose E\ a practitione

r acting in the usual course of professional The practitioner is responsiEle for the proper prescriEing and dispensing of controlled suEstances. ,n addition, a corresponding responsiEilit\ rests with the pharPacist who fills the prescription. An order purporting to Ee a prescription issued not in the usual course of professional treatPent or in legitiPate and authori]ed research is not a valid prescription within the Peaning and intent of the &ontrolled SuEstances Act and the person Nnowingl\ filling such a purported prescription, as well as the person issuing it, shall Ee suEject to the penalties provided for violations of the provisions of law relating to controlled suEstances. A prescription Pa\ not Ee issued in order for an individual practitioner to oEtain controlled suEstances for suppl\ing the individual practitioner for the purpose of general dispensing to patients. Schedule ,, controlled suEstances reTuire a written prescription which Pust Ee signed E\ the practitioner. There is no federal tiPe liPit within which a Schedule ,, prescri

ption Pust Ee filled after Eeing signed E\ the practitioner. :hile soPe states and Pan\ insurance carriers liPit the Tuantit\ of controlled suEstance dispensed to a 30-da\ suppl\, there are no specific federal liPits to Tuantities of drugs dispensed via a prescription. )or Schedule ,, controlled suEstances, an oral order is onl\ perPitted in an ePergenc\ situation. The refilling of a prescription for a controlled suEstance listed in Schedule ,, is prohiEited Title 21 8.S. &ode † 829 a . DEA has revised its regulations regarding the issuance of Pultiple prescriptions for schedule ,, controlled suEstances. 8nder the new regulation, which EecaPe effective DecePEer 19, 2007, an individual practitioner Pa\ issue Pultiple prescriptions authori]ing the patient to receive a total of up to a 90-da\ suppl\ of a schedule ,, controlled suEstance provided the following conditions are Pet: Each separate prescription is issued for a legitiPate Pedical purpose E\ an individual practitioner acting in the usual course of pro

fessional practice. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration The individual practitioner provides written instructions on each prescription other than the first prescription, if the prescriEing practitioner intends for that prescription to Ee filled iPPediatel\ indicating the earliest date on which a pharPac\ Pa\ fill each prescription. The individual practitioner concludes that providing the patient with Pultiple prescriptions in this Panner does not create an undue risN of diversion or The issuance of Pultiple prescriptions is perPissiEle under applicaEle state The individual practitioner coPplies full\ with all other applicaEle reTuirePents under the &ontrolled SuEstances Act and &ode of )ederal Regulations, as well as an\ additional reTuirePents under state law. ,t should Ee noted that the iPplePentation of this change in the regulation should not Ee construed as encouraging individual practitione

rs to issue Pultiple prescriptions or to see their patients onl\ once ever\ 90 da\s when prescriEing schedule ,, controlled suEstances. Rather, individual practitioners Pust deterPine on their own, Eased on sound Pedical judgPent, and in accordance with estaElished Pedical standards, whether it is appropriate to issue Pultiple prescriptions and how often to see their patients when doing so. ,n order to e[pedite the filling of a prescription, a prescriEer Pa\ transPit a Schedule ,, prescription to the pharPac\ E\ facsiPile. The original Schedule ,, prescription Pust Ee presented to the pharPacist for review prior to the actual dispensing of the controlled suEstance. ,n an ePergenc\, a practitioner Pa\ call-in a prescription for a Schedule ,, controlled suEstance E\ telephone to the pharPac\, and the pharPacist Pa\ dispense the prescription provided that the Tuantit\ prescriEed and dispensed is liPited to the aPount adeTuate to treat the patient during the ePergenc\ period. The prescriEing practitioner Pust provide a written and signed prescript

ion to the pharPacist within seven da\s. )urther, the pharPacist Pust notif\ DEA if the prescription is not received. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration DEA has granted three e[ceptions to the facsiPile prescription reTuirePents for Schedule ,, controlled suEstances. The facsiPile of a Schedule ,, prescription Pa\ serve as the original prescription as follows: A practitioner prescriEing Schedule ,, narcotic controlled suEstances to Ee coPpounded for the direct adPinistration to a patient E\ parenteral, intravenous, intraPuscular, suEcutaneous or intraspinal infusion Pa\ transPit the prescription E\ facsiPile. The pharPac\ will consider the facsiPile prescription a ³written prescription´ and no further prescription verification is All norPal reTuirePents of a legal prescription Pust Ee followed. 3ractitioners prescriEing Schedule ,, controlled suEstances for residents of /ong TerP &are )acilities /T&)&#

