2024 Illinois and Federal Pharmacy Law Review 2.15.24.pdf

2024 Illinois and Federal Pharmacy Law Review Pharmacylaw.net 1547 Warren Avenue Downers Grove, IL 60515 [email protected]...

2024 Illinois and Federal Pharmacy Law Review Pharmacylaw.net 1547 Warren Avenue Downers Grove, IL 60515 [email protected] www.pharmacylaw.net Presented by: Edward D. Rickert, B.S. Pharm., J.D. Section 1 Pharmacy Law Review – Main Handout Section 2 Practice Exam Questions Section 3 Federal Poison Prevention Packaging Act Section 4 Federal Health Insurance Portability and Accountability Act (“HIPAA”) Section 5 USP and Updates © 2024 GD Keats, Inc. dba Pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  SECTION 1 PHARMACY LAW REVIEW Main Handout © 2024 GD Keats, Inc. dba Pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  SECTION ONE GENERAL EXAM INFORMATION MPJE® Registration Bulletin has information about the exam. Much of the following information comes from that bulletin: https://nabp.pharmacy/programs/examinations/mpje/ Information about applying for the examination: https://nabp.pharmacy/programs/examinations/mpje/ Time allotment - 2.5 hours You will be given 3 hours from the time you sit at the computer to allow for time to read and agree to the confidentially/non-disclosure agreement, tutorial, and post-exam survey. o Getting comfortable with the format: There is a computerized tutorial that will let you get used to the computer and exam question format at the beginning. This DOES NOT count in your allotted time - take your time to use this to get comfortable with the equipment and exam question format. o No breaks – use the bathroom before you start the test. Materials available at Exam Location: The administrator will provide you with an erasable note board and pen. You may not remove these materials from the testing room at any time. Using your own scratch paper or pen is prohibited. No reference, study, or other materials or devices may be brought into the testing center. Calculator – No longer provided on computer for MPJE®. Cannot bring your own. The NABP bulletin states that a calculator is not required for the MPJE®, and if a candidate requests a calculator, it will NOT be provided. If there are calculations on MPJE® you will need to perform them the old- fashioned way. 120 questions o 100 will be used to produce a score and 20 will be non-scored pretest items. Pretest questions are scattered throughout the exam and are not identified. o You must answer all questions in the order presented; no skipping questions and you cannot change any answers once you have confirmed your answer and moved to the next question. o Penalty applied if you do not complete the exam:  To receive an MPJE® test score, you must have completed at least 107 questions on the examination. Candidates completing fewer than 107 questions will not have their scores reported.  Candidates who complete at least 107 questions, but fewer than 120 questions, will have a penalty applied and their scores adjusted to reflect the number of questions that remained unanswered. Therefore, it is in the candidate’s best interest to answer all questions presented. Except in rare circumstances the questions will draw no distinction made between federal law and state law. Rather, you will be required to answer questions based on the prevailing law in your jurisdiction. Scaling: Some questions may be "weighted" more heavily, but you will not be able to identify these. You need to score "75" to pass. This is a “scaled” score and does not mean 75% - you may pass with less than 75%, and may not with more than 75%. Depends on how questions are weighted. “Pharmacy Practice” questions are likely given greater weight. o NOTE: Your final score will not be provided to you; it will be reported only as "pass" or "fail". Adaptive Format - “Adaptive" = computer selects questions for each candidate based on candidate's ability level (your prior answers). If you answer a question correctly, the computer selects a more 3 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  difficult question; if you answer incorrectly, an easier question is selected. The number of questions answered correctly and the difficulty level are factored into the scoring DO NOT try to attempt to figure out if the questions are getting easier/harder. This will not help you; it will only distract you. Remember, the exam is based on your ability level - you will likely not be able to detect a difference! Answering questions: You'll be able to practice this in the tutorial before the real exam starts. Select; submit; confirm. Once you confirm an answer, you cannot change it! You will not be able to go back and change answers to your questions as you take the exam. AREAS COVERED ON EXAM (COMPETENCY STATEMENTS) Effective for Exams beginning March 2023 Area 1 — Licensure/Personnel (Approximately 22% of the Exam) 1.1 – Responsibilities of the pharmacist and non-pharmacist personnel: Qualifications, scope of duties, limitations and restrictions of duties, or conditions to practice for pharmacists-in-charge (or equivalent) and pharmacists Qualifications, scope of duties, limitations, and restrictions of duties, or conditions to practice for non- pharmacist personnel 1.2 – Licensures, registrations, and certifications for pharmacists or non-pharmacist personnel: Qualifications, examinations, internships, maintaining pharmacist competency, and renewals of licensures, registrations, or certifications Classifications and processes of disciplinary actions Reporting to and participating in programs addressing the inability to practice with reasonable skill and safety Area 2 — Pharmacist Practice (Approximately 33% of the Exam) 2.1 – Requirements for issuing prescriptions/drug orders: Requirements for drug uses, limitations, or restrictions Scope of authority, scope of practice, limitations or restrictions of practice, and valid registration of practitioners who are authorized to prescribe, dispense, or administer drugs Requirements for issuing non-controlled prescriptions/drug orders Requirements for issuing controlled prescriptions/drug orders Authority limitations of practitioners’ ability to authorize refills 2.2 – Conditions under which the pharmacist or non-pharmacist personnel participates in the administration of drugs in the management of patients’ therapy 2.3 – Requirements regarding counseling: Counseling or offering to counsel Documenting counseling or documenting offering to counsel 2.4 – Returning or reusing drugs 2.5 – Regulations and agencies regarding pharmacy practice: Requirements for promoting quality and safety of public health Protecting patient and health record confidentiality Area 3 — Dispensing Requirements (Approximately 24% of the Exam) 3.1 – Responsibilities for determining whether prescriptions/drug orders are issued for a legitimate medical purpose and within all applicable restrictions 3.2 – Transferring prescription/drug order information between pharmacies by authorized personnel 3.3 – Prospective drug utilization reviews: Requirements for reporting to PMP and accessing PMP data 3.4 – Exceptions to dispensing or refilling prescriptions/drug orders 3.5 – Labeling of dispensed drugs 3.6 – Packaging of dispensed drugs 3.7 – Drug product conditions prohibiting dispensing 3.8 – Requirements for the distribution and/or dispensing of non-prescription pharmaceutical products, including controlled substances and hazardous drugs: Dispensing or administration 4 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  Labeling of non-prescription drugs and devices Packaging and repackaging of non-prescription drugs and behind-the-counter products Dispensing restricted, non-prescription drugs Area 4 — Pharmacy Operations (Approximately 21% of the Exam) 4.1 – Ordering, acquisition, and distribution of drugs, including maintenance and content of such records: Ordering and acquisition, including the maintenance and content of such records Distribution, including the maintenance and content of such records 4.2 – Recordkeeping in compliance with legal requirements, including content, inventory, maintenance, storage, handling, and reporting: Non-dispensing requirements for operations of pharmacies or practice settings Possession, storage, and handling of non-hazardous drugs Training, possession, handling, storage, and disposal of hazardous drugs Allowing non-pharmacist personnel access to drugs Requirements for conducting controlled substance inventories 4.3 – Delivery of drugs 4.4 – Conditions for permitted or mandated product selection 4.5 – Compounding sterile, nonsterile, hazardous, and non-hazardous preparations 4.6 – Centralized prescription processing or central-fill pharmacy dispensing 4.7 – Requirements for the registration, licensure, certification, or permitting of a practice setting or business entity: Requirements for registration, license, certification, or permitting of a practice setting Requirements for the renewal or reinstatement of a license, registration, certificate, or permit of a practice setting Requirements for an inspection of a licensed, registered, certified, or permitted practice setting Classifications and processes of disciplinary actions that may be taken against a registered, licensed, certified, or permitted practice setting Exam Format (Directly from MPJE® Bulletin) – Revised as of 1-1-2023 Basic multiple choice: How many total continuing pharmacy education hours are required to be completed upon the second renewal of a pharmacist’s license in this jurisdiction? A. 15 B. 20 C. 25 D. 30 E. 40 Multiple Response: Which of the following medications are classified as Schedule II controlled substances in this jurisdiction? (Select ALL that apply.) A. Strattera B. Lisdexamfetamine