Drugs Of Abuse, A DEA Resource Guide (2020 Edition)

Schedule IV The drug or other substance has a low potential forabuse relative to the drugs or other substances inSchedule III. The drug or other substance has a currently acceptedmedical use in treatment in the United States. Abuse of the drug or other substance may leadto limited physical dependence or psychologicaldependence relative to the drugs or other substancesin Schedule III. Examples of drugs included in Schedule IV arealprazolam, clonazepam, and diazepam.Schedule V The drug or other substance has a low potential forabuse relative to the drugs or other substances inSchedule IV. The drug or other substance has a currently acceptedmedical use in treatment in the United States. Abuse of the drug or other substances may leadto limited physical dependence or psychologicaldependence relative to the drugs or other substancesin Schedule IV. Cough medicines with codeine are examples ofSchedule V drugs.When the DEA Administrator has determinedthat a drug or other substance should becontrolled, decontrolled, or rescheduled, aproposal to take action is published in the FederalRegister. The proposal invites all interestedpersons to file comments with the DEA and mayalso request a hearing with the DEA. If no hearingis requested, the DEA will evaluate all commentsreceived and publish a final order in the FederalRegister, controlling the drug as proposed or withmodifications based upon the written comments10 Drugs of Abuse A DEA Resource Guide: 2020 EDITIONfiled. This order will set the effective dates forimposing the various requirements of the CSA.If a hearing is requested, the DEA will enter intodiscussions with the party or parties requestinga hearing in an attempt to narrow the issue forlitigation. If necessary, a hearing will then beheld before an Administrative Law Judge. Thejudge will take evidence on factual issues andhear arguments on legal questions regardingthe control of the drug. Depending on the scopeand complexity of the issues, the hearing maybe brief or quite extensive. The AdministrativeLaw Judge, at the close of the hearing, preparesfindings of fact and conclusions of law and arecommended decision that is submitted to theDEA Administrator. The DEA Administrator willreview these documents, as well as the underlyingmaterial, and prepare his/her own findings of factand conclusions of law (which may or may not bethe same as those drafted by the AdministrativeLaw Judge). The DEA Administrator thenpublishes a final order in the Federal Registereither scheduling the drug or other substance ordeclining to do so.Once the final order is published in the FederalRegister, interested parties have 30 days toappeal to a U.S. Court of Appeals to challengethe order. Findings of fact by the Administrator aredeemed conclusive if supported by “substantialevidence.” The order imposing controls is notstayed during the appeal, however, unless soordered by the Court.Emergency or Temporary SchedulingThe CSA was amended by the ComprehensiveCrime Control Act of 1984. This Act included aprovision which allows the DEA Administrator toplace a substance, on a temporary basis, into

Schedule I, when necessary, to avoid an imminenthazard to public safety.This emergency scheduling authority permits thescheduling of a substance which is not currentlycontrolled, is being abused, and is a risk to publichealth while the formal rulemaking proceduresdescribed in the CSA are being conducted. Thisemergency scheduling applies only to substanceswith no accepted medical use.A temporary scheduling order may be issuedfor two years with a possible extension of up toone year if formal scheduling procedures havebeen initiated. The notice of intent and order arepublished in the Federal Register, as are theproposals and orders for formal scheduling. [21U.S.C. § 811 (h)]Controlled Substance analoguesControlled substance analogues are substancesthat are not formally controlled substances,but may be found in illicit trafficking. They arestructurally or pharmacologically similar toSchedule I or II controlled substances and haveno legitimate medical use. A substance that meetsthe definition of a controlled substance analogueand is intended for human consumption may betreated under the CSA as if it were a controlledsubstance in Schedule I. [21 U.S.C. § 802(32), 21U.S.C. § 813]International treaty obligationsUnited States treaty obligations may requirethat a drug or other substance be controlled underthe CSA, or rescheduled if existing controls areless stringent than those required by a treaty. Theprocedures for these scheduling actions are foundin Section 201 (d)of the Act. [21 U.S.C. § 811 (d)]The United States is a party to the SingleConvention on Narcotic Drugs of 1961, whichwas designed to establish effective control overinternational and domestic traffic in narcotics, cocaleaf, cocaine, and cannabis. A second treaty, theConvention on Psychotropic Substances of 1971,which entered into force in 1976 and was ratifiedby Congress in 1980, is designed to establishcomparable control over stimulants, depressants,and hallucinogens.REGULATIONThe CSA creates a closed system of distributionfor controlled substances. The cornerstone of thissystem is the registration of all those authorizedby DEA to handle controlled substances. Allindividuals and firms that are registered arerequired to maintain complete and accurateinventories, and records of all transactionsinvolving controlled substances, as well assecurity for the storage of controlled substances.RegistrationAny person who handles or intends to handlecontrolled substances must obtain a registrationissued by DEA. A unique number is assigned toeach legitimate handler of controlled drugs suchas importer, exporter, manufacturer, distributor,hospital, pharmacy, practitioner, and researcher.This number must be made available to thesupplier by the customer prior to the purchaseof a controlled substance, and its validity canbe verified online through the Diversion ControlDivision website at www.DEAdiversion.usdoj.gov. Thus, the opportunity for unauthorizedtransactions is greatly diminished.Drugs of Abuse A DEA Resource Guide: 2020 EDITION 11

