An Overview and Update of the Controlled Substances Act of 1970

February 1, 2007
Virgil Van Dusen, RPh, JD & Alan R. Spies, RPh, MBA, JD, PhD

Pharmacy Times, Volume 0,0

Behavioral Objectives

After completing this continuing education article, the pharmacist should be able to:

1. Describe the Controlled Substances Act (CSA) andexplain how it impacts the profession of pharmacy.

2. Appraise his or her practice setting for potential violations,and, if present, make the necessary changes tocomply with the federal law.

3. Discuss the recent changes (both enacted and proposed)to the CSA, while relating how these changes willimpact everyday pharmacy practice.

The Congress of the United Statesenacted into law the ControlledSubstances Act (CSA) as Title II ofthe Comprehensive Drug Abuse Preventionand Control Act of 1970.1 The CSAserves as the legal foundation of the government'sfight against drugs of abuse.This law consolidates numerous lawsregulating the manufacture and distributionof narcotics, stimulants, depressants,hallucinogens, anabolic steroids, andchemicals used in the illicit production ofcontrolled substances.

The major purpose of the CSA, however,was to enable the United States tocomply with the requirements of 2 internationaltreaties. These treaties, the 1961Single Convention on Narcotic Drugs andthe 1971 Convention on PsychotropicSubstances, set a system for classifyingcontrolled substances in several schedulesin accordance with binding scientificand medical findings of a public healthauthority. In the United States, that authorityrests with the Secretary of Healthand Human Services (HHS).

The Drug Enforcement Administration(DEA) carries out the enforcement of theCSA. Established in 1973, the DEA is thefederal agency responsible for the implementationof regulations related to theCSA.2 It replaced what was known at thetime as the Bureau of Narcotics and DangerousDrugs (BNDD). Currently, the DEAis a unit of the Federal Bureau of Investigationwithin the Department ofJustice. Although the federal BNDD hasbeen eliminated, many states continue tohave their own drug enforcement agency,with laws similar to federal statutes andregulations and known by the samename.

Registration

In enacting the CSA, Congress restrictedaccess to controlled substances tothose registered to manufacture, distribute,or dispense such products. Makingapplication on an appropriate form to theUS Attorney General provides registration.Pharmacies, as dispensers, currentlyregister for a period of 3 years.3 The DEAdivides the registrant population amongretail and wholesale lines, which includesmore than 1 million total registrants. Formore information, see Table 1.

Whereas the goal of the CSA may be tolimit access to controlled substances andensure accountability of certain drugs,exemptions do exist for registration. Themost notable exemption relating to thepractice of pharmacy is pharmacistsemployed by a registered pharmacy orinstitution. The exemption is universal inthat every pharmacy that handles controlledsubstances must be registered,which in turn provides the automaticexemption for the pharmacist who worksfor such a pharmacy.

Although federal provisions give someexemptions, the individual states mayremove such exemptions. For example, amanufacturer's representative who handlescontrolled substance samples maybe exempt from registration under federalrequirements.5 A state may requireregistration and accountability, however,under either statutory or regulatory provisions.6

Identification and Classification ofControlled Substances

The CSA places all regulated substancesunder existing federal law intoone of 5 schedules. This classification isbased on the substance's medical value,harmfulness, and potential for abuse oraddiction. Schedule I is reserved for themost dangerous drugs that have no recognizedmedical use, and Schedule V isthe classification used for the least dangerousdrugs. Dispensing pharmaciesshould never possess a Schedule I drug.7The CSA provides a mechanism for substancesto be controlled, added to aschedule, removed from a schedule, orrescheduled. This mechanism requiresinitiation by the DEA, by the HHS, or bypetition from any interested party. Theseinterested parties may include the manufacturerof a drug, a medical society orassociation, a pharmacy association, apublic interest group concerned withdrug abuse, a state or local governmentagency, or an individual citizen. When theDEA receives a petition, the agencybegins its own investigation of the drug,which includes a request to the HHS fora scientific and medical evaluationregarding whether the drug should becontrolled or removed from control. Thisrecommendation on scheduling is bindingonly to the extent that, if the HHS recommendsthat the substance not becontrolled, the DEA may not control thesubstance.