C. Meprobamate D. Pemoline E. Dexmethylphenidate Multiple-Choice, K-type Item (added to NABP Bulletin in 2023) 5 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  For which state is the Cardinal named as the state bird? I. Kentucky II. Indiana III. Montana A. I B. II C. III D. I and II Ordered Response Question Format (removed from NABP Bulletin in 2023, but may still be on exam): Place the following in the order in which they would expire according to federal regulations, starting with the earliest. (ALL options must be used.) 1 Left-click the mouse to highlight, drag, and order the answer options. Unordered Options Ordered Response 1. A partially filled methylphenidate prescription for a patient not in a long-term care facility 2. A phoned-in, emergency oxycodone prescription 3. A written bupropion prescription 4. An electronic pemoline prescription 5. A partially filled morphine prescription for patient in a long-term care facility 1 Answer: 1 (72 hours under state law/30 days under federal law), 2 (7 days), 5 (60 days), 4 (180 days), 3 (365 days). GENERAL TIPS FOR SUCCESS The exam has many "pharmacy practice" questions that are geared more towards retail pharmacy. “Pharmacy practice” questions may be weighed more heavily. Review the following: o For drugs that are available both OTC and Rx-only, you should know what strengths are OTC and which are RX-only. o You must be familiar with the names (brand and generic) and schedules of controlled substances. For non-controlled substances, know brand and generic names of commonly prescribed drugs. o Expect some off-the-wall questions that you cannot answer. Answer to the best of your ability and move on! Use common sense! Examples of “off-the-wall” questions: o How are poisons and alcohol regulated? o How long after a doctor dies can you continue to refill an otherwise refillable prescription? o If there is a fire in the front end of your pharmacy, but the flames do not reach the prescription department, are the drugs there (a) misbranded, (b) adulterated, (c) both, (d) neither? o Who is best suited to deliver a prescription to a patient in their home? (a) pharmacist, (b) technician, (c) cab driver, (d) non-pharmacist/non-technician clerk employed by the pharmacy. You must pick the BEST answer, even when there is more than one "good" choice, and even when none of the choices make sense. Do NOT overanalyze questions. They really are NOT trying to trick you. Take the exam seriously. Begin studying early. Use the Competency Statements as your guide to which areas to 6 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION focus most of your efforts. There is no penalty for guessing, but make educated guesses. Begin studying early – do not wait until the last minute. 7 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  ILLINOIS AND FEDERAL CONTROLLED SUBSTANCES ACTS The state and federal controlled substances acts regulate the manufacture, distribution, dispensing and delivery of controlled substances. The Drug Enforcement Administration (“DEA”) is the federal agency responsible for enforcing controlled substances laws. The Department of Human Services, Office of Alcoholism and Substance Abuse and the Department of Financial and Professional Regulation are the Illinois agencies responsible for monitoring and enforcement of the Illinois act. Suggested Reading: Pharmacist’s Manual Access at https://www.deadiversion.usdoj.gov/; click on “Resources”; then “Publications and Manuals”; then “Manuals”; then “Pharmacist’s Manual (available in both html and pdf formats) Also a good idea to review general “Q&A” page on DEA website. There is also a list of all federal scheduled controlled substances, information about forms, applications, and other useful information available on the site. Controlled substances are regulated by both Federal and State Laws If state law and federal law overlap, state law must be more stringent to be valid. (e.g. Illinois Controlled Substance Act) One notable “exception” is “Medical Marijuana ("MMJ")”; if there are questions on MMJ on the exam, MMJ is still considered a schedule I controlled substance under federal law. Note: questions on the MPJE® should be answered with the prevailing law in your jurisdiction. For the Illinois MPJE®, answer the question as though you are practicing pharmacy in Illinois. For example: o Federal law permits persons 18 years old or older to purchase certain liquid cough and cold preparations containing codeine (referred to as “exempt narcotics”) without a prescription. In Illinois, the purchaser must be at least 21 years old. Illinois law is more stringent. If the exam asks “In your jurisdiction, how old must a patient be to purchase exempt narcotics without a prescription”, and the choices are “a. 21 years old, b. 18 years old, c. 25 years old d. 16 years old, e. none of the above”, the correct answer is “a.” If you selected “b”, and sold the exempt narcotic to an 18 year old patient, you would violate Illinois law. You wouldn’t want to do that, would you? Drug Enforcement Administration (DEA) is part of the Department of Justice (DOJ) 1970 – Controlled Substances Act (CSA) Also known as Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 Gave FDA authority to determine the scheduling of controlled substances Repealed earlier laws and created a comprehensive approach to preventing drug abuse 1973 – Creation of the DEA by Department of Justice. Removed Scheduling responsibility from the FDA Provided the DEA with the following functions associated with CSA: Interpretation: Implementation; Enforcement; Development of regulations Exam Tip: Another mistake students sometimes make is to apply federal law even when federal law is wholly irrelevant. Remember that DEA only regulates federally scheduled controlled substances. For all other drugs, federal law is irrelevant. Federal recordkeeping, security, inventory, loss reporting, storage, prescribing, prescription requirements, prescription expiration and refill rules, etc., apply only to drugs that are scheduled as controlled substances under federal law. 8 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION Registration and Scheduling – Cornerstones of the “Closed System of Distribution”; the Closed System of Distribution means: (1) the drug substances themselves are scheduled, and (2) all persons with lawful access are registered. Access to controlled substances are restricted through REGISTRATION and SCHEDULING. Scheduling: Substances that have the potential for abuse, or can cause addiction, are scheduled into one of 5 schedules. Note that the laws of some states add additional schedules. Illinois law follows federal law, and has 5 schedules that correspond to the federal schedules. Registration: All who come in contact with controlled substances must be registered (or in some cases employed by a registered entity) with the exception of the patient that has a legitimate medical need for the medication, and accesses it through a valid prescription. Once a scheduled substance leaves the “closed system”, it cannot re-enter. o Example: - A manufacturer makes Vicodin, which it sells to a distributor. The distributor sells the product to the pharmacy. The pharmacy receives a prescription from a doctor. The manufacturer, distributor, pharmacy and prescriber are all registered with the DEA. The Vicodin prescription is filled by the pharmacy and dispensed to the patient. The patient is NOT registered with the DEA. The patient can access the medication only because s/he has a valid prescription. If a patient no longer wants the Vicodin, s/he can return it to the pharmacy only under very limited circumstances. Another example: A controlled substance is purchased from a wholesale drug distributor (“WDD”) that has an expired DEA registration. During the time that the drug was possessed by an unlicensed WDD, it was no longer in the closed system of distribution. The pharmacy should not accept the product. Returning Controlled Substances to a Pharmacy Question: What happens if the patient no longer needs the medication – can it be returned to the pharmacy?? Answer: No!!! When it is dispensed to the patient, it leaves the closed distribution network. It cannot re-enter that closed network. Exception: DEA regulations permit a CS can be returned to the pharmacy when: (1) There has been dispensing error, and the improperly dispensed CS is brought back to the pharmacy; (2) There has been a recall of the drug; or (3) The pharmacy elects to register as an authorized collector of controlled substances by amending its existing registration to add this additional category. See, http://www.deadiversion.usdoj.gov/faq/prescriptions.htm (accessed 2/14/2019). Note that in these situations, the pharmacy can take the drug back, but obviously cannot re-dispense it. Exam Tip: Only Manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies are permitted to be an authorized collector. Physicians and other practitioners, hospitals without a pharmacy, and clinics without a pharmacy cannot be an authorized collector of controlled substances. To qualify for registration as an authorized collector, the registrant must be registered to handle schedule II controlled substances. There are two permissible methods for an authorized collector to take back controlled substances: (1) maintaining collection receptacles and (2) administering mail-back programs. In addition, the regulations allow authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. 