MN Rules Ch. 6800 Part 1 Flashcards

Question

PHARMACY, SPACE, AND SECURITY

Answer 1

A. contains more than 250 square feet in the dispensing and drug storage area; B. maintains a prescription dispensing counter at least 18 inches deep that provides two linear feet, which must be kept clear and free of all merchandise and other materials not currently in use in the practice of compounding and dispensing, for each pharmacist and each technician working concurrently on compounding and dispensing; this counter shall provide an additional space for computers if they are used in the dispensing process; C. maintains an aisle behind the prescription dispensing counter at least 36 inches wide, extending the full length of the counter, which shall be kept free of obstruction at all times; D. issurrounded by a continuous partition or wall extending from the floor to the permanent ceiling, containing doors capable of being securely locked to prevent entry when the pharmacy is closed E. in the case of a community/outpatient pharmacy, contains an area where consultation between the patient and the pharmacist may be conducted with a reasonable assurance of privacy. All new and remodeled community/outpatient pharmacies must meet the standards of this item. A pharmacy licensed before January 1, 2011, must meet the standards within two years of that date, unless the pharmacy has an existing counseling area that has been deemed by the board to provide a reasonable assurance of privacy. If pharmacies use partitions to create a consultation area in which the patient will typically remain standing, the partitions must be sound-dulling and at least seven feet high and 24 inches deep. The patient must be able to enter the partitioned area so that the partitions are on each side of the patient. Consultation areas without partitions may be approved if the board deems the consultation area will provide a reasonable assurance of privacy. Consultation areas must not contain any item for sale apart from the articles needed for counseling sessions. Pharmacists must have access to patient profiles in order to comply with part 6800.0910. Consultation areas must be accessible to the patient from the outside of the prescription dispensing area and be open at all times when the pharmacy is open; and F. is lighted to a level of not less than 75-foot candles measured in the major work areas. Satellite waiver. In the interest of public health, the board may waive subpart 1, item A, for satellite pharmacies located in hospitals.

Answer 2

Change in location. Before a licensed pharmacy changesthe location of its business, it shall first submit to the Board of Pharmacy a new application for a license setting forth the changes and shall submit the information and documents required in an initial application for license. The new application and supporting documents shall be submitted at least 60 days before the proposed change in location. If the Board of Pharmacy approves the application, no additional charge shall be made for the new license. Change in dimension or security. No licensed pharmacy in Minnesota shall change its physical dimensions or elements of physical security until it has submitted documents and plans of the proposed changes to the Board of Pharmacy. The documents and plans shall be submitted at least 60 days before the proposed changes. The board shall, within 30 days after receipt of the proposed changes, notify the licensee that the proposed changes either comply or do not comply with part 6800.0700. Failure of the board to respond in writing within 30 days shall be considered to be approval of the proposed changes. Establishment of satellite. No licensed pharmacy in Minnesota shall establish a community or hospital satellite until it has submitted documents, plans, and operational policies and procedures for the proposed satellite to the Board of Pharmacy. The documents and plans must be submitted at least 60 days before the proposed establishment of the satellite. The board must, within 60 days after receipt of the proposal, notify the licensee that the proposed satellite either complies or does not comply with part 6800.0700. Failure of the board to respond in writing within 60 days shall be considered to be approval of the proposed satellite.

Answer 3

A. Upon receipt of a new Rx, following a review of the patient's record, a RPh shall personally initiate discussion of matters which in the professional judgment of the pharmacist will enhance or optimize drug therapy with each patient or the agent or caregiver of the patient. The discussion shall be in person, whenever applicable, may be supplemented with written material, and shall include appropriate elements of patient counseling. These elements include the following: (1) the name and description of the drug; (2) the dosage form, dose, route of administration, and duration of drug therapy; (3) intended use of the drug and expected action; (4) special directions and precautions for preparation, administration, and use by the patient; (5) 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; (6) techniques for self-monitoring of drug therapy; (7) proper storage; (8) prescription refill information; (9) action to be taken in the event of a missed dose; and (10) pharmacist comments relevant to the patient's drug therapy, including any other information peculiar to the specific patient or drug.

Answer 4

B. RPh must counsel the patient on refills if deemed necessary in the RPh's professional judgement. Must be in person when applicable. May vary or omit patient information if in the best interest of the patient due to the particular individual circumstances involved. Any variation or omission of counseling for 'new or refilled Rx's' and the circumstances involved shall be noted on the Rx, in the patient's records, OR in a specially developed log. Personal RPH communication is not required for inpatients of a Hospital or other institutions where other health care professionals are authorized to administer drugs or where the patient or patient's agent or caregiver has indicated desire not to receive the consultation. Mailed or delivered new & refilled Rxs: Consultation required and can be accomplished by providing written information and the availability of RPh to answer questions by providing a toll-free phone number for long distance calls. Nothing in this part prohibits RPhs from charging for these services.

Answer 5

14 Days before closing and ceasing operations must notify board on intentions. At time of closing: A. Return license to the board office - noting the closed date. B. Notify board as to the disposition of the Rx files, Insulin, Hypodermic Syringes & Needles, Contraceptives & Devices, Chemicals, and Non-Rx Drugs. D. If closing has been computerized - give a printout of all patient profiles to the pharmacy that is receiving the Rx files. E. Inform succeeding business occupying the premises & the landlord, if any, that it's unlawful to use the words "drugs, drug store, or pharmacy" or similar unless it is a licensed pharmacy. F. Controlled Substance Inventory - which will serve as the final inventory of closing pharmacy and initial inventory of the pharmacy receiving the controlled substances. A copy of the inventory shall be included in the records of both. Do NOT need to file inventory with DEA unless requested.

Answer 6

1. If controlled substances are to be destroyed - RPH-In-Charge must contact local DEA for instructions. 2. If CIII - V are being transferred must be done on duplicate invoices with each pharmacy keeping a copy. 3. CII narcotics being transferred must submit a DEA 222 form to the transferor. 4. If DEA does NOT approve of transfer, instructions must be provided to closing pharmacy to dispose of the drugs according to the written instructions provided by regional director.

Answer 7

Must notify by at least one of the following that informs patients that pharmacy will close of a specified Date & provides the Name, Address, & Phone Number of pharmacy where Rx files will be tranferred: A. Local Newspaper for One Week prior to date of closing. B. Direct mailing to Pts who have at least One Rx filled during the past 6 months preceding date of closing. Must reach Pts no later than ONE business day prior to closing. C. Distribute notice to Pts picking up Rxs at least 30 days prior to date of closing. LTC Facility: written notice to the patients, caregivers, OR LTC facilities where Pts reside at least 30 days prior to date of closing.

Answer 8

May be hard copy or electronic form (except as indicated). Laws of Pharmacy - most recent edition Rules of Board of Pharmacy DEA Regulations, Code of Federal Regulations title 21 parts 1300 - 1316 - current copy One current reference from each category A-C. A. Pharmacotherapy references: (1) Goodman and Gilman's The Pharmacological Basis of Therapeutics; (2) Applied Therapeutics: The Clinical Use of Drugs; (3) Pharmacotherapy: A Pathophysiologic Approach; and (4) Conn's Current Therapy. B. Dosage and Toxicology (1) American Hospital Formulary Service; (2) Facts and Comparisons; and (3) Drug Information Handbook. C. General References (1) Handbook of Nonprescription Drugs; (2) Physician's Desk Reference; (3) Remington: The Science and Practice of Pharmacy; (4) United States Pharmacopeia - National Formulary; (5) United States Pharmacopeia - Pharmacists' Pharmacopeia; (6) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations; (7) The Merck Manual. LTC Pharmacies - must ALSO have most recent edition of MN Dept of Health rules pertaining to medication handling in long-term care facilities and a current general reference on geriatric pharmacotherapy. Specialty Pharmacies serving a unique population must ALSO have a current reference appropriate to the patient base served.

Answer 9

Minimum Equipment -clean and in good working order: A. Rx Balance Class A defined by USP-Natl Formulary with one set of accurate metric weights from 50mg to 100 g OR an electronic balance of equal or greater accuracy. B Measuring devices - volumes from 1 ml to at least 500 ml. C. Mortars, Pestles, Spatulas, Funnels, Stirring Rods, and Heating Apparatus as necessary to meet the needs of that pharmacy. D. Other equipment as necessary to comply with requirements of USP chap 795 E. Refrigerator Only used for drug storage OR a separate compartment of refrigerator. Must record temperatures for proper storage of legend drugs manually in logs or electronic temperature recording. F. Sink w/ Hot & Cold water G. Toilet with hand-washing and disposable towels in a reasonably accessible area. In Pharmacy preparing Compounded Sterile Products ALSO must have: A. minimum equipment to comply with USP Chap 797 appropriate to risk-level requirements. B. Current reference materials or books for sterile products or IV imcompatibilities. C. USP chap 797 current copy

Answer 10

Expires March 1 of each year and shall be renewed annually on or before February 1. Fee is $105 Late fee after March 1 is 50% of renewal fee. Post in a conspicuous place within pharmacy. Community Rx must be visible to public.

Answer 11

Sworn statement not practicing in MN Continue to pay renewal fees Does NOT have to meet CE requirement To reactivate license: If inactive for 5 years must retake MPJE and show compliance with CE requirement in another state where they remained active OR show that 15 hrs of CE per year were obtained for the inactive years plus take MPJE is 5 years or more. Emeritus: retired RPh may apply if has not been disciplined by the board. It's a formal recognition of completion of that individuals pharmacy career in good standing.

