Keywords Controlled Substances Act (CSA), Drug Enforcement Administration (DEA), controlled substance.

CHAPTER PHARMACIST RESPONSIBILITIES IN THE MANAGEMENT OF CONTROLLED SUBSTANCES (1 CONTACT HOUR) By Brad Gillespie, PharmD who has over 20 years experience spanning the regulatory, pharmaceutical biotech and human nutritional supplement industries. Author Disclosure: Bradley Gillespie and Elite Professional Education do not have any actual or potential conflicts of interest in relation to this lesson. Universal Activity Number (UAN): 0761-9999-13-221-H01-P Activity Type: Application-based Initial Release Date: July 2, 2013 Expiration Date: July 2, 2015 Target Audience: Pharmacists in a community-based setting. To Obtain Credit: A minimum test score of 70 percent is needed to obtain a credit. Please submit your answers either by mail, fax, or online at pharmacy.elitecme.com. Questions regarding statements of credit and other customer service issues should be directed to 1-888- 666-9053. This lesson is $4.00. Educational Review Systems is accredited by the Accreditation Council of Pharmacy Education (ACPE) as a provider of continuing pharmaceutical education. This program is approved for 1 hour (0.1 CEU s) of continuing pharmacy education credit. Proof of participation will be posted to your NABP CPE profile within 4 to 6 weeks to participants who have successfully completed the post-test. Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit. Abstract Objective To increase pharmacist awareness about the requirements necessary to remain compliant with the federal Controlled Substance Act. Summary As practicing pharmacists, it is critical that we remain totally aware and compliant with all of the laws governing our practice. Because dispensing controlled substances is a major part of our work, and because they are susceptible to abuse, it is critical that we are well versed in all applicable laws governing the role of pharmacists in safely administering controlled substances to patients. Conclusion Evolving national trends in the abuse of controlled substances and the development of new regulations to combat this practice have created an ever-changing clinical practice environment as well as laws to govern it. It is critical that all practicing pharmacists understand how controlled substances are scheduled by the Controlled Substance Act and their responsibilities in ensuring that these potentially dangerous medications are managed throughout the prescribing system. Keywords Controlled Substances Act (CSA), Drug Enforcement Administration (DEA), controlled substance. Learning objectives After the pharmacist has concluded this knowledge-based activity, he or she will be qualified and able to: Understand the role of the Drug Enforcement Administration in regulating the use of controlled Appreciate the importance of a controlled system of distribution to best manage transactions involving controlled Develop a general understanding of how to schedule controlled Become familiar with the appropriate DEA forms needed to document the transaction of controlled Describe the requirements of both electronic and paper-based controlled substance record keeping systems. Understand the requirements for inventorying controlled Understand that there are requirements for Internet pharmacies dispensing controlled substances that are unique and apart from those needed to dispense non-controlled Pre-assessment questions Before beginning this activity, test your precourse knowledge by answering the following questions. Please be aware that these questions will also be included as part of the CPE final examination. 1. Jim Walters, PharmD, has completed his residency in community practice and is preparing to open his own pharmacy. Before he can begin to dispense controlled substances in his pharmacy, he will need to complete which of the following tasks? 2. When opening the pharmacy one morning, Jennifer Carlson, RPh, is horrified to find that the window of the front door to the store was broken, and that the lock had been forcibly opened. When she entered the actual pharmacy area, she was further distressed to find that the shelves had been ransacked, and it appeared that a number of units of anabolic steroids, narcotics and benzodiazepines were missing. In addition to calling the local police authorities, Jennifer will also be required to do which of the following: a. File DEA Form 106 within one business day with the DEA. d. Complete full interviews with all employees to rule out their involvement. 3. Davies Community Pharmacy is preparing for its biennial inventory of controlled While Steen Davies, PharmD, has an idea of how this should be conducted, there are a few key things that he should keep in mind when completing this important count of all controlled Some of things that he should think about when planning the specifics of the inventory include which of the following? substances, regardless of bottle size, is c. All documents created summarizing the inventory must be stored for a period of at least five years. inventory of controlled substances must be stored together to facilitate their simple retrieval. Introduction This course is designed to provide an overview of the Controlled Substances Act and allow practicing pharmacists the opportunity to test their knowledge by evaluating relevant case studies and applying information they have learned in this course to answer questions specific to those