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The key regulations and requirements for pharmacies operating in the state of missouri. It covers topics such as controlled substance distribution, dispensing errors, pharmacy classifications, labeling requirements, and the responsibilities of the missouri board of pharmacy. Detailed information on the legal and operational aspects of running a pharmacy in missouri, including the specific rules and guidelines that pharmacists and pharmacy staff must adhere to. This information would be highly relevant for pharmacy students, pharmacists, and pharmacy owners/operators in missouri who need to ensure their practices are compliant with state regulations.
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What bureau regulates controlled substance distribution in Missouri? -
Drugs (BNDD) The Missouri Department of Health and Senior Services (DHSS) has regulatory
Located within the "licensed premises" of hospitals (except for Class-B hospital pharmacies). What additional services can pharmacists perform in Missouri if properly certified and
medication by prescription order Immunizing by protocol Medication therapy services T/F: After a name change, you must request a new license with updated name. -
Address and employment changes must be reported to the board within __ days -
board Legal documentation
31st of every even numbered year
Two-way communication by audio, completion of employer approved training and compliance kept for 2 years, 5-year audit trail of all activity.
Naloxone, Naltrexone HIV PEP Emergency medication supply if unable to obtain refill authorizations
following the law
permit
A pharmacist located in another state can perform pharmacy services if -
working for a missouri licensed pharmacy.
to absent statutory direction. However pharmacists can't "diagnose"
Collect PMH Screen for high risk patients Prescribe based on clinical guidelines
Patient medical records kept at the pharmacy must be produced immediately or within _____ after request from the BOP. Records not maintained at a pharmacy
business days
Date pt seen
Documentation of screening/testing PMH Name and dosage of drug Any recommended plan, follow-up, or referral
There is no set amount of hours What are the requirements that must be met for a pharmacist to be PIC at more than
enough to be regularly engaged with the operations of the pharmacy (subject to interpretation by the PIC and permit holder) In the event of a PIC leaving, the pharmacy should notify the board within ____. -
CII-CV inventory must be counted (including pseudoephedrine) immediately prior to or at time of PIC change. Outgoing and incoming PIC may conduct inventory together. In the event of a PIC change, what are the pharmacy's options involving continuing
appointed or appoint someone Interim Supervising Pharmacist for a period no longer than 30 days. Does an inventory need to take place when an Interim supervising pharmacist is
years. An interim pharmacist may only serve for ___ days. After that if more time is needed,
Pharmacy permits may be owned by sole proprietors or LLP/LLCs. When must you
A new permit must be made anytime change of ownership occurs, even in the event of naming a new business partner. They are good for the life of that ownership. CVS is a publicly traded company that owns pharmacies across missouri. They have a new large shareholder of 10%. Does the board of pharmacy need to be notified of
corporations are owned by the corporation, not the shareholders.
How does missouri handle label requirements for patient use off-site for class b
patients to use off-site unless they are initiated onsite and continued offsite by an external or implanted medical delivery devices programmed by a healthcare professional. Under federal law, a missouri pharmacy must enroll as a drug distributor with the DEA if controlled substances exceed __% of drugs dispensed during the previous
It is allowed when authenticating product selection. It is not allowed when verifying final preparation (such as with a compound).
two or more pharmacies to provide pharmacy functions on behalf of one another (remote data entry, verification)
pharmacy
records of pharmacy operations and that controlled substances are not being dispensed. Dispensing errors at type L pharmacies must be reported to the PIC within -
bleeding disorders (dispense clotting factors).
12 months or the manufacturers expiration, whichever is sooner.
unique number, Pt name, Prescriber name, Directions, name and address of pharmacy, name and dosage of drug, manufacturer (if generic). Blood clotting factor concentrates must be delivered within __ days for established patients and __ days for new patients. If it is an emergency, established patients
hours
By providing a toll free number each time a rx is dispensed.
been dispensed to more than 3 times in a calendar year
provides services to indigent people that have been screened and approved by a charitable organization and deemed not to have sufficient funds to obtain needed medications.
Must be donated by a pharmacy, distributor, healthcare entity, or provider, in its original sealed package.
dispensing pharmacy
Continuous audio and video To be eligible for licensure, a class R pharmacy must be __ miles away and
pharmacy Class R pharmacies can participate in Class ,, or __ functions under their class
Supervising pharmacies of a class R pharmacy can be no more than __ miles away
How much experience must a tech have before working at a class R pharmacy?
