MN Rules Ch. 6800 Part 1 Flashcards
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Central service pharmacy definition?
“Central service pharmacy” means a pharmacy that
may provide dispensing functions, drug utilization review (DUR), packaging, labeling, or delivery
of a filled prescription for another pharmacy
Community/outpatient pharmacy definition
an
established place in which prescriptions, drugs, medicines, chemicals, and poisons are prepared,
compounded, dispensed, vended, distributed, or sold to or for the use of nonhospitalized patients
and from which related pharmaceutical care services are provided. Practitioners, as defined in
Minnesota Statutes, section 151.01, subdivision 23, dispensing prescription drugs to their own
patients in accordance with parts 6800.9950 to 6800.9954 are not included within this definition.
Community satellite definition
a site affiliated with a licensed
community pharmacy, which is dependent on the licensed community pharmacy for administrative
control, staffing, and drug procurement. A community satellite must be under the direction of a
licensed pharmacist and comply with the requirements of part 6800.0800, subpart 3.
Hospital pharmacy definition
an established place located in a
licensed hospital in which prescriptions, drugs, medicines, chemicals, and poisons are prepared,
compounded, dispensed, vended, distributed, orsold to hospitalized patients and from which related
pharmaceutical care services are delivered.
Hospital satellite definition
a site in a licensed hospital, which is
not physically connected with the centrally licensed pharmacy, but is within the same facility or
building and is dependent on the centrally licensed pharmacy for administrative control, staffing,
and drug procurement. A hospital satellite must be under the direction of a licensed pharmacist,
comply with the requirements of part 6800.0800, subpart 3, and provide pharmacy services to
hospital patients only
Long-term care pharmacy
an established place,
whether or not in conjunction with a hospital pharmacy or a community/outpatient pharmacy, in
which prescriptions, drugs, medicines, chemicals, or poisons are prepared, compounded, dispensed,
vended, distributed, orsold on a regular and recurring basisto or for the use of residents of a licensed nursing home, boarding care home, assisted living facility, or supervised living facility and from
which related pharmaceutical care services are delivered.
Nuclear pharmacy definition
an area, place, or premises described in
a license issued by the board with reference to plans approved by the board where radioactive drugs
are stored, prepared, manufactured, derived, manipulated, compounded, or dispensed and from
which related clinical services are provided.
Home health care pharmacy definition
s an established
place, whether or not in conjunction with a hospital pharmacy, long-term care pharmacy, or a
community/outpatient pharmacy, in which parenteral or enteral drugs or medicines are prepared,
compounded, and dispensed for the use of nonhospitalized patients and from which related
pharmaceutical care services are provided.
Pharmaceutical care definition
the responsible provision of
drug therapy and other pharmaceutical patient care services by a pharmacist intended to achieve
definite outcomes related to the cure or prevention of a disease, the elimination or reduction of a
patient’s symptoms, or the arresting or slowing of a disease process
Prescription drug order definition
a lawful written, oral,
or electronic order of a practitioner for a drug for a specific patient. A prescription drug order must
contain the information specified in this chapter and in Minnesota Statutes, section 151.01,
subdivision 16.
Prescription definition
a prescription drug order that is written or
printed on paper, an oral order reduced to writing by a pharmacist, or an electronic order.
To be valid a prescription must be issued for an individual patient by a practitioner within the scope and usual course of the practitioner’s practice, and
must contain:
date of issue,
name and address of the patient,
name and quantity of the drug prescribed,
directions for use,
name and address of the practitioner,
telephone number at which the practitioner can be reached.
A prescription written or printed on paper that is given to the patient or an agent of the patient, or transmitted
facsimile-to-facsimile must contain the practitioner’s manual signature. An electronic prescription
must contain the practitioner’s electronic signature.
Chart order definition
a prescription drug order for a drug that is to
be dispensed by a pharmacist, or by a pharmacist-intern under the direct supervision of a pharmacist, and administered by an authorized person only during the patient’s stay in a hospital or long-term
care facility. The chart order shall contain the name of the patient, another patient identifier such
as a birth date or medical record number, the drug ordered, and any directions as the practitioner
may prescribe concerning strength, dosage, frequency, and route of administration. The manual or
electronic signature of the practitioner must be affixed to the chart order at the time it is written or
at a later date in the case of verbal chart orders.
Prospective drug review definition
a review of a patient’s
drug therapy record and prescription drug order prior to the time of dispensing for purposes of
promoting therapeutic appropriateness.
Nonsterile preparation compounding definition
the preparation, mixing, assembling, altering, packaging, and labeling of a nonsterile drug
preparation, according to United States Pharmacopeia Chapter 795.
Sterile preparation compounding definition
s the
preparation, mixing, assembling, altering, packaging, and labeling of a drug preparation that achieves
sterility, according to United States Pharmacopeia Chapter 797
Limited service pharmacy definition
a pharmacy to
which the board may assign a restricted license to perform a narrow range of the activities that
constitute the practice of pharmacy
Unique identifier definition
a manual signature or initials, a
biometric identifier, or a board-approved electronic means of identifying only one individual.
High-alert drug definition
a drug that bears a heightened risk of
causing significant patient harm when it is used in error.
PHARMACY LICENSE AND FEE REQUIRED
No person or persons shall conduct a pharmacy in or outside of Minnesota that dispenses legend drugs for Minnesota residents and mails, ships, or delivers the legend drugs into this state unless the pharmacy is licensed by the Board of Pharmacy. A fee established in Minnesota Statutes, chapter 151, shall be charged for a license.