Answer 12

Grads of schools of pharmacy accredited by ACPE: Eligibility Application, Affidavits of Internship, Copy of Official & Certified Birth Record, Recent Photograph, Official Certified Final Transcript showing date graduated with BS or Doctor degree as the first professional undergraduate degree in pharmacy, Check for Application Fee. Register & Pay NABP for NABPLEX & MPJE. Both must be passed before licensure is granted. Canadian Council Accreditation of Pharmacy Program (CCAPP) grads with curriculum taught in English (between 1993 - 6/30/2004 Foreign Pharmacy Graduate Equivalency Exam and certification by FPGEC and English Tests not required) Before 1993 or after 6/30/2004 FPGE and certification by FPGEC IS required for English taught Canadians and Foreign Language taught Canadians and demonstrate English language proficiency by passing the TOEFL and the Test of Spoken English, or the TOEFL Internet-based Test. Plus obtain 1600 hrs of internship after certified by FPGEC. If obtaining internship in MN must register. Outside states must certify internship hours. In addition to the other application requirements. Foreign Pharmacy Grads: same as Canadians after 2004. Grads of 4 year foreign pharmacy schools/programs are not eligible for licensure as pharmacists in MN.

Answer 13

May retake within 18 months up to 3 times. After failing 3 x must petition the board and may have to resubmit full application and fee.

Answer 14

18 months Fees are not refundable

Answer 15

Examined and Licensed - Prior to 1/1/1973: 2080 hours practical experience under the instruction of a licensed RPH. Between 1/1/1973 - 5/1/2003: 1500 hours practical experience under the instruction of a licensed RPh to be acquired after successful completion of the 1st professional academic year of the standard 5 or 6 yr Rx curriculum, 400 of which may be acquired concurrently w/ college attendance, in clinical Rx programs, or in demonstration projects that have been approved by Tripartite Committe on Internship & the Board of teh active member state from which the applicant applies. After 5/1/2003: 1600 hours practical experience under licensed RPh, acquired p completion of 1st prof yr of standard 6 yr Rx curriculum, w/ 800 hours being of a traditional compounding, Pt counseling, & dispensing nature.

Answer 16

Practicing as a licensed RPH: the # of weeks the applicant has practiced as a licensed RPh must be = to or > the # of weeks the applicant is deficient in internship experience.

Answer 17

NAPLEX required if applicant has not practiced as a licensed RPh for the 2 years immediately preceding the time of filing of their application for reciprocity.

Answer 18

MPJE exam required

Answer 19

Annual license Post in conspicuous place Expires June 1st at midnight. Renew via application before May 1 each year + application fee. Late fee is 1/2 of the renewal fee. Application that is not completed within 12 months is no longer valid. Prohibition: place of business may not be personal residence. Separate licenses required: Each location of wholesale distribution in or out of Minnesota (if shipped from out of state into MN must have license). Manufacturer that does NOT ship drugs into MN from any location that it directly operates must STILL obtain a license if it does business with ACCOUNTS in MN.

Answer 20

The following information is required from each wholesale drug distributor applying for licensure or renewal: A. the name, full business address, and telephone number of the licensee; B. all trade or business names used by the licensee; C. addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of drugs; D. whether the ownership or operation is a partnership, corporation, or sole proprietorship; and E. the name of the owner and operator of the licensee, including: (1) if an individual, the name of the individual; (2) if a partnership, the name of each partner, and the name of the partnership; (3) if a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation; and (4) if a sole proprietorship, the full name of the sole proprietor, and the name of the business entity. Changes in any information in items A to E shall be submitted to the board within 30 days of the change.

Answer 21

Board may deny, suspend, revoke or refuse to renew any license for a wholesale drug distributor based on board's finding of any of the following: A. any convictions of the applicant under any federal, state, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances; B. any felony convictions of the applicant under federal, state, or local laws; C. the lack of previous experience on the part of the applicant in the manufacture or distribution of drugs, including controlled substances; D. the furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution; E. the suspension or revocation by federal, state, or local government bodies of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances; F. the lack of compliance by the applicant with licensing requirements under previously granted licenses, if any; G. the lack of compliance by the applicant with requirements to maintain or make available to the Board of Pharmacy or to federal, state, or local law enforcement officials those records required under this part; and H. the lack of compliance by the applicant with requirements for the storage and handling of drugs as specified in part 6800.1440.

Answer 22

Each employee must have education, training, and experience (in any combination) sufficient to do assigned work in a manner that maintains the quality, safety, and security of the drug products.

Answer 23

All facilities at which drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall: A. be of suitable size and construction to facilitate cleaning, maintenance, and proper operations; B. have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions; C. have a physically separate area for storage of all drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened; D. be maintained in a clean and orderly condition; and E. be free from infestation by insects, rodents, birds, or vermin of any kind.

Answer 24

A. All facilities used for wholesale drug distribution shall be secure from unauthorized entry as follows: (1) access from outside the premises shall be kept to a minimum and be well-controlled; (2) the outside perimeter of the premises shall be well-lighted; and (3) entry into areas where drugs are held shall be limited to authorized personnel. B. an alarm system to detect entry after hours. C. a security system that will provide suitable protection against theft and diversion, including protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records when applicable.

Answer 25

Store all drugs at temperatures according to USP/NF If no storage requirements in USP/NF store at controlled room temperature as defined by USP/NF. Must use some means of documenting proper storage of drugs. Record keeping in subpart 8 must be followed for all stored drugs.

Answer 26

Upon receipt visually inspect each shipping container for damage or contamination. Each outgoing shipment must be carefully inspected for identity of drug products and to ensure no delivery of damaged drugs or drug held under improper conditions. Record keeping required.

Answer 27

Drugs that are damaged, outdated, deteriorated, misbranded or adulterated must be physically separated until they are destroyed or returned to their supplier. Examination to determine this must include consideration of storage conditions under which the drug has been held, stored or shipped before or during its return and the condition of the container, carton, or labeling. Record keeping required.

Answer 28

Maintain Inventories and Records of all Transactions of receipt, distribution or other disposition of drugs. Records Include: 1. Source: name, principal address of seller or transferor & address where shipped. 2. Identity & quantity of drugs 3. Dates of receipt & distribution or other disposition Inventories must be available for 2 years following disposition of drugs. Records kept at inspections site OR electronically retrievable must be immediately available for authorized inspection. Records kept at a central location (not electronically retrievable) must be available w/i 2 weeks of request.

Answer 29

P&P for receipt, security, storage, inventory and distribution of drugs. Include P&P for identifying, recording, and reporting losses or thefts and for correcting all errors and inaccuracies in inventories. Include: 1. Oldest stock is distributed first. Deviation allowed if temporary and appropriate. 2. Recalls and Withdrawal of drugs form market (initiated by FDA, BOP, other legal state, federal or govt OR Voluntary w/d OR any action to promote public health and safety) 3. Prepare for any crisis effecting security or operation (strike, fire, natural disaster, state/local/federal emergency). 4. Ensure outdated drugs are segregated and destroyed/returned to manufacturer. Written documentation of disposition. Maintained for 2 years after disposition.

Answer 30

Maintain list of officers, directors, managers and other persons in charge including description of duties and summary of qualifications. Comply with federal, state, and local laws and regulations. Permit BOP and authorized federal, state, and local law enforcement to enter and INSPECT premises and delivery vehicles and to AUDIT at reasonable times and manner to the extent authorized by law. If deal with controlled substances must register with BOP and DEA and comply with all applicable laws.

Answer 31

A person engaged in the manufacturing of drugs, medicines, chemicals, or poisonsfor medicinal purposes whose place of business is located in Minnesota must comply with the current Good Manufacturing Practices regulations for finished pharmaceuticals published by the United States Food and Drug Administration

Answer 32

RPH - 30 hours in previous 2 years reported by September 30 even numbered years. An extension of 1 year may be granted by BOP. Maintain completed records. Tech - 20 hours per 2 years by July 31 odd numbered years. otherwise the same as above. CE Providers - may register with BOP. Details of program (everything), record keeping, evaluation, record keeping (3 years maintained), application must cover 2 year reporting period for which approval is sought, etc. Submit application at least 45 days prior to program. BOP will assign the # of CE hours. BOP approval or denial w/i 60 days of receiving application. RPH or Tech may submit completed CE for BOP approval w/i 90 days of completion. Provide: title, site, date, type, length, program outline, description of evaluation mechanism used at the program. CE for Presentation of Professional Lectures: RPH may apply for credit of in-service training programs or lectures of subjects including the definition of Continuing Pharmacy Education. Credit will be granted 1x per reporting period. CE for Preceptor Training Program - RPh who applies will be granted approval if program was developed by BOP. Program Promotion: no reference to "approved program provider" unless approved by BOP or ACPE. If endorsed may only state: : "This program is approved by the Minnesota Board of Pharmacy for ____ hours of continuing education credit." CE Advisory Task Force: no more than 10 members, 3 RPHs designated by MN State Pharmaceutical Assoc, 3 RPh designated by MN Society of Hospital Pharmacists, 2 RPh designated by College of Pharmacy of U of MN, 2 members designated by BOP. Task force will meet annually and elect a chair and vice chair from its membership. Executive Director of BOP is the Secretary of task force.

Answer 33

At least 1 RPH on duty and physically present at all times except for brief absences arising out and in the course of pharmacy practice. When closed or no RPh on duty, no one allowed access except as provided by law.

Answer 34

Max work hours is 12 continuous hours per day inclusive of breaks. Exception for emergencies: May work longer than 12 hours if required in order to minimize immediate health risks for patients. Breaks Required: > 6hrs - 30 minutes uninterrupted break during that time period. Bathroom breaks w/i 4 hours. May close but not required when RPH is on a break. If not closed RPH stays within in pharmacy or within establishment where pharmacy is located in order to be available for emergencies. The following applies during RPH break: 1. Techs etc (supportive staff) may continue to perform authorized duties. 2. No duties reserved to RPh & RPH Interns may be performed. 3. Only Rxs certified by a RPh may be dispensed. If counseling required may only be dispensed if the following conditions are met: a. Pharmacy develops of list of drugs that may not be dispensed while RPH on break w/o counseling b. Patient or Caregiver is told RPh is on break and is offered chance to wait. If they decline to wait the PHONE NUMBER is obtained and RPH makes reasonable effort to contact them by phone upon return & documents that counseling was provided OR if not provided documents why including - efforts made. Retain record for at least 2 years. Stagger breaks if more than 1 RPH is on duty.