9 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION The new regulations do not require a particular method of destruction, so long as the desired result is achieved. Pharmaceutical controlled substances must be rendered “non-retrievable” in compliance with all applicable Federal, State, tribal and local laws. This standard is intended to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances. “Non-retrievable” means the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance’s physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes. A controlled substance is considered “non-retrievable” when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. Collection by Law Enforcement Agencies – In addition to Authorized Collectors, law enforcement agencies are permitted to take back controlled substances. No DEA registration is required for the law enforcement agency. DEA Take Back programs: From time to time throughout the year, DEA sponsors “National Prescription Take Back Days”. It partners with local law enforcement to encourage patients to bring unused controlled substances to law enforcement for proper disposal. Exam Tip: Patients are not required to bring controlled substances to an authorized collector or to law enforcement for destruction. They are permitted to destroy substances themselves. Registration Every person or firm that manufactures, distributes, dispenses (including prescribing and administering), conducts instructional activities with, exports, imports or conducts narcotic maintenance or detoxification programs with controlled drugs must register with federal DEA unless exempted under law or regulations. Classifications - eleven (11) categories, grouped by activity: (1) manufacturer; (2) distributor; (3) dispenser (C-II thru C-V); (4) research; other than narcotic treatment program (C-II thru C-V); (5) instructional activities (C-II thru C-V); (6) narcotic treatment programs (C-II thru C-V); (7) research with C-I substances; (8) chemical analysis; (9) importer; (10) exporter (C-I thru C-IV); and (11) compounding by mixing, preparing, packaging or changing dosage form of C-II thru C-V narcotic for use in maintenance or detoxification by another narcotic treatment program. (“detox compounder”) For MPJE® purposes, the most important categories are: (1) manufacturer; (2) distributor; (3) dispenser (C-II thru C-V); (4) narcotic treatment program; and (5) detox compounder. That is because these are the types of registrations a pharmacy may be required to obtain, depending on its activities. Exam Tip: Note that a “dispenser” registration is the type of registration that is issued to a doctor or mid-level practitioner who “prescribes” a controlled substance. There is no such thing as a “prescriber” registration. Note – The Illinois and DEA registration can be limited by schedule. In other words, a practitioner can have a DEA registration for just CIII, IV and V substances. It can also be limited by drug class (narcotic versus non- narcotic). An application for controlled substance registration is divided into the following categories: II narcotic II non-narcotic III narcotic III non-narcotic IV V Exam Tip: A dispenser may voluntarily limit his/her registration, by selecting only certain schedules when completing the DEA registration application or renewal. In addition, the DEA may limit a dispenser's registration. This occurs when the DEA believes that continued registration in all categories is 10 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  inconsistent with the public interest. Exam Tip: In practice, pharmacists, physicians and other health care professionals sometimes refer to all CIIs as "narcotics". That is not correct. Narcotics are a limited subgroup of controlled substances. Under federal law, a "narcotic" means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis: (1) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium. (2) Poppy straw and concentrate of poppy straw. (3) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine and derivatives of ecgonine or their salts have been removed. (4) Cocaine, its salts, optical and geometric isomers, and salts of isomers. (5) Ecgonine, its derivatives, their salts, isomers and salts of isomers. (6) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in paragraphs (1) through (5) of this definition. Illinois defines a "narcotic" exactly the same way as the federal law. Applying for a DEA Registration Applicant for a Controlled Substance Registration: The applicant must be an owner, active partner, or any corporate officer. May assign, by power of attorney, another person to sign orders for purchases of controlled drugs. When an entity applies for the registration, the registration form is signed by the “owner”. The “owner” is: The “sole proprietor” if the entity is a sole proprietorship (i.e., “Joe’s Pharmacy” – Joe completes the form). Partnership – Any partner is the owner, and can complete the form (i.e., “Joe and Flo’s Pharmacy” – either Joe or Flo can complete the form.) Corporation – Any Officer or Director of the corporation can complete the form. The person who completes the form (i.e., the owner) is referred to as the “registrant”. The entity that receives the registration is also called the “registrant”. Power of Attorney ("POA") – Method for delegating responsibility to another person at the store level. The POA is an important concept. The POA is used to provide authority to execute federal order forms to obtain schedule II controlled substances. Exam Tip: The POA can be assigned to anyone - not just pharmacists, including non-pharmacist owners, technicians, pharmacy interns (students), and even unlicensed persons. However, read exam questions carefully, because it is always preferable (even if not legally required) that only pharmacists order controlled substances. 21 CFR §1305.05 Power of attorney. (a) A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant's behalf by executing a power of attorney for each such individual. The POA is maintained on-site at the registered location with executed Forms 222 where applicable, for the same period as any order 11 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  bearing the signature of the attorney. The power of attorney must be available for inspection together with other order records. (b) A registrant may revoke any power of attorney at any time by executing a notice of revocation. (c) The power of attorney and notice of revocation must be similar to the following format: Power of Attorney for DEA Forms 222 and Electronic Orders (Name of registrant) (Address of registrant) (DEA registration number) I, (name of person granting power), the undersigned, who am authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these presents, do make, constitute, and appoint (name of attorney-in-fact), my true and lawful attorney for me in my name, place, and stead, to execute applications for Forms 222 and to sign orders for Schedule I and II controlled substances, whether these orders be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part 1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney must lawfully do or cause to be done by virtue hereof. (Signature of person granting power) I, (name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature. (signature of attorney-in-fact) Witnesses: 1. 2. Signed and dated on the day of , (year), at. Notice of Revocation The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or the Controlled Substances Import and Export Act. Written notice of this revocation has been given to the attorney-in-fact this same day. (Signature of person revoking power) Witnesses: 1. 2. Signed and dated on the day of , (year), at. (d) A power of attorney must be executed by 1: (1) The registrant, if an individual; a partner of the registrant, if a partnership; or an officer of the registrant, if a corporation, corporate division, association, trust or other entity; (2) The person to whom the power of attorney is being granted; and (3) Two witnesses. (e) A power of attorney must be revoked by the person who signed the most recent application for DEA registration or reregistration, and two witnesses. (f) A power of attorney executed under this section may be signed electronically, by any or all of the persons required to sign. Exam Tip: The power of attorney is not submitted to DEA. It MUST be retained at the pharmacy and available to DEA if requested. Pharmacy Registration: Pharmacies register as a dispenser of controlled substances. One registration covers dispensing of all C-II thru C-V substances. Employee pharmacist need not obtain separate registration. Exam Tip: If RPh has prescribing authority, s/he will need to have his/her own individual DEA number (because s/he is not dispensing under the pharmacy registration, but is making an independent prescribing decision). Pharmacists do not have prescribing authority in Illinois, but in other states, a pharmacist with controlled substance prescriptive authority would register as a mid-level practitioner. Pharmacies and other dispensers register with DEA Form 224 for initial registration, and DEA 224a for renewal. Renewal is every 3 years. 