cases. This course is not designed to cover all situations. A more detailed and exhaustive program would be required to cover all eventualities that may be encountered by a pharmacist navigating the Controlled Substances Act. Further to that, this course covers only federal law. Pharmacists must also be familiar with the requirements laid out by their respective state pharmacy laws. What is the DEA, and what is the purpose of the Controlled Substances Act (CSA)? In 1973, the Drug Enforcement Administration (DEA) was formed. Its role was primarily to enforce all federal drug laws. The Controlled Substances Act (CSA) and associated regulations formed its backbone, implementing federal requirements governing the disposition of both legal and illicit drugs. In the context of pharmacy, the DEA has two major jobs: prevention of the diversion and abuse of controlled substances and at the same time, ensuring that the supply of legal controlled substances remain available to meet legitimate needs for these drugs. To carry out this important mission, DEA works hand-in-hand with state, local and other federal authorities. Key concepts Within the confines of the CSA, it is critical that all transactions involving controlled substances occur within a closed system of distribution. Within this controlled loop, all entities authorized to touch controlled substances manufacturers, distributors, doctors, and pharmacies must hold the proper DEA registration applicable to their practice. Further, all parties must maintain a strict accounting for all transactions, and maintain Elite Page 1

their records in such a way that they are kept separate from other documents and are readily retrievable. 1 Scheduling Substances that fit under the CSA are currently divided into five schedules based on whether they have an acceptable medical use and their relative potential for abuse and likelihood of causing dependence. Schedule I: Schedule I drugs either have no currently medically acceptable use or have a high potential for abuse. Schedule 1 substances include: MPPP, heroin, marijuana, LSD and methaqualone. Additionally, some materials can be temporarily included in Schedule I subject to emergency scheduling. 2 Schedule II: Substances categorized as schedule II all have a high potential for abuse. Further to that, the use of these drugs can lead to severe psychological or physical dependence. Schedule II drugs include codeine, morphine, cocaine, amphetamine, methylphenidate and phenylacetone. 3 Schedule III: Substances in this schedule generally are considered to have a potential for abuse less than substances listed in schedules I or II. The abuse of these drugs may lead to moderate or low physical dependence or high psychological dependence. Schedule II drugs include chlorphentermine; secobarbital; products containing not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit with one or more active, nonnarcotic ingredient in recognized therapeutic amounts; and anabolic steroids. 4 Schedule IV: Compared to substances categorized in schedule II and III, substances in schedule IV have a low potential for abuse or dependence. Schedule IV items include preparations containing not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit, alprazolam, fenfluramine, pentazocine and sibutramine. 5 Schedule V: Compared to substances categorized into schedules I, II, III and IV, substances in this schedule have a low potential for abuse and consist primarily of preparations containing limited quantities of certain narcotics. In most cases, preparations appearing in schedule V are used for their antitussive, antidiarrheal and analgesic properties. Examples of Schedule V products include preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams, pyrovalerone and ezogabine. 6 Registration requirements Before any controlled substances can be dispensed by a pharmacy, that pharmacy needs to be registered with the DEA. This is accomplished online 7 A certificate of this registration must be publically displayed at each pharmacy. This registration must be renewed every three years using DEA Form 224a. 8 Page 2 Transfer or disposal of controlled substances If a pharmacy should ever need to transfer or dispose of controlled substances to another properly registered facility, this transaction must be documented. These records must be maintained and kept available for inspection by DEA for a period of two years. For the transfer of schedule II products, a DEA Form 222 must be completed. 9 For Schedule III-V controlled substances, the transfer must be documented, including the drug name, dosage form, strength, quantity and date transferred. Additionally, the document must include the names, addresses, and DEA registration numbers of all parties involved in the transfer. How to manage a significant loss or theft of controlled substances The theft of a controlled substance is a criminal event that must be reported to the police and DEA within one business day. Should there be any question of whether a crime has occurred, pharmacists should err on the side of conservatism and report the event. 1 The theft of a controlled substance is documented using DEA Form 106. This documentation will describe the actual circumstances of the diversion and include all relevant details. 