x000C; Pa\ transPit a prescription E\ facsiPile to the dispensing pharPac\. The practitioner¶s agent Pa\ also transPit the prescription to the pharPac\. The facsiPile prescription serves as the original written prescription for the pharPac\A practitioner prescriEing a Schedule ,, narcotic controlled suEstance for a patient enrolled in a hospice care prograP certified and/or paid for E\ Medicare under Title ;V,,, or a hospice prograP which is licensed E\ the state Pa\ transPit a prescription to the dispensing pharPac\ E\ facsiPile. The practitioner or the practitioner¶s agent Pa\ transPit the prescription to the pharPac\. The practitioner or agent will note on the prescription that it is for a hospice patient. The facsiPile serves as the original written prescription. A prescription for controlled suEstances in Schedules ,,,, ,V, and V issued E\ a practitioner, Pa\ Ee coPPunicated either orall\, in writing, or E\ facsiPile to the pharPacist, and Pa\ Ee refilled if so authori]ed on the prescription or E\ call-in. Schedule ,,, and ,V controlled

suEstances Pa\ Ee refilled if authori]ed on the prescription. +owever, the prescription Pa\ onl\ Ee refilled up to five tiPes within si[ Ponths after the date on which the prescription was issued. After five refills or after si[ Ponths, whichever occurs first, a new prescription is reTuired. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration 3rescriptions for Schedules ,,,-V controlled suEstances Pa\ Ee transPitted E\ facsiPile froP the practitioner or an ePplo\ee or agent of the individual practitioner to the dispensing pharPac\. The facsiPile is considered to Ee eTuivalent to an original A pharPacist Pa\ dispense a controlled suEstance listed in Schedule ,,,, ,V, or V pursuant to an oral prescription Pade E\ an individual practitioner and proPptl\ reduced to writing E\ the pharPacist containing all inforPation reTuired for a valid prescription, e[cept for the signature of the practitioner. &ontrolled suEstances that are dispensed

pursuant to a legitiPate prescription Pa\ not Ee delivered or shipped to individuals in another countr\. An\ such deliver\ or shipPent is a prohiEited e[port under the &SA. Drug EnforcePent AdPinistration The Narcotic Addiction TreatPent Act of 197 and the Drug Addiction TreatPent Act of 2000 aPended the &SA with respect to the use of controlled suEstances in the Pedical treatPent of addiction. These laws estaElished the procedures for approval and licensing of practitioners involved in the treatPent of opioid addiction as well as iPproving the Tualit\ and deliver\ of that treatPent to the segPent of societ\ in need. 3ractitioners wishing to adPinister and dispense approved Schedule ,, controlled suEstances that is, Pethadone for Paintenance and deto[ification treatPent Pust oEtain a separate DEA registration as a Narcotic TreatPent 3rograP. Application for registration as a Narcotic TreatPent 3rograP is Pade using DEA )orP 363. ,n addition to oEtaining this separate DEA registration, this t\pe of activit\ al

so reTuires the approval and registration of the &enter for SuEstance AEuse TreatPent &SAT within the SuEstance AEuse and Mental +ealth Services AdPinistration SAM+SA of the DepartPent of +ealth and +uPan Services ++S , as well as the applicaEle state Pethadone authorit\. ,f a practitioner wishes to prescriEe, adPinister, or dispense Schedule ,,,, ,V, or V controlled suEstances approved for addiction treatPent i.e., Euprenorphine drug products , the practitioner Pust reTuest a waiver )orP SMA-167 and fulfill the reTuirePents of &SAT. &SAT will then notif\ DEA of all waiver reTuests. DEA will review each reTuest. ,f DEA approves this waiver, the practitioner will receive a 8niTue ,dentification NuPEer. ,f a practitioner chooses to dispense controlled suEstances, the practitioner Pust Paintain, separate froP all other records, for a period of at least two \ears, all reTuired records of receipt, storage, and distriEution. ,f a practitioner chooses to prescriEe these co

ntrolled suEstances, the practitioner Pust utili]e their 8niTue ,dentification NuPEer on the prescription in addition to his/her regular DEA registration nuPEer. The practitioner Pust also Paintain a record of each such prescription for a period of at least two \ears. 3ractitioners should Ee aware that there Pa\ Ee liPits on how Pan\ patients the\ Pa\ treat for opioid addiction at an\ given tiPe and should checN with SAM+SA to deterPine these liPits. Note that not all treatPent prograPs utili]e controlled suEstances, that is, soPe are drug free. Accordingl\, these activities do not reTuire DEA registration or approval. 3ractitioners can find additional inforPation regarding addiction treatPent E\ visiting DEA¶s ³3uElications,´ then ³Narcotic TreatPent 3rograPs: %est 3ractices *uidelines.´ The DEA application )orP 363 Pa\ Ee coPpleted on-line. To learn Pore aEout &SAT¶s reTuirePents, practitioners Pa\ visit one or Pore of the following weEsites: www.saPhsa.gov/centers/csat2002/csatBfraPe.htPlwww.csat.saPhsa.gov, or www.Euprenorphine.saPhs

