Federal Pharmacy Law MPJE Review Exam
Questions And 100% Correct Answers
Adulteration - ANSWER something wrong with the INSIDE i.e. errors in strength, purity,
contamination, faulty devices, etc
Misbranding - ANSWER something wrong with the outside i.e. the container, packaging,
warnings/directions, etc. also if something is prepared, packed, produced in unsanitary
conditions this is also adulteration. cGMP is considered with adulteration
Compounding vs manufacturing - ANSWER compounding: "the preparation, mixing,
assembling, altering, packaging, labeling, and/or modifying of a drug product for a
specific patient by a licensed pharmacist or physician (FL Statute 465.003) in response
to a practitioner's prescription using chemicals, drugs, or devices approved by the FDA
(and not recalled from the market because of safety concerns) because a commercial
medical product to meet the patients' needs is not available. compounding can also be
performed in anticipation of receiving prescriptions based on a history of orders. these
rules do not apply to PET drugs and radiopharmaceuticals.
The New Package Insert - ANSWER See pg 9 for the list of categories included in the
new package insert. bascially it covers anything you wanna know about the drug.
Know the difference between:
- contraindications: circumstances under which a drug should not be used because
risks exceed benefits
Warnings and Precautions Serious adverse effects or potential risks associated with the
drug, which may occur while taking the medication Adverse Reactions An unexpected,
unintentional, undesired, or excessive response to a drug (also referred to as a side
effect) OTC package labeling - ANSWER -Name of product
-name and address of either the manufacturer, the distributor or the packer
- the package net contents
- the generic names of all active ingredients
Amounts of all ingredients Names of habit-forming drugs in the product Warnings and
,cautions necessary to protect user Full directions for safe and effective use Lot-Specific
Requirements Conditions and purposes for which the drug is intended Usual dose for
each use for which it is intended, and the doses for people of different ages and physical
conditions
Recommended frequency and duration of use or administration
Administration or application in relation to meals, onset of symptoms or other time
factors
Route of administration or application
Method of preparation for use (e.g. shaking, mixing, etc.)
Also a lot number has to be on the package as well as a declaration of the presence of
sulfites and phenylalinine (when applicable)
postal regulations - ANSWER in 1994 restrictions were dropped so narcotic-containing
controlled substances can now be mailed via a commercial delivery system (such as
USPS, UPS, FedEx, etc)
pregnancy categories - ANSWER A: Adequate studies have been done in pregnant
(human) females and there is no evidence of risk
B: Animal studies have been done and no risk is demonstrated but no adequate studies
in females have been done OR animal studies have shown a potential risk but adequate
studies in females show no evidence of risk
C: Animal studies show a risk and there are no adequate studies in human females OR
no adequate studies in humans or animals
D - the drug has been shown to present a risk to the fetus, but may be used in
exceptional circumstances when the benefits may outweigh the risks;
X - studiestudies in either animals or humans have demonstrated fetal abnormalities,
and the risk of using the drug clearly outweighs the possible benefit. These medicines
are contraindicated in pregnancy.
child-resistant packaging-ANSWER The Poison Prevention Packaging Act of 1970
requires that oral prescription-only drugs and controlled substances be dispensed in
special packaging designed to keep 85% of children <5yoa from opening the container
(few drugs are exempted from this). 90% of normal adults can still open the containers
,but the adult can have the requirement waived by either having the physician write on
the Rx to cover the waiver for that drug on the fill and refills of that one rx OR the patient
can issue a blanket waiver to cover all the prescriptions that they receive. Plastic
child-resistance containers with plastic child-resistant lids may not be
reused/redispensed. Glass child-resistant containers with plastic child-resistant lids
may be reused if the lids are replaced each time. Non-child-resistant containers may be
redispensed.
PPPA Exemptions - ANSWER -sublingual nitroglycerin
-sublingual and chewable isosorbide dinitrate
-erythromycin ethyl succinate granules for oral suspension and oral suspensions in
packages containing not more than 8 grams of erythromycin
-oral contraceptives in mnemonic memory aid packaging
-anhydrous cholestyramine in powder form
-unit dose forms of KCl
This includes the following NaF drug preparations: those that contain less than 264 mg
of NaF per package if there are no other drugs in the package subject to the PPPA rules,
betamethasone tablets if in a package containing less than 12.6 mg of betamethasone,
pancrealipase preparations, prednisone tablets in container containing not more than
105 mg of prednisone, mebendazole tablets in packages containing no more than 600
mg of the drug, methylprednisolone tablets in containers with no more than 84 mg of the
drug
cholestipol powder in packages of not more than 5 grams of the drug erythromycin
ethylsuccinate tablets in packages of not more than 16 grams of the drug conjugated
estrogens USP of not more than 32 mg per package, or other quantity, provided the
package contains no other dosage form norethindrone acetate in mnemonic packages
containing less than 50 mcg per package sucrase in glycol and water hormone
replacement therapy products whose dosage and administration are based solely on 1
or more progesterones or estrogens colesevelam HCl of not more than 3.75 mg
sevelamer carbonate max 2.4 grams/package
some iron-containing animal feeds
iron-containing dietary supplements with some exceptions requiring "special
packaging"
the above are drugs that are always exceptions. the list of partial exceptions is too long
to memorize
, also hospital packages and long term care facility packages do not need to comply as
long as the patients are not given the packaging-the packaging is kept by staff/nurses
Prescription Drug Marketing Act (PDMA) of 1987-ANSWER products manufactured in
this country, then exported may not be imported back in unless: 1. there is no financial
gain-they pay the same price for the drug that they sold it for OR 2. there is an
emergency-i.e. critical shortage of a particular drug and the drug is needed for
humanitarian reasons. Also, drugs from another country can be brought over if for
personal use and in small quantities (<90 day supply).
