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#1 test review

pharmacy questions

QuestionAnswer
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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