a.gov Drug EnforcePent AdPinistration ,f the practitioner has a patient who is in need of addiction treatPent, Eut does not wish to treat the individual, the practitioner can refer the patient to an e[isting facilit\ through the following weEsite: www.findtreatPent.saPhsa.gov ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration Drug EnforcePent AdPinistration The direct application of a controlled suEstance to the Eod\ of a patient or research suEject E\ 1 a practitioner or in his presence E\ his authori]ed agent, or 2 the patient or research suEject at the direction and in the presence of the practitioner, whether such application is E\ injection, inhalation, ingestion, or an\ other Peans. To deliver a controlled suEstance to an ultiPate user or research suEject E\, or pursuant to the lawful order of, a practitioner, including the prescriEing and adPinisteri

ng of a controlled suEstance and the pacNaging, laEeling, or coPpounding necessar\ to prepare the suEstance for such deliver\. An individual practitioner, institutional practitioner, pharPac\ or, pharPacist who dispenses a controlled suEstance. A ph\sician, dentist, veterinarian, or other individual licensed, registered or otherwise perPitted, E\ the 8nited States or the jurisdiction in which the\ practice, to dispense a controlled suEstance in the course of professional practice, Eut does not include a pharPacist, a pharPac\, or an institutional practitioner. A hospital or other person other than an individual licensed, registered or otherwise perPitted, E\ the 8nited States or the jurisdiction in which it practices, to dispense a controlled suEstance in the course of professional practice, Eut does not include a pharPac\. All factor\ and Eranch stocNs in finished forP of a Easic class of controlled suEstance Panufactured or otherwise acTuired E\ a registrant, whether in EulN, coPPercial containers, or contained in pharPaceuti

cal preparations in the possession of the registrant including stocNs held E\ the registrant under separate registration as a Panufacturer, iPporter, e[porter, or distriEutor . ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration A nursing hoPe, retirePent care, Pental care, or other facilit\ or institution which provides e[tended health care to resident patients. An individual practitioner, other than a ph\sician, dentist, veterinarian, or podiatrist, who is licensed, registered or otherwise perPitted E\ the 8nited States or the jurisdiction in which he/she practices, to dispense a controlled suEstance in the course of professional practice. E[aPples of Pid-level practitioners include, Eut are not liPited to, health care providers such as nurse practitioners, nurse Pidwives, nurse anesthetists, clinical nurse specialists, and ph\sician assistants who are authori]ed to dispense controlled suEstances E\ the state in whic

h the\ practice. An\ pharPacist licensed E\ a state to dispense controlled suEstances, and shall include an\ other person e.g., pharPacist intern authori]ed E\ a state to dispense controlled suEstances under the supervision of a pharPacist licensed E\ such state. An order for Pedication which is dispensed to or for an ultiPate user Eut does not include an order for Pedication which is dispensed for iPPediate adPinistration to the ultiPate user e.g., an order to dispense a drug to a Eed patient for iPPediate adPinistration in a hospital is not a prescription . &ertain records are Nept E\ autoPatic data processing s\stePs or other electronic or Pechani]ed record Neeping s\stePs in such a Panner that the\ can Ee separated out froP all other records in a reasonaEle tiPe and/or records are Nept on which certain itePs are asterisNed, redlined, or in soPe other Panner visuall\ identifiaEle apart froP other itePs appearing on the records. Drug EnforcePent AdPinistration The following Tuestions are those that are D

iversion &ontrol and its field units. These Tuestions and their accoPpan\ing answers are provided in conte[t of the &SA and its federal regulations. A A separate registration is reTuired for each principal place of Eusiness or professional practice where controlled suEstances are stored or dispensed E\ a Separate registration is not reTuired in an office used E\ a practitioner who is registered at another location where controlled suEstances are prescriEed Eut neither adPinistered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled suEstances are Paintained. An individual practitioner who is an agent or ePplo\ee of another practitioner other than a Pid-level practitioner registered to dispense controlled suEstances Pa\, when acting in the norPal course of Eusiness or ePplo\Pent, adPinister or dispense other than E\ issuance of prescription controlled suEstances if and to the e[tent that such individual pr

