MPJE Worksheet - Illinois 2022-07 PDF

MPJE MPJE Worksheet Instructions: This is meant to be a guide that covers as many possible MPJE topics as possible. Each state has different laws, and you may find some boxes that are not addressed by...

MPJE MPJE Worksheet Instructions: This is meant to be a guide that covers as many possible MPJE topics as possible. Each state has different laws, and you may find some boxes that are not addressed by your state (in which case write n/a). Always check your state board for latest guidance. State Illinois The Board of Pharmacy 11 members appointed by the Governor: 8 licensed pharmacists o One shall have a primary site for the practice of pharmacy at an inpatient hospital pharmacy o Each of those 8 members must be a licensed pharmacist in good standing in this State, a graduate of an accredited college of pharmacy or hold a Bachelor of Science degree in Who are the Board Members? Pharmacy and have at least 5 years' practical experience in the practice of pharmacy subsequent to the date of his licensure as a licensed pharmacist in the State of Illinois. o There shall be one member who is a pharmacy technician. 2 public members who shall be voting members, who shall not be engaged in any way, directly or indirectly, as providers of health care in this State or any other state. Office of Executive Appointments - Appointments - Boards and Commissions Detail View Is the Board a Separate Entity or Under Illinois Department of Financial and Professional Regulation (IDFPR) Another Organization/Department? Elected by board Who Chairs the Board? Office of Executive Appointments - Appointments - Boards and Commissions Detail View How Are Board Members Selected? Appointed by the Governor of Illinois Appointment/Election? Office of Executive Appointments - Appointments - Boards and Commissions Detail View 5 years; no member is to serve more than 2 full terms in his/her lifetime How Long do Board Members Serve? Office of Executive Appointments - Appointments - Boards and Commissions Detail View Quarterly How Often Does the Board Convene? 225 ILCS 85/10 Section G Who Can Attend Meetings? General public Qualifications Pharmacists must have 5 years practical experience as a pharmacist subsequent to Illinois licensure. Office of Executive Appointments - Appointments - Boards and Commissions Detail View Licensure Requirements The Pharmacist New Transfer/Reciprocity Foreign Graduate Graduates of a first professional Graduation from a first degree program in pharmacy located professional degree program in Applicants currently licensed in outside the United States or its Who Can Apply? pharmacy another jurisdiction territories Section 1330.320 Application for Section 1330.350 Endorsement Section 1330.310 Graduates of Examination Programs Outside the United States $75 $200 Application Fee? $75 Section 1330.20 Fees Section 1330.20 Fees # of CE Hours for Renewal? 30 hours biennially Section 1330.100 Continuing Education 1 hour in sexual harassment prevention Special CE Requirements Continuing Education Fact Sheet Registered Pharmacists & Certified Pharmacy Technicians 1200 Minimum Intern Hours? Not Specified Section 1330.310 Graduates of Programs Outside the United States Degree/Education Required? Graduation from a board-approved school of pharmacy FPGEE TOEFL (Score >550) AND Paper TSE (Score >50) OR Computer-based TOEFL & TSE NAPLEX Examinations Required? IL MPJE Combination (Score >213) OR IL MPJE Internet-based TOEFL iBT (Score 88) + minimum Score 26 on speaking module Section 1330.310 Graduates of Programs Outside the United States © tl;dr pharmacy llc. All Rights Reserved  Certification by the state or Certification of graduation territory of original licensure from a first professional stating: degree program in pharmacy The time in which the OR applicant was licensed in Certification from the dean of FPGEC Certificate Documents (Transcript/Drug the state an approved pharmacy Section 1330.310 Graduates of Test/Background Check)? Any record of disciplinary program indicating the Programs Outside the United States action applicant is expected to Brief description of graduate examination and the Section 1330.320 Application for applicant’s grades Examination Section 1330.350 Endorsement Please see: Reinstatement Process? Section 1330.90 Restoration of a Pharmacist License Please see: Probation Reasons/Process? Section 1330.30 Unprofessional and Unethical Conduct Biennially Renewal Period? 225 ILCS 85/12 Pharmacy Intern New Foreign Graduate License/Registration Required? Yes Yes Any person registered as a pharmacy technician who is also enrolled in a first professional degree program in pharmacy in a school or college of pharmacy or a department of pharmacy Who Can Apply? of a university approved by the Department 225 ILCS 85/9 Section (c) For foreign graduate: 225 ILCS 85/9 Section (d) $40 Application Fee? Renewal: $25 Section 1330.20 Fees 1200 Hours Required? 225 ILCS 85/9 Current Enrollment/Good Standing Required? Must be enrolled in a board-approved school of pharmacy Yes (under the supervision of a licensed pharmacist) Preceptor Required? 225 ILCS 85/9 Section (a) The Department shall not renew the registered pharmacy technician license of any person who has been licensed as a registered pharmacy technician with the designation "student pharmacist" who: (1) has dropped out of or been expelled from an ACPE accredited college of Renewal Period? pharmacy; (2) has failed to complete his or her 1,200 hours of Board approved clinical training within 24 months; or (3) has failed the pharmacist licensure examination 3 times 225 ILCS 85/9 Section (e) Pharmacy Technician New Yes License/Registration Required? 225 ILCS 85/9.5 He or she has submitted a written application in the form and manner prescribed by the Board Age of 18 or older and is of good moral character Graduated from pharmacy technician training or obtained documentation of training from the pharmacist-in-charge of the pharmacy where the applicant is employed Has successfully passed an examination accredited by the National Commission for Certifying Agencies of the Institute for Credentialing Excellence (NCCA), as approved and Who Can Apply? required by the Board. The Division, upon the recommendation of the Board, has determined that the Exam for the Certification of Pharmacy Technicians offered by the Institute for the National Healthcareer Association (or its successor), and the Pharmacy Technician Certification Examination offered by the Pharmacy Technician Certification Board (or its successor), are accredited by NCCA and are, therefore, approved examinations for certification; and Has paid the required certification fees Section 1330.220 Application for Certificate of Registration as a Certified Pharmacy Technician 20 hours biennially # of CE Hours for Renewal? 225 ILCS 85/9.5 Section (e) 1 hour on pharmacy law Special CE Requirements (e.g. compounding, 1 hour on patient safety live, HIV, opioid, medication safety)? 