An Overview and Update of the Controlled Substances Act of 1970

Author: Virgil Van Dusen, RPh, JD & Alan R. Spies, RPh, MBA, JD, PhD

Behavioral Objectives

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

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

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

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


The Congress of the United States enacted into law the Controlled Substances Act (CSA) as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970.1 The CSA serves as the legal foundation of the government's fight against drugs of abuse. This law consolidates numerous laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances.

The major purpose of the CSA, however, was to enable the United States to comply with the requirements of 2 international treaties. These treaties, the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances, set a system for classifying controlled substances in several schedules in accordance with binding scientific and medical findings of a public health authority. In the United States, that authority rests with the Secretary of Health and Human Services (HHS).

The Drug Enforcement Administration (DEA) carries out the enforcement of the CSA. Established in 1973, the DEA is the federal agency responsible for the implementation of regulations related to the CSA.2 It replaced what was known at the time as the Bureau of Narcotics and Dangerous Drugs (BNDD). Currently, the DEA is a unit of the Federal Bureau of Investigation within the Department of Justice. Although the federal BNDD has been eliminated, many states continue to have their own drug enforcement agency, with laws similar to federal statutes and regulations and known by the same name.

Registration

In enacting the CSA, Congress restricted access to controlled substances to those registered to manufacture, distribute, or dispense such products. Making application on an appropriate form to the US Attorney General provides registration. Pharmacies, as dispensers, currently register for a period of 3 years.3 The DEA divides the registrant population among retail and wholesale lines, which includes more than 1 million total registrants. For more information, see Table 1.

Whereas the goal of the CSA may be to limit access to controlled substances and ensure accountability of certain drugs, exemptions do exist for registration. The most notable exemption relating to the practice of pharmacy is pharmacists employed by a registered pharmacy or institution. The exemption is universal in that every pharmacy that handles controlled substances must be registered, which in turn provides the automatic exemption for the pharmacist who works for such a pharmacy.

Although federal provisions give some exemptions, the individual states may remove such exemptions. For example, a manufacturer's representative who handles controlled substance samples may be exempt from registration under federal requirements.5 A state may require registration and accountability, however, under either statutory or regulatory provisions.6

Identification and Classification of Controlled Substances

The CSA places all regulated substances under existing federal law into one of 5 schedules. This classification is based on the substance's medical value, harmfulness, and potential for abuse or addiction. Schedule I is reserved for the most dangerous drugs that have no recognized medical use, and Schedule V is the classification used for the least dangerous drugs. Dispensing pharmacies should never possess a Schedule I drug.7 The CSA provides a mechanism for substances to be controlled, added to a schedule, removed from a schedule, or rescheduled. This mechanism requires initiation by the DEA, by the HHS, or by petition from any interested party. These interested parties may include the manufacturer of a drug, a medical society or association, a pharmacy association, a public interest group concerned with drug abuse, a state or local government agency, or an individual citizen. When the DEA receives a petition, the agency begins its own investigation of the drug, which includes a request to the HHS for a scientific and medical evaluation regarding whether the drug should be controlled or removed from control. This recommendation on scheduling is binding only to the extent that, if the HHS recommends that the substance not be controlled, the DEA may not control the substance.

Obtaining Controlled Substances by Pharmacies

Pharmacies may receive or transfer controlled substances to or from other registrants only by means of an invoice. This invoice creates a record of transfer, which the CSA requires. This record must contain (1) the name of the controlled substance, (2) the dosage form, (3) the strength or concentration of the dosage unit, and (4) the number of dosage units per commercial container. Additionally, the receipt record by the pharmacy to obtain the controlled substance must include the number of commercial containers received, the date of receipt, and the name, address, and DEA registration number of the supplier.8 A commercial invoice serves as a record of receipt for Schedules III, IV, and V drugs as long as the document contains required information.