Recordkeeping and ReportingThe CSA requires that complete and accuraterecords be kept of all quantities of controlledsubstances manufactured, imported, exported,received, delivered, distributed, dispensed,or otherwise disposed. Each substance mustbe physically inventoried every two years.Some limited exceptions to the recordkeepingrequirements apply to certain categories ofregistrants.From these records it is possible to trace theflow of any drug from the time it is first imported ormanufactured, through the distribution level, to thepharmacy or hospital that dispensed it, and thento the actual patient who received the drug. Themere existence of this requirement is sufficient todiscourage many forms of diversion. It actuallyserves large drug corporations as an internalcheck to uncover diversion, such as pilferage byemployees.There is one distinction between scheduleditems for record keeping requirements. Recordsfor Schedule I and II drugs must be kept separatefrom all other records maintained by the registrant.Records for Schedule III, IV, and V substancesmust be kept in a “readily retrievable” form, ormaintained separately from all other records.DistributionMaintaining records is required for distribution ofa controlled substance from one manufacturer toanother, from manufacturer to distributor, and fromdistributor to dispenser. In the case of ScheduleI and II drugs, the supplier must first receive aspecial order from the customer. This order form(DEA Form 222) is issued by DEA only to personswho are properly registered to handle Schedule Iand II controlled substances.12 Drugs of Abuse A DEA Resource Guide: 2020 EDITIONThe form is preprinted with the name andaddress of the customer. The drugs must beshipped to this name and address. The use of thisform is a special reinforcement of the registrationrequirement; it ensures that only authorizedindividuals may obtain Schedule I and II drugs.Controlled Substance Ordering System (CSOS)– Electronic Order FormsAny registrant permitted to order Schedule IIcontrolled substances may do so electronically viathe DEA Controlled Substance Ordering System(CSOS). The use of electronic orders is optional;registrants may continue to issue orders on apaper DEA Form 222. CSOS allows for secureelectronic transmission of controlled substanceorders without the supporting paper DEA Form222. The adoption of the CSOS standards is theonly allowance for the electronic transmission ofSchedule II controlled substance orders betweencontrolled substance manufacturers, distributors,pharmacies, and other DEA authorized entities.CSOS uses Public Key Infrastructure (PKI)technology, which requires CSOS users to obtaina CSOS digital certificate for electronic ordering.The electronic orders must be signed using adigital signature issued by a Certification Authority(CA) operated by DEA.Digital certificates can be obtained only byregistrants and individuals granted power ofattorney by registrants to sign orders. A registrantmust appoint a CSOS coordinator who will serveas that registrant’s recognized agent regardingissues pertaining to issuance of, revocationof, and changes to, digital certificates issuedunder that registrant’s DEA registration. A CSOSdigital certificate will be valid until the DEAregistration under which it is issued expires or

until the CSOS CA is notified that the certificateshould be revoked. Certificates will be revokedif the certificate holder is no longer authorizedto sign Schedule II orders for the registrant, ifthe information on which the certificate is basedchanges, or if the digital certificate used to signelectronic orders has been compromised, stolen,or lost.One benefit of using the CSOS system is thatparticipants who are registered in other schedulesin addition to Schedule II can then use this samesystem to also order those other controlledsubstances.Another benefit of the DEA Form 222 is thespecial monitoring it permits. The form is issuedin triplicate: the customer keeps one copy; twocopies go to the supplier, who, after filling theorder, keeps a copy and forwards the third copy tothe nearest DEA office.For drugs in Schedules III, IV, and V, no orderform is necessary, but both the supplier andthe purchaser must still maintain records of alltransactions involving these controlled substancesand those records must contain specificinformation required by DEA regulation.The supplier in each case, however, is underan obligation to verify the authenticity of thecustomer. The supplier is held fully accountablefor any drugs that are shipped to a purchaser whodoes not have a valid registration. Manufacturersmust submit periodic reports of the Schedule I andII controlled substances they produce in bulk anddosage forms.They also report the manufactured quantityand form of each narcotic substance listedin Schedule III. Distributors of controlledsubstances must report the quantity and form ofall their transactions of controlled drugs listed inSchedules I and II, narcotics listed in ScheduleIII, and GHB. Both manufacturers and distributorsare required to provide reports of their annualinventories of these controlled substances. Thisdata is entered into a system called the AutomatedReports and Consolidated Orders System(ARCOS). It enables the DEA to monitor thedistribution of controlled substances throughoutthe country, and to identify retail level registrantsthat receive unusual quantities of controlledsubstances.Dispensing to PatientsThe dispensing of a controlled substance isthe delivery by a practitioner of the controlledsubstance to the ultimate user, who may bea patient or research subject. Special controlmechanisms operate here as well. Schedule Idrugs are those that have no currently acceptedmedical use in the United States; therefore, theymay be used in the United States only in researchsituations.They generally are supplied by only a limitednumber of firms to properly registered andqualified researchers. Controlled substancesmay be dispensed by a practitioner by directadministration, by prescription, or by dispensing.Records must be maintained by the practitionerof all dispensing of controlled substances and ofcertain administrations.The CSA does not require the practitioner tomaintain copies of prescriptions unless suchsubstances are prescribed in the course ofmaintenance or detoxification treatment of anindividual. Certain states require the use ofmultiple-copy prescriptions for Schedule II andother specified controlled substances.The determination to place drugs on prescriptionDrugs of Abuse A DEA Resource Guide: 2020 EDITION 13