Answer 35

Prohibited conduct: A. Inference in public of professional superiority in practice of Rx that can't be substantiated. B. Publication of false, misleading or deceptive statements C. Refusing to compound or dispense Rxs that may be reasonably be expected except as provided by MN statutes 145. 414 and 145.42 D. Kickbacks, except monetary rebates or discounts which are returned to actual purchaser of drugs as a cost justified discount or to meet competition are permitted if they conform with existed state & federal rules & regulations. E. Discrimination by race, color, creed, religion, disability, national origin, marital status, sexual orientation, sex or age. F. Refusing to consult or attempting to circumvent consulting requirements. G. Can't require patrons to be members or any association as a condition for obtaining professional services. H. Violation of any law, rule, regulation, ordinance. I. Divulging PHI or any health information except where allowed by law. J. Participation in institutional drug distribution as a consultant without providing pharmaceutical services in accordance with accepted principles of pharmacy practice and in compliance with federal and state laws or rules. K. Engaging in any Rx practice which constitutes a danger to public including substantially departing form standard of care which could harm a patient.

Answer 36

Legend drug prices may be provided to public only by a pharmacy if all the following conditions are met: A. No representation concerning drug's safety, effectiveness, use, or competitive comparison shall be made. B. No reference to CII - IV of current Federal Controlled Substance Act and rules of MN BOP. C. Termination date for the prices must be in the ad.

Answer 37

The selling, giving away, or otherwise disposing of accessories(i.e., glassine papers, empty capsules, quinine, lactose, orsimilar products), chemicals, or drugsfound in illegal drug traffic is unprofessional conduct by a pharmacist when the pharmacist knows or should have known of their intended use in illegal activities.

Answer 38

It is unprofessional conduct for a pharmacist to sell, purchase, or trade, or offer to sell, purchase, or trade, any drug that was purchased by a public or private hospital or other health care entity or that was donated or supplied at a reduced price to a charitable organization. EXCEPTIONS: 1. Hospitals or Health care entities that are under common control. 2. Emergency Medical Reasons - i.e., temporary shortages 3. Pursuant to a prescription 4. Group purchasing organization

Answer 39

Maintain orderly, clean and sanitary conditions at all times.

Answer 40

Hazardous waste disposal must comply with chapter 7045 enforced by Pollution Control Agency (MPCA) & others.

Answer 41

Must be designated in the application for license and each renewal. Only ONE per location except may be waived if RPh is serving a hospital pharmacy on a part time basis. 1. Establish P& P's 2. Ensure everyone is licensed or registered with the board 3. Supervise all of the professional employees 4. Develop procedures for technicians 5. Establish and supervise meth and manner for storin and safekeeping of drugs 6. Establish and supervise record keeping 7. Notify board immediately upon receiving knowledge that his or her services as RPH -In-Charge have been or will be terminated. Pharmacy must notify immediately as well. BOP will supply successor forms that must be completed and filed within 10 days. Successor must acknowledge any variances and ensure that any conditions on granted variances continue to be met. 8. Respond to deficiency reports. * 30 days to submit in writing to the board the steps taken or proposed to eliminated deficiency - failure is grounds for disciplinary action by board. 9. Ensure staffing and operational quality assurance policies are developed, implemented and followed for purpose of decreasing and monitoring Rx errors.

Answer 42

Notify board immediately

Answer 43

Pharmacy must notify board > 60 days prior to initial use of device or system. BOP must provide written notification within 60 days of receiving documentation with steps required for pharmacy to use the system. Develop P & P May use unless notified by the BOP that the pharmacy may not. Provide Training on a regular basis and document training. Procedure to Calibrate and prevent cross contamination of cells and cassettes. Procedure to verify correct drug is being dispensed. Continuous Quality Assurance P & P's. RPH must review and approve each Rx order prior to dispensing. Access to drugs when RPH has not reviewed and approved Rx order allowed if there is a formal written decision to allow such access by pharmacy and therapeutics committee or equivalent. P & T must specify Pt care circumstances when it is allowed and the staff that are allowed to access. Access limited to Rx and Non-Rx authorized personnel that are assigned an individual access code or biometric id. P&P specifying time access parameters such as time-outs, log-offs, and lock-outs must be in place. System records must include: Identity of personnel who access it Reason for access Date & Time of access Name, Strength, Dosage Form, Quantity of drug removed, returned or wasted. Name of Patient Any additional info the RPH-In-Charge deems necessary RPh-In-Charge responsible for reviewing records on a periodic basis and ensure appropriate action for discrepancies. P & T committee develops and reviews a list of drugs prohibited from distribution through system at least annually. High alert drugs may be dispensed by system only if P & T determine not to include it on prohibited drug list. Pt specific additions determined by a RPh.

Answer 44

Allows access to more than one drug at a time. Must be limited to non-controlled drugs unless entire drawer contains only one controlled drug. Non-controlled may be stored in open matrix drawer if the following are met: 1. Large bulky items such as IV infusion bags 2. Non-legend drugs safely arranged. 3. Legend drugs that are not look-alike products 4. Drugs properly packaged and labeled for an individual patient

Answer 45

Must be checked by a 2nd licensed health care professional. This does NOT apply when: 1. A RPH has reviewed and approved the Rx drug order prior to removal of high-alert drug from the system. 2. A Licensed practitioner controls the ordering, prep & administration of the drug during a medical procedure 3. The prescribing practitioner has determined that the high-alert drug must be administered before the drug can be reviewed by a RPh or 2nd licensed health care professional.

Answer 46

RPh must certify unless the certification process utilizes a fail-safe bar coding. Certification must be documented and records maintained for 2 years. System must be secured or kept in a locked med room when not in use. Unused drugs must be returned to the pharmacy or to system's secure designated return bin or equivalent area. Restocking may only be performed by designated pharmacy personnel with required certification.

Answer 47

Must be done at least monthly at a minimum to ensure (all need not be assessed at the same time): 1. drugs are properly stored in their assigned locations and in pharmacy approved configurations. 2. outdated drugs are removed and replaced 3. only approved drugs are in the device 4. inventory levels are appropriate based on usage 5. device and drugs are secure Controlled drugs - audit by pharmacy at least monthly System must maintain patient confidentiality so that unauthorized people do not have access to patient data. Continuous QA developed for system. An ongoing failure mode effect analysis or QA process must be in place and address possible system failures, process failures, high-alert drugs, med errors, and controlled substance discrepancies.

Answer 48

Reuse prohibited except in a hospital with a licensed pharmacy where items for inpatients only have not left the span of control of the pharmacy. Nursing homes and Assisted Living Facilities. Returned drugs may be re-dispensed if: 1. facility has 24 hours on-site licensed nursing coverage 7 days a week. 2. drugs are returned to same pharmacy that dispensed them. 3. consultant RPH can assure proper storage conditions and the drugs are stored in a secure area. 4. integrity of packaging remains intact (no reconstituted drugs, no drugs requiring refrigeration, no controlled substances may be returned). 5. original manufacturer packaging or packaging by pharmacy meets or exceeds criteria for class B packaging established by USP and procedures have been developed and implemented to prevent commingling of dosage units of different lot numbers or expiration dates. Including: drug name, strength, packager's name, manufacturer's or packager's lot or batch number) Commingling of returned drugs or mixing of lot numbers upon or prior to repackaging shall result in drugs being deemed MISBRANDED and subject to embargo under MN Statues. This does not apply to medical devices provided that sanitary procedures are used prior to reuse, resale or re-rent thereof.

Answer 49

May not provide blanks that refer to any specific pharmacy or pharmacist in any manner whatsoever. No pharmacy or RPh shall actively or passively participate in any arrangement or agreement whereby prescriptions are prepared, written or issued in a manner which refers to a specific pharmacy or RPh.

Answer 50

Restrictions on Pickup or Delivery of Rx's: must be a licensed pharmacy except may pick-up or delivery at the home/office of prescriber, residence of patient, hospital or LTC facility in which patient is confined. May deliver filled Rx's at patient's place of employment or designated caregiver if the following are met: 1. obtains and documents authorization of Pt or Caregiver 2. delivered directly to Pt or Caregiver 3. ensure security of PHI

Answer 51

Pharmacy that employs USPS or other common carrier to deliver filled Rx's directly to a patient must: 1. use adequate storage/shipping containers/shipping process to ensure drug stability and potency. Use appropriate packaging material and devices according to recommendations of the manufacturer or US Pharmacopeia to ensure appropriate storage temps throughout delivery process. 2. Shipping containers are sealed to detect evidence of opening or tampering 3. P&P to ensure accountability, safe delivery and compliance with temperature requirements. Must address discrepancies and provisions for replacing drugs 4. Provide electronic, telephonic or written counseling to the patient by RPH or RPH intern. Must include information on what to do if integrity of the packaging or med has been compromised during shipment. Adulteration: a drug is adulterated if it has been exposed to fire, water, or extreme temps which have rendered it injurious to health.

Answer 52

For a pharmacy other than a hospital that is transmitting solely within the institutions, the procedures must ID the person sending the Rx order. If the fax copy is NOT readily readable for at least 5 years, ALL faxes must be followed by a hard copy within 72 hours OR the RPh must reduce the order to writing that is permanent quality. CII - IV Rx's must meet the rules of the federal DEA. May not fill or dispense Rx's faxed by the patient.