DEA Form 222

Schedule II drugs may be obtained by the use of a DEA Form 222.9 Obtaining DEA Form 222 initially occurs when a DEA registrant files an application for registration and asks for such forms by checking the appropriate box on the application. Subsequent order forms may be obtained by submitting DEA Form 222(a) to the registration branch of the DEA.10 DEA Form 222 is a triplicate form; the pharmacy keeps the third copy, which must contain a notation of the number of commercial containers received and the date of receipt.11 Pharmacists must send copies 1 and 2 of the triplicate form to the supplier, who then forwards copy 2 to the DEA. Unusually large purchases of certain kinds of Schedule II controlled substances may trigger a drug accountability audit by the DEA.

Electronic Orders for Controlled Substances

On April 1, 2005, the DEA issued a final rule that provides an electronic equivalent to DEA Form 222. New regulations now allow, but do not require, registrants to order Schedule II substances electronically and to maintain the records of these orders electronically.12 To be valid, the purchaser must sign an electronic order for a Schedule II controlled substance with a digital signature issued to the purchaser (or the purchaser's agent) by the DEA and must complete data fields that are found blank on the electronic order.13 Leaving data fields empty will require the supplier to reject the order and notify the purchaser of the rejection.14 Unique to this type of electronic order is that a purchaser may include controlled substances that are not in Schedule II as well as noncontrolled substances. To learn more about the electronic ordering of controlled substances, view the DEA Web site located at www.deaecom.gov.

Validity of Controlled Substance Prescriptions

To be valid, a controlled substance prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.15 Should a pharmacist knowingly fill a purported prescription not issued in the usual course of professional treatment, then that pharmacist is subject to penalties provided for violations relating to controlled substances.16 Whereas the prescribing practitioner may be held responsible for issuing a bogus controlled substance prescription, a corresponding responsibility and resulting criminal liability rests with the pharmacist who fills such a prescription. Pharmacists have been found guilty based on circumstantial evidence of prescription legitimacy.17 The DEA has published a guide to help pharmacists determine whether controlled substance prescriptions are being issued for a legitimate medical purpose (Table 2). Additional guidelines may be found at www.deadiversion.usdoj.gov/pubs/ brochures/pharmguide.htm.

DEA Policy Statement on Pain Treatment

On September 6, 2006, the DEA issued a policy statement regarding the dispensing of controlled substances for the treatment of pain.19 Although this policy primarily addresses physicians, the DEA also holds pharmacists to the same standard as referenced earlier?a registered physician acting within the usual course of professional practice must issue a prescription for a legitimate medical purpose. A recent survey conducted by the University of Michigan of 8th, 10th, and 12th graders indicated that, while a general decline in drug use has occurred, high rates of nonmedical use of prescription medications continue, especially opioid pain killers.20 For example, in 2005, 9.5% of 12th graders reported using Vicodin (hydrocodone) in the past year, and 5.5% of these students reported using OxyContin (oxycodone) in the past year.21 Before pharmacists become overly concerned about dispensing controlled substances for pain control, they should note that the treatment of pain with controlled substances is unquestionably a legitimate medical purpose. The overwhelming majority of physicians who prescribe controlled substances do so in a legitimate manner that will never warrant investigation by federal or state law enforcement officials. Reports indicate that in any given year, including 2005, fewer than 1 of every 10,000 physicians in the United States (<0.01%) lose their controlled substance registrations based on a DEA investigation of improper prescribing. The majority of these cases in which physicians lose their DEA registrations result from actions by state medical boards to revoke or suspend the physician's state medical license. In recent years, many state medical boards have developed guidelines for the proper use and prescribing of controlled substances for pain control.

Facsimile Prescriptions

When the CSA first came into existence, valid prescriptions for controlled substances in Schedules III, IV, and V needed to be in writing or based on an oral order of the physician. Schedule II drugs prescriptions could only be in writing or based on an emergency prescription order. Today, a facsimile prescription for a Schedule III, IV, or V drug may serve as the original order.22

Exceptions to the written requirement for Schedule II also exist today. These exceptions are permitted if the faxed prescription is:

1. For a narcotic Schedule II substance, which is to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion.23

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

3. For a patient enrolled in a hospice certified by Medicare under Title XVIII or licensed by the state, and if the prescription notes that the patient is a hospice patient.25