1Prior to September 2019, the POA could be issued by any person authorized to sign an application for a DEA registration. The regulation was changed in 2019 to make it clear that only the registrant can issue the POA. 12 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  Separate registration needed for each pharmacy owned or operated by same entity. Exam Tip: Neither federal nor Illinois law require the applicant or the person with POA to be pharmacist. However, under state law, the ordering, securing and dispensing of controlled substances is responsibility of PIC, regardless of whether the PIC is the registrant, and regardless of whether the PIC has POA. Hospital registrations: Hospitals register “institutional practitioners”. This registration is issued to the entire hospital, allowing controlled substances to be stored anywhere in the registered location, and to give employee practitioners, nurses, pharmacists the authority to possess, prescribe, dispense, and administer controlled substances. A separate registration for pharmacy is not required; pharmacy is permitted to use the institutional dispenser registration issued to hospital. An institutional practitioner registration is also available to clinics that are licensed under state law. A doctor employed by a hospital can, in some limited circumstances, use the hospital’s registration to prescribe to the hospital’s patients. This will be discussed in greater detail below. Multiple Registration Requirement – A separate registration is required for each: (1) Location: A registration is required for each site with different street address Example: A chain pharmacy may have thousands of pharmacies, all owned by the same corporation. Each pharmacy location has its own DEA number, even though all locations share the same owner. (2) Activity: For each activity, even if all activity is occurring at a single site. (see below for discussion of activities that trigger need for multiple registrations at a single location). Example: single pharmacy could be required to have multiple DEA numbers, depending on its activities (i.e., it needs a dispenser’s registration to dispense, but would need a separate detox compounder registration if it compounded and provided product to a narcotic treatment program. Activities that Trigger Multiple Registrations 1. Pharmacy as Distributor - Pharmacy must register as a controlled substances distributor if: It participates in joint buying activities, and is the location from which drugs are stored and shipped to other pharmacies; or Its annual distribution of controlled substances to other pharmacies or practitioners exceeds five percent (5%) of the total number of dosage units dispensed. 2. Pharmacy as Manufacturer – Pharmacy must register as a controlled substances distributor if: It purchases of controlled substances for purposes of repackaging for sale within the pharmacy without a prescription or to other registrants requires registration as a manufacturer. It compounds for office use, if permitted under state law. (Note: Office use compounding is considered to be manufacturing, and is NOT permitted, so this "exception" no longer has validity.) Exam Tip: Remember that if a practitioner orders a controlled substance for office administration by issuing a patient specific prescription, the pharmacy is acting as a dispenser when it fills that order. Accordingly, a dispenser registration is all that is required. 3. Pharmacy as “DETOX COMPOUNDER” - Pharmacy must register as a “detox compounder” if: It compounds a controlled substance product for sale or distribution to a narcotic treatment program for purposes of addiction treatment. Note that the NTP must be registered with DEA. Do not confuse registration requirement for detox compounders with office use compounders! Manufacturers/wholesalers/importers/exporters/researchers register with DEA Form 225, and renew with 225a. Renewal is every 3 years. Same multiple registration rules apply. Denial or Revocation of Registration DEA may deny registration if the Applicant has: 13 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  Materially falsified information in application; Been convicted of a drug-related felony; Committed such acts as to make registration inconsistent with the public interest; or Has had its state license suspended, revoked or denied. DEA may revoke registration for same reasons, and in addition: Where applicant has been subject to mandatory exclusion from participation in the Medicare or any state health care program. Illinois registration requirements: Some states, including Illinois, require a separate state controlled substance registration, in addition to the DEA registration, and in addition to the pharmacy or other practitioner's state professional license. 2 Exam Tip: If asked what type of license a pharmacy in your jurisdiction must possess in order to dispense all prescription drugs, the answer would be: a pharmacy license, a federal DEA registration, and a state controlled substance license or registration. Illinois CS registration Issued by the Illinois Department of Financial and Professional Regulation (“IDFPR”) following submission of an application and payment of the licensure fee. Registration expires on date the pharmacy’s license expires (i.e. March 31 on even years). Denial and revocation standards are similar to federal law. IDFPR shall issue the controlled substance registration unless it determines that the issuance of that license would be inconsistent with the public interest. In determining the public interest, the Department of Financial and Professional Regulation shall consider the following: maintenance of effective controls against diversion of controlled substances into other than lawful medical, scientific, or industrial channels; compliance with applicable Federal, State and local law; any convictions of the applicant, or the designated agent of the applicant where applicable, under any law of the United States or of any State relating to any controlled substance; past experience in the manufacture or distribution of controlled substances, and the existence in the applicant's establishment of effective controls against diversion; furnishing by the applicant of false or fraudulent material in any application filed under this Act; suspension or revocation of the applicant's Federal registration to manufacture, distribute, or dispense controlled substances, or purchase, store, or administer euthanasia drugs, as authorized by Federal law; whether the applicant is suitably equipped with the facilities appropriate to carry on the operation described in his or her application; whether the applicant is of good moral character or, if the applicant is a partnership, association, corporation or other organization, whether the partners, directors, governing committee and managing officers are of good moral character; any other factors relevant to and consistent with the public health and safety; and evidence from court, medical disciplinary and pharmacy board records and those of State and Federal investigatory bodies that the applicant has not or does not prescribe controlled substances within the provisions of this Act. Exam Tip: Note that the practitioner’s state registration need not appear on the prescription, just the 2 For a list of states that require a separate state license or registration, See, https://www.deadiversion.usdoj.gov/drugreg/reg_apps/pract_state_lic_require.htm. 14 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  DEA number. However, the practitioner, as well as the pharmacy, must have both a DEA registration number, and a state controlled substances license. DEA Registration Number - Once registered, a registrant will receive a DEA registration number. A DEA number is a series of two letters, followed by seven numerical digits. Registrant type (first letter of DEA Number): A/B/F/G – Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy (“G” has been added for Department of Defense practitioners). M – Mid-Level Practitioner Nurse practitioners Physician assistants Optometrists Pharmacists Chiropractic, naturopaths Psychologists L - Reverse Distributors P/R – Manufacturer/Distributor/Researcher/Analytical Lab/Importer/Exporter/Reverse Distributor/Narcotic Treatment Program X - DEA number was required for use by a practitioner in the treatment of addictions on an outpatient basis. However, effective January 2023, the “X” DEA registration is no longer required. Verification of DEA registration number First letter identifies type of registration. The second letter is usually (but is not always) the first letter of the prescriber’s last name. For example, a practitioner is not required to change his/her DEA number if his/her name changes. Thus, if “Dr. Sheila Smith” obtains a DEA registration number, it could start with “AS” as the first two letters. If later in life she married, and her name is legally changed to “Sheila Jones”, she is not required to get a new DEA registration number. Although her last name is “Jones”, her DEA number. would begin “AS”. The two letters are followed by 7 numbers. The numbers follow a formula that can be used to verify the number: Add digits 1, 3, and 5 Add digits 2, 4, and 6, and multiply the sum by two. Add the results of the above and the last number of the summation should equal last number in the DEA number o Example: DEA No. AB387843n can be verified as follows: 3 + 7 + 4 = 14; 8 + 8 + 3 = 19; 19 x 2 = 38; 14 + 38 = 52 The seventh digit of the DEA number should be “2” (i.e. AB38784332). If it is not, the number is incorrect, and fraud may be suspected. Exam Tip: When reviewing a fact pattern, look at the letters in the DEA number. If it starts with “M”, immediately recognize that this is a MLP, and there may be limited prescriptive authority. Conversely, if the fact patter identifies the prescriber as a MLP, but provides a DEA number that starts with an A, B, F, or G, you should treat the DEA number, and the Rx, as invalid. Exam Tip: Do not assume that the numerical sequence provided in a DEA number is correct. DO THE MATH. If the numbers are incorrect based on the formula, the DEA number, and the Rx, are invalid. 