225 ILCS 85/9.5 Section (e) © tl;dr pharmacy llc. All Rights Reserved  $40 Application Fee? Renewal: $25 Section 1330.20 Fees Approved exams: Exam for the Certification of Pharmacy Technicians offered by the Institute for the National Healthcareer Association Requirements? Examination, PTCB, Education? OR Drug Test? Background Check? Pharmacy Technician Certification Examination offered by the Pharmacy Technician Certification Board Section 1330.220 Application for Certificate of Registration as a Certified Pharmacy Technician The application which you submit is valid for 3 years from date of receipt. If you are issued a license, it will expire annually on March 31 regardless of date of issuance. Pharmacy Technician New Application Checklist UPDATE (2/16/2022): Pursuant to the authority granted to me by 68 Illinois Administrative Code 1330.70, I hereby Renewal Period? grant a Variance to 68 Illinois Administrative Code 1330.80, which requires pharmacies and pharmacy technicians to submit renewal documentation and pay certain renewal fees by the deadline of March 31, 2022. Such individuals or entities are granted until May 31, 2022, to complete the renewal process. Variance | Renewal Deadline Extension The Pharmacy The Physical Space When the pharmacy is closed, the public and any employees not registered under the Act are to be prohibited access to the filling and dispensing area. Section 1330.520 Offsite Institutional Pharmacy Services (b)(5)(d) Any pharmacy investigator authorized by the Department has the right of entry for inspection during Specific Requirements on Who normal business hours of premises purporting or appearing to be used by a wholesale drug distributor in Can Access the Pharmacy? this State, including the business premises of a person licensed pursuant to this Act. This right of entry Without Pharmacist? BOP? shall permit the authorized pharmacy investigator unfettered access to the entire business premises. Any Police? attempt to hinder an authorized pharmacy investigator from inspecting the business premises and documenting the inspection shall be a violation of this Act. The duly authorized investigators shall be required to show appropriate identification before being given access to a wholesale drug distributor's premises and delivery vehicles Illinois Compiled Statutes Minimum Square Footage? Minimum Counter Space? Not Specified Counseling Area Requirements? Whenever the pharmacy (prescription area) is not occupied by a registrant, the pharmacy (prescription area) must be secured and inaccessible to non-licensed persons (employees and public). This may be accomplished Security System Requirements by measures such as walling off, locking doors or electronic security equipment, as approved by the Division. Section 1330.600 Security Requirements Specifications on Alarms? Not Specified Connectivity A telephone shall be immediately accessible in the pharmacy area. (Phone/Fax/Internet Required)? Section 1330.610 Pharmacy Structural/Equipment Standards Separate Storage for Follows federal regulations Prescription Hard Copies by PART 1304 - Section 1304.04 Maintenance of records and inventories (h) Control? Drugs by Control? Must Storage Area Be Locked Not Specified for Hard Copies? Drugs? Must Storage Area Be On Site May be kept electronically as long as the system is capable of producing a hard copy at request of the board for Hard Copies? Drugs? 225 ILCS 85/18 Signage Every licensed pharmacy directly serving patients at a physical location must conspicuously post a sign provided by the Division containing a statement that the patient has the right to counseling, the Division's consumer hotline number, information on how to file a complaint for failure to counsel, and any other Sign Requirement for information the Division deems appropriate. The sign must be printed in color ink or displayed electronically in Counseling? color, measure at least 8½ x 11 inches in size, and be posted at either a cashier counter or waiting area clearly visible to patients. Licensed pharmacies that do not maintain a physical location directly serving patients must include a copy of the sign within any dispensed prescriptions. Section 1330.700 Patient Counseling Whenever the hours of the pharmacy differ from those of the establishment in which the pharmacy is located, Sign Requirement for Hours? the schedule during which pharmacy services are provided shall be conspicuously displayed Section 1330.500 Community Pharmacy Services © tl;dr pharmacy llc. All Rights Reserved  Sign Requirement for PIC Not Specified Change? Notify customers of the closure at least 15 days in advance of the closing date and where the customer's records will be maintained Sign Requirement for Closures? Cover all signage indicating "Drug Store" or "Pharmacy" as soon as practicable. The signage shall be removed in a timely manner. A sign shall be prominently posted that the pharmacy is closed Section 1330.790 Closing a Pharmacy Whenever a pharmacy is open and a pharmacist is not present and available to provide pharmacy services, a Other Signage Requirements? sign stating that situation shall be conspicuously displayed Section 1330.500 Community Pharmacy Services Board Notification Time to Notify Board of No specific time frame mentioned. Application for change of ownership should be submitted to the board “promptly” Changes to Ownership? Pharmacy APP 0404.indd Time to Notify Board of 30 days Changes to PIC? Section 1330.660 Pharmacist-in-Charge Time to Notify Board of 14 days Changes to Address? Illinois Compiled Statutes Time to Notify Board of 30 days Changes to Hours? Section 1330.400 Application for a Pharmacy License Equipment Type of Prescription Balance Not Specified Required? The pharmacy area and all store rooms shall be well-lighted and properly ventilated. Refrigerators shall be for the exclusive use of prescription drugs. No personal or food items shall be stored in the refrigerator. Refrigeration shall be capable of maintaining temperature within a range compatible with the proper storage of drugs requiring refrigeration or freezing. The pharmacy area shall not be used for storage of merchandise that interferes with the practice of pharmacy. Suitable current reference sources, either in book or electronic data form (available in the pharmacy or on- line), which shall include Facts and Comparisons (http://www.factsandcomparisons.com) or other suitable references determined by the Division to be pertinent to the practice carried on in the licensed pharmacy. A telephone shall be immediately accessible in the pharmacy area. Section 1330.610 Pharmacy Structural/Equipment Standards (c)-(g) AND A separate storage area for materials used in compounding; Other Equipment Required? Scales or measuring devices with sufficient accuracy for the products to be compounded; An area of the pharmacy used exclusively for compounding; A logbook or record keeping system to track each compounded drug, which must include the lot number, expiration date of components used, and beyond-use date of compounded drug. This applies to each nonsterile compounded drug and each sterile compounded drug with a beyond-use date greater than 24 hours; The current edition of the USP Compounding Compendium. This publication may be in electronic format and/or available via the internet; If engaged in veterinary drug compounding, "Plumb's Veterinary Drug Handbook" or any other similar publication approved by the Division; Consumable materials, as appropriate to the pharmacy services provided at that specific pharmacy, including but not limited to: filter paper, powder papers, empty capsules, ointment jars, bottles, vials, safety closures, powder boxes, labels and distilled water Section 1330.640 Pharmaceutical Compounding Standards (e)(1-7) Special Rules on Automated There are many special rules surrounding the use of automated dispensing cabinets. Please see Section Dispensing Cabinets? 1330.680 Automated Dispensing and Storage Systems Access It shall be unlawful for the owner of any pharmacy, as defined in this Act, to operate or conduct the same, or to allow the same to be operated or conducted, unless: Must RPh Be On-Site for (a) It has a licensed pharmacist, authorized to practice pharmacy in this State under the provisions of this Act, Access to Pharmacy? on duty whenever the practice of pharmacy is conducted 225 ILCS 85/15 Sec. 15. Pharmacy requirements 1. Locked cabinet or other enclosure located outside of the pharmacy area containing a minimal supply of the most frequently required medication, may be utilized provided that only specifically authorized After Hours Dispensing personnel can obtain access. Allowed? Requirements (i.e. 2. Must be sufficiently secure to deny access to unauthorized persons. Dispensing Cabinet? 