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PTCB Latest Exam Questions And Verified Solutions @ 2024
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PTCB Latest Exam Questions And VerifiedSolutions @ 2024
food and drug administration -Answer the leading enforcement agency at the federal level
for regulations concerning drug products
drug enforcement administration DEA -Answer the agency that controls the distribution
of drugs that may be easily abused
food and drug act of 1906 -Answer prohibited interstate commerce in adulterated or
misbranded food drinks and drugs.government preapproved of drugs is required.
1938 Food, Drug and Cosmetic Act In response to the fatal poisoning of 107 people,
most of them children, by an untested sulfanilamide concoction this far-reaching law
mandates that new drugs be proven safe before being sold
1951 Durham Humphrey Amendment- This law defines what drugs require a prescription
by a licensed practioner and requires them to include this legend on the label"Caution
federal law prohibits dispensing without a prescription
1962 Kegauver-Harris Amendment- requires drug manufacturers to provide proof of
bothsafety and effectiveness before marketing the drug
1970 poison prevention packaging act- Response should include childproof packaging on
all controlled and most prescription drugs dispensed by pharmacies
1907 controlled substances act CSA- Response should classify drugs that can be readily
abused and ban their distribution.it is policed by the drug enforcement administration
DEA within the justice department
1990 Omnibus Budget Reconciliation Act OBRA - Answer among other things this act
,required pharmacists to offer counseling to Medicaid patients regarding medications,
effectively putting the common practice into law
1996 Health Insurance Portability and Accountability Act
HIPAA - Answer provided broad and stringent regulations to protect patients privacy
Patent Protection ANSWER Patent for a new drug gives its manufacturer an exclusive
right to market the drug for a certain period of time under a brand name. A drug's patent
is in effect for 17 years from the date of the drug's discovery. Hatch-Waxman Act of 1984
provided for up to five-year extensions of patent protection to the patent holders to
makeup for time lost while the products went through the FDA approval process.
Prescription minimum requirements - Answer name
address of dispenser
prescription serial number
date of prescription or filling
name of prescriber
name of patient
directions for use
cautionary statements
ndc - Answer national drug code the number assigned by the manufacturer each ndc has
three parts or sets of number the first set indicates the manufacturer the next set
indicates the medication ,its strength and dosage form,the last set indicates the package
size.
formula dea number - 2 letters followed by seven single digit numbers. the formula for
checking a dea number on a prescription form is :take the sum of the first,third,and fifth
digits *add this to the next number* the 2nd,4th,6th, numbers *times this by 2* *add the 2
totals together. the second number in the total should match the last number of the dea.
Recall Class I - where there is a strong likelyhood that the product may cause serious
, adverse effects or death
Recall Class II - Where product may cause temporary but reversible adverse effects or in
which there is little likelyhood of serious adverse effects
Recall Class III - Where a product is not likely to cause adverse effects
medwatch- Answer fda reporting program for health care professionals to report adverse
effects that occur from the use of an approved drug or other medical product
medwatch online voluntary reporting form 3500- Answer used for fda regulated
drugs,biologics,medical devices,and special nutritional products and cosmetics
liability- Answer legal liability means you can be prosecuted for misconduct
negligence- Answer failing to do something that should or must be done
schedule I - Answer no accepted medical use in the US it may not be prescribed.
heroin, various opium derivatives, hallucinogenic substances
schedule II - Answer high potential for abuse and may lead to physcial or psychological
dependence but also has a currently accepted medical use in the US
amphetamines
cocaine
methadone
various opiates
schedule III-Answer abuse may lead to moderate to low physical dependence or high
psychological dependence. anabolic steroids and various compounds containing limited
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