10 Prescription records Should the pharmacy determine there is a conflict between the requirements of federal and state requirements for record keeping, the pharmacy will need to develop a filing system that complies with both federal and state law. Regardless of the filing system chosen, all prescriptions and supporting documents need to be stored in a way that makes them readily retrievable for DEA inspection. If a paper-based system is used, all schedule II prescriptions must be kept separate from all other documents. 1 The requirements governing the use of electronic prescriptions for controlled substances are outlined in 21 C.F.R. 1311. Briefly, all electronic records must be maintained for two years (although this time requirement does not preempt any longer periods of retention that may be required by other applicable laws or regulations). The electronic system must allow the records to be separated from other prescriptions and must be easily rendered into a readable format. Lastly, prescription records must be sortable by prescriber name, patient, drug and date dispensed. 11 Controlled substances inventory requirements An inventory is a comprehensive and accurate count of all controlled substances on hand. This accounting will be based on an actual count of schedule II controlled substances and a reasonable estimate of schedule III-V controlled substances (except in case of containers holding 1,000 or more dosage units, in which case an actual count is required). The CSA dictates that all inventory records be maintained for at least two years. Schedule II inventory records must be kept separate from all other inventory documents. When are inventories required? At the time of initial DEA registration. Biennially (every two years following initial inventory). For newly scheduled controlled substances, they must be completed as of the effective date of scheduling or change in schedule.1 Ordering controlled substances Only schedule II controlled substances require a specific ordering protocol. DEA Form 222 is required on each occasion that a schedule II controlled substance is distributed, purchased or transferred between properly registered facilities. 9 For schedule III-V controlled substances, pharmacists are required to maintain an invoice or packing slip stating the date that the products were received and confirmation of the order s accuracy. Additionally, these receipts must also document the name of the controlled substance, the formulation, the number of dosage units, and the total number of containers received. These receipts must be maintained using a system that allows them to be readily retrieved for inspection by DEA. 1 Prescription requirements The basic elements for a controlled substance prescription do not vary greatly from those needed for any other prescription based on the CSA, although states may have their own laws governing the prescription of these products. With that said, pharmacists must be cognizant of their responsibility to ensure that every prescription they fill is legitimate within the meaning and intent of the CSA. If a pharmacist has any doubt about the authenticity or validity of a prescription, he or she is under no obligation to fill it. 12 To the contrary, any pharmacist who knowingly fills a questionable prescription for a controlled substance is committing a felony offense. 13 The use of electronic prescriptions for controlled substances is permitted only after their system has obtained a third party audit or certification review, determining that the application meets DEA requirements. Refills are not permitted for schedule II controlled Up to five refills may be obtained for a schedule III-V controlled substances within six months of issuance of the original prescription. 1 Dispensing requirements Labeling requirements for controlled substances are generally the same as for other prescription medications. When actually dispensing, though, controlled substances may be received only by the actual patient or a member of the patient s household. Schedule II controlled substances may be dispensed only pursuant to a written prescription, except in cases of a bona fide emergency, in which case the prescription can be transmitted to the pharmacy telephonically. In this case, the prescriber must provide a written prescription to the pharmacy within seven days. Prescriptions for schedule III-V controlled Elite

substances can be delivered by paper, facsimile, orally or electronically, so long as they meet the DEA requirements for such prescriptions. 1 The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 Amended the CSA by including a number of new provisions designed to prevent the illegal distribution and dispensing of controlled substances over the Internet. This act, designed to counteract rogue Internet sites, applies to all controlled Under this act, it is illegal to deliver, distribute or dispense a controlled substance by means of the Internet unless the online pharmacy holds a modified DEA registration authorizing it to operate as an online pharmacy. Operating counter to this act is in violation of 21 U.S.C. 841(h)(1) and subject to potential criminal prosecution. 