Prescription Monitoring Programs

Courts have established that the prescribing of an inordinately large quantity of controlled substances can be evidence of a violation of the CSA. The DEA can only view such a distribution of controlled substances if relevant information is made available. In 2003, the federal National All Schedules Prescription Electronic Reporting Act was introduced in Congress. The purpose of the act was to establish an electronic system for practitioner monitoring of the dispensing of controlled substances in Schedules II, III, and IV. This act would require that certain information be reported, such as a patient identifier, drug dispensed, quantity dispensed, as well as the prescriber and the dispenser. Although this federal legislation has not been enacted, many states have enacted similar legislation requiring prescription monitoring programs.26 As of August 2005, 22 states had such programs operating, and an additional 4 states were in the start-up phase. An additional 21 states are in the process of proposing, preparing, or considering similar legislation. The information required of pharmacists may be submitted electronically. Such programs effectively prevent "doctor shopping" and assist in helping pharmacists identify prescription forgeries. Whereas state legislation has been helpful, a national electronic database would be more helpful in identifying jurisdictional controlled substance shopping and regional physicians bent on abusing prescriptive authority privileges.

Verification of DEA Physician Registration Number

The law requires prescribers to include their registration number on each controlled substance prescription. Determining the validity of the number is possible. A DEA registration number is a 9-character number consisting of 2 alphabet letters followed by 7 digits. Registration numbers for physician practitioners may legitimately begin with the letters A, B, or C. Registration numbers for mid-level practitioners (eg, physician assistants, nurse practitioners) begin with the letter M. The second letter in the registration number is usually, but not always, the first letter of the registrant's last name. The next 6 positions represent a computer- generated number unique to each registrant. The final position, or seventh number, is a computer-calculated check digit or verifying number. To confirm the validity of the DEA registration number, the pharmacist should add the first, third, and fifth digits together, then add the second, fourth, and sixth digits, multiplying that sum by 2. The right-most digit of the sum of these 2 calculations will correspond with the final, or seventh, digit of a valid number. While this method may be useful in determining an invalid registration number, an apparently valid registration number cannot be assured as indeed valid. Forgers may be familiar with this verification process and could invent a number that may appear valid.

Schedule II, III, IV, and V Prescription Requirements

Insertion of Corrected or Missing Information

A pharmacist may change certain items on a controlled substance prescription, provided that he or she has received authorization from the prescriber.27 Even with the proper authorization, however, documenting his or her actions is imperative for the pharmacist.

After consultation with the prescribing practitioner, the pharmacist is permitted to add or change the:

The pharmacist is permitted to make information additions that the patient or bearer provides, such as the patient's address, but such additions should be verified. The pharmacist is never permitted to make changes to:

Emergency Oral Schedule II Prescriptions

An emergency situation can permit the dispensing of a Schedule II drug without meeting the general requirement of a written prescription. An emergency situation is defined as a situation in which:

  1. Immediate administration of the controlled substance is necessary for the proper treatment of the patient.
  2. No appropriate alternative treatment is available.
  3. Provision of a written prescription to the pharmacist prior to dispensing is not reasonably possible for the prescribing physician.28

In order to comply with the provisions permitting the pharmacist to fill an oral Schedule II emergency prescription, the pharmacist must meet the requirements found in Table 3.

Emergency Schedule II Requirements

Partial Filling of Schedule II Prescriptions

The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription, and if he or she makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.30

A prescription for a Schedule II controlled substance written for a patient in an LTCF or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If any question exists as to whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to ensure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the act. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in an LTCF or for patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless terminated sooner by the discontinuance of medication. Information pertaining to current Schedule II prescriptions for patients in an LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit storage and retrieval of significant information.31

Pre-or Postdating Schedule II Prescriptions

According to the CSA, a prescription for a controlled substance must be dated and signed on the date when issued (Practitioner's Manual). This provision has become a real problem for pharmacists who receive pre-or postdated Schedule II prescriptions.A prescription that is preor postdated refers to the fact that the prescription was either (1) written and signed on a different date than when issued or (2) written on the same day as issuance with instructions such as "do not fill until a later date." Under the current regulations, both of these prescriptions are invalid and must not be filled by the pharmacist.