3. After-hour cabinets shall only be used in the absence of a pharmacist. When medication is removed, written physician’s orders authorizing the removal of the medication shall be placed in the cabinet. © tl;dr pharmacy llc. All Rights Reserved  4. A log shall be maintained within the cabinet and personnel removing medication shall sign it and indicate the name, strength, and quantity of the medication removed and the time of removal. Section 1330.530 Onsite Institutional Pharmacy Services (e)(1) Emergency Access to Not Specified Pharmacy Procedures? Mail Order Mail Allowed? (In-State to Out, Yes: Out-of-State to In) 225 ILCS 85/16a License Required for Mail to Not Specified Other States? Ownership Requirements What Are the Fees for A $100 Pharmacy License? Section 1330.20 Fees Who Can Apply? Anyone No, however a pharmacy shall have one pharmacist-in-charge who shall be routinely and actively involved in the operation of the pharmacy. A pharmacist may be the pharmacist-in-charge for more than one pharmacy; Must be RPh to Own however, the pharmacist-in-charge must work an average of at least 8 hours per week at each location where Pharmacy? he or she is the pharmacist-in-charge. If a pharmacist in charge is on a leave of more than 90 days, a new pharmacist-in-charge must be designated. (Section 1330.660) Every licensed pharmacy shall conduct an annual self-inspection using forms provided by the Division. The Additional Requirements for annual self-inspection shall be conducted during the same month, annually, as determined by the pharmacy. Ownership? Documentation of the self-inspection shall be maintained at the pharmacy for 5 years. (Section 1330.800) A new pharmacy application must be filed whenever: 10% or more of the ownership of the business, other than a publicly traded business, to which the pharmacy licensee was issued is sold or otherwise transferred to a person or entity that does not hold any Rules on Sales/Transfers interest in the business issued the pharmacy license prior to the sale or transfer; or More than half the board of directors or executive officers of a business issued a pharmacy license change. Section 1330.780 Change of Ownership of a Pharmacy Application and fee required Application/Fees Required? Pharmacy APP 0404.indd How Long for Notification See ‘Board Notification’ above Period? It shall be unlawful for any person, who is not a licensed pharmacy or health care facility, to purport to be such or to use in name, title, or sign designating, or in connection with that place of business, any of the words: "pharmacy", "pharmacist", "pharmacy department", "apothecary", "druggist", "drug", "drugs", "medicines", "medicine store", "drug sundries", "prescriptions filled", or any list of words indicating that drugs are Signage Requirements? compounded or sold to the lay public, or prescriptions are dispensed therein. Each day during which, or a part which, such representation is made or appears or such a sign is allowed to remain upon or in such a place of business shall constitute a separate offense under this Act Illinois Compiled Statutes (4) Staffing Requirements RPh-Tech Ratio? Different by Setting? RPh-Intern Ratio? Different by Setting? Not Specified RPh-Staff (Clerk/Delivery Driver/Cashier) Ratio? Different by Setting? Compounding If sterile compounding for office-use, must register as an outsourcing facility and become licensed as a wholesale drug distributor pursuant to the Wholesale Drug Distribution Licensing Act (c) Is Facility Licensure Required for Any pharmacy that, after initial licensure, chooses to add sterile compounding to the services it General Compounding? Sterile provides must be inspected by, and the compounding area must be approved by, the Department. It Compounding? shall be the responsibility of the pharmacist-in-charge to notify the Department and arrange for the inspection (i) Section 1330.640 Pharmaceutical Compounding Standards Compounding in anticipation of receiving a prescription or order must be based on routine, readily observed dispensing patterns (e)(10) Restrictions on Compounding A pharmacy may compound a reasonable quantity of sterile and nonsterile drug products for office use Without Prescription? by a veterinarian (g) Section 1330.640 Pharmaceutical Compounding Standards Follows current standards set forth by USP Chapters 795, 797 and 800 Stability of Compounded Product? USP-NF: USP–NF © tl;dr pharmacy llc. All Rights Reserved  Special Volume Requirements? Manufacturer License Required? Certifications/Licensure Required? Not Specified Special Requirements for Patent Drugs? Controlled Drugs? OTC? Dispensing Without Prescription A pharmacy may only dispense compounded drugs pursuant to a valid patient-specific prescription Allowed? Which Drugs? Section 1330.640 Pharmaceutical Compounding Standards Behind the Counter Can Legend Drugs (e.g. Codeine, Yes Opium Tinctures) Be Dispensed Any Schedule V substance which contains codeine, dihydrocodeine, or ethylmorphine Without Prescription? Which Ones? No more than 120 mL or 120 g in a 96-hour period Logging Requirements? Illinois Compiled Statutes Section (c)(4) Targeted methamphetamine precursors Which Drugs Are Required to Be Codeine, dihydrocodeine, ethylmorphine Behind the Counter? 720 ILCS 648/25 The purchaser must be at least 21 years of age and present 2 positive documents of identification (c)(2) Dispensing Requirements The dispenser shall record the name and address of the purchaser, the name and quantity of the (Maximum Allowed/Logging)? product, the date and time of the sale, and the dispenser's signature (c)(3) All records and sales should be maintained for a minimum of 2 years (c)(6) Illinois Compiled Statutes A pharmacist may sell up to 100 sterile hypodermic syringes or needles to a person who is at least 18 years of age. A syringe or needle sold under this subsection (b) must be stored at a pharmacy and in a Can Syringes Be Dispensed Without manner that limits access to the syringes or needles to pharmacists employed at the pharmacy and any Prescription? Logging Requirement? persons designated by the pharmacists. A syringe or needle sold at a pharmacy under this subsection (b) may be sold only from the pharmacy department of the pharmacy. (b) Illinois Compiled Statutes Must be 18 years of age or older Provide valid government-issued ID Sign a log documenting the name and address of the person, date and time of the transaction, brand and product name and total quantity distributed No more than 7,500 mg of ephedrine or pseudoephedrine or their optical isomers may be purchased What are the Rules Around in a 30-day period Pseudoephedrine? Limits? Except as provided in subsections (d) and (e) of this Section, no person shall knowingly purchase, receive, or otherwise acquire more than 2 targeted packages in a single retail transaction. Except as provided in subsection (e) of this Section, no person shall knowingly purchase, receive, or otherwise acquire more than one convenience package from a retail location other than a pharmacy counter in a 24-hour period Illinois Compiled Statutes Drug Administration A pharmacist, or student pharmacist under the direct supervision of a pharmacist, may administer vaccinations/immunizations to persons who are 14 years of age or older pursuant to a valid patient specific prescription or a standing order by a physician licensed to practice medicine in all of its branches under the Can Pharmacists Medical Practice Act of 1987 [225 ILCS 60]. Administer Immunizations? A pharmacist, or student pharmacist under the direct supervision