Answer 53

Practitioner or their agent only may transmit an Rx to answering machine/voice recording device. RPh or Intern working under RPh only can retrieve NEW Rx. Technician may retrieve refills of an Rx already dispensed if no changes. Clerical personnel may not retrieve any drug orders/refills. Verbal Rx's must be reduced to writing meeting all criteria required for written Rx's.

Answer 54

Performed only by a RPh, Practitioner or RPH Intern under direct supervision of RPH: a. determination of brands and suppliers b. receipt of verbal Rx (must include documentation of person communicating order and RPh or Intern receiving order) c. verification of Rx (must be of the Original Rx) d. selection of the drug to be used in filling Rx e. establishment and validation of the initial formulation record of all compounded preparations f. certification of the filled Rx: check the original labeled container (or computerized image of oral solid drugs), check labeling on the container that will be dispensed, check contents and appearance of total product to ensure all the doses are the correct drug - strength - dosage form prescribed, review Pt's med profile for a prospective drug review and accuracy of the addition to the profile of the drug dispensed, place Rph/Practitioner/RPh Intern's unique identifier on the Rx order or other permanently maintained record (if using automated dispensing system P&P provides that all certification steps are performed and documented before med is dispensed and is available to the BOP for inspection upon request) g. ensure permission to refill is obtained from an authorized practitioner, noting on reverse side of Rx or in electronic record the following data: 1. date refilled 2. name of practitioner's agent communicating/transmitting refill 3. name of practitioner's agent authorizing communication where applicable. 4. quantity of drug dispensed if different from original Rx 5. unique identifier of the RPh refilling the Rx h. supervising clerical personnel and technicians

Answer 55

For prescriptions filled in a pharmacy, the unique identifier of each pharmacist, pharmacist-intern, or pharmacy technician who performs any portion of the prescription filling process must be documented, with the documentation maintained for a minimum of 2 years. The documentation must indicate which portion of the prescription filling process each pharmacist, pharmacist-intern, or pharmacy technician completed. For prescriptions filled by a practitioner, the unique identifier of each practitioner and each individual who assists the practitioner be documented and the documentation maintained for a minimum of 2 years.

Answer 56

A pharmacy utilizing a CSP must notify the pharmacy's patients of this fact.

Answer 57

Applies to all pharmacies. Provided, however, that nothing in this part prevents RPh's in Hospitals from dispensing to hospital inpatients according to 6800.7100 to 6800.7950

Answer 58

System required. Immediate retrieval of information. One profile record may be maintained for all members of a family living at the same address and possessing the same family name. Minimum information required: a. name, address, phone number, DOB or age, gender b. individual history including: disease state(s), known allergies & drug interactions, list of prescriptions including Rx # - name strength of drug/device - quantity - date received by the Pt - name of Prescriber, if info received by someone other than RPh the RPh must review it with the patient c. RPh comments relevant to Pt drug therapy including where appropriate: pharmaceutical care needs of the patient, services rendered by the RPh, RPh's impression of the Pt's drug therapy This documentation is not required for residents of a licensed nursing home where a consultant RPh is performing regular DURs. Prospective DUR's may rely on computerized medication profile review provided it includes all drugs dispensed by the pharmacy during at least the preceding 6 months. RPH-In-Charge must develop procedures for handling alerts. Only a RPh or RPh Intern may override the alerts. Patient Profile must be maintained for at least 2 years from the date of the last entry in hard copy or computerized.

Answer 59

CII cannot be transferred CIII-V have additional limitation on transfers by DEA. Duties of transferring RPh or Intern: 1. write VOID across face of current Rx OR if computerized void all remaining refills 2. record on reverse side of voided Rx or in electronic record: Name, Address, Phone# of receiving pharmacy and Name of of receiving RPh or Intern, Date of transfer 3. additional info for CIII - V: also record the DEA Registration Number of the receiving pharmacy and names of receiving and transferring RPhs or Interns. *keep original on file for 2 years from date of last filling Duties of receiving RPh or Intern: 1. write TRANSFER or COPY or word of similar import on the face of the transferred Rx (plus info required on an Rx by law) plus: 2. Date of Issuance and of Filling of the original Rx 3. original # of Refills 4. # of valid refills remaining 5. date of last refill 6. original Rx # 7. transferring pharmacy's name, address, phone #, names of transferring RPh or Intern 8. plus DEA Registration # for CIII - V *keep transferred Rx order on file for at least 2 years from date of last filling. Notify the patient that the transferred Rx has been invalidated. Pharmacies accessing a common electronic file or data base used to maintain required dispensing information are not required to transfer prescription drug orders or information for dispensing purposes between or among pharmacies participating in the same common prescription file or data base; provided, however, that any such common file or database must contain complete records of each prescription drug order and refill dispensed and further, that a hard copy record of each prescription drug order transferred or accessed for purposes of refilling must be generated and maintained at the pharmacy refilling the prescription or to which the prescription has been transferred. Prescription drug order information shared between two pharmacies which are accessing the same real-time, online database, according to the operation of a board-approved central service operation shall not be considered a prescription copy and is not subject to the requirements of this part.

Answer 60

Supervising RPh shall cause to be prepared and keep a packaging control record containing the following: 1. Date 2. ID of drug - name, dosage form, manufacturer or distributor, lot #, strength, original expiration date 3. container specifications 4. copy of the label 5. unique identifier of packager 6. ID of supervising RPH 7. quantity per container 8. internal control number or date Labeling: 1. name of drug 2. strength 3. name of manufacturer or distributor 4. a beyond use date or earlier date in the RPh's professional judgement 5. internal control # or date 6. after 7/1/2008 - a physical description including any ID code that appears on dosage form or a bar code based on the NDC. Such description does not need to be placed on individual unit-doses provided that the pharmacy dispenses the unit doses in outer packaging that contains a physical description of the drug OR the pharmacy dispenses less than a 72-hour supply of the unit doses 7. radiopharmaceuticals must be labeled according to law

Answer 61

Nonsterile compounding must follow USP chap 795 standards Sterile compounding must follow USP chap 797 standards Develop list of HIGH-ALERT compounds for which a RPH must certify each component used in compounding to ensure it has been accurately weighed, measured, or subdivided, as appropriate, at each stage of the compounding procedure (effective 1/2/2013)

Answer 62

Prepackaged, Unit of use, blister card: no more than 1 year from packaging date MUST be placed on ALL. Rx Vials: An expiration date is NOT required. If there is one must meet the above.

Answer 63

Applies to all Rxs dispensed to a patient except radiopharmaceuticals or inpatient of a hospital. 1. Pharmacy name, address, phone # (central service pharmacy uses name of dispensing pharmacy) 2. Patient's name 3. Rx # 4. Sig 5. Manufacturer or Distributor name 6. Auxiliary labels as needed 7. Date of Original issue or renewal 8. Drug generic or trade name & strength (except when specified by prescriber to the contrary) 9. Central Service Pharmacy filled Rx must bear identifier that indicates CSP where filled. 10. Post 7/1/2008 if not dispensed in original manufacturer bottle must label with physical description including ID codes that appear of tablet or capsule. (except drugs dispensed in investigational study) 10a. If immediate container of med does NOT permit full labeling, a PARTIAL label containing at MINIMUM Patient Name & Rx # may be placed WITH the COMPLETE labeling applied to an appropriate OUTER container. 10b. Customized patient med packages allowed WITH Patient/Caregiver or Prescriber CONSENT as defined by USP chap 661 standards.

Answer 64

Veterinary Rx dispensed by a RPh must include: 1. Non-food producing animals, the name of the Client OR Animal OR 1A. Food producing animals, the name of OWNER & Specific Name & Address of the Facility where Rx will be used. 2. Species 3. Drug name, strength, Qty (except when specified to the contrary OR if combining premanufactured drug products - the names of the products OR category of use may suffice) 4. Manufacturer or Distributor NAME 5. Date of Issue 6. Sig 7. Withdrawal Time (excluding non-food producing animals) 8. Cautionary Statements if appropriate for the drug 9. Pharmacy name, address, phone # 10. Prescribing Vet's name & address (except address not required for non-food producing animals) 11. Rx # When drug is in manufacturer's original package and all above is required EACH Individual bottle or package MUST be labeled. Radiopharmaceutical labeling must comply with statutory laws.

Answer 65

IV's dispensed to a patient except in a hospital labeling must contain: 1. Compounded Date 2. Expiration Date 3. Storage Requirements (if other than room temperature) 4. Infusion/Administration Rate 5. Time OR Frequency of Administration (or both) 6. Cautionary information necessary for proper use and safety in profession judgement of RPh Additions to Admixtures: Label on Original label OR with distinctive Supplementary label with the Drug Name & Amount added, Date & Time of addition, Expiration, & Unique ID of person adding drug. Audit Trail: Develop a 5 year audit trail system that ID's the dispensing RPh of each unit dispensed.

Answer 66

12 months from date of issue. No refills added after 12 months. Need new Rx after 12 months.