actitioner is authori]ed or perPitted to do so E\ the jurisdiction in which he or she practices, under the registration of the ePplo\er or principal practitioner in lieu of Eeing registered hiP/herself. An individual practitioner who is an agent or ePplo\ee of a hospital or other institution Pa\, when acting in the norPal course of Eusiness or ePplo\Pent, adPinister, dispense, or prescriEe controlled suEstances under the registration of the hospital or other institution which is registered in lieu of Eeing registered provided that additional reTuirePents as set forth in the &)R are Pet. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration Registration is waived for an\ official of the 8.S. ArP\, Nav\, Marine &orps, Air )orce, or &oast *uard who is authori]ed to prescriEe, dispense, or adPinister, Eut not procure or purchase, controlled suEstances in the course of his/her official duties. Such officials Pust follow procedures s

et forth in 21 &)R 3art 1306 regarding prescriptions. %ranch of service or agenc\ and the service identification nuPEer of the issuing official is reTuired on the prescription forP in lieu of the DEA registration nuPEer. ,f an\ e[ePpted official engages as a private individual in an\ activit\ or group of activities for which registration is reTuired, that individual Pust oEtain a registration for those private activities. )urther, practitioners serving in the 8.S. Militar\ are e[ePpt froP registering with DEA, Eut are not authori]ed to procure or purchase controlled suEstances in the course of their official duties. A nuPEer of states also reTuire Pilitar\ practitioners to acTuire a separate state license if the\ issue prescriptions that are filled outside the Pilitar\ facilit\ where the\ practice. Are contract practitioners working at U.S. Military Installations also exempt The\ are not e[ePpt. A contract practitioner who is not an official of the Pilitar\ on active dut\, Eut is engaged in Pedical practice at a Pilitar\ installation, Pust po

ssess a current DEA registration. The individual Pust also possess a valid state license for the saPe state in which he/she is registered with DEA. Registrants Pust notif\ the DEA field office in their area of the theft or significant loss of an\ controlled suEstances upon discover\. The registrant Pust also coPplete DEA )orP 106 docuPenting the loss or theft. ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration The legal standard that a controlled suEstance Pa\ onl\ Ee prescriEed, adPinistered, or dispensed for a legitiPate Pedical purpose E\ a ph\sician acting in the usual course of professional practice has Eeen construed to Pean that the prescription Pust Ee ³in accordance with a standard of Pedical practice generall\ recogni]ed and accepted in the 8nited States.´ )ederal courts have long recogni]ed that it is not possiEle to e[pand on the phrase ³legitiPate Pedical purpose in the usual course of professional practice´ in a w

a\ that will provide definitive guidelines to address all the varied situations ph\sicians Pa\ :hile there are no criteria to address ever\ conceivaEle instance of prescriEing, there are recurring patterns that Pa\ Ee indicative of inappropriate prescriEing: An inordinatel\ large Tuantit\ of controlled suEstances prescriEed or large nuPEers of prescriptions issued coPpared to other ph\sicians in an area No ph\sical e[aPination was given :arnings to the patient to fill prescriptions at different drug stores ,ssuing prescriptions Nnowing that the patient was delivering the drugs to ,ssuing prescriptions in e[change for se[ual favors or for Pone\ 3rescriEing of controlled drugs at intervals inconsistent with legitiPate Pedical treatPent The use of street slang rather than Pedical terPinolog\ for the drugs prescriEed or o logical relationship Eetween the drugs prescriEed and treatPent of the condition allegedl\ e[isting. Each case Pust Ee evaluated Eased on its own Perits in view of the totalit\ of c

ircuPstances particular to the ph\sician and patient. )or e[aPple, what constitutes ³an inordinatel\ large Tuantit\ of controlled suEstances,´ can var\ greatl\ froP patient to patient. A particular Tuantit\ of a powerful Schedule ,, opioid Pight Ee Elatantl\ e[cessive for the treatPent of a particular patient s Pild tePporar\ pain, \et insufficient to treat the severe unrePitting pain of a cancer patient. What information is required to be provided on a written prescription? All written prescriptions for controlled suEstances Pust Ee dated as of, and signed on, the date when issued. Each prescription Pust indicate the full naPe and address of the patient, the drug naPe, strength, dosage forP, Tuantit\ prescriEed, ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration directions for use and the naPe, address, and DEA nuPEer of the practitioner. )urther, prescriptions Pust Ee written in inN, indeliEle pencil, or E\ t\pewriter, and Pust

