T/F. Federal law controls state lows.
TRUE
What is the Durham-Humphrey Amendment of 1951 about?
Formally distinguish between prescription and over-the-counter
drugs. Before that, all drugs could be purchased
over-the-counter by consumers.
Name 4 sections mentioned under
Durham-Humphrey Amendment of 1951
A. Created a class of �prescription only drug� hence created the
modern profession of pharmacy because only a pharmacist can dispense
Rx drugs.B. Restricted to Rx only if...C. Prescription can
be dispensed ONLY when there is a:practitioner (where
allowed)D. Law MOST LIKELY TO BE VIOLATED BY PHARMACISTS!
Regarding
Durham-Humphrey Amendment of 1951,
Created a class of ___ hence created the modern
profession of pharmacy because____
�prescription only drug� only a pharmacist can
dispense Rx drugs.
Regarding
Durham-Humphrey Amendment of 1951,
Restricted to Rx only if: ____2 conditions
Too dangerous to use alone Experimental
Regarding
Durham-Humphrey Amendment of 1951,
Prescription can be dispensed ONLY when there is a___3
conditions
Written Rx by a LICENSED practitioner (ie MD) Oral Rx
by a LICENSED practitioner (where allowed) By refilling
either a or b if authorized
=> If a prescription is dispensed contrary to these
provisions, it is considered MISBRANDED
Regarding
Durham-Humphrey Amendment of 1951,
Law MOST LIKELY TO BE VIOLATED BY
PHARMACISTS! TRUE OR FALSE?
TRUE
What us the Act that sets important definitions to the study &
review of laws?
What are its 6 important definitions?
Food Drug & Cosmetic Act of 1938 (FD&C)
?�interstate commerce� ?�drug� ?�official
compendium� ?�label� ?�labeling�
?�knowingly�
According to Food Drug & Cosmetic Act of 1938 (FD&C),
What is the correct definition of
Interstate
Commerce
Commerce between states or even within states if it impacts things
outside that state.
According to Food Drug & Cosmetic Act of 1938 (FD&C),
What is the correct definition of
Drug?
should
know them
Article recognized in �official compendia� (i.e. US
pharmacopeia, Homeopathic pharmacopeia of the US, National
Formulary)
Articles intended
for use in the diagnosis, cure, mitigation treatment or prevention
of disease in man or animal. Articles (other than
food) intended to affect the structure or any function of the body
of man or other animals.
According to Food Drug & Cosmetic Act of 1938 (FD&C),
What is the correct definition of official compendium?
official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, official National Formulary, or
any supplement to any of them.
According to Food Drug & Cosmetic Act of 1938 (FD&C),
What is the correct definition of Label?
Critical
concept. Know the definition as written here
#1 form of communication (indirect) with the patient
Display of written, printed or graphic matter on the immediate
container (bottle or box) of any article. (i.e. Outer
Labeling)
According to Food Drug & Cosmetic Act of 1938 (FD&C),
What is the correct definition of
Labeling?
All labels and other written, printed or graphic matters on the
container or accompanying the article.
Includes: Print-out w/ patient info stapled to the
bag Written instructions Package insert
Auxiliary stickers. If labeling is
incorrect, the drug is considered MISBRANDED
According to Food Drug & Cosmetic Act of 1938 (FD&C),
What is the correct definition of Knowingly?
person has:
Actual knowledge of the information or Acts in
deliberate ignorance or reckless disregard of the truth. (i.e. has
adequate reason to suspect a prescription is fraudulent but fills it
anyway)
What are adulterated drugs & what are 3 conditions?
Poisonous, insanitary, etc., ingredients; adequate controls in
manufacture: Drug that there is something physically or chemically
wrong with. Strength, quality or purity different from
official compendium Misrepresentation of strength, etc.,
where drug is unrecognized in compendium Mixture or
substitution with another drug (e.g. Adding binder that reduces
potency of drugs )or substituting drug x for drug
Drug is �dirty� Conditions where drug is made are
�dirty� Manufactured or stored NOT in compliance w/ GMP
What category is the drug? Adulterated or misbranded?
Adulterated:
Poisonous, unsanitary
Supposed to be one thing but is actually another Label
says �10mg� but actually only �8mg�
What category is the drug? Adulterated or misbranded?
Adulterated:
Strength, quality or purity different from official
compendium
T/F. 60% of pharmacy errors occur through misbranding
FALSE. it's 90%
What is definition for misbranded? Name 5 conditions where drug is
considered misbranded?
False or misleading label: Wrong name, DOB, doctor�s name,
etc. Package form; contents of label Prominence of
information on the label (no fine written) � needs to be at a level
that can be understood by the patient Designation of drug
or devices by established name (can�t
make up a name) Directions for use and warnings
What the package form/ contents of label contain? 3 things
the name and place of business of the manufacturer, packer, or
distributor; and an accurate statement of the quantity of
the contents in terms of weight, measure, or numerical count:
Provided, That under clause (2) of this paragraph
reasonable variations shall be permitted, and exemptions as to small
packages shall be established, by regulations prescribed by the
Secretary
Why we have to caution about direction for use & warnings?