is within the jurisdiction of the FDA. Unlikeother prescription drugs, however, controlledsubstances are subject to additional restrictions.Schedule II prescription orders must be writtenand signed by the practitioner; they may notbe telephoned into the pharmacy except in anemergency. In addition, a prescription for aSchedule II drug may not be refilled. For ScheduleIII and IV drugs, the prescription order maybe either written or oral (that is, by telephoneto the pharmacy). In addition, the patient may(if authorized by the practitioner) have theprescription refilled up to five times and at any timewithin six months from the date the prescriptionwas issued.Schedule V includes some prescription drugsand many narcotic preparations, includingantitussives and antidiarrheals. Even here,however, the law imposes restrictions beyondthose normally required for the over-the-countersales; for example, the patient must be at least 18years of age, must offer some form of identification,and have his or her name entered into a speciallog maintained by the pharmacist as part of aspecial record.Electronic PrescriptionsOn March 31, 2010, DEA published in theFederal Register the Electronic Prescriptions forControlled Substances interim final rule whichbecame effective June 1, 2010. The rule providespractitioners with the option of writing prescriptionsfor controlled substances electronically and alsopermits pharmacies to receive, dispense, andarchive these electronic prescriptions.Persons who wish to dispense controlledsubstances using electronic prescriptions mustselect software that meets the requirements of14 Drugs of Abuse A DEA Resource Guide: 2020 EDITIONthis rule. As of June 1, 2010, only those electronicapplications that comply with all of DEA’srequirements as set forth in 21 C.F.R. §1311 maybe used to electronically create, transmit, receive/archive controlled substances prescriptions, anddispense controlled substances based on thoseprescriptions.Ryan Haight Online Pharmacy ConsumerProtection Act of 2008On October 15, 2008, the President signed intolaw the Ryan Haight Online Pharmacy ConsumerProtection Act of 2008, often referred to as theRyan Haight Act. This law amends the CSA byadding a series of new regulatory requirementsand criminal provisions designed to combat theproliferation of so-called “rogue Internet sites”that unlawfully dispense controlled substancesby means of the Internet. The Ryan HaightAct applies to all controlled substances in allschedules. An online pharmacy is a person, entity,or Internet site, whether in the United States orabroad, that knowingly or intentionally delivers,distributes, or dispenses, or offers or attemptsto deliver, distribute, or dispense, a controlledsubstance by means of the Internet.This law became effective April 13, 2009. As ofthat date, it is illegal under federal law to deliver,distribute, or dispense a controlled substanceby means of the Internet unless the onlinepharmacy holds a modification of DEA registrationauthorizing it to operate as an online pharmacy.QuotasDEA limits the quantity of Schedule I andII controlled substances and specific List Ichemicals (pseudoephedrine, ephedrine, andphenylpropanolamine) that may be produced in

the United States in any given calendar year forlegitimate medical, scientific and research needs,inventory, and lawful exports. By utilizing availabledata on sales and inventories of these controlledsubstances, and taking into account estimatesof drug usage provided by the FDA, the DEAestablishes annual aggregate production quotasfor Schedule I and II controlled substances andthe List I chemicals pseudoephedrine, ephedrine,and phenylpropanolamine.The aggregate production quotas and theassessment of annual needs are allocated amongthe various manufacturers who are registeredto manufacture the specific substance or listedchemical. DEA also allocates the amount ofbulk material that may be procured by thoseDEA registered manufacturers that prepare thesubstances into dosage units.SecurityDEA registrants are required by regulationto maintain certain security for the storageand distribution of controlled substances.Manufacturers and

10 Drugs of Abuse A DEA Resource Guide: 2020 EDITION Schedule IV The drug or other substance has a low potential for abuse relative to the drugs or other substances in Schedule III. The drug or other substance has a currently accepted medical use in treatment in the Unite