Ee Panuall\ signed E\ the practitioner. The date a prescription is issued is the saPe date that the prescriEing practitioner actuall\ writes and signs the prescription. There is no federal tiPe liPit for filling Schedule ,, prescriptions. +owever, soPe state laws do set tiPe liPits. Drug EnforcePent AdPinistration No more than 5 within 6 As authorized when Pust Ee Paintained for 2 \ears, unless a state reTuires a longer period. A facsiPile prescription serves as the original prescription when issued to residents of /ong TerP &are )acilities, +ospice patients, or coPpounded ,V narcotic Pedications. :here authori]ed E\ state controlled suEstances authorit\. Drug EnforcePent AdPinistration www.DEAdiversion.usdoj.gov www.dea. www.gpoaccess.3rovides access to the &ode of )ederal Regulations 21 &)R, 3arts 1300 to end , priPar\ source for the 3ractitioner¶s Manual, and the )ederal Register which contains proposed and finali]ed

aPendPents to the &)R. www.whitehousedrugpolicy.gov www.health.org www.csat.samhsa.gov www.FSMB.org www.nabp.net www.nascsa.org ------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration 3ractitioner¶s Manual APPENDIX E Drug Enforcement Administration )or address and telephone e see e DEA E pages 3-39 of this Panual contained outdated )ield Office ,nforPation and therefore have Eeen rePoved. 3lease refer to the aEove linN for current Diversion )ield 2006 Edition Drug EnforcePent AdPinistration The SPall %usiness and Agriculture Regulator\ EnforcePent OPEudsPan and 10 Regional )airness %oards were estaElished to receive coPPents froP sPall Eusinesses aEout federal agenc\ enforcePent actions. The OPEudsPan will annuall\ evaluate the enforcePent activities and rate each agenc\¶s responsiveness to sPall Eusiness. ,f \ou wish to coPPent on DEA enforcePent actions, \ou Pa\ contact the OPEudsPan at 1-888-RE*-)A,R 1-888-73

7;-327 . Drug EnforcePent AdPinistration This puElication is intended to provide guidance and inforPation on the reTuirePents of the &ontrolled SuEstances Act and its iPplePenting regulations. ,f \ou reTuire additional clarification or assistance, or wish to coPPent on an\ Patter regarding the DEA¶s reTuirePents or regulator\ activities, please contact \our local DEA Diversion field office see Appendi[ E . Ever\ effort will Ee Pade to respond proPptl\ to \our The Drug EnforcePent AdPinistration has Pade ever\ effort to write this Panual in clear, plain language. ,f \ou have suggestions as to how to iPprove the clarit\ of this Panual, please contact us at: /iaison and 3olic\ ��------------------------------------------------------------------------------------------------------------ Drug EnforcePent AdPinistration The following pages provide saPples of several forPs freTuentl\ encountered E\ DEA registrants. ,ncluded are: Registrants ,nventor\ of Drugs Su

rrendered 8.S. Official Order )orP for &ontrolled SuEstances Application for Registration Application for Registration as a Narcotic TreatPent 3rograP Renewal Application for DEA Registration as a Narcotic TreatPent 3rograP ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration  ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration  ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration  ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration 

Drug EnforcePent AdPinistration DEPICTION of PAGE 1 of DEA FORM-222 U.S. OFFICIAL ORDER FORM - SCHEDULES I & II See Reverse of PURCHASER’S Copy of Instructions No order forP Pa\ Ee issued for Schedule , and ,, suEstances unless a coPpleted application forP has Eeen received, 21 &)R 1305.0 . OMB APPROVAL No. 1117-0010 TO: (Name of Supplier) STREET ADDRESS CITY and STATE DATE TO BE FILLED IN BY SUPPLIER SUPPLIERS DEA REGISTRATION No. No. TO BE FILLED IN BY PURCHASER No. of Packages Size of Package Name of Item National Drug Code Packages Shipped Date Shipped 2 3 4 5 6 7 8 9 10 LAST LINE COMPLETED (MUST BE 10 OR LESS) SIGNATURE OR PURCHASER OR ATTORNEY OR AGENT Date Issued DEA Registration No. Name and Address of Registrant Schedules Registered as a No. of this Order Form DEA Form-222 U.S. OFFICIAL ORDER FORMS - SCHEDULES I & II (Oct. 1992) DRUG ENFORCEMENT ADMINISTRATION SUPPLIER’S Copy 1 Note: The graphic illustrated above is not intended to be used as an actual order form. ��

;------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration  ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration  ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration  ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration  ��------------------------------------------------------------------------------------------------------------ &#x/MCI; 0 ;&#x/MCI; 0 ;Drug EnforcePent AdPinistration  ��----------------------------------------------------

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