�Adequate
directions for use� means directions under
which the layman can use the drug safely for the purpose for which
it is intended. (e.g. Take one tablet daily) Warnings
against use in pathological conditions or by children where its use
may be dangerous to health, or against unsafe dosage or
duration.
Name other 5 conditions where drug is considered misbranded?
Accurate
representation of drug: (e.g. If there are
certain directions for drug x which are not mentioned on the
label)
Deteriorative
drugs (need to label drugs that need special storage
(e.g. refrigeration))
Misleading
container, imitation, offer for sale under a different
name (e.g. �fake� container or drug shape that is
attempting to look like another drug)
Health-endangering when used as prescribed.
(dangerous even when used the right way � problem assoc. with
manufacturer NOT pharmacist unless directions are wrong �e.g. take
500 a day�) Restricted devices using false or misleading
advertising or used in violation of regulations Packaging
or labeling of drugs in violation of regulations
Nonprescription drugs
When are the directions adequate for OTC?
for Rx?
For OTC, you need to give to enough info so that they can self
administer For Rx, PRN is accepted because healthcare
professionals can understand
What are 4 behaviors that are considered Prohibited Acts?
The introduction or delivery into interstate commerce of any
drug that is adulterated or misbranded The actual
adulteration or misbranding of a drug Receiving a drug that
is misbranded or adulterated Refusing to permit entry or
inspection of a DEA agent
What is the Federal Legend requirement?
TQ
Every Rx drug needs
to have on its commercial container �Caution: federal law prohibits
dispensing without a prescription� or at a minimum �Rx only�
A drug that is [a prescription drug] shall be deemed to be misbranded
if at any time prior to dispensing the label of the drug fails to
bear, at a minimum, the symbol �Rx only�. The drug is called?
Misbranded - Federal legend
A drug [that is NOT a prescription drug] shall be deemed to be
misbranded if at any time prior to dispensing the label of the drug
bears the symbol �Rx only�. The drug is called?
Misbranded - Federal legend
Name 7-point label for OTC products?
KNOW THEM!!
Name of product Name of manufacturer,
distributors Net contents
All the active
ingredients
Name of
habit-forming drug Cautions and warnings
Adequate directions for safe and effective use
What are considered
Adequate directions for safe and effective use for OTC use?
All indications, purposes, uses. Plus Can�t give �Rx level
doses� of OTC drugs Quantity of dose for different
ages Frequency Duration Time of
administration Route of administration Preparations
for use
What is mentioned in
Poison
Prevention Packaging Act of 1970 (PPPA)?
All hazardous substances require special /compliant
/child-resistant/ CR packaging (default is ALWAYS CR packaging
including dropper bottles. Can give alternate non-compliant
packaging but this is discouraged.)
What are the 4 exemptions mentioned in Poison Prevention
Packaging Act of 1970?
PATIENT'S CHOICE Single-size OTC bottle
Ipecac Syrup Pharmacy- bulk packaging
According to Poison Prevention Packaging Act,
what is/ are the correct definitions of Household substance?
any substance which is customarily produced or distributed for sale
for consumption or use, or customarily stored, that is:
A hazardous substance A food, drug, or cosmetic
A substance intended for use as fuel for heating, cooking, or
refrigeration system of a house.
What definitions are included in Poison Prevention Packaging
Act?
Household substance Package Special
packaging
According to Poison Prevention Packaging Act,
what is the definition of package?
immediate container or wrapping in which any household substance is
contained for consumption in the household
According to Poison Prevention Packaging Act,
what is
NOT included in package?
Any shipping container or wrapping used solely for the
transportation of any household substance in bulk or in quantity to
manufacturers, packers, or processors, or to wholesale or retail
distributors thereof; or Any shipping container or outer
wrapping used by retailers to ship or deliver any household
substance to consumers unless it is the only such container or
wrapping
What are 4 exemptions for CHILD-RESISTANT packaging & How?
PATIENT'S CHOICE Single-size OTC bottle
Ipecac Syrup Pharmacy- bulk packaging
T/F. According to Poison Prevention Packaging Act,
patients can only request NON-child resistant on SOME prescriptions only.
FALSE.
They can request Non-child resistant on ALL prescriptions using a
blanket waiver.
How CHILD-RESISTANT packaging is exempted by patient's choice?
i.e. Patient says they NEVER want CR packaging
Should document this choice even though not technically required
by law
How CHILD-RESISTANT packaging is exempted by physician? can they
give blanket waiver?
Can also request non-CR packaging on a prescription by
prescription basis Patient can overrule
this decision
Physician
CANNOT request a blanket waiver!
T/F. Patients can obtain blanket waiver at physician office to exempt
non CHILD-RESISTANT packaging
FALSE.
Physician
CANNOT give a blanket waiver!
Describe Poison Prevention Packaging Act, Exceptions- Single
Size OTC?
Noncomplying package requirements.
Patients can request noncomplying packaging of a
single size provided that complying packaging is also supplied
and the noncomplying
packages are conspicuously labeled to indicate that
they should not be used in households where young children are
present.