Obtaining Controlled Substancesby Pharmacies

Pharmacies may receive or transfercontrolled substances to or from otherregistrants only by means of an invoice.This invoice creates a record of transfer,which the CSA requires. This record mustcontain (1) the name of the controlledsubstance, (2) the dosage form, (3) thestrength or concentration of the dosageunit, and (4) the number of dosage unitsper commercial container. Additionally, thereceipt record by the pharmacy to obtainthe controlled substance must include thenumber of commercial containers received,the date of receipt, and the name,address, and DEA registration number ofthe supplier.8 A commercial invoice servesas a record of receipt for Schedules III, IV,and V drugs as long as the documentcontains required information.

DEA Form 222

Schedule II drugs may be obtained bythe use of a DEA Form 222.9 ObtainingDEA Form 222 initially occurs when aDEA registrant files an application forregistration and asks for such forms bychecking the appropriate box on theapplication. Subsequent order formsmay be obtained by submitting DEAForm 222(a) to the registration branch ofthe DEA.10 DEA Form 222 is a triplicateform; the pharmacy keeps the third copy,which must contain a notation of thenumber of commercial containersreceived and the date of receipt.11Pharmacists must send copies 1 and 2 ofthe triplicate form to the supplier, whothen forwards copy 2 to the DEA.Unusually large purchases of certainkinds of Schedule II controlled substancesmay trigger a drug accountabilityaudit by the DEA.

Electronic Orders for ControlledSubstances

On April 1, 2005, the DEA issued a finalrule that provides an electronic equivalentto DEA Form 222. New regulationsnow allow, but do not require, registrantsto order Schedule II substances electronicallyand to maintain the records ofthese orders electronically.12 To be valid,the purchaser must sign an electronicorder for a Schedule II controlled substancewith a digital signature issued tothe purchaser (or the purchaser's agent)by the DEA and must complete datafields that are found blank on the electronicorder.13 Leaving data fields emptywill require the supplier to reject theorder and notify the purchaser of therejection.14 Unique to this type of electronicorder is that a purchaser mayinclude controlled substances that arenot in Schedule II as well as noncontrolledsubstances. To learn more aboutthe electronic ordering of controlled substances,view the DEA Web site locatedat www.deaecom.gov.

Validity of Controlled SubstancePrescriptions

To be valid, a controlled substance prescriptionmust be issued for a legitimatemedical purpose by an individual practitioneracting in the usual course of hisprofessional practice.15 Should a pharmacistknowingly fill a purported prescriptionnot issued in the usual course ofprofessional treatment, then that pharmacistis subject to penalties providedfor violations relating to controlled substances.16 Whereas the prescribing practitionermay be held responsible for issuinga bogus controlled substance prescription,a corresponding responsibilityand resulting criminal liability rests withthe pharmacist who fills such a prescription.Pharmacists have been found guiltybased on circumstantial evidence of prescriptionlegitimacy.17 The DEA has publisheda guide to help pharmacists determinewhether controlled substance prescriptionsare being issued for alegitimate medical purpose (Table 2).Additional guidelines may be found atwww.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm.

DEA Policy Statement on PainTreatment

On September 6, 2006, the DEA issueda policy statement regarding the dispensingof controlled substances for thetreatment of pain.19 Although this policyprimarily addresses physicians, the DEAalso holds pharmacists to the same standardas referenced earlier?a registeredphysician acting within the usual courseof professional practice must issue a prescriptionfor a legitimate medical purpose.A recent survey conducted by theUniversity of Michigan of 8th, 10th, and12th graders indicated that, while a generaldecline in drug use has occurred,high rates of nonmedical use of prescriptionmedications continue, especially opioidpain killers.20 For example, in 2005,9.5% of 12th graders reported usingVicodin (hydrocodone) in the past year,and 5.5% of these students reportedusing OxyContin (oxycodone) in the pastyear.21 Before pharmacists become overlyconcerned about dispensing controlledsubstances for pain control, they shouldnote that the treatment of pain with controlledsubstances is unquestionably alegitimate medical purpose. The overwhelmingmajority of physicians whoprescribe controlled substances do so ina legitimate manner that will never warrantinvestigation by federal or state lawenforcement officials. Reports indicatethat in any given year, including 2005,fewer than 1 of every 10,000 physiciansin the United States (<0.01%) lose theircontrolled substance registrations basedon a DEA investigation of improper prescribing.The majority of these cases inwhich physicians lose their DEA registrationsresult from actions by state medicalboards to revoke or suspend the physician'sstate medical license. In recentyears, many state medical boards havedeveloped guidelines for the proper useand prescribing of controlled substancesfor pain control.