Drug Samples (as mentioned in the PDMA) - ANSWER drug samples can be given to
health care providers, but not pharmacies unless it's an institutional pharmacy. they are
not intended for sale. (Free samples given to pharmacies as a "prescription saver" are
ok since they are for resale thus not a sample.) It is also illegal to sell or purchase
prescription coupons that are distributed free from companies to defray the costs of
prescriptions
preferentially-priced drugs - ANSWER Special pricing arrangements are made between
manufacturers and users, non-profits, charities, etc in the US. Pharmacies that don't
have those deals can't purchase drugs elsewhere-for instance, a local hospital-for less
money, but can "borrow" it. Similarly, if a hospital is covered under the same deal, then
it may sell that same drug to another hospital, as that's how much the hospital would be
paying for it anyway and isn't getting a special deal from getting it from the other
hospital versus the manufacturer. Has to do with antitrust law.
medical devices - ANSWER devices are classified by class into 3 categories (low to high
standards). Pre-market notification is needed for some class I devices and all of class II
devices. Pre-market approval is needed for some class II and all of class III.
class I: low potential for causing harm, premarket testing not considered necessary. ex:
scissors, needles
class II: have particular performance standards established by a panel of experts may
require premarket approval ex. hearing aids, thermometers, catheters
Class III: significant testing and standards are available for these. FDA premarket
approval for these is not dissimilar from approval done for drugs. Used in life-supporting
situations where failure may result in death or serious injury. ex: indwelling
neuromuscular stimulators and some types of contact lenses
restricted devices: restricted to certain sellers/ can only be used by certain specially
Questions And 100% Correct Answers
Adulteration - ANSWER something wrong with the INSIDE i.e. errors in strength, purity,
contamination, faulty devices, etc
Misbranding - ANSWER something wrong with the outside i.e. the container, packaging,
warnings/directions, etc. also if something is prepared, packed, produced in unsanitary
conditions this is also adulteration. cGMP is considered with adulteration
Compounding vs manufacturing - ANSWER compounding: "the preparation, mixing,
assembling, altering, packaging, labeling, and/or modifying of a drug product for a
specific patient by a licensed pharmacist or physician (FL Statute 465.003) in response
to a practitioner's prescription using chemicals, drugs, or devices approved by the FDA
(and not recalled from the market because of safety concerns) because a commercial
medical product to meet the patients' needs is not available. compounding can also be
performed in anticipation of receiving prescriptions based on a history of orders. these
rules do not apply to PET drugs and radiopharmaceuticals.
The New Package Insert - ANSWER See pg 9 for the list of categories included in the
new package insert. bascially it covers anything you wanna know about the drug.
Know the difference between:
- contraindications: circumstances under which a drug should not be used because
risks exceed benefits
Warnings and Precautions Serious adverse effects or potential risks associated with the
drug, which may occur while taking the medication Adverse Reactions An unexpected,
unintentional, undesired, or excessive response to a drug (also referred to as a side
effect) OTC package labeling - ANSWER -Name of product
-name and address of either the manufacturer, the distributor or the packer
- the package net contents
- the generic names of all active ingredients
Amounts of all ingredients Names of habit-forming drugs in the product Warnings and
,cautions necessary to protect user Full directions for safe and effective use Lot-Specific
Requirements Conditions and purposes for which the drug is intended Usual dose for
each use for which it is intended, and the doses for people of different ages and physical
conditions
Recommended frequency and duration of use or administration
Administration or application in relation to meals, onset of symptoms or other time
factors
Route of administration or application
Method of preparation for use (e.g. shaking, mixing, etc.)