For some patients, obtaining a new prescription each month presents tremendous difficulty. Furthermore, many physicians have expressed concern as to why the stringent regulations were enacted. As a result, the DEA proposed a new rule on September 6, 2006, that would amend the current regulation. This proposed rule, in part, is provided here.

Sec. 1306.12 Refilling Prescriptions; Issuance of Multiple Prescriptions

(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.

(b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:

(i) The individual practitioner properly determines there is a legitimate medical purpose for the patient to be prescribed that controlled substance and the individual practitioner is acting in the usual course of professional practice;

(ii) The individual practitioner writes instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill the prescription;

(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;

(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and

(v) The individual practitioner complies fully with all other applicable requirements under the act and these regulations as well as any additional requirements under state law.

(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances.

Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.32

This new rule would permit an individual practitioner to issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance. Due to the fact that the public comment period of 60 days has now concluded, the DEA is responsible for determining whether this proposed regulation becomes law.

Partial Filling of Schedule III, IV, and V Prescriptions

Pharmacists often question the DEA rule regarding the partial refilling of Schedule III, IV, and V prescriptions as stated in Section 1306.23 of the Code of Federal Regulations. Confusion lies in whether to consider a partial fill or refill as one fill or as a refill, or if the prescription can be dispensed any number of times until the total quantity prescribed is met or 6 months has passed. According to the DEA's interpretation, as long as the total quantity dispensed meets the total quantity authorized and the refills are dispensed within the 6-month period, the number of refills is irrelevant. For more information, refer to Table 4.

Transferring of Controlled Substance Prescriptions

The DEA allows the transfer of original prescription information for Schedule III, IV, and V controlled substances for the purpose of refill dispensing between pharmacies on a one-time basis if state law permits. If pharmacies share a realtime, online database, however, then the prescription may be transferred up to the maximum number of refills permitted by law and authorized by the prescriber. Such systems must contain the information required for any valid controlled substance prescription.

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

Records and Inventories of Controlled Substances

Reporting Theft or Significant Loss of Controlled Substances

The law requires that pharmacies report the theft or significant loss of controlled substances immediately upon discovery to the nearest DEA office and local police.35 Such a report is made on a DEA Form 106. The form may either be completed manually or submitted online through a secure connection via the Internet to DEA headquarters. The new interactive form is located at the Diversion Control Program's Web site at www.deadiversion.usdoj.gov.

Waiver of Employment of Convicted Individuals

A pharmacy registrant must not employ an individual in a position that will allow access to controlled substances if that individual has been convicted of a felony relating to controlled substances or has had an application for registration denied, revoked, or surrendered for cause. "For cause" means surrendering a registration in lieu of, or as a consequence of, any federal or state administrative, civil, or criminal action resulting from an investigation of the individual's handling of controlled substances.

Should a pharmacy registrant desire to employ an individual who meets any of the criteria mentioned above, the registrant must apply for an exception with the administrator of the DEA. All such requests are then sent to the appropriate DEA field office for a thorough investigation. Information the registrant must provide in the waiver request includes (1) the circumstances of the employee's or prospective employee's conviction of loss/surrender of DEA registration; (2) the status of the individual's state licenses; (3) the circumstances surrounding the individual's access to controlled substances, plus safeguards the registrant intends to implement to guard against diversion; and (4) other detailed information, such as board actions, to enable the DEA to make a fair evaluation of the situation.36

New Laws: Combat Methamphetamine Epidemic Act

In 2006, new requirements of the federal Combat Methamphetamine Epidemic Act passed by Congress for all single- and multi-ingredient pseudoephedrine- and ephedrine-containing products became effective. This new law placed nonprescription ephedrine, pseudoephedrine, and phenylpropanolamine in the new CSA category of "scheduled listed chemical products." Products containing the ingredients listed above are subject to sales restrictions, storage requirements, and record-keeping requirements.

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

A summary of this act's requirements can be found on the DEA Web site at www.deadiversion.usdoj.gov/meth/ cma2005.htm.