Answer 67

Control: RPh-In-Charge. Dispensing reserved for RPh and RPH Interns Packaging: Unit dose preserves ID & Integrity of drug until administered to patient. From Manufacturer: Manuf. Name, Lot #, Exp Date Individual doses attached to each other in a card or container must provide continuous ID of contents and when dispensed the Name and Location of Patient, Name of Prescriber, Rx #, Date, Directions for Use, ID of Pharmacy

Answer 68

Must provide and RPh must utilize: a. a means of separating drugs by Patient Name & Bed 3 b. separating by day of administration c. ID individual doses dispensed, doses administered, and doses returned. d. ID for dosage regimen of each drug, including date of original drug order & date of changes if any e. ID total dosage regimen of each patient f. ID the Time of Admin of each drug g. means for RPh to verify the original drug order h. means for RPh to certify the accuracy of the selected drug before the dose is delivered for admin to the patient

Answer 69

Written Policies: specify the categories of drugs which will or will not be dispensed under unit does system. Policies available for inspections by BOP. Unit Dose Preferred: In as far as practicable all drugs be in unit dose packaging when dispensed. Controlled Substances: II - IV may be included if in compliance with federal and state laws and rules. Legend Drugs: if not dispensed in unit dose system must meets other labeling required by law. Who may perform non-dispensing functions: Selection of individual unit does packaging for placement in individual patient containers etc is not dispensing and may be performed by supportive personnell. Dispensing occurs upon certification of accuracy and must be done by RPH before it is delivered to the patient. Storage: All controlled must be in a locked area or locked cart at all times. Non-controlled must locked when a patient care area is not staffed.

Answer 70

Registration required before performing pharmacy tasks not specifically reserved to a licensed RPh. BOP may deny, suspend, revoke, refuse to renew or place conditions on registration for violation of the rules of the BOP of this or any state or the US relating to the practice of pharmacy or controlled substances. Registration, Renewals: Expires each year on December 31, renew annually by applying on or before December 1st of each year. Initial registration is prorated. Fee: Due when renew, if late additional 50% Notify within 10 days change of name, address, place of employment ID badge must be worn while on duty that clearly identifies them as a Pharmacy Technician, except where allows by USP Chap 797 Post Registration in conspicuous place, readily accessible to BOP Minimum Age: 16 prior to 1/01/2021. 18 after 1/01/2012

Answer 71

High School Equivalent required after 1/01/2013. If registered prior to 2013 must maintain license uninterrupted. If lapses for > 1 year must meet current registration requirements if applying for reinstatement. Renewal of Registration: Effective 1/02/2014 must provide BOP evidence of completion of one of the following training programs. 1. Board-Approved, Accredited Vocational/Technical Inst. or College 2. Accredited by Board-Approved National Org that accredits Technician training programs 3. Program provided by a branch of the US Armed Forces or Public Health Service 4. Employer Based program that included at least 240 hours on a 1 year period to include both theoretical and practical instruction. Employer must develop a training manual available for BOP inspection. Must include written guidelines, P & P that define the specific tasks the Technician will be expected to perform. May apply for renewal if training NOT completed if < 6 months since initial registration AND evidence of being enrolled in 1 or 2 if program is longer than 6 months. Written Procedures: developed by RPh-In-Charge. Copy given to each Technician and a copy kept on file in the pharmacy, Must include details of tasks performed, Name -Address -Registration # of Technicians, Certification steps performed by RPhs to verify Tech work. Update every 5 years or whenever a significant change occurs. Techs review at initial employment any any time of significant change. Documentation of training maintained in pharmacy for at least 2 years after training occurs. Supervised in same work area. Ratios: 2 Technicians to 1 RPh with exceptions as follows. 1. IV admixture preparation (3:1) 2. Unit Dose or Modified UD packaging (3:1) 2. Compounding (3:1) Delivery personnel or clerical typist not included in ratio if typing/keyboarding does not involve Rx data entry, record keeping, filing, billing and completing sale transactions. Intern not considered part of ratio of techs to RPh.

Answer 72

Double Check by RPh or Intern comparing the original written Rx/or image of it to the information entered in the computer. May be immediately double checked by a 2nd RPh/Intern or no sooner than 2 hours after Rx initially certified by the original RPH if QA'ing themselves. Must complete within 72 hours. Alternative for hospitals providing inpatient pharmacy services may elect to develop a plan for safeguard against errors due to data entry. Written procedures required. Available to BOP upon request. Lost information due to system interruptions must be reported to BOP within 72 hours.

Answer 73

If located in another state that provides services to a pharmacy in MN must be licensed as a NONRESDIDENT pharmacy. Same owner OR have a written contract outlining services provided and responsibilities and accountabilities of each party in fulfilling the terms of contract and COMPLIANCE with federal and state laws. Share common electronic file OR have technology adequate to access sufficient info to fill/refill an Rx orde. Provide BOP copy of P&P manual at least 30 DAYS before processing services begin. P&P Manual available to BOP upon request and included at least the following: 1. how parties will comply with federal and state laws and regulations 2. records to ID RPh dispensing and counseling 3. tracking the Rx drug order during each step of dispensing process 4. ID on Rx LABEL all pharmacies involved in dispensing 5. Adequate security to protect integrity and PHI 6. Continuous Quality Improvement Program The RPh/Intern at the pharmacy who dispenses, delivers, mails, ships the completed Rx to the patient is responsible for certifying the completed Rx order & counseling the patient. Pts must be notified of use of Central Filling Services.

Answer 74

"Caution: Taking this drug alone or with alcohol may impair your ability to drive." "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

Answer 75

A. Opiates (unless listed in another category) 1. Acetylmethadol 2. Allylprodine & Betaprodine & Diamprodine 3. Alphacetylmethadol (except levo - alphacetylmethadol also know as LAAM) 4. Alpha & Betameprodine 5. Alpha & Betamethadol & Betacetylmethadol 6. Alpha-methylfentanyl 7. Benzethidine 8. Clonitazene 9. Dextromoramide 10. Diethylthiambutene 11. Difenoxine 12. Dimenoxadol 13. Dimepheptanol 14. Dimethylthiambutene 15. Dioxaphetyl butyrate 16. Dipipanone 17. Ethylmethylthiambutene 18. Etonitazene 19. Etoxeridine 20. Furethidine 21. Hydroxypethidine 22. Ketobemidone 23. Levomoramide 24. Levophenacylmorphan 25. Methyl substituted isomers of Fentanyl (10 of them) 26. Morpheridine 27. MPPP 1-methyl-4-phenyl-4-propionoxypiperidine 28. Noracymethadol 29. Norlevorphanol 30. Normethadone 31. Norpipanone 32. PEPAP 1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine 33. Phenadoxone 34. Phenampromide 35. Phenomorphan 36. Phenoperidine 37. Piritramide 38. Proheptazine 39. Properidine 40. Propiram 41. Racemoramide 42. Tilidine 43. Trimeperidine B. Opium Derivatives (1) Acetorphine; (2) Acetyldihydrocodeine; (3) Benzylmorphine; (4) Codeine methylbromide; (5) Codeine-N-Oxide (6) Cyprenorphine; (7) Desomorphine; (8) Dihydromorphine; (9) Drotebanol; (10) Etorphine (except hydrochloride salt); (11) Heroin; (12) Hydromorphinol; (13) Methyldesorphine; (14) Methyldihydromorphine; (15) Morphine Methylbromide; (16) Morphine Methylsulfonate; (17) Morphine-N-Oxide; (18) Myrophine; (19) Nicocodeine; (20) Nicomorphine; (21) Normorphine; (22) Pholcodine; and (23) Thebacon

Answer 76

(1) 4-Bromo-2,5-Dimethoxyamphetamine (2) 2,5-Dimethoxyamphetamine (3) 4-Methoxyamphetamine (4) 5-Methoxy-3, 4-Methylenedioxyamphetamine (5) 4-Methyl-2,5-Dimethoxyamphetamine (6) 3,4-Methylenedioxy Amphetamine MDA (7) 3,4-Methylenedioxymeth-amphetamine MDMA (8) 3,4-Methylenedioxy-N-ethylamphetamine MDEA 9) N-hydroxy-3, 4-Methylenedioxy-amphetamine (10) 3,4,5-Trimethoxy Amphetamine TMA (11) Alpha-Ethyltryptamine AET (12) Bufotenine (13) Diethyltryptamine DET (14) Dimethyltryptamine DMT (15) Ibogaine (16) Lysergic acid diethylamide LSD (17) Marijuana (18) Mescaline (19) Parahexyl (20) Peyote (all parts of the plant classified as Lophophora Williamsii Lemaire) (21) N-ethyl-3-piperidyl Benzilate (22) N-methyl-3-piperidyl Benzilate (23) Psilocybin (24) Psilocyn (25) Tetrahydrocannabinols THC (including synthetic) (26) Ethylamine analog of phencyclidine PCE (27) Pyrrolidine analog of phencyclidine (28) Thiophene analog of phencyclidine (29) 2-thienyl Pyrrolidine analog of Phencyclidine (30) 4-bromo-2,5-dimethoxyphenethylamin (31) 2,5-dimethoxy-4-ethylamphetamine DOET (32) 2,5-dimethoxyl-4-(n)-propylthiophenethylamine (33) Alpha-methyltryptamine AMT (34) 5-methoxy-N,N-diisopropyltryptamine

Answer 77

CI listing does not apply to nondrug use of peyote in bona fide religious ceremonies of the Native American Church and its members, however annual federal registration is required to comply with law.

Answer 78

(1) Flunitrazepam; (2) Gamma-hydroxybutyric acid, including its esters and ethers (some other names include GHB, gamma-hydroxybutyrate, 4-hydroxybutanoic acid, sodium oxybate, sodium oxybutyrate); (3) Mecloqualone; (4) Methaqualone.