Facsimile Prescriptions

When the CSA first came into existence,valid prescriptions for controlledsubstances in Schedules III, IV, and Vneeded to be in writing or based on anoral order of the physician. Schedule IIdrugs prescriptions could only be in writingor based on an emergency prescriptionorder. Today, a facsimile prescriptionfor a Schedule III, IV, or V drug may serveas the original order.22

Exceptions to the written requirementfor Schedule II also exist today. Theseexceptions are permitted if the faxedprescription is:

1. For a narcotic Schedule II substance,which is to be compounded fordirect administration to a patient byparenteral, intravenous, intramuscular,subcutaneous, or intraspinalinfusion.23

2. For a Schedule II substance for aresident of a long-term care facility(LTCF).24

3. For a patient enrolled in a hospicecertified by Medicare under TitleXVIII or licensed by the state, and ifthe prescription notes that thepatient is a hospice patient.25

Prescription Monitoring Programs

Courts have established that the prescribingof an inordinately large quantityof controlled substances can be evidence of a violation of the CSA. The DEAcan only view such a distribution of controlledsubstances if relevant informationis made available. In 2003, the federalNational All Schedules PrescriptionElectronic Reporting Act was introducedin Congress. The purpose of the act wasto establish an electronic system forpractitioner monitoring of the dispensingof controlled substances in Schedules II,III, and IV. This act would require that certaininformation be reported, such as apatient identifier, drug dispensed, quantitydispensed, as well as the prescriberand the dispenser. Although this federallegislation has not been enacted, manystates have enacted similar legislationrequiring prescription monitoring programs.26 As of August 2005, 22 states hadsuch programs operating, and an additional4 states were in the start-upphase. An additional 21 states are in theprocess of proposing, preparing, or consideringsimilar legislation. The informationrequired of pharmacists may be submittedelectronically. Such programseffectively prevent "doctor shopping"and assist in helping pharmacists identifyprescription forgeries. Whereas statelegislation has been helpful, a nationalelectronic database would be more helpfulin identifying jurisdictional controlledsubstance shopping and regional physiciansbent on abusing prescriptiveauthority privileges.

Verification of DEA PhysicianRegistration Number

The law requires prescribers to includetheir registration number on each controlledsubstance prescription. Determiningthe validity of the number is possible.A DEA registration number is a 9-characternumber consisting of 2 alphabet lettersfollowed by 7 digits. Registrationnumbers for physician practitioners maylegitimately begin with the letters A, B, orC. Registration numbers for mid-levelpractitioners (eg, physician assistants,nurse practitioners) begin with the letterM. The second letter in the registrationnumber is usually, but not always, thefirst letter of the registrant's last name.The next 6 positions represent a computer-generated number unique to each registrant.The final position, or seventhnumber, is a computer-calculated checkdigit or verifying number. To confirm thevalidity of the DEA registration number,the pharmacist should add the first, third,and fifth digits together, then add thesecond, fourth, and sixth digits, multiplyingthat sum by 2. The right-most digit ofthe sum of these 2 calculations will correspondwith the final, or seventh, digit ofa valid number. While this method maybe useful in determining an invalid registrationnumber, an apparently valid registrationnumber cannot be assured asindeed valid. Forgers may be familiarwith this verification process and couldinvent a number that may appear valid.