How CHILD-RESISTANT packaging is exempted by Elderly/Handicapped
Single Size Bottles of OTC Products?
Only ONE
size can be non-CR! (e.g. 3 strengths available: 20mg, 50mg and
100mg. You can pick one that is also non-CR�but you still need
to offer the CR version. For example if you choose the 50mg, You
need to offer BOTH the CR 50mg AND the non-CR
50mg) Needs to be conspicuously marked as
non-CR. �Not intended for use in households with small
children�
What does this pic tell you as mentioned in class?
TQ
Patients
got to pick labeling size that is non-child resistant or
child-resistant.
If they
chose non-child resistant, Pharmacists have to
also offer child-resistant packaging
and for non- CR, it has to
specifically say that it�s non-child resistant in the
label
Describe Poison Prevention Packaging Act, Exceptions-
Pharmacy �bulk� packaging?
Special packaging for substances subject to a standard that are
distributed to pharmacies to be dispensed pursuant to an order of a
licensed medical practitioner.
depending on whether the manufacturer intends that the
package will be the one in which the drug is ultimately given to
the consumer
What are 2 special specifications for packaging standards?
CR packaging- We have to get > 80% children out of the
opening packaging. Ease of adult opening - Allow 90% of
elders be able to open packaging
There's questions about Patient Package Inserts in PPPA pdf he will
use for exam
CHECK IT OUT
Can Ipecac syrup be sold without prescription?
TQ on this
YES
What are the 3 requirements to sell Ipecac syrup?
A red letter boxed
warning: ��For emergency use to cause vomiting in poisoning.
Before using, call physician, the Poison Control Center, or
hospital emergency room immediately for advice.��
A warning to the
effect: ��Warning�Keep out of reach of children. Do not use in
unconscious persons. Ordinarily, this drug should not be used if
strychnine, corrosives such as alkalies (lye) and strong acids, or
petroleum distillates such as kerosine, gasoline, coal oil, fuel
oil, paint thinner, or cleaning fluid have been
ingested.�
Usual dosage: 1
tablespoon (15 milliliters) in persons over 1 year of age.
It can only packaged in 30 mL size
allowed
Ipecac syrup is available OTC, it's dosed in____ for >1 year of
age & can be packaged in___
KNOW THIS WELL
1 tablespoon (15
milliliters)
can only packaged
in 30 mL size allowed
What are other products that can be sold without Rx prescription?
�Nitroglycerin (need immediately) � but quantity can be
limited Topical drugs (low absorption)
Inhaler Hospital/Nursing Home drugs for inpatient use
(unless brought from home) Bulk commercial packages that
are meant to be separated in to smaller CR packaging � i.e. assumed
that these large packages will NEVER be given directly into the
hands of patients
What are 2 conditions of
The TEST (Effectiveness Specifications: is the package
acceptable as special packaging?)
Need to keep
80% of children OUT of the package
Need to have at
least 90% of senior adults (SAUE) be able to get
IN to the package
What are 2 drugs that that REQUIRE the dispensing of patient
package inserts with the drugs for EVERY filling (except for
hospitals which require it for the 1st fill and every 30
days thereafter)
Estrogens
Oral Contraceptives
What are the purpose of Prescription Drug Marketing Act?
To maintain the integrity of the distribution system for
marketed prescription drugs To investigate and take
corrective action Prohibits the reimportation
Prohibits the sale, purchase or trade or the offer to sell,
purchase or trade any drug sample or coupon redeemable for a drug
product
Under Prescription Drug Marketing Act,
____ to prescribe such drugs may be provided samples.
requires ___ requires establishment of strict
accountability of samples delivered by sales representatives.
requires annual inventory and balancing of sales
representatives' sample inventories. requires written
receipt of samples delivered by mail or common carrier and a system
to detect patterns of non-return.
only practitioners licensed written
request and written receipt.
T/F. Under Prescription Drug Marketing Act,
Pharmacists can request drug product samples and retail
pharmacists can distribute drug product samples.
FALSE.
The law doesn't allow pharmacists request and distribute drug samples
Under what circumstances pharmacy can distribute drug sample?
A physician can request a drug sample and pharmacy can
distribute drug sample under physicians supervision
Under prescription drug marketing act, the legislation requires that
practitioners requesting samples must submit their DEA and state
license numbers and mandates that this information be stored by the
pharmaceutical manufacturer for at least____
three years
T/F. Under prescription drug marketing act, the transfer of
prescription drugs by retail pharmacy to another retail pharmacy in
order to alleviate a temporary shortage will be considered as
"wholesale distribution," and is NOT allowed.
FALSE.
not be interpreted to be
is allowed
Under prescription drug marketing act, no person may distribute any
drug sample, EXCEPT for 3 ways:___
practitioner licensed to prescribe such drug, health
care professional acting at the direction and under the supervision
of such a practitioner, or pharmacy of a hospital or of
another health care entity that is acting at the direction of such a
practitioner and that received such sample pursuant to paragraph (2)
or (3).
T/F. It is perfectly LEGAL to give a patient a DRUG package insert
(different from patient package insert)
TRUE
BUT it is discouraged because most patients will not be able to
understand it.