14 The information contained in this section above is included only as a brief summary. A full description of the requirement of this act is beyond the scope of this course. Pharmacists and pharmacies needing more complete and comprehensive information describing the act should access the actual text of the CSA and DEA regulations. Controlled Substance Act scenarios Scenario 1 Winter Pharmacy is preparing a record keeping system to account for the acquisition, storage and dispensing of controlled To accomplish this within the guidelines set out by the Controlled Substances Act, its owners wisely choose to design a closed system. Critical elements of this inventory control system will include which of the following? a. For sake of simplicity, make sure that all prescriptions (non-controlled and controlled substances) are filed in a single location. b. Maintain a strict accounting of all transactions of controlled c. Ensure that only the pharmacy has the proper DEA registration permits. d. None of the above. Answer: To comply with all provisions of the CSA, any pharmacy that dispenses controlled substances must operate within the confines of a closed system. In essence, this means that every entity that comes into contact with the controlled substance must be properly licensed, registered, and follow proper guidelines. One such guideline stipulates that all involved parties, including Winter Pharmacy, must provide a comprehensive and thorough accounting of all transactions involving controlled Further, all documents on controlled substances must be kept separate and readily retrievable from other records. Scenario 2 Jim Walters, PharmD, has completed his residency in community practice and is preparing to open his own pharmacy. Before he can begin to dispense controlled substances in his pharmacy, he will need to complete which of the following tasks: Answer: Although many procedures must be followed to properly open a pharmacy, if that pharmacy chooses to dispense controlled substances, the CSA requires that additional tasks must also be completed. The first task for Dr. Walters is to properly register his pharmacy with the DEA, After he receives this registration, the certificate indicating his registration needs to be prominently displayed in the pharmacy. In order to procure schedule II controlled substances, Dr. Walters must do so using DEA Form 222. This form is not required for acquiring schedule III-V controlled Scenario 3 After Dr. Walters has been in business for some time, he realizes that due to poor inventory control, he has a number of dosages of oxycodone that have reached their expiry date and are thus not suitable for sale to patients. In response to this finding, Dr. Walters should: a. Mail them back to his wholesaler without documentation. b. Discard the expired pills in an approved refuse receptacle. c. Complete DEA Form 222 and transfer to a properly licensed facility (page 4). d. Contact the manufacturer to request an extension on the expiry date. Answer: The CSA makes it clear that any change in disposition of schedule II controlled substances, including oxycodone, needs to be documented using DEA Form 222. To either return to the wholesaler without documentation or simply discard the doses would be a clear violation of the CSA. It would not be appropriate for Dr. Walters to request an extension on the expiry date. To move these schedule II controlled substances from his inventory, the only legal way to accomplish this, is to send them to another properly licensed facility. This transaction will need to be appropriately documented using DEA Form 222. Scenario 4 When opening the pharmacy one morning, Jennifer Carlson, RPh, is horrified to find that the window of the front door to the store was broken, and that the lock had been forcibly opened. When she entered the actual pharmacy area, she was further distressed to find that the shelves had been ransacked, and it appeared that a number of units of anabolic steroids, narcotics and benzodiazepines were missing. In addition to calling the local police authorities, Jennifer will also be required to which of the following: a. File DEA Form 106 within one business day with the DEA. d. Complete full interviews with all employees to rule out their involvement. Answer: While there may be a number of business-related responses to a theft of controlled substances that Jennifer may elect to accomplish, the CSA is clear that a DEA Form 106 needs to be filed with DEA within one business day. DEA Form 106 describes the circumstances and details of the theft. Although items b, c and d, may be reasonable responses, they are not mandated by the CSA. Scenario 5 Mammoth Lakes Community Pharmacy, in an effort to create greater levels of patient safety and improve efficiencies, is considering replacing its antiquated paper record keeping system with a state-of-theart electronic system. Unfortunately, the pharmacy manager, Jim Edwards, PharmD, finds that the more vendors he speaks to, the more confused he gets about the requirements of such a system. Whichever system Mammoth Lakes ends up using, it is critical that it addresses which of the following key elements? a. The selected system complies only with federal DEA regulations, as these supersede state laws. b. The system should simplify its approach to filing by making sure that all prescriptions for controlled substances remain together. c. To comply with DEA regulations, all schedule II prescriptions need to be maintained in a readily retrievable state for a period of at least two years. d. None of the above elements are needed. Answer: Electronic pharmacy data systems can be complex, creating confusion for the people who need to select an appropriately designed system. Nonetheless, whether a paper, or electronic structure is employed, the CSA is clear that prescriptions for all schedule II controlled substances need to be kept separate from other documents in a readily retrievable state for no less than two years. Further to that, systems need to be designed to be compliant with all laws, both state and federal. Scenario 6 Davies Community Pharmacy is preparing for its biennial inventory of controlled While Steen Davies, PharmD, has an idea of how this should be conducted, there are a few key things that he should keep in mind when completing this important count of all controlled Some of things that he should think about when planning the specifics of the inventory include which of the following? Elite Page 3