of a pharmacist, may administer influenza Which Ones Can They (inactivated influenza vaccine and live attenuated influenza intranasal vaccine) and Tdap (tetanus, diphtheria, Administer? acellular pertussis) vaccines/immunizations to persons who are 10 to 13 years of age pursuant to a valid patient specific prescription or a standing order by a physician Section 1330.50 Vaccinations/Immunizations Yes - long-acting or extended-release form opioid antagonists for the treatment of substance use disorder) pursuant to a valid prescription by a physician licensed to practice medicine in all its branches, upon completion Can Pharmacists of appropriate training), alpha-hydroxyprogesterone caproate (pursuant to a valid prescription, by a physician Administer Medications? licensed to practice medicine in all its branches, upon completion of appropriate training), long-term antipsychotic Which Ones Can They medications (pursuant to a valid prescription by a physician licensed to practice medicine in all its branches, upon Administer? completion of appropriate training conducted by an Accreditation Council of Pharmaceutical Education accredited provider), and others in the context of patient education on the proper use or delivery of medications. (225 ILCS 85/3)(B-5)-(D) Is a Collaborative Practice Vaccination protocol or prescription required Agreement/Other Required? Section 1330.50 Vaccinations/Immunizations Facility Requirements? Not Specified Private Space/Partition? 10 to 13 years of age for influenza or Tdap Other Requirements? 14 years of age or older for all other vaccines Patient Age Limit? Section 1330.50 Vaccinations/Immunizations © tl;dr pharmacy llc. All Rights Reserved Are There Laws/Protections for Emergencies (e.g. Not Specified Anaphylaxis, Overdose)? Drugs Covered? Pharmacists’ Rights Can Pharmacists Refuse to Fill a Valid Prescription (e.g. Birth Control, Yes. A prescription for a controlled substance must be issued for a Narcotics)? In What Circumstances? legitimate medical purpose by an individual practitioner acting in the Requirements for Refusal? usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon Religious Objection? the prescribing practitioner, but a corresponding responsibility rests What Actions Can Be Taken Against RPh License for Refusal to Fill? with the pharmacist who fills the prescription. Appeals Process on Actions? Section 3100.380 Purpose of Issuance of a Prescription (a) Other Settings Long-Term Care Who Can Dispense/Administer Nurse or physician licensed to practice in Illinois Medication? Section 350 Section K An after-hour cabinet, which is a locked cabinet or other enclosure located outside of the pharmacy area containing a minimal supply of the most frequently required medication, may be utilized provided that only Who Can Access Dispensing personnel specifically authorized by the institution in which the pharmacy is located may obtain access and it is Units? Special Requirements? sufficiently secure to deny access to unauthorized persons. After-hour cabinets shall only be used in the absence of a pharmacist. Section 1330.520 Offsite Institutional Pharmacy Services Section G (1) Emergency kits containing those drugs that may be required to meet the immediate therapeutic needs of the patient, and that are not available from any other source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining the drugs from the other source, may be utilized. Emergency kits shall be supplied and maintained under the supervision of a pharmacist. Drugs shall be removed from emergency kits only by authorized pharmacy personnel or persons authorized to administer medication pursuant to a valid physician's order of a physician licensed to practice medicine in all of its branches in Illinois. Emergency kits shall be sealed in some manner that will indicate when the kit has been opened. A label shall be affixed to the outside of the emergency kit indicating the beyond use date of the emergency kit. The beyond use date of the emergency kit shall be the earliest beyond use date of any drug contained in the kit. After an emergency kit has been used or upon discovery that the seal has been broken or upon the occurrence of the beyond use date, the kit shall be secured and returned to the pharmacy to be checked and/or restocked by the last authorized user. If the pharmacy is closed at that time, the kit shall be returned when it opens. An automated dispensing and storage system may be used as an emergency kit. This use shall be in compliance with Section 1330.680. Whenever any drug is not available from night cabinets or emergency kits, and the drug is required to treat the immediate needs of a patient, the drug may be obtained from the pharmacy in sufficient quantity to Who Can Access Medications meet the immediate need by an authorized nurse. When medication is removed from the pharmacy by an Without Pharmacy Staff? authorized nurse, a copy of the physician's order authorizing the removal of the medication shall be conspicuously placed in the pharmacy with the container from which the drug was removed so that it will be found by a pharmacist and checked promptly. A form shall be available in the pharmacy upon which shall be recorded the signature of the authorized nurse who removed the medication, the name, strength (if applicable) and quantity of medication removed. An after-hour cabinet, which is a locked cabinet or other enclosure located outside of the pharmacy area containing a minimal supply of the most frequently required medication, may be utilized provided that only personnel specifically authorized by the institution in which the pharmacy is located may obtain access and it is sufficiently secure to deny access to unauthorized persons. After-hour cabinets shall only be used in the absence of a pharmacist. When medication is removed from the cabinet or enclosure, written physician's orders authorizing the removal of the medication shall be placed in the cabinet or enclosure. A log shall be maintained within the cabinet or enclosure and authorized personnel removing medication shall indicate on the log the signature of the authorized personnel removing the medication, the name of the medication removed, the strength (if applicable), the quantity removed and the time of removal. An automated dispensing and storage system may be used as an after hours cabinet. This use shall be in compliance with Section 1330.680. Section 1330.520 Offsite Institutional Pharmacy Services(g) Parenteral solutions to which a drug or diluent has been added or that are not in their original manufacturer's packaging shall contain the following information on the outer label: Name, concentration and volume of the base parenteral solution; Name and strength of drugs added; Requirements on IV Labeling Beyond use date and date of the admixture. Beyond use date, unless otherwise specified in the individual for Dispensing Unit compendia monograph shall be not later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged, whichever is earlier; and Reference code to identify source and lot number of drugs added. Section 1330.520 Offsite Institutional Pharmacy Services (e)(1)(A) © tl;dr pharmacy llc. All Rights Reserved  Pharmacies dispensing medications to a specific resident or patient in the facility via unit dose shall label each order with the following information: Name of the resident; Resident's room and bed number; Requirements on Unit Dose Date of order; Labeling for Dispensing Unit Name, strength and dosage form of drug, or description of the medical device ordered; Directions for use; and Prescriber's name. Section 1330.520 Offsite Institutional Pharmacy Services (e)(2)(B) Non-parenterals repackaged for future use shall be identified with the following information: Brand and/or generic