15 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  Scheduling Controlled substances are scheduled by DEA into one of five (5) schedules, based on the medical utility of the substances, compared to its abuse potential and addictive propensities. Schedules established in federal law are, with limited exceptions, followed in Illinois. CS scheduling is “automatically” made uniform with federal law thirty days after federal scheduling unless Dept. of Human Services objects and holds hearing to place in different schedule. Comprehensive list at http://www.deadiversion.usdoj.gov/schedules/ Note: Some states have 6 or more schedules There are five (5) schedules under federal law; Illinois largely follows federal law: Schedule I: High potential for abuse, no currently acceptable medical use, and lack of accepted safety for use under medical supervision. If used medically, must be approved by FDA and DEA under investigational protocol. Heroin LSD Mescaline Marijuana – even “medical marijuana”; but not Marinol® Methaqualone Peyote Psilocybin Controlled substance analogs (essentially an illegal copy of a FDA/DEA approved controlled substance) Schedule II: Currently accepted medical use and high abuse potential, with severe psychological or physical dependence. Narcotic analgesics Amphetamines and derivatives Barbiturates – short acting Examples: o Amphetamine o Cocaine o Codeine Sulphate or Phosphate o Fentanyl (Sublimaze, Duragesic, Actiq) o Hydromorphone (Dilaudid) o Mepridine (Demerol) o Methylphenidate (Ritalin) o Methadone (Dolophine) o Morphine (MS Contin) o Methamphetamine (Desoxyn) o Pentobarbital (Nembutal) o Oxycodone/APAP (Percocet) o Oxymorphone (Numorphan) o Secobarbital (Seconal) o Sufentanil (Sufenta) o Tincture of opium o Oxycodone HCl (Oxycontin, Percodan) 16 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  o Tapentadol (Nucynta) o Lisdexamfetamine (Vyvanse) o Hydrocodone Products All commercial products containing any amount of hydrocodone from CIII to CII. Examples include: Hydrocodone /APAP (Vicodin, Lortab, Norco) Hydrocodone/ibuprofen (Vicoprofen) Note: Pentazocine (Talwin) – If not mixed with any other substance, pentazocine is a Schedule II in Illinois; All pentacozine products are Schedule IV under federal law. Schedule III: Currently acceptable medical use. Abuse potential less than C-I and C-II, but abuse may be dangerous, or lead to moderate or low physical dependence or high psychological dependence. Anabolic steroids have been placed in this category. Mainly analgesics. Examples: o Acetaminophen with codeine (Empirin #3, Empirin #4; Tylenol #3 or #4) o Anabolic steroids (Testoderm, Winstrol) o Aprobarbital (Alurate) o Butalbital (Butisol, Fiorinal)  Combination products are either CIII or are not scheduled at all Fiorinal (butalbital w/ASA) – CIII under both Illinois and federal law. Fioricet and Esgic (butalbital w/APAP) – Some formulations are CIII under Illinois and federal law. 3 o Ketamine (Ketlar) o Paregoric o Pentobarbital rectal suppository (Nembutal suppositories) o Thiopental (Pentothal) o Buprenorphine (Suboxone, Subutex) o Benzphetamine (Didrex) o Butobarbital (Soneryl) o Butabarbital (Butisol, Butibel) o Phendimetrazine (Plegine) o Dihydrocodeine (Synalgos-DC) o Thiopental (Pentothal) GHB - schedule I or III under both Illinois and federal law (recent change): o Gamma Hydroxybutyric Acid (GHB) - GHB, gamma hydroxybutyrate, sodium oxybate, non- pharmaceutical is a schedule I. o Gamma Hydroxybutyric Acid preparations – Commercially available/FDA approved drug products (Xyrem, GHB, gamma hydroxybutyrate) are schedule III. Schedule IV: Currently acceptable medical use and lesser abuse potential than drugs in C-III category. Abuse may lead to only a limited physical or psychological dependence. Generally: Anxiolytics; sedatives Examples: o Alprazolam (Xanax) 3 There is some ambiguity in Illinois law about the status of combination products that contain butalbital. The state CSA suggests that all products that contain any amount of butalbital are schedule III, unless "specifically excepted". IDFPR and the state PMP program take the view that the federal exemption creates the exception, and therefore, the federal schedule prevails. 17 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  o Butorphanol (Stadol) o Chloral Hydrate (Noctec) o Chlordizepoxide (Librium) o Diazepam (Valium) o Flurazepam (Dalmane) o Meprobamate (Equanil, Miltown) o Oxazepam (Serax) o Phenobarbital o Propoxyphene (Darvon, Darvocet) o Triazolam (Halcion) o Zaleplon (Sonata) o Zolpedim (Ambien) o Clonazepam (Klonopin) o Tenazepam (Restoril) o Lorezepam (Ativan) o Carisoprodol (Soma, Soprodal, Vanadom) - a muscle relaxant o Dichloralphenazone (Midrin) - Sedative for tension relief/vascular headaches o Fospropofol (Lusedra) - Sedative/hypnotic; note – NOT propofol (Diprivan) o Zopiclone (Imovane) - Non-benzodiazepine hypnotic o Tramadol (Ultram) – Synthetic Opioid Agonist o Pemoline (Cylert) Schedule V: Current accepted medical use and low abuse potential. Limited physical and psychological dependence compared to C-IV substances (“Exempt” Narcotics). Limited quantities may be purchased without a prescription. (rules outlined below) Mainly: Cough; Cold; Anti-diarrheals Examples: o Acetaminophen with codeine elixir o Actifed with Codeine o Dimetane-DC o Novahistine DH o Phenergan with Codeine o Phenergan VC with Codeine o Robitussin A-C with Codeine o Robitussin DAC with Codeine o Triaminic Expectorant with Codeine o Diphenoxylate with Atropine (Lomotil) o Lacosamide (Vimpat) - Anti-seizure medication; neuropathic pain o Pregabalin (Lyrica) - Anti-seizure; neuropathic pain o Ezogabine (Potiga) – adjunctive treatment for partial-onset seizures Products containing not more than 10* milligrams of dihydrocodeine; or any of its salts, per 100ml or per 100 grams are also considered to be CV substances (*was 100 milligrams). Exam Tips: Hemp derivatives, including cannabidiol (“CBD”) used to be schedule I. However, as a result of Agriculture Improvement Act of 2018 (the “Farm Bill”), products that contain no more than 0.3% tetrahydrocannabinol (“THC”) were removed from federal scheduling. FDA approved Cannabadiol (Epidiolex®) is derived from cannabis (but not from hemp) was previously a schedule V controlled substance. However, in 2020, it was removed from federal scheduling. A handful of states still schedule Epidiolex as a C-V. It is NOT scheduled under Illinois law. 18 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  Dronabinol (Marinol®) – A FDA approved synthetic THC in sesame oil/soft gelatin is a schedule III controlled substance. Medical and recreational marijuana, though “legal” in many states, is still a schedule I controlled substance under federal law. Methamphetamine Precursors – not scheduled under federal law; but there is significant variation from state to state: o Ephedrine (EPH) and pseudoephedrine (PSE) are Schedule V in Illinois; not scheduled under federal; RX only in some states (not IL); restricted distribution in most states (See below for IL rules). o Methamphetamine precursors are substances used to produce illicit methamphetamine. These products are classified as List I chemicals under federal law. o Other chemicals used to manufacture illicit substances like methamphetamine (including, for example, acetone and HCl), are List II chemicals under federal law. There are certain restrictions imposed on the manufacture, distribution, and sale of List I and II chemicals, though that level of detail is unlikely to be included in the MPJE. General Rules for Scheduling Short acting and/or quickly absorbed products are more prone to be abused, and will be scheduled accordingly. Examples: o barbiturates:  Schedule II- short-acting (pentobarbital, secobarbital) – oral and injectable  Schedule III - combination barbiturates, suppository forms of short acting barbiturates  Schedule IV - long acting (phenobarbital) o amphetamines: all are in Schedule II o Anabolic steroids are schedule III controlled substances. Schedule IV is the entry point for newly scheduled controlled drugs (interesting but relatively useless information, except for MPJE® purposes); reality is that a controlled substance is already placed in the appropriate schedule by the time it is approved for marketing. Exempt Narcotics - Dispensing Schedule V Controlled Substances without Prescription Illinois and Federal Law permit a pharmacy to sell certain Schedule V controlled substances without a prescription. This category of drugs is sometimes referred to as exempt narcotics. Here are some important points to remember: State and federal laws are different in several respects, with Illinois law being stricter. Many states do not permit the sale of exempt narcotics without a prescription. Verify your state’s law before the exam. Under federal and state law, a patient may obtain up to four (4) ounces of a CV controlled substance without a prescription. In Illinois, no person shall purchase or be dispensed more than 120 milliliters or more than 120 grams of any Schedule V substance which contains codeine, dihydrocodeine, or any salts thereof, in any 96 hour period. Important Exam Tip: Do not confuse these rules with the rules applicable to the sale of PSE and other Methamphetamine Precursors. EPH and PSE are NOT controlled substances under federal law, or under the laws of some other states. Different sales rules apply!!! 