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37 Cards in this Set
- Front
- Back
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Who issues a license to a business to operate as a pharmacy?
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The state board of pharmacy
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How many categories may a pharmacy have a license under?
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Up to 16
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Do Mail Order pharmacies have to abide by the same laws as in-state pharmacies?
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Generally no, most commonly some states may require that the pharmacy be licensed in the state of residence and to comply with special recordkeeping
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How long must a business license be on file, with fees paid, before action is taken by the board?
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30 days
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What is the maximum amount of time it would take the board to approve a business license as a pharmacy?
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60 days
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Is a business license for a pharmacy divisible among multiple sites?
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No, each license is for a pharmacy in one physical location. If said pharmacy moves to a new area, different from the original location, a new license must be granted.
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In what time frame must a pharmacy owner notify the board of a change in managing pharmacist?
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5 days
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What is the minimum size of the professional service area of the pharmacy?
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250 square feet
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What is the maximum amount of floor space that can be used for the storage of bulk pharmaceuticals?
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20%
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What are the legal requirements for the dimensions of a pharmacy counter?
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18 inches in width and with an area of 12 sq feet.
This area can only be used for compounding and dispensing. |
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Under what conditions is a pharmacy not required to convert to a non-prescription or sundry outlet?
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If...
1) The pharmacist is absent for a time period of 1/2 hour or less 2) The pharmacist is accessible by the staff by phone, pager or other device 3) The pharmacy must indicate the pharmacist is not available in the professional service area, indicate the length of absence and return time 4) A pharmacy technician may only perform nominal duties |
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How long does it take the board to respond to plans for a remodel?
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60 days
Seems like everything takes 60 days |
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What is required to comply with sanitation regulations in a pharmacy?
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A sink with hot and cold running water for cleaning pharmaceutical equipment, as well as detergent and a waste container in the professional service area
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What are the minimum pieces of equipment for a pharmacy per regulations? (12 items)
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1) Electronic balance w/ sensitivity of 1mg or torsion balance w/ sensitivity of 6mg
2) Accurate weights for torsion balance 3) Transparent glass graduates ranging from 5-10 mL 4) An accurate device to measure <5 mL 5) Wedgewood and glass mortar and pestles 6) Stainless steel spatulas and at least 1 hard rubber spatula 7) Acid, base and solvent-resistant funnels 8) Heating device for compounding 9) Ointment slab or paper 10) Latest and immediately accessible version of state/federal pharmacy laws 11) References 12) Telephone number to poison center |
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What sources of state and federal pharmacy laws are required in a pharmacy?
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1) Drug enforcement administration regulations
2) Wisconsin pharmacy laws 3) Wisconsin controlled substances act 4) Wisconsin administrative code, rules of the pharmacy examining board |
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What are the regulations for storage in the pharmacy?
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1) A refridgerator
2) Sufficient shelf, drawer and cabinet space for Rx labels, containers, drugs, etc 3) Controlled substances shall be housed in a securely locked and heavily constructed cabinet OR dispersed throughout the non-controlled inventory in a manner that obstructs theft |
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Do out of state pharmacies have to be licensed in Wisconsin?
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Yup
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What is required for a license application for an out-of-state pharmacy?
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Application Must State:
1) Location 2) Name and address of the person holding the title and ownership of the location 3) Name of the managing pharmacist 4) Statement declaring the PIC is aware of Wisconsin laws 5) Submits evidence that it is licensed in the state it is located 6) Pays the credentialing fee |
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What regulations outline patient contact with an out-of-state pharmacy?
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Regulations state that the pharmacy should provide a phone number to patients in this state and that phone number must be active during regular business hours for at least 40 hours per week
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What is required on a license application for an in-state pharmacy?
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1) Location
2) Floor plan 3) Name and address of the person holding the title and ownership of said location 4) Name of PIC |
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What is the penalty for failing to license their place of practice?