Schedule II, III, IV, and VPrescription Requirements

Insertion of Corrected or MissingInformation

A pharmacist may change certainitems on a controlled substance prescription,provided that he or she hasreceived authorization from the prescriber.27 Even with the proper authorization,however, documenting his or heractions is imperative for the pharmacist.

After consultation with the prescribingpractitioner, the pharmacist is permittedto add or change the:

  • Dosage form
  • Drug strength
  • Drug quantity
  • Directions for use
  • Issue date

The pharmacist is permitted to makeinformation additions that the patient orbearer provides, such as the patient'saddress, but such additions should beverified. The pharmacist is never permittedto make changes to:

  • The patient's name
  • The controlled substance prescribed(except for generic substitution permittedby state law)
  • The prescriber's signature

Emergency Oral Schedule IIPrescriptions

An emergency situation can permitthe dispensing of a Schedule II drug withoutmeeting the general requirement of awritten prescription. An emergency situationis defined as a situation in which:

  • Immediate administration of thecontrolled substance is necessaryfor the proper treatment of thepatient.
  • No appropriate alternative treatmentis available.
  • Provision of a written prescription tothe pharmacist prior to dispensing isnot reasonably possible for the prescribingphysician.28

In order to comply with the provisionspermitting the pharmacist to fill an oralSchedule II emergency prescription, thepharmacist must meet the requirementsfound in Table 3.

Emergency Schedule IIRequirements

Partial Filling of Schedule IIPrescriptions

The partial filling of a prescription for acontrolled substance listed in Schedule IIis permissible, if the pharmacist is unableto supply the full quantity called for in awritten or emergency oral prescription,and if he or she makes a notation of thequantity supplied on the face of the writtenprescription (or written record of theemergency oral prescription). The remainingportion of the prescription maybe filled within 72 hours of the first partialfilling; however, if the remaining portionis not or cannot be filled within the72-hour period, the pharmacist shall sonotify the prescribing individual practitioner.No further quantity may be suppliedbeyond 72 hours without a newprescription.30

A prescription for a Schedule II controlledsubstance written for a patient inan LTCF or for a patient with a medicaldiagnosis documenting a terminal illnessmay be filled in partial quantities to includeindividual dosage units. If any questionexists as to whether a patient maybe classified as having a terminal illness,the pharmacist must contact the practitionerprior to partially filling the prescription.Both the pharmacist and the prescribingpractitioner have a correspondingresponsibility to ensure that thecontrolled substance is for a terminally illpatient. The pharmacist must record onthe prescription whether the patient is"terminally ill" or an "LTCF patient." A prescriptionthat is partially filled and doesnot contain the notation "terminally ill" or"LTCF patient" shall be deemed to havebeen filled in violation of the act. Foreach partial filling, the dispensing pharmacistshall record on the back of theprescription (or on another appropriaterecord, uniformly maintained, and readilyretrievable) the date of the partial filling,quantity dispensed, remaining quantityauthorized to be dispensed, and theidentification of the dispensing pharmacist.The total quantity of Schedule II controlledsubstances dispensed in all partialfillings must not exceed the total quantityprescribed. Schedule II prescriptionsfor patients in an LTCF or for patientswith a medical diagnosis documenting aterminal illness shall be valid for a periodnot to exceed 60 days from the issuedate unless terminated sooner by thediscontinuance of medication. Informationpertaining to current Schedule II prescriptionsfor patients in an LTCF or forpatients with a medical diagnosis documentinga terminal illness may be maintainedin a computerized system if thissystem has the capability to permit storageand retrieval of significant information.31

Pre-or Postdating Schedule IIPrescriptions

According to the CSA, a prescriptionfor a controlled substance must be datedand signed on the date when issued(Practitioner's Manual). This provision hasbecome a real problem for pharmacistswho receive pre-or postdated ScheduleII prescriptions.A prescription that is preorpostdated refers to the fact that theprescription was either (1) written andsigned on a different date than whenissued or (2) written on the same day asissuance with instructions such as "donot fill until a later date." Under the currentregulations, both of these prescriptionsare invalid and must not be filled bythe pharmacist.