19 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  Comparison of Illinois Law and Federal Law on Schedule V Substances (Exempt Narcotics) Requirement Illinois Law Federal Law Quantity Not more than 120 milliliters or more than Not more than 120 milliliters or more than 120 grams 120 grams Age 21 yrs. Old 18 yrs, old Two (2) positive forms of identification Must provide 1 valid ID required Time Limitation at least 96 hours at least 48 hours Records signature of purchaser, certification of no initials of purchaser, date of sale, and purchases within 96 hours, time of sale, initials of RPh and signature of pharmacist. Reporting maintain records for 2 years and send maintain records for two years copy to IDPR by 15th of next month Possession Limits not more than 4.5 liters per drug product silent plus amount of product needed for dispensing during busiest week Refills if RX Max of 5 refills or 6 months, whichever No max time limit or refills comes first Exam tip: Under IL law, only a pharmacist can “sell” an exempt narcotic. This means a pharmacist must complete the log book, verify the age of the seller, etc. After that part of the transaction is complete, however, anyone can ring up the sale. Exam tip: EPH and PSE are different. Technicians can “sell” these products, including obtaining the required identification and patient signature. Do NOT confuse the requirements applicable to the exempt narcotics with the requirements applicable to these “methamphetamine precursors” (PSE and EPH). Exempt narcotics include schedule V cough and cold preparations containing codeine, and anti-diarrheal products. Illinois PSE and EPH Laws Both Illinois and federal law require a patient to jump through hoops to purchase most PSE and EPH containing products without a prescription. There are quantity limitations in terms of what can be sold to an individual patient per transaction and per month. Illinois law is stricter than federal law. Products: Single entity and combination ephedrine (EPH) and pseudoephedrine (PSE) products in all forms are C-V controlled substances. Product Exemptions: o “Convenience packages” may be sold by non-pharmacy retailers so long as the requirements of the law (ID, log books, quantity limitations, etc.) are complied with. Note: Convenience packages are defined as 360 mg or less of EPH or PSE or their 20 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION   salts in liquid or liquid-filled capsule form.  Targeted packages are defined as any package, including convenience packages, containing any amount of a methamphetamine precursor. o Dispensing pursuant to a valid prescription for PSE or EPH is exempt from these requirements and limitations. o (720 ILCS 648/10; 720 ILCS 570/212; 720 ILCS 570/201). Sales Limits: No person may knowingly purchase products containing more than 7500 mg of EPH or PSE within any 30 day period, and retailers, pharmacy operators, pharmacists and technicians may not knowingly distribute more than 7500 mg within 30 days to any single person (720 ILCS 648/20; 720 ILCS 648/30). No person may knowingly purchase more than one convenience package within a 24 hour period, and retailers, pharmacy operators, pharmacists and technicians may not knowingly distribute more than one convenience package within a 24 hour period to any single person. (720 ILCS 648/20; 720 ILCS 648/30). No person may knowingly purchase more than two packages of products containing PSE or EPH (including convenience packages) per transaction. Pharmacy operators, pharmacists and technicians may not knowingly distribute more than two packages of products containing PSE or EPH (including convenience packages) per transaction. (720 ILCS 648/20; 720 ILCS 648/25). Sales Restrictions: All prescription-only products containing PSE and EPH are designated as Schedule V drugs (for more information, see “product exceptions” above). (720 ILCS 570/212). PSE and EPH products may only be administered, dispensed or distributed by pharmacists, practitioners authorized to do so by the Illinois Controlled Substances Act, a pharmacy, a retail distributor (defined as grocery store, general merchandise store, drug store, other merchandise store, or a distributor authorized by DEA to distribute bulk quantities of List I chemicals (720 ILCS 648/15). Anyone who purchases PSE or EPH products must be at least 18 years old. Retailer distributors, pharmacy operators, pharmacists and technicians may not knowingly distribute to anyone under 18. (720 ILCS 648/20; SB 273 – 720 ILCS 648/30). Products containing PSE and EPH must be packaged in blister packs, with each blister containing not more than 2 dosage units, or when the use of blister packs is technically infeasible, in unit dose packets and contain no more than 3,000 milligrams of PSE or EPH or their salts or isomers. (720 ILCS 648/25). PSE products sold in pharmacies may only be distributed by a pharmacist or pharmacy technician licensed under the Pharmacy Practice Act. (720 ILCS 648/25). Non-pharmacy retailers may sell convenience packages only. Convenience packages are defined as 360 mg or less of EPH or PSE or their salts in liquid or liquid-filled capsule form. ID Requirements: Purchaser must provide a driver’s license or other government issued ID showing purchaser’s name, date of birth and photograph (720 ILCS 648/20). It is the responsibility of any retail distributor operating a pharmacy and retail distributors in general as well as pharmacists or pharmacy technicians involved in the transaction to verify that the purchaser is at least 18 years old and resemble the photo on the ID. They must also verify that the name entered into the log correspond to the name on the purchaser’s government issued ID (720 ILCS 648/25; 720 ILCS 648/30) Recordkeeping Requirements: Purchasers of PSE and EPH products must sign a log including purchaser’s name and address, the 21 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  date and time of the transaction, the brand, product name and quantity of PSE / EPH distributed. The log may be maintained in electronic format if it includes all of the above listed information. (720 ILCS 648/20; 720 ILCS 648/25). Logs must be kept confidential and maintained for not less than 2 years. (720 ILCS 648/25; 720 ILCS 648/30). Product Placement: All PSE and EPH products sold in pharmacies must behind the pharmacy counter and distributed by a pharmacist or pharmacy technician licensed under the Pharmacy Practice Act. (720 ILCS 648/25). Convenience packages sold by retail distributors must be displayed behind store counters or in locked case so that customers must request store employee assistance to access the products. (720 ILCS 648/30). Key Points for Pharmacists Only persons aged 18 years or older may purchase PSE and EPH. Purchaser must present a valid driver's license or other government-issued identification showing the person's name, date of birth, and photograph. Verify that the purchaser resembles the photograph on the identification presented Document the purchaser's name and address, date and time of transaction, brand name/product name, and quantity purchased. Records must be kept for at least 4 years. Quantity of PSE or EPH that can be sold within a 30-day period must not exceed 7500 mg. Number of PSE or EPH targeted packages that can be sold to an individual, in one transaction, must not exceed 2 packages. PSE and EPH are to be stored behind the pharmacy counter and sold by a pharmacist, pharmacy technician or an agent of the pharmacist or the pharmacy technician. Compounded/Combination Products MPJE® may ask you to calculate the amount of controlled substance in a compounded product, and determine the correct schedule for the substance. Unless specifically excepted, or listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts, calculated as the free anhydrous base or alkaloid, are placed in schedule III or schedule V, as follows: Schedule III (720 ILCS 570/208): Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 mg. per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium. Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 mg. per dosage unit, with 1 or more active, non-narcotic ingredients in recognized therapeutic amounts. Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 mg. per dosage unit, with 1 or more active, non-narcotic ingredients in recognized therapeutic amounts. Not more than 300 mg of ethylmorphine per 100 milliliters or not more than 15 mg. per dosage unit, with 1 or more active, non-narcotic ingredients in recognized therapeutic amounts. Not more than 500 mg. of opium per 100 milliliters or per 100 grams or not more than 25 mg. per dosage unit, with 1 or more active, non-narcotic ingredients in recognized therapeutic amounts. Not more than 50 mg. of morphine per 100 milliliters or per 100 grams, with 1 or more active, non- narcotic ingredients in recognized therapeutic amounts. Schedule V: When combined with 1 or more active, non-narcotic ingredients in sufficient proportion to confer upon the mixture valuable medicinal qualities other than those possessed by narcotic drugs alone, the following are placed in schedule V: (720 ILCS 570/212) Not more than 200 mg. of codeine per 100 milliliters or per 100 grams. 22 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  Federal Law- Not more than 100 mg. of dihydrocodeine per 100 milliliters or per 100 grams. o Illinois law is stricter - In IL, if not more than 10 milligrams of dihydrocodeine; or any of its salts, per 100ml or per 100 grams (effective 1/1/2012) Not more than 100 mg. of ethylmorphine per 100 milliliters or per 100 grams. Not more than 2.5 mg. of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit. Not more than 100 mg. of opium per 100 milliliters or per 100 grams. Not more than 0.5 mg. of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit. Exam Tip: Compounded products containing any amount of dihydrcodeinone/hydrocodone should be treated as a CII. Exam Tip: Compounded products are NOT considered to be exempt narcotics, and always will require a prescription. Sample Question: Pharmacy receives RX asking RPH to compound: Codeine 2 grams APAP 12 grams Q.S. Cherry syrup 200 mL Sig: 2 tsp q 4 hrs prn HA Question - How often can this RX be refilled? Answer: Two step process: Step 1: Determine amount of codeine per 100 mL: o Codeine: o 2 grams/200 mL = x grams/mL o 2000 mg/200 mL = x mg/mL o X = 10 mg = 1,000 mg/100 mL o < 1.8 gm/100 mL; > 200 mg /100mL Since it is more than 200 mg, but less than 1.8 gm, this would be a C III, refillable 5 times in 6 months. However, you must also determine how much codeine there is per dose Step 2: Determine amount of codeine per dose o 10 mg/mL = x mg/10 mL o X = 100 mg per each 10 ml (2 tsp) dose Therefore, this RX is for a C II controlled substance, and cannot be refilled! EXAM TIP: Occasionally, there are some strange, off the wall drugs mentioned in the exam. A list of most controlled substances, by brand and generic name, is available on the DEA web site at http://www.usdoj.gov/dea/pubs/scheduling.html. CAUTION: Do not attempt to memorize the entire list, but review it and look for familiar names to learn what class they belong in, and then become generally familiar with other names. 