Conclusion

The CSA of 1970 continues to play an important role in the day-to-day activities of pharmacy practice. As the law continues to evolve, pharmacists must stay abreast of the many changes that continue to occur. As noted in several cases that have been brought against pharmacists, ignorance of the law is no defense. Therefore, each and every pharmacist must be responsible to not only uphold the dignity and honor of the profession, but furthermore to practice pharmacy within 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 accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is approved for 2.0 contact hours (0.20 CEUs) under the ACPE universal program number of 290-000-07-001-H03. The program is available for CE credit through 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 by Congress in what year?

  1. 1961
  2. 1970
  3. 1971
  4. 1973

2. Under the CSA, pharmacies register with the Drug Enforcement Administration (DEA) every ____ year(s).

  1. 1
  2. 2
  3. 3
  4. 4

3. How many schedules are mandated by the CSA?

  1. 2
  2. 3
  3. 4
  4. 5

4. When ordering Schedule II drugs via DEA Form 222, which of the triplicate form(s) is/are sent to the supplier?

  1. Copy 1
  2. Copy 2
  3. Copy 3
  4. Copies 1 and 2

5. For a controlled substance prescription to be valid under federal law, it must be:

  1. Issued for a legitimate medical purpose.
  2. Prescribed by an individual practitioner acting within the usual course of professional practice.
  3. Written for no greater than a 1-month supply.
  4. Both a and b

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

  1. Prescription is illegible
  2. Directions are written with abbreviations
  3. Prescription appears to be a textbook presentation
  4. Both a and b

7. In any given year, what percentage of physicians lose their controlled substances registration based on a DEA investigation?

  1. Less than 0.01%
  2. Less than 0.1%
  3. Less than 1%
  4. Less than 10%

8. A facsimile may serve as the original prescription for which of the following?

  1. Schedule II prescription to treat a child's attentiondeficit/ hyperactivity disorder
  2. Schedule III, IV, or V prescription
  3. Both a and b
  4. No faxed controlled substance prescription may serve as the original.

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

  1. AM1234561
  2. AS1463253
  3. MS1257232
  4. AS1387425

10. After consulting the patient's prescriber, a pharmacist is allowed to change which of the following on the face of a controlled substance prescription?

  1. The patient's name
  2. The prescriber's signature
  3. The directions for use
  4. Both a and c

11. Within ______ days after authorizing an oral emergency prescription, the prescriber must deliver a written prescription for the emergency quantity dispensed to the pharmacist.

  1. 3
  2. 5
  3. 7
  4. 10

12. When partially filling a Schedule II prescription for a patient (assume that the patient is not "terminally ill" or a long-term care facility patient), a pharmacist has up to __________ days to provide the remaining quantity to the patient once the prescription has been filled.

  1. 2
  2. 3
  3. 7
  4. 60

13. Under the proposed DEA regulation, a prescriber could issue up to a _______ supply of a Schedule II medication for a patient.

  1. 45-day
  2. 60-day
  3. 90-day
  4. 120-day

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

  1. 3 months
  2. 6 months
  3. 1 year
  4. There is no time requirement for a Schedule III prescription.

15. When partially filling a Schedule IV prescription, which of the following is/are required?

  1. No dispensing occurs after 12 months following the date on which the prescription was issued.
  2. Each partial filling is recorded in the same manner as a refilling.
  3. Both a and b
  4. Schedule IV prescriptions may not be partially filled.

16. Under federal law, how many times may a Schedule III, IV, or V controlled substance be transferred from 2 different chain pharmacies?

  1. None
  2. Once
  3. Twice
  4. Up to the number of refills authorized by the prescriber

17. The pharmacist receiving the transferred prescription shall write the word __________ on the face of the transferred prescription.

  1. Transfer
  2. Void
  3. Invalid
  4. Both a and b

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

  1. DEA Form 222
  2. DEA Form 41
  3. DEA Form 106
  4. DEA Form 224

19. Which of the following product(s) is/are included in the new CSA category of "scheduled listed chemical products"?

  1. Phenylpropanolamine
  2. Pseudoephedrine
  3. Ephedrine
  4. All of the above

20. Under the Combat Methamphetamine Epidemic Act, the seller is required to maintain which of the following in the logbook?

  1. Purchase price
  2. Purchaser's date of birth
  3. Name of pharmacy
  4. Time of the sale

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