name; Strength (if applicable); Requirements on Multi- Beyond use date. Unless otherwise specified in the individual monograph, the beyond use date shall be not Dose/Repackaging later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged, whichever is earlier; and Reference code to identify source and lot number. Section 1330.520 Offsite Institutional Pharmacy Services (e)(1)(B) No facility shall maintain a stock supply of controlled drugs or legend drugs, except for those in emergency Requirements on Storage of medication kits or convenience boxes Controlled Medication? Section 350.1410 Medication Policies and Procedures (g) Only the director of nursing, registered nurse on duty, licensed practical nurse on duty, consultant pharmacist or Who can Access Controlled licensed prescriber shall have access to controlled substances stored in emergency medication kits Medications? Section 350.1410 Medication Policies and Procedures (k)(3) Drugs shall be removed from emergency kits only by authorized pharmacy personnel or persons authorized to administer medication pursuant to a valid physician's order of a physician licensed to practice medicine in all of its branches in Illinois. Emergency kits shall be sealed in some manner that will indicate when the kit has been opened. A label shall be affixed to the outside of the emergency kit indicating the beyond use date of the emergency kit. Emergency Dispensing The beyond use date of the emergency kit shall be the earliest beyond use date of any drug contained in the Requirements? kit. After an emergency kit has been used or upon discovery that the seal has been broken or upon the occurrence of the beyond use date, the kit shall be secured and returned to the pharmacy to be checked and/or restocked by the last authorized user. If the pharmacy is closed at that time, the kit shall be returned when it opens. An automated dispensing and storage system may be used as an emergency kit. Section 1330.520 Offsite Institutional Pharmacy Services (g)(2) In addition to the recordkeeping requirements of subsection (b)(2), a uniformly maintained, readily retrievable hard copy record or back-up documentation of each prescription or order dispensed shall be maintained by the pharmacy for 5 years and shall include: Name of resident; Date of order; Name, strength and dosage form of drug, or description of the medical device ordered; Quantity dispensed (a separate record should be maintained when the quantity billed differs from the Record Keeping quantity dispensed, e.g., unit dose transfer systems); Requirements? Directions for use; Quantity billed; Prescriber's name; Prescriber's signature and/or DEA number when required for controlled substances; and The drug name and identification code or the manufacturer in case of a generically ordered medication or a generic interchange. Section 1330.520 Offsite Institutional Pharmacy Services (b)(3) Nuclear A nuclear pharmacist who serves as the pharmacist-in-charge of a nuclear pharmacy and all other pharmacists employed in the pharmacy shall provide evidence to the Division of the following: 1. Licensure as a pharmacist in the State of Illinois; and 2. That he/she is named as an authorized user, or works under the supervision of a pharmacist who is named RPh Special Requirements? as an authorized user, on a commercial nuclear pharmacy license issued by the Illinois Emergency Management Agency (IEMA) or, when a nuclear pharmacist who works under a broad medical license at a university or research hospital has been approved as a user by that institution's radiation safety committee in accordance with conditions of the license issued by IEMA. Section 1330.540 Nuclear Pharmacy Services (i) The pharmacy shall have: 1. Space commensurate with the scope of services provided, but at least 300 square feet; and Facility Special Requirements? 2. A radioactive storage and product decay facility separate from and exclusive of the "hot" laboratory, compounding, dispensing, quality assurance and office areas. Each nuclear pharmacy shall have the following equipment: © tl;dr pharmacy llc. All Rights Reserved  1. Laminar flow hood; 2. Fume hood – minimum of 30 inches in height, which shall be vented through a filter with a direct outlet to the outside; 3. Dose calibrator; 4. Refrigerator; 5. Class A prescription balance or a balance of greater sensitivity; 6. Single-channel or multi-channel gamma scintillation counter; 7. Microscope; 8. Low level, thin-window portable radiation survey meter; 9. Drawing station – lead glass and lead lined; 10. Syringe shields; and 11. Energy Compensated Geiger Mueller (GM) Probe or ion chamber. Each nuclear pharmacy shall have the following reference texts available: 1. The current edition or revision of the United States Pharmacopoeia – Dispensing Information; 2. The current edition or revision of the United States Pharmacopoeia/National Formulary; 3. State and federal regulations governing the use of applicable radioactive material; and 4. U.S. Public Health Service Radiological Health Handbook. Section 1330.540 Nuclear Pharmacy Services (c)-(e) Remote Registration required: Special Licensure Any nonresident pharmacy remote prescription/medication order processing services shall first be registered in Requirements? its resident state and registered in Illinois Section 1330.560 Remote Prescription/Medication Order Processing (a)(1) Must Pharmacy Be Located at Not Specified Dispensing Site? Allowed, pending all requirements are met. Please see: Telework? From Out of State? Section 1330.550 Nonresident Pharmacies All pharmacists providing remote prescription/medication order processing at a remote pharmacy shall be licensed in Illinois. However, when pharmacists are providing remote prescription/medication order processing Must Pharmacist Have an In- for a community pharmacy licensed in Illinois from a community pharmacy licensed in Illinois but located out- State License? of-state, only the pharmacist-in-charge of the remote pharmacy must be licensed in Illinois Section 1330.560 Remote Prescription/Medication Order Processing (c) A pharmacy licensed under this Act may perform centralized prescription filling for another pharmacy, provided that both pharmacies have the same owner or have a written contract specifying: (i) the services to be provided by each pharmacy, Central Fill Allowed? (ii) the responsibilities of each pharmacy, and (iii) the manner in which the pharmacies shall comply with federal and State laws, rules, and regulations 225 ILCS 85/25.5 (b) Medical Offices Which Type of Providers Can Anyone licensed to practice medicine is authorized to purchase legend drugs and may dispense legend drugs in Receive/Store Medications? the regular course of practicing medicine. Administer? 