Answer 79

1. Aminorex 2. Cathinone 3. Fenethylline 4. Methcathinone 5. + & - cis-4-methylaminorex 6. N-ethylamphetamine 7. N,N-dimethylamphetamine 8. N-benzylpiperazine

Answer 80

Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate, EXCLUDING apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, nalmefene, naloxone, and naltrexone, and their respective salts, and isoquinoline alkoloids of opium but including the following: 1. Opium (s) including Tincture of Opium (Laudanum), Opium Poppy & Poppy Straw, Concentrated Poppy Straw that contains phenanthrene alkaloids of the opium poppy. 2. Codeine 4. Dihydroetorphine 5. Ethylmorphine 6. Etorphine HCL 7. Hydrocodone 8. Hydromorphone 9. Metopon 10. Morphine 11. Oxycodone 12. Oxymorphone 13. Thebaine 14. Oripavine 15. Coca Leaves and any form that includes Cocaine (decocainized leaves/extract etc excepted) Opiates: 1. Alfentanil (Alfenta) 2. Alphaprodine (Nisentil) 3. Anileridine (Leritine) 4. Bezitramide 5. Bulk Dextropropoxyphene (nondosage forms) 6. Carfentanil 7. Dihydrocodeine (Paracodin) 8. Dihydromorphinone (Dilaudid) 9. Diphenoxylate 10. Fentanyl (Sublimaze, Innovar) 11. Isomethadone 12. Levo-alpha-acetylmethadol (LAAM) 13. Levomethorphan 14. Levorphanol (Levo-Dromoran) 15. Metazocine 16. Methadone (Dolophine, Amidone, Adanon) 17. Methadone-Intermediate 4-cyano-2-dimethylamino-4, 4-diphenylbutane 18. Moramide-intermediate 2-methyl-3-morpholino-1, 1-diphenyl-propane-carboxylic acid 19. Pethidine (meperidine) 20. Pethidine - Intermediate-A, 4-dyano-1-methyl-4-phenylpiperidine 21. Pethidine-Intermediate B, ethyl-4-phenylpiperidine-4-carboxylate 22. Pethidine-Intermediate C, 1-methyl-4-phenylpiperidine-4-carboxylic acid 23. Phenazocine (Prinadol) 24. Piminodine (Alvodine) 25. Racemethorphan 26. Racemorphan (Dromoran) 27. Remifentanil 28. Sufentanil 29. Tapentadol

Answer 81

1. Amphetamine 2. Methamphetamine 3. Phenmetrazine 4. Methylphenidate 5. Lisdexamfetamine

Answer 82

Depressants: 1. Amobarbital 2. Glutethimide 3. Pentobarbital 4. Phencyclidine 5. Secobarbital And and precursors to the above Hallucinogenic substances 1. Nabilone

Answer 83

1. Amphetamine, Methamphetamine, Methylphenidate and Phenmetrazine, when required by federal law to be labeled with either of the following symbols: C-III or III. 2. Benzphetamine (Didrex) 3. Chlorphentermine (Pre-Sate) 4. Clortermine (Voranil) 5. Phendimetrazine

Answer 84

1. Amobarbitol 2. Secobarbitol 3. Pentobarbital 4. Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid, except those substances which are specifically excepted or listed in other schedules. 5. Chlorhexadol 6. Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the federal FDCA. 7. Ketamine 8. Lysergic Acid 9. Methyprylon 10. sulfondiethylmethane 11. Sulfonethylmehane 12. Sulfonmethane 13. Tiletamine & Zolazepam or any salf of Telazol 14. Embutramide 15. Nalorphine (Nalline)

Answer 85

1. Not more than 1.8 gm Codeine per 100 ml OR 90mg per dosage unit with an equal or greater qty of an isoquinoline alkaloid of opium; Copavin 2. < 1.8gm Codeine/100ml OR < 90mg/dosage unit + one or more active nonnarcotic ingredient (Cheracol, Elixir, Terpine Hydrate and Codeine, Cosadein, Prunicodeine, Robitussin AC) 3. Not more than 300 mg dihydrocodeinone/100 ml OR not more than 15 mg/dose with a 4 fold or greater qty of an isoquinoline alkaloid of opium 4. <300mg dihydrocodeinone/100ml OR < 15 mg/dose with one or more active nonnarcotic in recognized amounts (Ambenyl, Tussend, Hycomine, Tussionex) 5. <1.8gm dihydrocodeine/100ml OR < 90mg/dose with one or more active nonnarcotic ingred. 6. <300mg ethylmorphine/100ml OR < 15mg/dose with one or more active nonnarcotic (Cidicol) 7. <500mg Opium/100ml OR per 100gms OR <25mg/dose with one or more active nonnarcotic (Paregoric, Camphorated Opium Tincture) 8. <50mg morphine/100mls or 100gms with one or more active nonnarcotic

Answer 86

Clostebol, Chorionic gonadotropin, Dehydrochlor-ethyltestosterone, Ethylestrenol, Fluoxymesterone, Human growth hormones, Mesterolone, Methandienone, Methandrostenolone, Methenolone, Methyltestosterone, Nandrolone, Nandrolone phenpropionate, Norethandrolone, Oxandrolone, Oxymesterone, Oxymetholone, Stanozolol, Testosterone propionate, Testosterone-like related compounds

Answer 87

Hallucinogenic - Dronabinol FDA approved product Buprenorphine

Answer 88

Narcotics: 1. Not more than 1mg difenoxine & not less than 25mg atropine sulfate/dosage unit 2. Dextropropoxyphene (Darvon, Darvocet) Depressants: 1. Alprazolam 2.Barbital 3. Bromazepam 4. Camazepam 5. Chloral betaine, Chloral hydrate 6. Chlordiazepoxide 7. Clobazam 8. Clonazepam 9. Clorazepate 10. Clotiazepam 11. Cloxazolam 12. Delorazepam, Lorazepam 13. Diazepam, Fludiazepam, Nordiazepam 14. Dichloralphenazone 15. Estazolam 16. Ethchlorvynol (Placideyl) 17. Ethinamate 18. Ethyl Loflazepate 19. Glurazepam 20. Halazepam 21. Haloxazolam 22. Ketazolam 23. Loprazolam 24. Lorazepam 25. Lormetazepam 26. Mebutamate 27. Medazepam 28. Meprobamate 29. Methohexital 30. Methylphenobarbital 31. Midazolam 32. Nimetazepam 33. Nitrazepam 34. Oxazepam 35. Oxazolam 36. Paraldehyde 37. Petrichloral 38. Phenobarbital 39. Pinazepam 40. Prazepam 41. Quazepam 42. Temazepam 43. Tetrazepam 44. Triazolam 45. Zaleplon 46. Zolpidem 47. Zopiclone Fenfluramine (Pondamin) Stimulants: 1. Cathine + - Norpseudoephedrine 2. Diethylpropion 3. Fencamfamine 4. Fenproporex 5. Mazindol 6. Mefenorex 7. Modafinil 8. Pemoline 9. Phentermine 10. Pipradrol 11. Sibutramine 12. SPA Other: Pentazocine (Talwin) Butorphanol Stimulants: Pyrovalerone Depressants: 1. Pregabalin 2. Lacosamide

Answer 89

Partial fills allowed. Records for partial fills: Record on the back of the Rx or readily retrievable record the DATE of partial dispensing, Qty dispensed, Remaining Qty, ID of dispensing RPH. Record if "terminally ill" or "LTCF patient". Total Qty does not exceed qty prescribed. Rx Valid for no more than 60 days from issue date. Computerization of information allowed if capability permits: Output by display or printout of Rx #, ID of Patient, ID of LTCF, ID of Drug, Dosage Form, Strength, Qty, Listing of Partial Dispensing. Must allow for immediate or real time updating of the Rx record each time a partial fill is dispensed.

Answer 90

Person who engages in research, teaching or educational projects involving use, study or testing of controlled substances shall ANNUALLY on or before June 1 apply for registration by the BOP. Application includes documentation of an approved protocol, payment of fee of $25 and authentication of the application by the BOP. P&P and Records for effective controls to protect against theft and diversion, restrict access, drug wastage and returns. Record show purchase, receipt, use, transfer and disposal. Inventory must be done annually.

Answer 91

Perpetual inventory must be reconciled monthly. Reconciliation documentation retained for 2 years. Hospital pharmacy must have a QA plan for distribution of controlled substances from the pharmacy to nursing stations and other drug storage locations.

Answer 92

If attributable to other than inadvertent error must report the loss in writing to the BOP and DEA immediately. Report includes: description of how loss occurred, date loss occurred if known, steps to prevent future loss and inventory of missing drugs.

Answer 93

Means the pharmacy practice experience component of the pharmacy curriculum of an accredited college of pharmacy.

Answer 94

Means the Internship experience during the 2nd, 3rd, and 4th academic years while a full-time student (12 or more credits).

Answer 95

Registration required for internship, residency and fellowship. Remains in effect for until licensed as a RPH, completion of residency or fellowship or 2 years (whichever comes first). Progress report affidavits or similar forms are required. Notify IMMEDIATELY of change of address. Manual: if completing 400 hours or more in Minnesota must complete a board provided internship manual.

Answer 96

Preceptors must register. Expires EVERY OTHER YEAR on anniversary of issuance. Training & Practice: must show they are participating in the Experiential Education Program of the University of Minnesota College of Pharmacy as an approved preceptor, OR They have completed at least 4,000 hours of practice as a licensed pharmacist, with at least 2,000 hours of that practice occurring within the state of Minnesota. In practice at least 20 hours/week as a RPH. Hx of exemplary practice and compliance with state and federal laws. Provide time, at least 3 times/month, for purpose of helping their interns meet the competencies of the internship program. For renewal of registration, must have participated in an instructional program specifically for preceptors approved by BOP within the previous 24 months.