23 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  Ordering Controlled Substances Schedule II Ordering (also applies to Schedule I) – DEA 222 Order Form (21 §1305.13) Pharmacies or other registrants that order controlled substances must use DEA form 222 to order CI and II substances. The pharmacy or other registrant will initiate the transaction by completing the DEA 222 form. Must be signed by original DEA registrant or person given power of attorney to order. Power of Attorney is given by the DEA registrant. For example, the pharmacist-in-charge may be given power of attorney for a particular store by a corporate chain. Applicants receive a maximum of 6 order form books, each containing 7 numbered blank forms. Each form contains 10 lines. (only 1 item per line, no alterations or erasures) Must Include: o Name of drug o NDC number of drug (if available) o Strength, package size and number of packages o Number of lines completed o Signature of purchaser or agent o DEA number of pharmacy o Date form issued When drugs are received, the registrant, POA, or any person designated by the registrant or POA, is required to: o Verify all drugs ordered have been received. 24 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  o Indicate receipt on the form. o Date and sign the form to confirm receipt of the order. Items received are recorded and the signed and dated form is filed for 2 years If any drug not received (if, for example, the drug is out of stock), the form remains active for 60 days. Order can be completed anytime during that 60 day period. If not received after 60 days, item is voided, and new order must be placed in order to receive the drug. The form may be refused by the seller/distributor: o If improperly completed o Appears altered Triplicate 222 forms have been eliminated by DEA, replaced by a single page form (effective October 30, 2019). Registrants may continue to use existing stocks of the triplicate DEA Form 222 until October 30, 2021. In any case, as soon as a registrant's supply of triplicate DEA Forms 222 is exhausted, the registrant must use the new single- sheet DEA Form 222. After October 30, 2019, the DEA will no longer issue triplicate forms. Triplicate DEA Forms 222 will not be accepted after October 30, 2021. 21 CFR Sec. 1305.11 Procedure for obtaining DEA Forms 222. (a) DEA Forms 222 are issued in mailing envelopes containing a predetermined number of forms based on the business activity of the registrant, each form consisting of one single-sheet. A limit, which is based on the business activity of the registrant, will be imposed on the number of DEA Forms 222 that will be furnished upon a requisition for order forms unless additional forms are specifically requested and a reasonable need for such additional forms is shown. (b) Any person with an active registration that is authorized to order schedule I and II controlled substances is entitled to obtain a DEA Form 222, which will be supplied at any time after the DEA registration is granted. Any person holding a registration authorizing the person to obtain a DEA Form 222 may requisition the forms through a DEA secured network connection or by contacting any Division Office or the Registration Section of the Administration through the customer service center. (c) Each requisition must show the name, address, and registration number of the registrant and the number of DEA Forms 222 desired. (d) DEA Forms 222 will have an order form number and be issued with the name, address and registration number of the registrant, the authorized activity, and schedules of the registrant. This information cannot be altered or changed by the registrant; the registrant must report any errors to the local Division Office or the Registration Section of the Administration to modify the registration. 21 CFR Sec. 1305.12 Procedure for executing DEA Forms 222. (a) A purchaser must prepare and execute a DEA Form 222 by use of a typewriter, computer printer, pen, or indelible pencil. 21 CFR Sec. 1305.13 Procedure for filling DEA Forms 222. (a) A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form. (b) A supplier may fill the order, if possible and if the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number and the number of commercial or bulk containers furnished on each item and 25 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  the date on which the containers are shipped to the purchaser. If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section. (d) The supplier must retain the original DEA Form 222 for the supplier's files in accordance with Sec. 1305.17(c). Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under Sec. 1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to [email protected]. The copy must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, the copy must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires. (e) The purchaser must record on its copy of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser. (f) DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order 21 CFR Sec. 1305.14 Procedure for endorsing DEA Forms 222. (a) A DEA Form 222, made out to any supplier who cannot fill all or a part of the order within the time limitation set forth in Sec. 1305.13, may be endorsed to another supplier for filling. The endorsement must be made only by the supplier to whom the DEA Form 222 was first made, must state (in the spaces provided in Part 3 on the original DEA Form 222) the DEA number of the second supplier, and must be signed and dated by a person authorized to obtain and execute DEA Forms 222 on behalf of the first supplier. * * * (b) Distributions made on endorsed DEA Forms 222 must be reported by the second supplier in the same manner as all other distributions. 21 CFR Sec. 1305.15 Unaccepted and defective DEA Forms 222. A DEA Form 222 must not be filled if either of the following apply: (1) The order is not complete, legible, or properly prepared, executed, or endorsed. (2) The order shows any alteration, erasure, or change of any description. (b) If a DEA Form 222 cannot be filled for any reason under this section, the supplier must return the original DEA Form 222 to the purchaser with a statement as to the reason (e.g., illegible or altered). (c) A supplier may for any reason refuse to accept any order and if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient for purposes of this paragraph. (c) When a purchaser receives an unaccepted order, the original DEA Form 222 and the statement must be retained in the files of the purchaser in accordance with § 1305.17. A defective DEA Form 222 may not be corrected; it must be replaced by a new DEA Form 222 for the order to be filled. 26 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION 21 CFR Sec. 1305.16 Lost and stolen DEA Forms 222. (a) If a purchaser ascertains that an unfilled DEA Form 222 has been lost, the purchaser must execute another and attach a statement containing the order form number and date of the lost form, and stating that the goods covered by the first DEA Form 222 were not received through loss of that DEA Form 222. A copy of the second form and a copy of the statement must be retained with a copy of the DEA Form 222 first executed. A copy of the statement must be attached to a copy of the second DEA Form 222 sent to the supplier. If the first DEA Form 222 is subsequently received by the supplier to whom it was directed, the supplier must mark upon the face “Not accepted” and return the original DEA Form 222 to the purchaser, who must attach it to the statement. (b) Whenever any used or unused DEA Forms 222 are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier must immediately upon discovery of the theft or loss, report the theft or loss to the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost. (c) If the theft or loss includes any original DEA Forms 222 received from purchasers and the supplier is unable to state the serial numbers of the DEA Forms 222, the supplier must report the date or approximate date of receipt and the names and addresses of the purchasers. (d) If any DEA Forms 222 are lost or stolen, and the purchaser is unable to state the order form numbers of the DEA Forms 222, the purchaser must report, in lieu of numbers of the forms, the date or approximate date of issuance. (e) If any unused DEA Form 222 reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located must immediately be notified. 