225 ILCS 60/33 (a) Cannot be sold. This is grounds for disciplinary action by the board. Illinois Compiled Statutes Restrictions on Drug Samples? A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. Section 3100.380 Purpose of Issuance of a Prescription (b) Prior to dispensing a prescription to a patient, the physician shall offer a written prescription to the patient which the patient may elect to have filled by the physician or any licensed pharmacy Label requirements: o Date on which such drug or medicine is dispensed o Name of the patient o Last name of the person dispensing such drug or medicine Can Prescribers o Directions for use Prepare/Dispense o Proprietary name or names or, if there are none, the established name or names of the drug or Prescriptions? Controlled? medicine, the dosage and quantity, except as otherwise authorized by regulation of the Department. Sterile Compounding? The labeling requirements set forth in subsection (a) shall not apply to drugs or medicines in a package which bears a label of the manufacturer containing information describing its contents which is in compliance with requirements of the Federal Food, Drug, and Cosmetic Act and the Illinois Food, Drug, and Cosmetic Act. "Drug" and "medicine" have the meanings ascribed to them in the Pharmacy Practice Act, as now or hereafter amended; "good faith" has the meaning ascribed to it in subsection (u) of Section 102 of the Illinois Controlled Substances Act. 225 ILCS 60/33 Those licensed to practice medicine in Illinois must maintain a file of prescriptions and preserve these files for Requirements on at least five (5) years. However, a practitioner is not required to maintain a file of prescriptions when he/she Preparation/Storage/Logging? dispenses professional samples that do not exceed a 72 hour supply © tl;dr pharmacy llc. All Rights Reserved  225 ILCS 60/33 Drug Sources? Can Not Specified Pharmacies Supply Offices? Miscellaneous Correctional Facilities Section 1330.530 Onsite Institutional Pharmacy Services Dispensing Rules Veterinary/Animal Dispensing Not Specified Rules 1. Drugs may be dispensed by a licensed practitioner and only to patients treated in the institution during hours the outpatient institutional pharmacy services are not available. 2. Dispensed drugs should be limited to no more than a 72-hour supply, except: antimicrobials, unit of use Emergency Room/Urgent Care packages (inhalers, ophthalmics, otics, etc.); and drugs dispensed via a Remote Automated Pharmacy Dispensing Rules System. 3. Drugs dispensed from the ER must meet all labeling requirements applicable to community pharmacies. Section 1330.530 Onsite Institutional Pharmacy Services (e)(4) Other Facilities & Dispensing N/A Rules International Drug Sources Not Specified Rules PBM Rules Illinois Compiled Statutes Records Patient Records Yes. Records kept pursuant to this Section may be retained in an alternative data retention system, such as direct digital imaging system, provided that: The records maintained in the alternative data retention system contain all of the information required in a manual record Can Records be Held Digitally? The data processing system is capable of producing hard copy of the electronic record on the request Requirements for Printed Copy? of the Board, its representative, or other authorized local, State, or federal law enforcement or Other Requirements? regulatory agency The digital images are recorded and stored only by means of a technology that does not allow subsequent revision or replacement of the images The prescriptions may be retained in written form or recorded in a data processing system, provided that such order can be produced in printed form upon lawful request 225 ILCS 85/18 How Long do Controlled In-house for a minimum of 2 years Prescriptions Need to Be Held? CII? Illinois Compiled Statutes Section (b) CIII to V? How Long do Legend Prescriptions 5 years Need to Be Held? Section 1330.500 Community Pharmacy Services Every private and public health care facility shall, upon the request of any patient who has been treated in such health care facility, or any person, entity, or organization presenting a valid authorization for the release of records signed by the patient or the patient's legally authorized representative, or as authorized by Section 8-2001.5, permit the patient, his or her health care practitioner, authorized attorney, or any Who Can Request or Receive person, entity, or organization presenting a valid authorization for the release of records signed by the Records (Family, Others)? Any patient or the patient's legally authorized representative to examine the health care facility patient care Restrictions? POA? records, including but not limited to the history, bedside notes, charts, pictures and plates, kept in connection with the treatment of such patient, and permit copies of such records to be made by him or her or his or her health care practitioner or authorized attorney. Illinois Compiled Statutes (b) Reporting A. The recipient's name and address. B. The recipient's date of birth and gender. C. The national drug code number of the controlled substance dispensed. D. The date the controlled substance is dispensed. E. The quantity of the controlled substance dispensed and days supply. Requirements for Drug Monitoring F. The dispenser's United States Drug Enforcement Administration registration number. Programs? G. The prescriber's United States Drug Enforcement Administration registration number. H. The dates the controlled substance prescription is filled. I. The payment type used to purchase the controlled substance (i.e. Medicaid, cash, third party insurance). J. The patient location code (i.e. home, nursing home, outpatient, etc.) for the controlled substances other than those filled at a retail pharmacy. © tl;dr pharmacy llc. All Rights Reserved  The information required to be transmitted under this Section must be transmitted not later than the end of the business day on which a controlled substance is dispensed, or at such other time as may be required by the Department by administrative rule. Illinois Compiled Statutes (1)-(2) In every instance that a pharmacy is required by federal regulation (21 CFR 1301.76; 2014) to file with the U.S. Drug Enforcement Agency a Report of Theft or Loss of Controlled Substances (Form 106), a copy Requirements for Reporting shall concurrently be sent to the Division, Attention of the Drug Compliance Unit, along with the printed Suspected Fraud/Abuse? name of the person who signed the form. Failure to do so may result in discipline of the pharmacy or the pharmacist-in-charge. Section 1330.710 Reporting Theft or Loss of Controlled Substances Reports of adverse health care events required. Each health care facility shall report to the Department the occurrence of any adverse health care events no later than 30 days after discovery of the event. The report shall be filed in a format specified by the Department and shall identify the health care facility, but shall Requirements for Reporting ADRs? not include any information identifying or that tends to identify any of the health care professionals, employees, or patients involved Illinois Compiled Statutes (a) Requirements for Reporting Illinois Compiled Statutes (B) Licensure Violations? Requirements for Reporting Privacy Not Specified Violations? Patient Profile What Must RPh Review on Patient Drug regimen review includes the evaluation of prescription drug orders and patient records for Profile Prior to Dispensing? REMS 1. known allergies; Requirements? 2. drug or potential therapy contraindications; 3. reasonable dose, duration of use, and route of administration, taking into consideration factors such as age, gender, and contraindications; 4. reasonable directions for use; 5. potential or actual adverse drug reactions; 6. drug-drug interactions; Specific Requirements for Checking 7. drug-food interactions; PDMP/Interactions/Indication? 