Answer 97

Training in another state may be acceptable if the intern abides by the rules in that state and provides evidence from that state's BOP confirming the completion of the number of hours for which credit is being requested. May deny if does not meet the standards described in this statute. Must be substantially equivalent and in compliance with internship standards of the NABP. Max 2 Intern/Preceptor in an Experiential Education Program Immediate Supervision ratio (in same work area) when intern is dispensing or compounding. Otherwise, Max 1 Intern/Preceptor Immediate Supervision ratio (in same work area) when intern is dispensing or compounding (other than EEP). Immediate & Direct supervision not required for tasks other than dispensing or compounding. However, all drug therapy and related recommendations that an intern proposes to make to other health professionals and patients must be reviewed and approved by a licensed pharmacist before they are made. An intern's supervising pharmacist is responsible for the accuracy and completeness of statements made by the intern while providing counseling to patients or health-related education to patients or staff. Competencies: the board provided MANUAL lists the minimum competencies and suggests types and order of training experience to ensure practical experience is commensurate with intern's education level and broad in scope. 1600 hours required after May 1 2003. It was 1500 after 9/17/1973. Credit only granted after completion of 3rd year of 5 or 6 year pharmacy curriculum provided that no more than 400 hours concurrent time and 800 hours through EEP experience that do NOT have as their focus traditional compounding, dispensing, and related patient counseling. Remaining 800 hours of the 1600 hour total must focus on compounding, dispensing and patient counseling.

Answer 98

Board appointed advisory committee on internship to advise board on administration of statutes. Includes: Practicing RPh's, Pharmacist-Educators, Pharmacist-Interns, and Representatives of the board.

Answer 99

Verbal or Telephone Orders: Allowed for licensed RPH, RN, LPN who are employed by LTCF and authorized by facility's administrator and action on the behalf of the prescriber. Whenever possible Rx or should be transmitted by FAX or secure Electronic format to the pharmacy that produces a direct copy of the chart order which the prescriber will sign at a later date. Pharmacy will record name of the person who transmits the order in addition to other required information. Written orders: a copy that is signed by the prescriber may be delivered to the pharmacy by an individual authorized by the facility. CII orders: Must be an original written Rx manually signed by the prescriber OR an oral order reduced to writing in emergencies as allowed by these criteria: 1. Immediate administration of CII is necessary for proper treament of the patient. 2. No appropriate alternative is available. 3. Not reasonable possible for prescriber to provide a written Rx order prior to dispensing.

Answer 100

In addition to 6800.3400: 1. Qty of drug dispensed 2. Date of original issue OR for refills the most recent date 3. Expiration date of all time dated drugs. If the directions for an Rx change, personnel of the LTCF may affix supplemental labels alerting staff to the change in accordance with facility's QA committee. Subsequent refills must be appropriately labeled with directions in effect at time of dispensing. 6800.3400 Applies to all Rxs dispensed to a patient except radiopharmaceuticals or inpatient of a hospital. 1. Pharmacy name, address, phone # (central service pharmacy uses name of dispensing pharmacy) 2. Patient's name 3. Rx # 4. Sig 5. Manufacturer or Distributor name 6. Auxiliary labels as needed 7. Date of Original issue or renewal 8. Drug generic or trade name & strength (except when specified by prescriber to the contrary) 9. Central Service Pharmacy filled Rx must bear identifier that indicates CSP where filled. 10. Post 7/1/2008 if not dispensed in original manufacturer bottle must label with physical description including ID codes that appear of tablet or capsule. (except drugs dispensed in investigational study) 10a. If immediate container of med does NOT permit full labeling, a PARTIAL label containing at MINIMUM Patient Name & Rx # may be placed WITH the COMPLETE labeling applied to an appropriate OUTER container. 10b. Customized patient med packages allowed WITH Patient/Caregiver or Prescriber CONSENT as defined by USP chap 661 standards.

Answer 101

Written Agreement: separate from that provided for supplying Rx drug services. Responsibilities: a. prepare and revise P&P governing pharmaceutical services b. development, coordination, and direction or supervision of all pharmaceutical services c. review drug regimen of each resident and prepare reports and recommendations including at least a review of all drugs currently ordered; information concerning patient's condition as it relates to drug therapy; and medication administration records, physician progress notes, nurse's notes, and lab test results d. report in writing irregularities in the storage, dispensing, and administration of drugs and other matters to the administrator and other appropriate health professionals e. quarterly report on the status of pharmaceutical service and staff performance and submit report to administrator and quality assurance and assessment committee f. develop policies for destroying any unused portion of Rx drugs remaining at the facility after death or discharge or any permanently DC'd Rx's. g. provide in-service training to nursing personnel h. develop P&P for issuance of medications to residents who are going on leave from facility. Allow preparation, by the facility's LPN or RN's of up to a 72-hour supply of drugs in paper envelopes or other suitable containers for when residents temporarily leave or when pharmacy is closed or cannot supply drugs in a timely manner. A container may hold only one drug. Label includes - DATE, Resident's Name, Name of Drug, Strength, Dose and Time of Admin, and Initials of person preparing label i. prepare P&P for disposition of drugs

Answer 102

72 hr supply of 15 drugs not including AB, 6 single doses each of CS, no CS stimulants. Pharmacy may provide upon request from Quality Assurance & Assessment Committee, limited supplies, for life threatening situations. Must comply with the following: a. Limit to 72 hour supply, sealed in ampules, vials or prefilled syringes. Oral dosage form is allowed if not available in parenteral form. Limit 15 different drugs (NOT including oral antibiotics) used for symptomatic distress or emergencies. Unlimited # of antibiotics allowed in 72 hour supply each. Inclusion of other legend drugs allowed only through a variance. Labeled with expiration date and lot #'s. b. Stored in container sealed by RPh or RPH's agent with a tamperproof seal, stored in a locked area. c. RPh must notify the LTCF when drugs have been used or the seal was broken. d. Drugs replaced by submitting an Rx Drug Order for the used item to the RPh within 72 hours. e. RPH sees that the contents of the kit are listed on the container and accounted for f. Monthly inventory by RPh Controlled Substances allowed in limited supplies if the following are met: a. supplied by DEA licensed pharmacy b. kit kept in locked room or medicine cabinet c. access limited to the following individuals - Licensed Nurse employed by the LTCF, RPh designated by LTCF pharmaceutical services committee, Licensed Medical Practitioner d. Limit of 6 single doses of any controlled substance e. Dispensing pharmacy keeps record of each CS including Name of Drug & # of Doses in kit. f. LTCF keeps record of use of CS from kit for 2 year including Patient's Name, Date of Use, Name of Drug used, Strength, # of Doses Used, Signature of person administering dose g. CS used only in an emergency provided - no appropriate alternative, not possible for prescriber to provide a written Rx to the RPH to dispense CS. No CS Stimulants may be included in the kit. Revocation of privilege to maintain an emergency kit if LTCF is noncompliant.

Answer 103

Pharmacy may supply to LTCF a supply of drugs for prophylaxis regimen currently recommended by CDC for prevention of HIV due to accidental contact with contaminated body fluids by health care workers.

Answer 104

Pharmaceutical services in hospitals may ONLY be organized and directed by a RPh and personnel under RPh supervision. RPH-In-Charge: Must be licensed in Minnesota On-site pharmacies must be staffed at least part time 5 days/week. Off-site pharmaceutical services - RPh must maintain a Drug Room with weekly on-premises visits. Control extends to all areas where drugs are stored. MONTHLY inspections documented. Responsibilities of RPH-In-Charge (in addition to 6800.2400): (not complete list) a. development of hospital formulary system b. maintain stock of antidotes and emergency drugs c. cooperating in teaching and research programs

Answer 105

Pharmaceutical Service Policies must include: 1. providing of drug information to patients and health professionals 2. limiting of drug admin 3. ongoing proactive program to identify risks to patient safety and to reduce errors 4. self-administration of drugs by patients 5. use of drugs brought into the hospital by Pts. Must be packaged, sealed, stored and returned to the Pt at discharge. 6. Use of investigational drugs 7. Prep and disposal of chemotherapy drugs 8. Prep of Compounded Sterile and Nonsterile products

Answer 106

Dispensing Drugs: (not a complete list) 1. supplying of prepackaged legend drugs which are accessible for use without entering either the pharmacy or drug room maintained for use when a pharmacist is not available. Such supply may be located in nursing units, with access limited to designated registered nurses. No hospital pharmacy shall utilize a floor stock drug distribution system of this or any other type as its primary system of drug delivery. 2.specify permissible supply of nonprescription drugs in nursing service units. 3. drug recall procedure that can be implemented no more than 24 hours after recall from manufacturer. 4. system for accountability of inpatient dispensing 5. establish a RPh Monitoring System that reconciles a nurse prepared MAR to the pharmacy profile. 6. require authorization for standing orders in Pt medical record. Must include circumstances when drug can be administered, the drug, dosage, route, frequency of admin and duration. 7. when drug therapy is not renewed on an established regular basis the therapy is limited either by the prescriber's specific indication or by automatic stop orders. 8. QA documentation for safe admixture of parental drug developed in writing. IV prep limited to RPH, Interns, RPH supervised personnel, licensed practitioners, licensed nurses. 9. Investigational drug use is in accordance with federal law. basic information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions, and symptoms of toxicity of such drugs shall be available in the pharmacy (investigational drugs shall be distributed only from the pharmacy). 10. CS system developed and maintained. CS must be accounted for by either 10a. "proof of use" sign out sheet where each dose is accounted for by the licensed health professional who procures the drug. Must include at least the Date & Time, Patient's Name, Dose Administered, Licensed Health Professional's Signature. 10b. OR dispensing of drug after pharmacy received a drug order. 10c. OR Computer system that has electronic distribution records of CS transactions and must comply allow retrieval of all info for 2 years; weekly printouts unless a daily 24 hour backup is performed; and complete transaction file that is printable on request, or have a "lock-out" feature that prevent editing; and allows 2 year transaction printing that includes at least the ID of User Accessing the system, Date & Time CS are distributed or removed from auto distro machine, Qty of CS removed, Drug Name, Strength, Dosage Form, Patient Name, Practitioner Name. 11. Policy for issuing drugs to patients going on leave temporarily from hospital. Similar to LTCF paper envelope or suitable container 72-hour process.