Pharmacists supervising a class R pharmacy must be employed by and located at -
hours per month
Individuals/entities acquiring more than __% must notify the board within __ dyas -
Dispensing errors that reached the patient must be reported within __ days of
Recall of a compounded preparation must be reported to the board and _______
Theft or diversion from a controlled substance waste container must be reported
If a chiropractor has prescriptive authority in another state, can the script be filled at
A candian licensed physician writes a prescription brought to a missouri pharmacy.
Dentists, podiatrists, veterinarians, and optometrists may prescribe control/non-
their scope.
controlled substances and controlled substances only in emergency situations?
Yes, as long as they keep the same record as they would for a patient A retired physician wishes to prescribe an antibiotic for a grandson. Can he? -
(granted inactive status by the board of healing arts) he may prescribe non-control substances for himself or immediate family members.
If it is electronically signed
signature
waiver from mandated electronic prescribing). If a patient present a prescription written by a deceased prescriber, may it be filled? -
professional judgement.
E-prescribed controlled substances (not faxed CS)
All scripts except e-prescribed CS
months
no refills. 90 days with documented medical reason ____________ control substances may be written for a quantity of 90 days without
As many as the prescriber wants
A patient has a script for Norco 5-325 #30 1t PO q6h PRN acute pain. This patient recently filled a prescription for this medication 3 months prior. Can this prescription
Yes, but not for the quantity prescribed. Only 7 days supply may be dispensed, as long the patient has seen the prescriber for a consultation. Who is exempt from 7 day supply opioid limits with control substances? -
Can a hospital allow a telemedicine doctor to use their DEA license number? -
Which providers can purchase, administer, or dispense controlled substances? -
products only Limited to a 5 day or 120 hour supply
products only Limited to a 5 day or 120 hour supply
a 5 day 120 hour supply Prescription valid for 6 months No refills
to a 5 day 120 hour supply Prescription valid for 6 months No refills
Full authority to prescribe 90 - day quantity limits Prescription valid for 6 months
Limited to a 5 day 120 hour supply Prescription valid for 6 months No refills
limit supply c4 scripts valid for 6 months c5 scripts valid for 12 months
limit supply c4 scripts valid for 6 months c5 scripts valid for 12 months
X-DEA number What are the limits for a c2 rx written by an out of state midlevel practitioner -
Refills: none Supply limits:
Refills: as allowed in home state Supply limit:
Refills: as allowed in home state Supply limit:
(final product) What type of medication cannot solely be electronically verified by a pharmacist
Compounded medications System validation (auto-verify) records of validation/revalidation must be kept... -
What allowances do techs/interns have with technology-assisted verification? -
Prescriber has approved of any change Patient has been counseled
is the original 90 days that it was given.
Who can receive meds sealed in a med pak that has been returned? What about
initially packaged for. They cannot be distributed if they were previously comingled with other medications. Meds from an LTC facility may be reused unless they are multi-med pak or controlled substance.
Only the patient
blanket request.
(not to the stock bottle), expire 1 year from dispensing or manuf expiration (whichever is sooner). Drugs may also be returned to an automated filling system, but the expiration of all meds in that pocket must be updated. Drugs returned from the patient because the wrong medication was filled must
Epi-pens and asthma medication A prescription written to Cass County Parks and Rec for epi-pen by John Doe NP is
physicians may write a prescription for a school or other entity for epi pens or albuterol A class __ permit is required for pharmacies that do sterile compounding. -
valid prescription for a compound has been written for the patient it is to be used on (not for office use), or if it is for a veterinarians office. Can a pharmacy compound a stock supply? If so what are the limits? -
dispense and an established relationship must exist between the pharmacy, patient, and prescriber. 1 year supply of topicals and 3 month supply of a batched product.
Batched and returned to stock
q 6 months for level 3 compounds annually for level 1 and 2 Hospitals may accept the media fill test from another facility in an emergency. After
throughout the day with a germicidal followed by alcohol.
daily
monthly
months
compound as long as they use a germicidal and sporicidal. Resampling is required.
The signed protocol must indicate that information. Prescription must be obtained or created within __ after an immunization under
30 days
days
licensed physician
Changes made through MTS must be communicated to who, and within what time
24 hours. __ hours of CE specifically in MTS must be obtained each renewal period for MTS
Rx's
MTS protocols
MTS patient records What actions/breaches must be reported to the board within 7 days? -
location) Breach of security at a class R pharmacy
What actions/breaches must be reported to the board within 15 days? -
worker Final adverse action or license surrender of a pharmacy Out of business notification Change of employment location Change of PIC
Change of partner in an LLC OR LLP Missouri MPJE