For some patients, obtaining a newprescription each month presentstremendous difficulty. Furthermore,many physicians have expressed concernas to why the stringent regulationswere enacted. As a result, the DEA proposeda new rule on September 6, 2006,that would amend the current regulation.This proposed rule, in part, is providedhere.

Sec. 1306.12 Refilling Prescriptions;Issuance of Multiple Prescriptions

(a) The refilling of a prescription for acontrolled substance listed in Schedule IIis prohibited.

(b)(1) An individual practitioner mayissue multiple prescriptions authorizingthe patient to receive a total of up to a90-day supply of a Schedule II controlledsubstance provided the following conditionsare met:

(i) The individual practitioner properlydetermines there is a legitimate medicalpurpose for the patient to be prescribedthat controlled substance and the individualpractitioner is acting in the usualcourse of professional practice;

(ii) The individual practitioner writesinstructions on each prescription (otherthan the first prescription, if the prescribingpractitioner intends for that prescriptionto be filled immediately) indicatingthe earliest date on which a pharmacymay fill the prescription;

(iii) The individual practitioner concludesthat providing the patient withmultiple prescriptions in this mannerdoes not create an undue risk of diversionor abuse;

(iv) The issuance of multiple prescriptionsas described in this section is permissibleunder the applicable statelaws; and

(v) The individual practitioner compliesfully with all other applicable requirementsunder the act and these regulationsas well as any additional requirementsunder state law.

(2) Nothing in this paragraph (b) shallbe construed as mandating or encouragingindividual practitioners to issue multipleprescriptions or to see their patientsonly once every 90 days when prescribingSchedule II controlled substances.

Rather, individual practitioners mustdetermine on their own, based on soundmedical judgment, and in accordancewith established medical standards,whether it is appropriate to issue multipleprescriptions and how often to seetheir patients when doing so.32

This new rule would permit an individualpractitioner to issue multiple prescriptionsauthorizing the patient toreceive a total of up to a 90-day supply ofa Schedule II controlled substance. Dueto the fact that the public comment periodof 60 days has now concluded, theDEA is responsible for determiningwhether this proposed regulationbecomes law.

Partial Filling of Schedule III, IV, and VPrescriptions

Pharmacists often question the DEArule regarding the partial refilling ofSchedule III, IV, and V prescriptions asstated in Section 1306.23 of the Code ofFederal Regulations. Confusion lies inwhether to consider a partial fill or refillas one fill or as a refill, or if the prescriptioncan be dispensed any number oftimes until the total quantity prescribedis met or 6 months has passed. Accordingto the DEA's interpretation, as long asthe total quantity dispensed meets thetotal quantity authorized and the refillsare dispensed within the 6-month period,the number of refills is irrelevant. Formore information, refer to Table 4.

Transferring of ControlledSubstance Prescriptions

The DEA allows the transfer of originalprescription information for Schedule III,IV, and V controlled substances for thepurpose of refill dispensing betweenpharmacies on a one-time basis if statelaw permits. If pharmacies share a realtime,online database, however, then theprescription may be transferred up to themaximum number of refills permitted bylaw and authorized by the prescriber.Such systems must contain the informationrequired for any valid controlled substanceprescription.

For detailed information required to benoted in the transfer, refer to Table 5.

Records and Inventoriesof Controlled Substances

Reporting Theft or Significant Lossof Controlled Substances

The law requires that pharmaciesreport the theft or significant loss of controlledsubstances immediately upon discoveryto the nearest DEA office andlocal police.35 Such a report is made on aDEA Form 106. The form may either becompleted manually or submitted onlinethrough a secure connection via theInternet to DEA headquarters. The newinteractive form is located at theDiversion Control Program's Web site atwww.deadiversion.usdoj.gov.

Waiver of Employment of ConvictedIndividuals

A pharmacy registrant must notemploy an individual in a position thatwill allow access to controlled substancesif that individual has been convictedof a felony relating to controlledsubstances or has had an application forregistration denied, revoked, or surrenderedfor cause. "For cause" means surrenderinga registration in lieu of, or as aconsequence of, any federal or stateadministrative, civil, or criminal actionresulting from an investigation of theindividual's handling of controlled substances.