Also a lot number has to be on the package as well as a declaration of the presence of
sulfites and phenylalinine (when applicable)
postal regulations - ANSWER in 1994 restrictions were dropped so narcotic-containing
controlled substances can now be mailed via a commercial delivery system (such as
USPS, UPS, FedEx, etc)
pregnancy categories - ANSWER A: Adequate studies have been done in pregnant
(human) females and there is no evidence of risk
B: Animal studies have been done and no risk is demonstrated but no adequate studies
in females have been done OR animal studies have shown a potential risk but adequate
studies in females show no evidence of risk
C: Animal studies show a risk and there are no adequate studies in human females OR
no adequate studies in humans or animals
D - the drug has been shown to present a risk to the fetus, but may be used in
exceptional circumstances when the benefits may outweigh the risks;
X - studiestudies in either animals or humans have demonstrated fetal abnormalities,
and the risk of using the drug clearly outweighs the possible benefit. These medicines
are contraindicated in pregnancy.
child-resistant packaging-ANSWER The Poison Prevention Packaging Act of 1970
requires that oral prescription-only drugs and controlled substances be dispensed in
special packaging designed to keep 85% of children <5yoa from opening the container
(few drugs are exempted from this). 90% of normal adults can still open the containers
,but the adult can have the requirement waived by either having the physician write on
the Rx to cover the waiver for that drug on the fill and refills of that one rx OR the patient
can issue a blanket waiver to cover all the prescriptions that they receive. Plastic
child-resistance containers with plastic child-resistant lids may not be
reused/redispensed. Glass child-resistant containers with plastic child-resistant lids
may be reused if the lids are replaced each time. Non-child-resistant containers may be
redispensed.
PPPA Exemptions - ANSWER -sublingual nitroglycerin
-sublingual and chewable isosorbide dinitrate
-erythromycin ethyl succinate granules for oral suspension and oral suspensions in
packages containing not more than 8 grams of erythromycin
-oral contraceptives in mnemonic memory aid packaging
-anhydrous cholestyramine in powder form
-unit dose forms of KCl
This includes the following NaF drug preparations: those that contain less than 264 mg
of NaF per package if there are no other drugs in the package subject to the PPPA rules,
betamethasone tablets if in a package containing less than 12.6 mg of betamethasone,
pancrealipase preparations, prednisone tablets in container containing not more than
105 mg of prednisone, mebendazole tablets in packages containing no more than 600
mg of the drug, methylprednisolone tablets in containers with no more than 84 mg of the
drug
cholestipol powder in packages of not more than 5 grams of the drug erythromycin
ethylsuccinate tablets in packages of not more than 16 grams of the drug conjugated
estrogens USP of not more than 32 mg per package, or other quantity, provided the
package contains no other dosage form norethindrone acetate in mnemonic packages
containing less than 50 mcg per package sucrase in glycol and water hormone
replacement therapy products whose dosage and administration are based solely on 1
or more progesterones or estrogens colesevelam HCl of not more than 3.75 mg
sevelamer carbonate max 2.4 grams/package
some iron-containing animal feeds
iron-containing dietary supplements with some exceptions requiring "special
packaging"
the above are drugs that are always exceptions. the list of partial exceptions is too long
to memorize
, also hospital packages and long term care facility packages do not need to comply as
long as the patients are not given the packaging-the packaging is kept by staff/nurses
Prescription Drug Marketing Act (PDMA) of 1987-ANSWER products manufactured in
this country, then exported may not be imported back in unless: 1. there is no financial
gain-they pay the same price for the drug that they sold it for OR 2. there is an
emergency-i.e. critical shortage of a particular drug and the drug is needed for
humanitarian reasons. Also, drugs from another country can be brought over if for
personal use and in small quantities (<90 day supply).
Drug Samples (as mentioned in the PDMA) - ANSWER drug samples can be given to
health care providers, but not pharmacies unless it's an institutional pharmacy. they are
not intended for sale. (Free samples given to pharmacies as a "prescription saver" are
ok since they are for resale thus not a sample.) It is also illegal to sell or purchase
prescription coupons that are distributed free from companies to defray the costs of
prescriptions
preferentially-priced drugs - ANSWER Special pricing arrangements are made between
manufacturers and users, non-profits, charities, etc in the US. Pharmacies that don't
have those deals can't purchase drugs elsewhere-for instance, a local hospital-for less
money, but can "borrow" it. Similarly, if a hospital is covered under the same deal, then
it may sell that same drug to another hospital, as that's how much the hospital would be
paying for it anyway and isn't getting a special deal from getting it from the other
hospital versus the manufacturer. Has to do with antitrust law.
medical devices - ANSWER devices are classified by class into 3 categories (low to high
standards). Pre-market notification is needed for some class I devices and all of class II
devices. Pre-market approval is needed for some class II and all of class III.
class I: low potential for causing harm, premarket testing not considered necessary. ex:
scissors, needles
class II: have particular performance standards established by a panel of experts may
require premarket approval ex. hearing aids, thermometers, catheters
Class III: significant testing and standards are available for these. FDA premarket
approval for these is not dissimilar from approval done for drugs. Used in life-supporting
situations where failure may result in death or serious injury. ex: indwelling
neuromuscular stimulators and some types of contact lenses
restricted devices: restricted to certain sellers/ can only be used by certain specially