Page 4 substances, regardless of bottle size, is c. All documents created summarizing the inventory must be stored for a period of at least five years. inventory of controlled substances must be stored together to facilitate their simple retrieval Answer: The inventorying of all controlled substances is critical to maintaining compliance with the CSA. Exact counts are required only for schedule II controlled substances and other controlled substances in bottles containing 1,000 or more dosage units. All documents must be maintained for at least two years, with schedule II records kept separate from the others. Scenario 7 Kim Maxon, PharmD, the pharmacist in charge of Arrow Community Pharmacy, is working with her pharmacy technician to prepare its regular medication order. In addition to non-controlled substances, this order will also call for a number of medications that are categorized as schedule III-V, as well as for some ADHD medications, which fall under schedule II. To complete the submission and receipt of this order, Kim will need to ensure that which of the following tasks is accomplished? a. All of the ADHD medications will need to be ordered using DEA Form 222. b. DEA Form 222 will need to be completed, including all of the controlled c. For the schedule III-V controlled substances, Kim is required to maintain an invoice or packing slip stating the date that the products were ordered from the wholesaler. d. The receipts or invoices that are included with the shipment must be accounted for and signed by Dr. Maxon, as she is the pharmacist in charge Answer: According to ordering provisions laid out in the CSA, all orders for schedule II controlled substances will need to be made using DEA Form 222. The other controlled substances can be ordered using regular order forms. The CSA does not require that receipts or invoices documenting the orders are signed for by the pharmacist in charge, but does require that the receipt date is noted on the invoice and that it is filed in a way that they can be readily retrieved by DEA. Scenario 8 Lawrence Campbell, RPh, is nearing the end of his shift at the Eagle Community Pharmacy when a man approaches the prescription drop-off area. The well-dressed man presents a prescription to Lawrence for a total of 30 10-milligram oxycodone tablets. While at first glance, the prescription appears legitimate, upon closer examination, Lawrence notes that the patient s name is slightly smeared. To try to validate the prescription, Lawrence asks the man why he was being prescribed the medication. The customer hesitates slightly, and then, without making eye contact, states that it is for back pain. Based on these series of events, the best initial approach to managing this situation is for Mr. Campbell to: a. Dispense the medication. b. Contact the prescribing physician to verify the prescription. c. Detain the customer and call the police. d. Ask the customer whether the prescription is authentic. Answer: Lawrence was wise to question the validity of the prescription. Based on the response to his additional inquiry, the patient gave the impression that there may be a problem with the authenticity of the prescription. Based on this, Lawrence had an obligation to ensure that the prescription was genuine before filling it. The proper next steps are subjective, but there are some basic ideas to keep in mind when considering this situation. Dispensing the prescription under these circumstances would be wrong, and a potential violation of the CSA. Detention of the patient, and calling the police, may be appropriate, but is likely not the best initial approach. The best tactic would be to simply contact the physician who allegedly wrote the prescription and ask him or her to verify that it is bona fide. Scenario 9 Jeanna Andrew, pharmacist in charge of Century City Pharmacy, is putting together a list of special requirements specific to the dispensing of schedule II controlled Some of the key elements that must be discussed in her checklist include which of the following? a. The transfer of schedule II substances must be documented using DEA Form 222. b. Schedule II inventory records must be kept separate from all other pharmacy documents. c. If schedule II substances are dispensed under an emergency situation without a written prescription, a paper prescription from the prescriber must be provided to the dispensing pharmacy within seven days. Answer: The CSA is especially clear on the guidelines for handling schedule II controlled All changes in disposition of schedule II controlled substances must be documented using DEA Form 222. Regular inventorying of schedule II controlled substances is also required, and resultant documents must be kept separate from all other pharmacy records in an easily retrievable state. While telephonic emergency prescriptions for schedule II controlled substances are allowed in some circumstances, it is incumbent on the prescribing physician to provide a supportive written prescription within seven days. Scenario 10 James Gilbert, PharmD is realizing his career goals by establishing a large, Internet-based pharmacy. He believes that by opening this service, he can provide excellent service to his customers at competitive prices because of the efficiencies of scale and reduced overhead costs. In addition to regulations and laws governing all pharmacies, though, he should be especially concerned with the rules included in which of the following acts? a. