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#1 test review
pharmacy questions
| Question | Answer |
|---|---|
| the agency charged with the approval to market new drug entities is the ? | FDA |
| responsibilities of the FDA include | regulating package units, regulating drug advertising, and issuing recalls when necessary |
| the agency which licenses the pharmacy is the ? | the state board of pharmacy |
| the rules governing the practice of pharmacy in a state are known as the ? | pharmacy practice act |
| who are you most likely to see conducting a routine inspection of your pharmacy? | a state pharmacy compliance officer |
| usually a state will have 3 pieces of legislation governing the practice of pharmacy. what are they ? | pharmacy practice act, administrative code, and state controlled substances act |
| the federal DEA has jurisdiction on any | controlled substances which have crossed state lines |
| True or false: it is possible for a drug to be defined as a controlled substance within your state if it doesn't appear on a federal DEA controlled substance schedule | True |
| the governing body of pharmacy within the state is known as the | board of pharmacy |
| the first piece of legislation which covered the purity of drugs was the ? | the federal drug and food act |
| a bottle that contained Dyazide but was labeled Diabeta would be said to be adulterated, misbranded, both or neither of these? | misbranded |
| the federal food, drug, and cosmetic act was important for the fact that it was the first legislation to demand? | safety of the product |
| Durham-Humphrey and Kefauver-Harris are both amendments of the? | federal food, drug and cosmetic act |
| what amendment created the class known as "legend drugs"? | Durham-Humphrey |
| what amendment demanded proof of effectiveness before a new drug could be manufactured ? | Kefauver-Harris |
| the first attempt at controlling narcotics involved the use of ? | taxation |
| Pharmacy laws can be enacted by ? | the local gov, the state gov, and the fed gov |
| the level to which a practitioner is expected to perform is called the? | standard of practice |
| the organization involved in certifying institutional health care organizations is called? | JCAHO joint commission on accreditation of healthcare organizations |
| possible causes for a violation on a third party audit can include? | wrong pack size billed, no patient signature on file, wrong quantity billed |
| the NDA (new drug application) is used to do what? | approve a new drug product for sale |
| the IND (investigational New Drug review) is used to ? | transport an investigational drug across state lines |
| in order to get an approval on an NDA, the applicant would need to show? | safety of the drug, effectiveness of the drug, proper labeling of the drug, and proper manufacturing of the drug |
| True or false: The same drug may be sold under more than one trade name | true |
| the name that is used in a clinical journal will be the ? | generic name |
| AMPI25016 would probably be an example of a(n)? | mnemonic name |
| the abbreviation INH stands for ? | isoniazid |
| in the abbreviation D5NS, what is the concentration of sugar? | 5% |
| true or false: a patent forbids other US manufacturers from producing the same product | true |
| what are some facts about a DEA number? | it can be issued to a business, it is a series of 2 letters and 7 numbers, the second letter should be the first letter of the practitioner's last name |
| the current system of handling controlled substances is? | a closed system |
| you receive a prescription from dr goodguy for a controlled substance. the DEA number written by the doctor is AG7266908. you should? | fill the prescription and ready it for the final check by the pharmacist because the DEA number can be verified through its self check |
| the contents of which schedule have no accepted medical use? | schedule I |
| cocaine is a member of what schedule? | schedule II |
| which schedule would propoxyphene be found in? | schedule IV |
| which schedule would contain drugs with the lowest potential for abuse? | schedule V |
| when dispensing a controlled substance prescription in a retail store, what must appear on the bottle? | the symbol RX only, statement that says caution: federal law prohibits the transfer of this drug to any other person than who it was prescribed to, and caution: federal law prohibits dispensing without a prescription |
| when looking at a stock bottle you can tell a drug is a controlled substance because ? | the symbol C is written on it followed by the number of the schedule to which it belongs |
| route of administration refers to ? | the way which a drug enters into the body |
| which of the following is a parenteral route of administration? PO, SL, transdermal or IC | IC |
| what would not be an appropriate route for a drug which is extremely irritating to the stomach? | NG (nasogastric) |
| why must the route of administration be written on the drug order ? | some drugs come in different forms for different routes of administrations |
| true of false: capsules may be an enteric coated product | true |
| a cream is what kind of dosage form? | semi-solid |
| a patient who cannot have products containing alcohol should not take? | an elixir |
| a drug product which consists of drug product dissolved in oil droplets that are suspended in a water based vehicle is called an ? | emulsion |
| in a phase 1 clinical trial the investigators are testing an applicant drug's ? | maximum tolerated dose |
| NDA phase IV testing of an applicant drug takes place ? | after NDA approval is given and the drug is marketed |
| the average drug takes how long to get approval of its NDA? | 12 to 16 years |
| in the NDC number 00087-6071-11, the number 00087 indicates the ? | manufacturer of the drug |
Created by:
sloank121
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