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$25-50 per offense per day
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Define: "Aseptic preparation"
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Prep using procedures designed to preclude contamination of drugs, packaging equipment or supplies
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Define: "Biological Safety Cabinet"
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A containment unit suitable for the prep of low to moderate risk agents in order to protect personnel and the environment
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Define: "Class 100 environment"
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An atmospheric environment that contains less than 100 particles 0.5 microns in diameter per cubic foot of air
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Define: "Critical Activities"
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Activities that are different from other activities due to the increased potential opportunity for contamination to occur
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Define: "Critical Objects"
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Objects that are different from other objects due to the increased potential opportunity for contamination to occur
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What is required to maintain an aseptic enviroment per regulations?
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1) An enviroment control device capable of maintaining at least a Class 100 Environment
2) Disposal containers as required by OSHA for used needles, syringes, cytotoxic and infectious wastes 3) Class II biological safety cabinetry where cytotoxic drugs are prepared 4) Temp-controlled delivery containers as necessary 5) A sink w/ hot & cold running water in close proximity 6) Administration devices as necessary |
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What specific reports and records must be kept pertaining to sterile pharmaceuticals?
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1) Training and competency evaluations of personnel
2) Documentation of refrigerator and freezer temperatures 3) Certification of laminar airflow hoods |
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What is the minimum labeling requirements for sterile drugs prepared for a single patient if it is to be completely administered within 28 hours?
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1) Identity of all solutions, ingredients, amounts and concentrations, and they should be clearly marked
2) Identity of personnel involved in preparation 3) Date and time of preparation 4) Final sterile pharmaceuticals expiration date and storage requirements |
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What must all cytotoxic drugs be compounded in?
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In a vertical flow, Class II, biological safety cabinet.
Cabinet must be decontaminated before use of non-cytotoxic compounds is allowed |
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What are additional labeling requirements for sterile products?
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Normal labeling requirements PLUS
1) Control or lot number 2) Expiration date and time 3) Auxiliary labeling and precautions 4) Storage requirements 5) ID of the responsible pharmacist |
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What is required to be on the form submitted for a wholesale distributor license? (9 items)
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1) Name, address and telephone number of applicant
2) All trade/business names used 3) Names, addresses and telephone numbers of all facilities used by the applicant 4) Type of ownership or operation for applicant's business 5) Name of each partner and name of partnership (if applicable) 6) Name of each corporate officer director, name of corporation and state of incorporation (if applicable) 7) List of all licenses and permits issued to the applicant by any other state pertaining to prescription drugs 8) Name of sole proprietor and business entity (if applicable) 9) Name, address and phone number of a designated representative |
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What personal information is required for a designated representative of a wholesale distributor?
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1) Date and place of birth
2) Places of residence for the past 7 years 3) Occupations, positions of employment and offices held for the past 7 years 4) Name and addresses for businesses listed above 5) Statement indicating any business or professional license revocation in the past 7 years 6) Statement indicating any legal barring from possessing, controlling or distributing legal drugs in the past 7 years 7) Description of any involvement with a business in the past 7 years 8) Description of any misdemeanor or felony criminal offense found guilty, guilt with withheld, pleaded or guilty or no contest 9) Photography from within 12 months of application date |
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What is the only legal way for a wholesaler to rid themselves of expired, damaged, recalled or non-saleable prescription drugs?
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They can only be send back to the original manufacturer or a 3rd party returns processor
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Under what time frame must a wholesale distributor be inspected preceding an application for a license?
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3 years
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Define: "Pedigree"
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A history outlining the path of a specific drug product if it leaves a normal distribution channel (i.e. not a regular pharmacy).
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What is the required information needed for a pedigree?
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1) Name, address, phone number and electronic mail address of each recipient or distributor
2) Name and address of each facility from which the drug was distributed 3) The date of each distribution 4) Certification that every recipient has authenticated the pedigree prior to distribution 5) The name, strength, size/number of containers, lot number and name of manufacturer for each drug |