Answer 107

CS system developed and maintained. 1. CS must be accounted for by either a. "proof of use" sign out sheet where each dose is accounted for by the licensed health professional who procures the drug. Must include at least the Date & Time, Patient's Name, Dose Administered, Licensed Health Professional's Signature. b. OR dispensing of drug after pharmacy received a drug order. c. OR Computer system that has electronic distribution records of CS transactions and must comply allow retrieval of all info for 2 years; weekly printouts unless a daily 24 hour backup is performed; and complete transaction file that is printable on request, or have a "lock-out" feature that prevent editing; and allows 2 year transaction printing that includes at least the ID of User Accessing the system, Date & Time CS are distributed or removed from auto distro machine, Qty of CS removed, Drug Name, Strength, Dosage Form, Patient Name, Practitioner Name. 2. Wasting CS doses must be carried out/documented/accuracy certified w/ signature by 2 licensed people who have access to CS. 3. System for reconciling proof-of-use sheets in the pharmacy to assure accountability of sheets sent to the various nursing stations. 4. Single unit of use doses used when possible 5. Perpetual inventory of CII maintained

Answer 108

may not be complete list RPH-In-Charge maintains: 1. statement of service philosophy and objectives 2. job descriptions 3. list of committees on which pharmaceutical services is represented and the minutes/attendance records. 4. 2 years of CS procurement records 5. 2 years of Rxs or other forms initiated by prescriber. 6. 2 years records of packaging, bulk compounding, or manufacturing (or as required by law) 7. 2 years records of actions taken for drug recalls 8. 2 years special reports concerning narcotics or other drugs 9. 2 years inspection of drugs maintained outside of pharmacy 10. 2 years records of withdrawals by Non-Pharmacists of prepackaged drugs from the pharmacy or drug room Other documents maintained: 1. current organizational chart of intra-service structure/lines of authority describing pharmacy relationship to the administration, organized medical staff and other relevant hospital services. 2. List of all licensed and credentialed personnel w/verification of present validity of those licenses/credentials. 3. Record of # of people employed by pharmacy services 4. 2 years copies of weekly work schedules 5. 2 years receipts/invoices for drugs and supplies 6. agreement/contract between off-site pharmacy and hospital.

Answer 109

Disaster - Hospital administrator may allow access for purposes of emergency maintenance, disaster prevention and control and patient safety Emergencies: RPH-In-Charge develops procedures and may make provisions for unit dose packages for withdrawal limited to # of doses usually required by a patient. Emergency access: a Designated RN (one/shift) may be given emergency access. Bulk stock withdrawals documented on a form - Patient's Name, Name of Drug and Dose Prescribed, Strength, Amt taken, Time & Date, Signature of RN. Leave stock bottle on top of form for purposes of verification by RPH.

Answer 110

Inpatient Chart Orders: Patient Name Drug Name Route of Admin when needed for clarification Strength Aux Labels as needed Expiration Date if applicable Date Dispenses Drugs packaged for Emergency Use: ID of Pharmacy or Source Drug Name or list of Ingredients Strength or Amt of Ingred Aux Labels if needed Usual Dose Control # or Date of Issue IV Admixtures: Solution Name and Volume Patient Name Control # or Sequence # Name & Qty of each Additive Infusion Rate if appropriate Storage Requirements if other than Room Temp Date & Time of Admin if appropriate Exp Date Aux Precaution Labels Anytime a drug is added to a parenteral solution a distinctive label is required.

Answer 111

Applies to Sterile Products Compounded by a RPh Annually reviewed P&P Manual required for licensure. P&P includes: a. compliance with USP chap 797 b. clinical services c. cytotoxics handling, storage, disposal d. disposal of unused supplies and drugs e. drug destruction and returns f. drug dispensing g. drug labeling & relabeling h. drug storage i. duties and qualifications for staff j. equipment k. handling of infectious waste, pharmaceutical waste, hazardous waste l. infusion devices and drug delivery systems m. investigational drugs n. obtaining protocol on investigational drugs from principal investigator o. public safety p. QA procedures including - recall, storage & dating, educational procedures for staff and patients, sterile procedures including log of refridg temp -routine maintenance-report of hood certification, sterile testing of the product q. record keeping r. reference materials s. sanitation t. security u. sterile product prep procedures v. transportation

Answer 112

Must be managed by a Minnesota licensed RPh knowledgeable in sterile product compounding. Supportive personnel must have specialized training and work under direct supervision of licensed RPh. Training must be in writing in a training manual.

Answer 113

Must comply the following: 1. Compounded in a Vertical Flow Class II Biological Safety Cabinet 2. Protective Apparel i.e., disposable masks, gloves, gowns w/tight cuffs worn by personnel compounding 3. Appropriate safety and containment techniques used in conjunction with aseptic techniques 4. Disposal complies with all local, state federal requirements 5. Written procedures for major and minor spills developed and included in manual 6. Dispenses and Shipped to minimize risk of accidental rupture of container

Answer 114

DUR must be developed/documented to assure appropriate patient outcomes.

Answer 115

Primary Provider: RPh must ensure & document that there is a a clear understanding between the PCP, Home Care Agency (if any), and RPh in the areas of delivery of care and monitoring of the patient. Patient Training: Pharmacy documents Patient training and competency in the home environment related to drug compounding, labeling, storage, or incompatibility. Patient Monitoring: RPH requests and monitors clinical and lab data for each patient. Notifies prescriber of anything unexpected. If the RPh does not obtain the data and is not doing the monitoring, the id of the health prof who assumed the responsibility is documented in the Pt profile. Emergency Kit: May supply to be used by designated RN employed in hospice or home health care. Minimum requirements: 1. ownership/responsibility by pharmacy of kit and contents. 2. copy of P&P developed by hospice/home health care & pharmacy submitted to BOP. must address the following: a. prescriber's protocols for use of drugs in kit, how prescriber is notified, and how Rx order for drugs used is transmitted to the pharmacy. b. storage and proper transport of portable kit. c. security and who has access. An acceptable method is assigning responsibility by numbering system for each separate box designated to each separate RN. e. replace used drugs w/i 72 hours & tamper proof seals f. method of supplying pharmacy with drug orders that will trigger replacements g. inspection system every 60 days h. each kit has tamper proof seal, labeled with contents and quantities, contains NO CS.

Answer 116

Documented ongoing QA program examined on a sampling basis by RPH-In-Charge. Hood certification: every 12 months Prefilters: replaced on a regular basis Bulk Compounding: If using nonsterile compounds must extensively test end product before release from quarantine. Process must include testing for sterility and pyrogens. Expiration Dates beyond 7 days must be supported by in-house data or data in the literature to assure sterility and stability when used by Pt.

Answer 117

Radiopharmaceutical definition: A radiopharmaceutical is any substance defined as a drug in section 201 (g) (1) of the Federal Food, Drug, and Cosmetic Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or protons and includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that contain trace quantities of naturally occurring radionuclides.

Answer 118

Compliance with laws and regs of US Nuclear Regulatory Commission and other agencies. May be exempt from other pharmacy requirements if solely handling radioactive drugs if BOP deems in public interest.

Answer 119

All RPHs must complete a nuclear pharmacy course and/or acquired experience in programs approved by BOP. unapproved courses may be approved if boards deems them substantially the same. RPH-In-Charge: licensed Minnesota RPH qualified in radiopharmaceuticals. Either Certified as a Nuclear RPh by the Board of Pharmaceutical Specialties or meet the following standards: 1. minimum 200 hours of INSTRUCTION in nuclear Rx from an accredited college of Rx with emphasis on radiation physics & instrumentation, radiation protection, mathematics of radioactivity, radiation biology and chemistry 2. minimum 500 hours TRAINING clinical nuclear Rx under the supervision of a qualified nuclear RPH AND 3. Submit and affidavit of experience and training to the BOP.

Answer 120

Each container: 1. Symbol of radiation with words "Caution - Radioactive Material" 2. radiopharmaceutical name or abbreviation 3. radiopharmaceutical lot # In addition Outer Container must include: 4. amount of radioactivity 5. calibration date & time 6. Expiration date & time 7. volume of liquid OR weight of solid OR # of capsules of gas 8. added substances - stabilizers, preservatives 9. name, address, phone # of nuclear pharmacy (if transferred for commercial distribution) 10. Initials of preparing RPh (if transferred for commercial distribution) In addition for each container dispensed: 11. Rx # or Lot # 12. Patient Name

Answer 121

additional records - Investigational - copy of Human Use Committee approval, copy of Pt consent form, and a letter from the manufacturer-sponsor indicating physician requesting the radiopharmaceutical is a qualified investigator.

Answer 122

Annual registration if selling or distributing medical gas if not already licensed as a pharmacy, pharmacist, medical gas manufacturer/wholesaler or practitioner. Expires December 1st. after December 1st $25 late fee. Separate registration for each location. Change in location requires re-registration. Sales Restricted: may only sell or distribute gases at retail to a Pt on the basis of a prescription from a practitioner OR a hospital/practitioner/licensed pharmacy/other licensed institution/other persons licensed to possess medical gases for use in the usual course of business. Must have intact manufacturer's federally required label. May not dispense without a prescription/order of a licensed practitioner. Maintain Rx for 2 years, filed by Patient Name. Rx must have at least the Patient's Name & Address, Date, Name & Qty of gas, Name & Address of Prescriber. Refills must be recorded and maintained for 2 years

Answer 123

Written Rx required Dispense in containers meeting USP tight or well closed definition, must be Child-Resistant as required by federal Poison Prevention Packaging Act unless Pt specifically requests otherwise and is documented. CS filed in accordance with federal and state laws for CS. Must meet labeling requirements. Must maintain records.

MN Rules Ch. 6800 Part 1 Flashcards

Pg 1 - 10