21 CFR Sec. 1305.17 Preservation of DEA Forms 222. (a) The purchaser must retain a copy of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. (b) The supplier must retain the original of each DEA Form 222 that it has filled. (c) DEA Forms 222 must be maintained separately from all other records of the registrant. DEA Forms 222 are required to be kept available for inspection for a period of two years. If a purchaser has several registered locations, the purchaser must retain a copy of the executed DEA Form 222 and any attached statements or other related documents (not including unexecuted DEA Forms 222, which may be kept elsewhere under Sec. 1305.12(e)), at the registered location printed on the DEA Form 222. (d) The supplier of thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine must maintain DEA Forms 222 for these substances separately from all other DEA Forms 222 and records required to be maintained by the registrant. (e) Electronic copies of DEA Forms 222 will be deemed to be maintained separately from all other records of the registrant, for the purposes of this section, if such copies are readily retrievable separately from all other records. Electronic copies of DEA Forms 222 may be stored on a system at a location different from the registered location, provided such copies are readily retrievable at the registered location. 21 CFR Sec. 1305.18 Return of unused DEA Forms 222. If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked under Sec. 1301.36 of this chapter for all Schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused DEA Forms 222 to the Registration Section. 21 CFR Sec. 1305.19 Cancellation and voiding of DEA Forms 222. (a) A purchaser may cancel part or all of an order on a DEA Form 222 by notifying the supplier in writing of the cancellation. The supplier must indicate the cancellation on the original DEA Form 222 sent by the purchaser by drawing a line through the canceled items and printing “canceled” in the space provided for the number of 27 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  items shipped. (b) A supplier may void part or all of an order on a DEA Form 222 by notifying the purchaser in writing of the voiding. The supplier must indicate the voiding in the manner prescribed for cancellation in paragraph (a) of this section. Electronic Ordering of C-IIs (“CSOS”) The Controlled Substance Ordering System (“CSOS”), which allows pharmacies to order C-I and C-II controlled substances electronically. The CSOS system is optional, but offers many efficiencies that encourage the use of electronic ordering to replace the paper 222 forms. DEA's CSOS program allows for secure electronic controlled substances orders without the supporting paper DEA Form 222. Using a technology called “Public Key Infrastructure” (“PKI”), CSOS requires that each individual purchaser enroll with DEA to acquire a CSOS digital certificate. CSOS subscribers achieve the following benefits: Ordering Freedom: CSOS transactions are the only allowance for electronic ordering of Schedule I and II controlled substances, but may also be used for Schedule III-V substances. Additionally, CSOS has no line item limit for a single order. Faster Transactions: CSOS certificates contain the same identification information as DEA Form 222, which allows for timely and accurate validation by the supplier. Faster transactions allow for just-in- time ordering and smaller inventories. Accurate Orders: CSOS reduces the number of ordering errors. Decreased Cost: Order accuracy and decreased paper work result in a lower transaction cost. DEA will require a one-time, independent, third-party audit of any vendor's software for CSOS purchaser or supplier functions to certify that it performs the necessary PKI functions. McFaul said the agency would not routinely be checking purchasers' and suppliers' systems, but that it might check a system if a concern exists about it. Beyond inventory and turnaround advantages, the electronic format will also accommodate the Schedules I, II, III, IV, and V drug orders. (The paper form can be used only for Schedules I and II drugs.) The electronic version will also allow drugs from the different schedules to be ordered on the same form. The electronic form can hold any number of orders, in contrast to the paper form's limit of 10. Under the rules, while the software packages may allow the purchaser simply to enter the NDC number rather than the entire product description, the software must be able to automatically retrieve the product description. Illinois C-II Duplicate Order Requirement Applies only to Illinois C-I and C-II substances which are not so classified under federal law. Presently, only one substance - Talwin® (pentazocine) - is in this category. Requires written order, in duplicate, containing the following information: 28 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  name, address and DEA number of ordering registrant; name, address and DEA number of selling or transferring registrant; name of drug ordered; finished bulk form and strength of substance (e.g. 50 mg. tablet); number of units or volume in each container (e.g. 100 tablet bottle/10 ml. vial); number of containers ordered; and name and quantity per unit of the controlled substance contained in the order if not in pure form. Form to be signed and dated by person authorized to execute federal order form Original to be maintained by selling/transferring registrant, copy to be maintained by ordering registrant, both for two years. Ordering C-III through C-V Substances No special form required. However, the invoice for the product must contain: 1. Name of the controlled substance 2. Dosage form and strength 3. Number of units per container (such as, 100 tablet bottle) 4. Number of containers 5. Date of receipt 6. Name, address, and DEA number of registrant supplying the controlled substance Must maintain all records in “readily retrievable” form, so that inspection can be accomplished efficiently. Prescription Requirements Content: (1) Signed and dated on the date of issuance; (2) full name and address of patient; (3) name, address and DEA number of prescriber; (3) drug name, strength, dosage form and quantity; (4) directions for use; (5) if written, must be in ink. If oral, reduced to writing by pharmacist with same information. Illinois law does not permit pre-printed prescriptions. However, “Pre-printed” means a written RX in which the drug name has been indicated prior to the time of issuance, including any pre-inked stamp that would be applied to a RX blank. Computer generated or printed prescription forms are not considered to be “pre- printed” (if they are not prepared in advance of the time that the patient is seen by the practitioner). Exam tip: If the questions suggests that the prescription is printed in advance of, err on the side of saying that it cannot be filled until verified. Exam tip: Computer generated prescriptions that are printed out or faxed must be manually signed. Prescriptions sent by fax are NOT electronic prescriptions. Agents may prepare a CS RX for practitioner’s signature. However, neither a pharmacist nor a technician may act as an agent of a practitioner. DEA takes the view that a pharmacy cannot provide in whole, or in part, pre-populated information on a document and have that document then become the prescription. Persons Authorized to Issue Controlled Substance Prescriptions Federal law defers to state law. Illinois law identifies physicians, dentists, podiatrists, and veterinarians as authorized to prescribe controlled substances. Also allows: o PAs, Nurse practitioners o Optometrist 29 © 2024, GD Keats, Inc. dba pharmacylaw.net (All Rights Reserved) DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION  o Clinical Psychologists Prescribing under hospital DEA Number Exception to requirement that all practitioners have their own dispenser’s registration number. Interns, residents, and foreign-trained physicians, as well as Advance Practice Nurses and Physician Assistants, may dispense, administer and prescribe controlled substances under the registration of the hospital or other institution, provided that: o it is done in the usual course of his professional practice; o state law permits; o hospital has verified that state law permits; o prescriber is acting only within scope of his employment in the hospital; o the hospital authorizes the prescriber to dispense or prescribe under the hospital registration, and designates a specific internal code number for each such prescriber. The code number shall consist of numbers, letter, or a combination, and shall be a suffix to the hospital’s DEA number, preceded by a hyphen; and o a current list of internal codes and the corresponding prescriber is kept by the hospital and is made available to other registrants and law enforcement agencies for the purpose of verifying the prescriber’s authority. Note: Hospital residents who also practice outside of the hospital may not prescribe under the authority of the hospital. In order to prescribe a controlled substance outside the hospital, the resident must have his/her own individual DEA registration, or must have permission from the other hospital to use the facility’s DEA registration. Exam tip: There are no limitations on the prescriptive authority for a resident or other physician who is operating under a hospital’s DEA registration. The scope of authority can be as broad as the facility’s, or can be limited by the facility. A common misconception is that residents cannot prescribe CIIs. That is NOT true! Note: Hospital residents who practice outside of the hospital must have a state medical registration number, and may not prescribe under the authority of the hospital. Mid-Level Practitioners 77 IL ADC 3100.80 - Allows Advance Practice Nurses and Physician Assistants to use the institution’s DEA registration to prescribe controlled substances. In a licensed hospital, hospital affiliate, or licensed ambulatory surgical treatment center ("institution") a licensed advanced practice nurse or a physician assistant may be granted clinical privileges, including the authority to select, order and administer, and issue discharge prescriptions for, controlled substances under the DEA registration number of the hospital, hospi