A completed new pharmacy license application together with a blueprint of the proposed pharmacy showing size, layout, and security and a check for the proper fee must be received in the board office at least 60 days prior to the proposed opening date of the pharmacy.
An application for a pharmacy license which has not been completed within 12 months of the date on which the board received the application is no longer valid.
LICENSE CATEGORIES
A pharmacy must be licensed in one or more of the following categories:
A. community/outpatient;
B. hospital;
C. home health care;
D. long-term care;
E. nuclear;
F. central service;
G. nonsterile preparation compounding;
H. sterile preparation compounding;
I. veterinary;
J. limited service.
Licensing of a pharmacy in more than one category shall not result in an increase in the license
fee.
No pharmacy may engage in providing products or services in categories for which it is not licensed. A pharmacy must designate its category or categories on license renewal or application for an initial license. Effective July 1, 2012: an initial or renewed license issued by the board shall
list each license category for which the pharmacy has received board approval; a pharmacy must receive board approval before providing services in a license category not listed on its license; a pharmacy must notify the board if the pharmacy no longer provides services in a license category;
and the board shall issue a revised license without imposing an additional fee, if it approves a pharmacy’s request to provide services in additional license categories or if a pharmacy no longer provides services in one or more license categories.
The board may establish special conditions for licensure, appropriate to the situation, before approving a license application for a pharmacy with a limited service license category. Such pharmacies must also apply for and receive any necessary variances, according to part 6800.9900,
before an application for licensure is approved.
ANNUAL LICENSE RENEWAL DATE AND FEES
Each pharmacy license shall expire on June 30 of each year and shall be renewed annually by filing an application for license renewal, on or before June 1 of each year, together with a fee established in Minnesota Statutes, chapter 151. Renewal applications received on or after July 1 are subject to a late filing fee of an amount equal to 50 percent of the renewal fee in addition to the renewal fee.
Transfer of license restrictions
A separate license shall be required for each
pharmacy and is not transferable. The following shall be considered a transfer of ownership requiring
relicensure:
A. the sale of all or substantially all of the assets of the pharmacy;
B. the addition or deletion of one or more partners in a partnership to which a pharmacy
license has been issued;
C. the change of ownership of 20 percent or more of the issued voting stock of a corporation
pharmacy since the issuance of the license or the last renewal; this does not apply to any corporation
the voting stock of which is actively traded on any securities exchange or in any over-the-counter
market; or
D. the change in ownership from one form to another: sole proprietor, partnership, or
corporation.
Transfer of ownership
For a transfer of ownership, the new owner must submit a
completed pharmacy license application prior to the effective date of the transfer. Upon a transfer
of ownership, the new owner can continue operation of the pharmacy under the license issued to
the prior owner for 14 days after the effective date of the change of ownership or until the board
issues a new license, whichever is earlier. After the 14-day period, the license issued to the prior
owner is void and must be surrendered to the director of the board.
POSTING LICENSE
Each pharmacy license shall be posted in a conspicuous place in the pharmacy for which the
license has been issued.
PHARMACY, SPACE, AND SECURITY
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.
LOCATION, DIMENSION, OR SECURITY CHANGES.
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.
PATIENT ACCESS TO PHARMACIST - Consultation Required Part A
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.
PATIENT ACCESS TO PHARMACIST - Consultation Required Part B
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.
CLOSING A PHARMACY
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.
CLOSING PHARMACY: Transferring Controlled Substances-Inventory
- If controlled substances are to be destroyed - RPH-In-Charge must contact local DEA for instructions.
- If CIII - V are being transferred must be done on duplicate invoices with each pharmacy keeping a copy.
- CII narcotics being transferred must submit a DEA 222 form to the transferor.
- 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.
CLOSING PHARMACY - public notification
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.
REQUIRED REFERENCE BOOKS
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.
Required Equipment
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
Pharmacist License Renewal - when/how much does it cost/posting
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.
Inactive License
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.
Application for Licensure Requirements
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.
Retaking Exam
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.
Deadline for Completion of Licensure Process
18 months
Fees are not refundable
Reciprocity - Eligibility
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.
Reciprocity - Substitution for Internship
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.
Reciprocity - NAPLEX exam
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.
Reciprocity - law exam
MPJE exam required
Drug Manufacturer or Wholesaler License
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.
Drug Manufacturer or Wholesaler License - minimum info req for licensure
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.
Drug Wholesaler License - Minimum Qualifications
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.
Drug Wholesaler License - Personnel Requirements
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.
WHOLESALE DRUG DISTRIBUTORS - Facilities
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.
WHOLESALE DRUG DISTRIBUTORS - Security
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.
WHOLESALE DRUG DISTRIBUTORS - Storage
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.
Wholesale Drug Distributors - Examination of Materials
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.
Wholesale Drug Distributors - Returned, Damaged, Outdated Drugs
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.
Wholesale Drug Distributors - Record Keeping
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.
Wholesale Drug Distributors - Written Policies
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.
Wholesale Drug Distributors - Responsible Persons List & Comply with Laws
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.
Manufacturing Procedures
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
Continuing Education
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.
Operation of Pharmacies - Pharmacist on Duty
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.
Operation of Pharmacies - Pharmacy Work Conditions
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.