8. drug-disease contraindications; 9. therapeutic duplication; 10. patient laboratory values when authorized and available; 11. proper utilization (including over or under utilization) and optimum therapeutic outcomes; and 12. abuse and misuse 225 ILCS 85/3 Section (Y) Notes on Laws & Requirements FD&C Federal Food, Drug, and Cosmetic Act Established FDA Durham-Humphrey Amendment OTC vs. Rx Kefauver Harris Amendment Thalidomide PPPA Poison Prevention Packaging Act Child-resistant packaging requirement (PPPA) HIPAA Health Insurance Portability and Privacy of identifiable health information and security of electronic PHI Accountability Act HITECH Health Information Technology for Electronic health record implementation Economic and Clinical Health Act Adulterated vs. Misbranded Adulterated Sec. 14. A drug or device is adulterated Misbranded (410 ILCS 620/16) (f) Recalls Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, FDA Class I Recall a violative product will cause serious adverse health consequences or death. Class II Recall is a situation in which use of, or exposure to, a violative product may cause temporary FDA Class II Recall or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. © tl;dr pharmacy llc. All Rights Reserved  Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause FDA Class III Recall adverse health consequences. Other Recalls Additional Reading Definitions/References Red Book Drug Pricing Orange Book Therapeutic Equivalence Yellow Book International Travel Vaccines Green Book Animal Drug Products Pink Book Vaccine-Preventable Diseases Purple Book Biological Products USP 795 Nonsterile Compounding USP 797 Sterile Compounding USP 800 Hazardous Drug Handling The Prescription Required Fields 1. Name of the patient 2. Date when prescription was issued 3. Name and strength of drug or description of the medical device with directions for use 4. Quantity What Are the Required Elements for a 5. Directions for use Valid Prescription (ex. Name, DOB, 6. Prescriber’s name, address, and signature Address, Etc.)? 7. DEA number for controlled substances. DEA numbers shall not be required on inpatient drug orders 8. Prescription may, but is not required to, list the illness, disease, or condition for which the drug or device is being prescribed 225 ILCS 85/3 Section (e) Legend not specified. C-II: A pharmacist may not change the following components of a prescription for a Schedule II controlled substance: Date written, or add the date; What can RPh Correct/Change/Add to Name of the patient; Prescription (Legend/Controlled)? Name of the prescriber, or add a signature; and Name of the drug. Any other components of a prescription for a Schedule II controlled substance may be changed after consultation with the prescriber. Section 3100.400 Requirement of Prescription for Schedule II Controlled Substances What can non-RPh Pharmacy Staff Correct/Change/Add to a Prescription Not Specified (Legend/Controlled)? What Type of Substitutions Are Allowed? A generic drug determined to be therapeutically equivalent by the United States Food and Drug (Generic, Orange Book Equivalence, Administration (FDA) shall be available for substitution in Illinois Therapeutic Substitution, Etc.) 225 ILCS 85/25 Special Restrictions on Drugs/Refills? A pharmacist may exercise professional judgment to dispense an emergency supply of medication for a chronic disease or condition if the pharmacist is unable to obtain refill authorization from the prescriber, up to a maximum of 30 days supply. (225 ILCS 85/15.3) Special Requirements for Prescription No prescription may be dispensed after one year from the date of the original issuance of the Pads? prescription by the prescriber. ((Section 1330.500) (c)(1) A prescription for medication other than controlled substances shall be valid for up to 15 months from the date issued for the purpose of refills, unless the prescription states otherwise. (225 ILCS 85/3) (e) Fax Prescriptions Requirements for Type of Fax Machine? Can Patients Fax Their Prescription? Not Specified Prescribers from Outside Their Practice? What Controlled Schedules are Allowed? Electronic transmission of prescriptions shall be allowed, provided the following conditions are met: The prescription shall be transmitted directly, or through an intermediary, from the authorized Miscellaneous licensed prescriber to the pharmacy of the patient's choice. No intermediary shall alter the prescription information or content of the prescription. © tl;dr pharmacy llc. All Rights Reserved  The prescriptions shall comply with all applicable statutes and rules regarding the form, content, record keeping and processing of a prescription drug. The electronically transmitted prescription shall include the following: o The transmitting prescriber's facsimile number, if applicable; o The time and date of the transmission; o The identity of the person sending the prescription; o The address and contact information of the person transmitting the prescription. The electronic device in the pharmacy that receives the electronically transmitted prescription shall be located within the pharmacy area. A facsimile of an electronically transmitted prescription shall be non-fading and remain legible. The facsimile of the electronically transmitted prescription shall be stored in the pharmacy as required by State and federal laws or rules and may serve as the record of the prescription. The electronically transmitted prescription shall serve as the record of the prescription so long as the electronically submitted prescription can be stored and is readily retrievable so as to comply with federal and State record keeping requirements. To maintain confidentiality, adequate security and systems safeguards designed to prevent and detect unauthorized access, modification or manipulation of electronically transmitted prescriptions is required. A pharmacy or pharmacist shall not enter into an agreement with a practitioner or healthcare facility concerning the provision of any means for the electronic transmission of prescriptions that would adversely affect a patient's freedom to select the pharmacy or pharmacy department of his or her choice. Electronically transmitted prescriptions for controlled substances may be dispensed only as provided by federal law Section 1330.760 Electronic Transmission of Prescriptions Electronic Rx The prescription shall be transmitted directly, or through an intermediary, from the authorized licensed prescriber to the pharmacy of the patient's choice. No intermediary shall alter the prescription information or content of the prescription. Requirements for Electronic Prescribing? The prescriptions shall comply with all applicable statutes and rules regarding the form, content, record keeping and processing of a prescription drug Section 1330.760 Electronic Transmission of Prescriptions (a)(b) To maintain confidentiality, adequate security and systems safeguards designed to prevent and Requirements for detect unauthorized access, modification or manipulation of electronically transmitted prescriptions Certification/Technology? is required Section 1330.760 Electronic Transmission of Prescriptions (h) 1. Name of the patient, date when prescription was issued 2. Name, strength, and quantity of drug or description of the medical device with directions for use 3. Prescriber’s name, address, and signature; and DEA number for controlled substances. DEA numbers shall not be required on inpatient drug orders 4. Prescription may, but is not required to, list the illness, disease, or condition for which the drug or device is being prescribed Required Fields on Electronic 225 ILCS 85/3 (e) Prescriptions? The electronically transmitted prescription shall include the following: The transmitting prescriber's facsimile number, if applicable; The time and date of the transmission; The identity of the person sending the prescription; The address and contact information of the person transmitting the prescription. Section 1330.760 Electronic Transmission of Prescriptions (c) Schedule II - V What Control Schedules Are Allowed? Illinois Compiled Statutes Can RPh Make Changes to Electronic Not Specified Prescriptions? When filling or refilling a valid prescription on file in another state, the dispensing pharmacist shall be required to follow all the requirements of Illinois law which apply to the dispensing of prescription Can Electronic Prescriptions Be drugs. If anything in Illinois law prevents the filling or refilling of the original prescription it shall be Transmitted Across State Lines? unlawful to dispense 225 ILCS 85/19 (4) Phone Rx Name of the patient, date when prescription was issued Name, strength, and quantity of drug or description of the medical device with directions for use Prescriber’s name, address, and signature; and DEA number for controlled substances. DEA What Information Must Be Provided? numbers shall not be required on inpatient drug orders Prescription may, but is not required to, list the illness, disease, or condition for which the drug or device is being prescribed 225 ILCS 85/3 (e) © tl;dr pharmacy llc. All Rights Reserved  Who Can Phone in Prescriptions Not Specified (Prescriber, Staff, Receptionist)? Yes, student pharmacists may, under the supervision of a pharmacist, assist in the practice of Can Interns Receive New Prescriptions pharmacy and perform any and all functions delegated to him or her by the pharmacist. Via Phone/Voicemail? Refills? 