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008. b. The Consumer Protection Act. c. The 1962 Kefauver Harris Amendment. d. The 1952 Durham-Humphrey Amendment. Answer: To remain current and relevant, the CSA was amended in 2008 to more closely govern the dispensing of controlled substances over the Internet. Under the provisions of this act, it is illegal to sell controlled substances over the Internet without proper DEA registration (in addition to the requirements of traditional pharmacies). The acts identified in items b, c and d, while important to pharmacy practice, in general, are not as closely aligned with the dispensing of controlled substances over the Internet as that described in item a. References 1. U.S. Department of Justice (2010). Pharmacist s Manual: An Informational Outline of the Controlled Substances Act. Accessed online 26 May 2013 at: http://www. deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf 2. Code of Federal Regulations (2013). 1308.11. Accessed online 26 May 2013 at http:// 3. Code of Federal Regulations (2013). 1308.12. Accessed online 26 May 2013 at http:// 4. Code of Federal Regulations (2013). 1308.13. Accessed online 26 May 2013 at http:// 5. Code of Federal Regulations (2013). 1308.14. Accessed online 26 May 2013 at http:// 6. Code of Federal Regulations (2013). 1308.15. Accessed online 26 May 2013 at http:// 7. U.S. Department of Justice: Drug Enforcement Administration (2013). DEA Form 224. Accessed online 26 May 2013 at: http://www.deadiversion.usdoj.gov/drugreg/ reg_apps/224/224_instruct.htm 8. U.S. Department of Justice: Drug Enforcement Administration (2013). DEA Form 224a. Accessed online 26 May 2013 at: http://www.deadiversion.usdoj.gov/fed_regs/ notices/2009/fr08212.htm 9. U.S. Department of Justice: Drug Enforcement Administration (2013). DEA Form 222. Accessed online 26 May 2013 at: http://www.deadiversion.usdoj.gov/faq/dea222.htm 10. U.S. Department of Justice: Drug Enforcement Administration (2013). DEA Form 106. Accessed online 26 May 2013 at: http://www.deadiversion.usdoj.gov/21cfr_ reports/theft/ 11. U.S. Department of Justice: Drug Enforcement Administration (2013). Part 1311 digital certificates- Subpart C electronic prescriptions. Accessed online 26 May 2013 at: http://www.deadiversion.usdoj.gov/21cfr/cfr/1311/subpart_c100.htm 12. U.S. Department of Justice: Drug Enforcement Administration (2013). Title 21 United States Code (USC) Controlled Substances Act: Section 829. Prescriptions. Accessed online 26 May 2013 at: http://www.deadiversion.usdoj.gov/21cfr/21usc/829. htm 13. United States v. Kershman, 555 F.2d 198 (United States Court Of Appeals, Eighth Circuit, 1977). Accessed on 26 May 2013 line at: https://bulk.resource.org/courts. gov/c/f2/555/555.f2d.198.76-2075.html 14. Department Of Justice, Drug Enforcement Administration. 21 CFR Parts 1300, 1301, 1304, 1306, Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (2008). Accessed on 26 May 2013 line at: http://www.deadiversion.usdoj. gov/fed_regs/rules/2009/fr0406.pdf (Final examination questions on next page) Elite

PHARMACIST RESPONSIBILITIES IN THE MANAGEMENT OF CONTROLLED SUBSTANCES Final Examination Questions Choose the best answer for questions 1 through 5 and mark your answers online at pharmacy.elitecme.com. 1. Critical elements of a closed inventory control system will include which of the following? a. For sake of simplicity, make sure that all prescriptions (non-controlled and controlled substances) are filed in a single location. b. Maintain a strict accounting of all transactions of controlled c. Ensure that only the pharmacy has the proper DEA registration permits. d. None of the above. 5. What is one of the inventory requirements of the inventory of controlled substances? substances, regardless of bottle size is c. All documents created summarizing the inventory must be stored for a period of at least five years. inventory of controlled substances must be stored together to facilitate their simple retrieval. 2. Before a new pharmacy can begin dispense controlled substances, which task must the pharmacy complete? 3. If a pharmacy should ever need to transfer or dispose of controlled substances to another properly registered facility, the pharmacy must: a. Mail back the controlled substances without documentation. b. Discard the expired pills in an approved refuse receptacle. c. Complete DEA Form 222 and transfer to a properly licensed facility. d. Contact the manufacturer to request an extension on the expiry date. 4. According to the Controlled Substance Act, what is the procedure when a theft of a controlled substance occurs? a. Report to the police and file DEA Form 106 within one business day with the DEA. d. Complete full interviews with all employees to rule out their involvement. RPUS01PRE13 Elite Page 5