Ptcb Exam Study Guide:
GRADED A+. Practice
Questions and Verified
Answers. Latest 2026 Update
food and drug administration - Ans✔✔-the leading enforcement agency at the
federal level for regulations concerning drug products
drug enforcement administration DEA - Ans✔✔-the agency that controls the
distribution of drugs that may be easily abused
food and drug act of 1906 - Ans✔✔-prohibited interstate commerce in
adulterated or misbranded food drinks and drugs.government preapproved of
drugs is required.
1938 food drug and cosmetic act fdc - Ans✔✔-in response the fatal poisoning
of 107 people primarily children by and untested sulfanilamide concoction this
comprehensive law requires new drugs be shown to be safe before marketing
1951 durham humphrey amendment - Ans✔✔-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 - Ans✔✔-requires drug manufacturers to
provide proof of bothsafety and effectiveness before marketing the drug
1970 poison prevention packaging act - Ans✔✔-requires childproof packaging
on all controlled and most prescription drugs dispensed by pharmacies
1907 controlled substances act CSA - Ans✔✔-classifies drugs that may be easily
abused and restricts their distribution.it is enforced by the drug enforcement
administration DEA within the justice department
1990 omnibus budget reconciliation act OBRA - Ans✔✔-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 - Ans✔✔-provided broad and stingent regulations to protect patients
privacy
patent protection - Ans✔✔-patent for a new drug gives its manufacturer an
exclusive right to market the drug for a specific period of time under a brand
name.a drugs patent is in effect for 17 years from the date of the drugs
discovery.The Hatch-Waxman act of 1984 provided for up to five year
extensions of patent protection toe the patent holders to make up for time lost
while products went through the FDA approval process
prescription minimum requirements - Ans✔✔-name
address of dispenser
, prescription serial number
date of prescription or filling
name of prescriber
name of patient
directions for use
cautionary statements
ndc - Ans✔✔-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.
dea number formula - Ans✔✔-2 letters followed by seven single digit numbers.
the formula for checking a DEA number on a prescription form is :if 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 - Ans✔✔-where this is a stong likelyhood that the product may
cause serious adverse effects or death
recall class II - Ans✔✔-where product may cause temporary but reversible
adverse effects or in which there is little likelyhood of serious adverse effects
recall class III - Ans✔✔-where a product is not likely to cause adverse effects
GRADED A+. Practice
Questions and Verified
Answers. Latest 2026 Update
food and drug administration - Ans✔✔-the leading enforcement agency at the
federal level for regulations concerning drug products
drug enforcement administration DEA - Ans✔✔-the agency that controls the
distribution of drugs that may be easily abused
food and drug act of 1906 - Ans✔✔-prohibited interstate commerce in
adulterated or misbranded food drinks and drugs.government preapproved of
drugs is required.
1938 food drug and cosmetic act fdc - Ans✔✔-in response the fatal poisoning
of 107 people primarily children by and untested sulfanilamide concoction this
comprehensive law requires new drugs be shown to be safe before marketing
1951 durham humphrey amendment - Ans✔✔-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 - Ans✔✔-requires drug manufacturers to
provide proof of bothsafety and effectiveness before marketing the drug
1970 poison prevention packaging act - Ans✔✔-requires childproof packaging
on all controlled and most prescription drugs dispensed by pharmacies
1907 controlled substances act CSA - Ans✔✔-classifies drugs that may be easily
abused and restricts their distribution.it is enforced by the drug enforcement
administration DEA within the justice department
1990 omnibus budget reconciliation act OBRA - Ans✔✔-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 - Ans✔✔-provided broad and stingent regulations to protect patients
privacy
patent protection - Ans✔✔-patent for a new drug gives its manufacturer an
exclusive right to market the drug for a specific period of time under a brand
name.a drugs patent is in effect for 17 years from the date of the drugs
discovery.The Hatch-Waxman act of 1984 provided for up to five year
extensions of patent protection toe the patent holders to make up for time lost
while products went through the FDA approval process
prescription minimum requirements - Ans✔✔-name
address of dispenser
, prescription serial number
date of prescription or filling
name of prescriber
name of patient
directions for use
cautionary statements
ndc - Ans✔✔-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.
dea number formula - Ans✔✔-2 letters followed by seven single digit numbers.
the formula for checking a DEA number on a prescription form is :if 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 - Ans✔✔-where this is a stong likelyhood that the product may
cause serious adverse effects or death
recall class II - Ans✔✔-where product may cause temporary but reversible
adverse effects or in which there is little likelyhood of serious adverse effects
recall class III - Ans✔✔-where a product is not likely to cause adverse effects