225 ILCS 85/9 (c) Yes Can Technicians Receive New A registered pharmacy technician may be delegated to perform any task within the practice of Prescriptions Via Phone/Voicemail? pharmacy if specifically trained for that task, except for patient counseling, drug regimen review, or Refills? clinical conflict resolution. 225 ILCS 85/9 (a) Can Clerks/Cashiers/Others Receive New Prescriptions Via No Phone/Voicemail? Refills? Transfer Rx The pharmacist receiving the transferred prescription directly from the other pharmacist records the following: 1. The pharmacist transferring the prescription invalidates the prescription on file and records to which pharmacy the prescription was transferred, the date of issuance of the copy and the name of the pharmacist issuing the transferred prescription order; and 2. The name, address and original prescription number of the pharmacy from which the prescription What Information Must Be Provided? was transferred; 3. All information constituting a prescription order, including the following: name of the drug, original amount dispensed, date of original issuance of the prescription, and number of valid refills remaining; and 4. The pharmacist receiving the transferred prescription informs the patient that the original prescription has been cancelled at the pharmacy from which it has been transferred. Section 1330.720 Transfer of Prescription (a) Yes, student pharmacists may, under the supervision of a pharmacist, assist in the practice of Can Interns Transfer Prescriptions? pharmacy and perform any and all functions delegated to him or her by the pharmacist. 225 ILCS 85/9 No Can Technicians Transfer Prescriptions? The pharmacist transferring the prescription --The pharmacist receiving the transferred prescription Section 1330.720 Transfer of Prescription (a) A prescription for Schedule III, IV and V drugs may be transferred only from the original pharmacy and only one time for the purpose of original fill or refill dispensing and may not be transferred further. How Many Fills Can Be Transferred? However, a pharmacist who is electronically sharing real-time on-line computerized systems may transfer up to the maximum refills permitted by law and the prescriber's authorization. Section 1330.720 Transfer of Prescription (b) When filling or refilling a valid prescription on file in another state, the dispensing pharmacist shall be required to follow all the requirements of Illinois law which apply to the dispensing of prescription Any Specific Rules for Out-Of-State? drugs. If anything in Illinois law prevents the filling or refilling of the original prescription it shall be unlawful to dispense. 225 ILCS 85/19 (4) Packaging a) the name and address of the pharmacy wherein the same is sold or dispensed; b) the name or initials of the person, authorized to practice pharmacy under the provisions of this Act, selling or dispensing the same, c) the date on which such prescription was filled; d) the name of the patient; Information Required on Label? (List the e) the serial number of such prescription as filed in the prescription files; Data Elements) f) the last name of the practitioner who prescribed such prescriptions; g) the directions for use thereof as contained in such prescription; and h) the proprietary name or names or the established name or names of the drugs, the dosage and quantity 225 ILCS 85/22 OTC Label Requirements Labeling Requirements for OTC Drugs Follows federal guidelines: Child Safety Cap Requirements Poison Prevention Packaging Act | CPSC.gov Maximum beyond-use date allowed for prepackaged drugs shall be the manufacturers beyond-use Expiration/Use-By Date? date or 12 months, whichever is less Section 1330.730 Drug Prepackaging (b) Prescriber Special Authority or Restrictions by Type of Provider? (Dentists, Optometrists, Not Specified Etc.) © tl;dr pharmacy llc. All Rights Reserved  Counseling Prior to dispensing a prescription to a new patient, a new medication to an existing patient, or a medication that has had a change in the dose, strength, route of administration or directions for use, Requirements for Counseling the pharmacist, or a student pharmacist directed and supervised by the pharmacist, shall provide verbal counseling to the patient or patient's agent on pertinent medication information. Section 1330.700 Patient Counseling (a) Counseling shall include, but is not limited to: 1) Name and description of medication; 2) Dosage form and dosage; 3) Route of administration; 4) Duration of therapy; 5) Techniques for self-monitoring; Required Topics to Cover 6) Proper storage; 7) Refill information; 8) Actions to be taken in cases of missed doses; 9) Special directions and precautions for preparation, administration and use; 10) Common severe side effects, adverse effects, or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur. Section 1330.700 Patient Counseling (a) Disposal/Donation Used, expired, or unwanted pharmaceuticals may include unused medication and prescription drugs, as well as controlled substances if collected in accordance with federal law. This receptacle shall only permit the deposit of items, and the contents shall be locked and secured. The container shall be Special Disposal Requirements? accessible to the public and shall have posted clearly legible signage indicating that expired or unwanted prescription drugs may be disposed of in the receptacle. Illinois Compiled Statutes Disposal of unused medications prohibited. a) Except for medications contained in intraperitoneal solutions, intravenous fluids, syringes, or transdermal patches, no health care institution, nor any employee, staff person, contractor, or other person acting under the direction or supervision of a health care institution, may discharge, Patient Waste/Disposal? dispose of, flush, pour, or empty any unused medication into a public wastewater collection system or septic system 210 ILCS 150/ Safe Pharmaceutical Disposal Act. Section 150/10 Donations? Not Specified Drug Take-Back Days? Yes, if the drug had been dispensed to a patient of an institutional health care facility where a licensed healthcare professional administers the drug and the pharmacist ensures that: Are Returns Allowed? Drugs were stored in compliance with sanitary and facility requirements Drugs are not contaminated, deteriorated, or beyond their use date Section 1330.750 Return of Drugs No Can Returns be Dispensed? Section 1330.750 Return of Drugs Controlled Substances Note: Review List of Drugs by Schedule at https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf Prescriptions Special Prescription Pad Tamper-resistant Requirements? Section 140.443 Filling of Prescriptions (b) In addition to notifying the Division within 30 days, the departing pharmacist-in-charge shall, on the effective date of the change, inventory the following controlled substances: State Specific Restrictions? All Schedule II drugs, as defined in the Illinois Controlled Subs