Should a pharmacy registrant desire toemploy an individual who meets any ofthe criteria mentioned above, the registrantmust apply for an exception withthe administrator of the DEA. All suchrequests are then sent to the appropriateDEA field office for a thorough investigation.Information the registrant must providein the waiver request includes(1) the circumstances of the employee'sor prospective employee's conviction ofloss/surrender of DEA registration; (2) thestatus of the individual's state licenses;(3) the circumstances surrounding theindividual's access to controlled substances,plus safeguards the registrantintends to implement to guard againstdiversion; and (4) other detailed information,such as board actions, to enable theDEA to make a fair evaluation of thesituation.36

New Laws: CombatMethamphetamine Epidemic Act

In 2006, new requirements of the federalCombat Methamphetamine EpidemicAct passed by Congress for all single-and multi-ingredient pseudoephedrine-and ephedrine-containingproducts became effective. This new lawplaced nonprescription ephedrine, pseudoephedrine,and phenylpropanolamine inthe new CSA category of "scheduled listedchemical products." Products containingthe ingredients listed above aresubject to sales restrictions, storagerequirements, and record-keepingrequirements.

A 3.6-g/day base product sales limit, 9-g/30-day base product purchase limit, ablister package requirement, and mailorderrestrictions went into effect onApril 8, 2006, for all sellers of these products.Logbook requirements went intoeffect on September 30, 2006 (Table 6).

A summary of this act's requirementscan be found on the DEA Web site atwww.deadiversion.usdoj.gov/meth/cma2005.htm.

Conclusion

The CSA of 1970 continues to play animportant role in the day-to-day activitiesof pharmacy practice. As the law continuesto evolve, pharmacists must stayabreast of the many changes that continueto occur. As noted in several casesthat have been brought against pharmacists,ignorance of the law is no defense.Therefore, each and every pharmacistmust be responsible to not only upholdthe dignity and honor of the profession,but furthermore to practice pharmacywithin its legal framework.

Virgil Van Dusen, RPh, JD, Professor of Pharmacy Administration, Southwestern Oklahoma State University, Weatherford, Okla; Alan R. Spies, RPh, MBA, JD, PhD, Assistant Professor of Pharmaceutical, Social, and Administrative Sciences, Samford University, Birmingham, Ala.

Pharmacy Times/Ascend Media Office of Continuing Professional Education is accreditedby the Accreditation Council for Pharmacy Education as a provider of continuing pharmacyeducation. This program is approved for 2.0 contact hours (0.20 CEUs) under the ACPEuniversal program number of 290-000-07-001-H03. The program is available for CE creditthrough February 1, 2010.

References

1. Controlled Substances Act, 21 USC ?801 et seq (2002).

2. Drug Law Enforcement, Executive Order No. 11727, July 6, 1973, 38 FR 18357.

3. Application for Registration (codified at 21 CFR ?1301.13(d)).

4. Registrant Population-Summary. Drug Enforcement Administration Office of Diversion Control Web site. Available at: https://www.deadiversion.usdoj.gov/webforms/jsp/odrReports/odrRegSummaryReport.jsp. Accessed December 6, 2006.

5. Controlled Substances Act, 21 USC ?822c (2002).

6. Oklahoma State Bureau of Narcotics and Dangerous Drugs Control, Title 475: 20-1-5(d) (2001).

7. Application for Registration, 21 CFR ?1301.13(e)(1)(iii).

8. Records for Manufacturers, Distributors, Dispensers, Researchers, Importers and Exporters, 21 CFR ?1304.22(c).

9. Procedure for Obtaining DEA Forms 222 (codified at 21 CFR ?1305.11).

10. Procedure for Obtaining DEA Forms 222 (codified at 21 CFR ?1305.11(b)).

11. Records for Manufacturers, Distributors, Dispensers, Researchers, Importers and Exporters (codified at 21 CFR ?1304.22(c)).

