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15 Cards in this Set
- Front
- Back
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Is the transfer of medications between pharmacies/distribution centers under the control of the same company considered wholesale distribution?
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Not sure. I don't think so. "Intracompany sales" are not considered wholesale distribution, but warehouses and chain pharmacy warehouses that conduct wholesale distribution are considered wholesale distributors.
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Is the distribution of prescription drug samples considered to be wholesale distribution?
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No
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Is the distribution of prescriptions drugs to general practitioners for their dispensing considered to be wholesale distribution?
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No, as long as total number of dosage units distributed per year does not exceed 5% of all dosage units dispensed/distributed per year. Controlled substance distribution must also be less than 5% of controlled substance distribution/dispensing.
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Is the sale, purchase, or trade of a drug pursuant to a prescription considered to be wholesale distribution?
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No
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Is the transfer of an expired prescription from a pharmacy back to a manufacturer considered to be wholesale distribution?
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No
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What is required for application for a wholesale distributors license?
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-pay the fee
-pass an inspection within the previous 3 year period by the board, PEB, NABP, or other accrediting body -register with the DEA if applicable |
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How large of a surety bond or irrevocable letter of credit must a wholesale distributor supply to the board before licensure?
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$5,000,000
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How quickly must the board act when reviewing an application for wholesale distribution?
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60 days
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T/F: wholesale distribution facilities must be kept free from infestation by insects, rodents, birds, or vermin of any kind
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duh
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What are the security requirements for a wholesale distribution facility?
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-access from the outside is minimized or well controlled
-outer perimeter is well lighted -entry to drug storage area is limited to authorized personnel -alarm system to detect eafter hours entry -suitable security system to prevent against computer tampering |
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What records are wholesale distributors required to keep?
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-source of the drugs (name and address)
-identity and quantity of the drugs received and distributed and disposed of -dates of receipt and distribution |
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How long are wholesale distributors required to keep records of distribution for?
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3 years
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How quickly must records be provided to the board when requested?
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immediately if kept on site;; within 2 days if kept off site
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What P&Ps must a wholesaler create and maintain?
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written P&Ps for the receipt, security, storage, inventory, and distribution of rx drugs
-reporting thefts and losses -correcting inaccuracies in inventory -stock rotation -recalls -disaster plans -expired drug segregation (including documentation of destruction, which is maintained for at least 3 years) |
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T/F: Wholesale distributors should allow board members and law enforcement officers to inspect their properties
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true
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