12. Persons Entitled to Order Schedule I and II Controlled Substances (codified at 21 CFR ?1305.04).

13. Requirements for Electronic Orders (codified at 21 CFR ?1305.21).

14. Unaccepted and Defective Electronic Orders (codified at 21 CFR ?1305.25).

15. Purpose of Issue of Prescription (codified at 21 CFR ?1306.04(a)).

16. Controlled Substance Act, 21 USC ?842 (2002).

17. Vermont & 110th Medical Arts Pharmacy v. State Board of Pharmacy, 177 Cal Rptr 807 (Cal App 2d 1981).

18. Pharmacist's Manual, An Information Outline of the Controlled Substances Act of 1970. Drug Enforcement Administration Office of Diversion Control Web site. Available at: www.deadiversion.usdoj.gov/pubs/manuals/pharm2/2pharm_manual.pdf. Accessed December 6, 2006.

19. DEA Policy Statement on Dispensing Controlled Substances for the Treatment of Pain. Drug Enforcement Administration Office of Diversion Control Web site. Available at: www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm. Accessed December 6, 2006.

20. Monitoring the Future. Available at: http://monitoringthefuture.org. Accessed December 6, 2006.

21. 2005 Monitoring the Future Survey Shows Continued Decline in Drug Use by Students [NIDA news release]. December 19, 2005. Available at: www.nih.gov/news/pr/dec2005/nida-19.htm. Accessed December 6, 2006.

22. Requirement of Prescription (codified at 21 CFR ?1306.21(c)).

23. Requirement of Prescription (codified at 21 CFR ?1306.11(e)).

24. Requirement of Prescription (codified at 21 CFR ?1306.11(f)).

25. Requirement of Prescription (codified at 21 CFR ?1306.11(g)).

26. State Prescription Monitoring Programs. Drug Enforcement Administration Office of Diversion Control Web site. Available at: www.deadiversion.usdoj.gov/faq/rx_monitor.htm. Accessed December 6, 2006.

27. General Questions and Answers. Drug Enforcement Administration Office of Diversion Control Web site. Available at: www.deadiversion.usdoj.gov/faq/general.htm. Accessed December 6, 2006.

28. Controlled Drugs (codified at 21 CFR ?290.10).

29. Requirement of Prescription (codified at 21 CFR ?1306.11(d)).

30. Partial filling of prescriptions (codified at 21 CFR ?1306.13(a)).

31. Partial filling of prescriptions (codified at 21 CFR ?1306.13(b)).

32. Issuance of Multiple Prescriptions for Schedule II Controlled Substances. Drug Enforcement Administration Office of Diversion Control Web site. Available at: www.deadiversion.usdoj.gov/fed_regs/rules/2006/fr0906.htm. Accessed December 6, 2006.

33. Partial filling of prescriptions (codified at 21 CFR ?1306.23).

34. Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes (codified at 21 CFR ?1306.25).

35. Other Security Controls for Practitioners (codified at 21 CFR 1301.76(b)).

36. Requests for Waivers. Drug Enforcement Administration Office of Diversion Control Web site. Available at: www.deadiversion.usdoj.gov/faq/waiver_1301_76.htm. Accessed December 6, 2006.

This educational lesson will be available to pharmacists online at www.pharmacytimes.com.(Based on the article starting on page 107) Choose the 1 most correct answer.

1. The Controlled Substances Act(CSA) was enacted into law byCongress in what year?

  • 1961
  • 1970
  • 1971
  • 1973

2. Under the CSA, pharmacies registerwith the Drug EnforcementAdministration (DEA) every ____year(s).

  • 1
  • 2
  • 3
  • 4

3. How many schedules are mandatedby the CSA?

  • 2
  • 3
  • 4
  • 5

4. When ordering Schedule II drugsvia DEA Form 222, which of thetriplicate form(s) is/are sent to thesupplier?

  • Copy 1
  • Copy 2
  • Copy 3
  • Copies 1 and 2

5. For a controlled substance prescriptionto be valid under federallaw, it must be:

  • Issued for a legitimate medicalpurpose.
  • Prescribed by an individualpractitioner acting within theusual course of professionalpractice.
  • Written for no greater than a1-month supply.
  • Both a and b

6. Which of the following are characteristicsof a forged prescription?

  • Prescription is illegible
  • Directions are written withabbreviations
  • Prescription appears to be atextbook presentation
  • Both a and b

7. In any given year, what percentageof physicians lose their controlledsubstances registrationbased on a DEA investigation?

  • Less than 0.01%
  • Less than 0.1%
  • Less than 1%
  • Less than 10%

8. A facsimile may serve as theoriginal prescription for which ofthe following?

  • Schedule II prescription totreat a child's attentiondeficit/hyperactivity disorder
  • Schedule III, IV, or V prescription
  • Both a and b
  • No faxed controlled substanceprescription mayserve as the original.

9. Which of the following DEA numbersare correct for Moe Stooge,MD?

  • AM1234561
  • AS1463253
  • MS1257232
  • AS1387425

10. After consulting the patient'sprescriber, a pharmacist is allowedto change which of the following onthe face of a controlled substanceprescription?

  • The patient's name
  • The prescriber's signature
  • The directions for use
  • Both a and c

11. Within ______ days after authorizingan oral emergency prescription,the prescriber must deliver awritten prescription for the emergencyquantity dispensed to thepharmacist.

  • 3
  • 5
  • 7
  • 10

12. When partially filling a ScheduleII prescription for a patient (assumethat the patient is not "terminallyill" or a long-term care facilitypatient), a pharmacist has up to__________ days to provide theremaining quantity to the patientonce the prescription has beenfilled.

  • 2
  • 3
  • 7
  • 60

13. Under the proposed DEAregulation, a prescriber couldissue up to a _______ supply of aSchedule II medication for a patient.

  • 45-day
  • 60-day
  • 90-day
  • 120-day

14. In what time frame maySchedule III prescriptions, if authorized,be refilled?

  • 3 months
  • 6 months
  • 1 year
  • There is no time requirementfor a Schedule III prescription.

15. When partially filling a ScheduleIV prescription, which of the followingis/are required?

  • No dispensing occurs after12 months following thedate on which the prescriptionwas issued.
  • Each partial filling is recordedin the same manner as arefilling.
  • Both a and b
  • Schedule IV prescriptionsmay not be partially filled.

16. Under federal law, how manytimes may a Schedule III, IV, or Vcontrolled substance be transferredfrom 2 different chain pharmacies?

  • None
  • Once
  • Twice
  • Up to the number of refillsauthorized by the prescriber

17. The pharmacist receiving thetransferred prescription shall writethe word __________ on the face ofthe transferred prescription.

  • Transfer
  • Void
  • Invalid
  • Both a and b

18. Which DEA form is used bypharmacists to report theft or loss?

  • DEA Form 222
  • DEA Form 41
  • DEA Form 106
  • DEA Form 224

19. Which of the following product(s) is/are included in the newCSA category of "scheduled listedchemical products"?

  • Phenylpropanolamine
  • Pseudoephedrine
  • Ephedrine
  • All of the above

20. Under the Combat MethamphetamineEpidemic Act, the selleris required to maintain which of thefollowing in the logbook?

  • Purchase price
  • Purchaser's date of birth
  • Name of pharmacy
  • Time of the sale

TESTING AND GRADING PROCEDURES

  • Each participant achieving a passing grade of 70% or higher on any examination will receive a statement of credit giving the number of CE credits earned. This form should be safeguarded and may be used as documentation of credits earned.
  • Participants receiving a failing grade on any exam will be notified and permitted to take 1 reexamination at no extra cost.
  • All answers should be recorded on the answer form attached. For each question, decide which choice is the best answer, and circle the letter of the response representing your choice.
  • Mail your completed exam form to the following address: Pharmacy Times, 405 Glenn Drive, Suite 4, Sterling, VA 20164-4432.

NEW SCORING OPTIONS

  • Mail
  • Fax: 703-404-1801
  • Phone-in: 800-899-6350 (9 AM-5 PM ET, Mon.-Fri.)
  • This lesson is FREE on-line; receive instant grading, and download your certificate?www.pharmacytimes.com.