Federal Pharmacy Law and Regulation: Reading 2

Question 1

Define “drug” (4 clauses)

Answer 1

1 - an article recognized in the official compendium or any supplement of the official compendium, AND
2 - an article intended for use in the diagnosis, cure, mitigiation, treatment, or prevention of disease in man or other animal, AND
3- an article other than food intended to affect the structure or any function of the body in man or other animal, AND
4- intended for use as a component of any article specified 1, 2, or 3

Question 2

What is the official compendium?

Answer 2

The United States Pharmacopeia (USP), National Formulary (NF) - now “USP-NF”
Homeopathic Pharmacopeia of the United States (HPUS)

Question 3

What do the USP-NF and HPUS do?

Answer 3

develop and publish standards for drug substances, drug products, excipients, dietary supplements, and homeopathic articles

contribute most to adulteration and misbranding

Question 4

a _________ ______ can be defined as “ a drug intended for use by man which (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or (B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug…”

Answer 4

prescription drug

**MUST have the symbol “Rx only” on the product label” **

Question 5

________ drugs are those that are safe and effective for use without a prescriber’s supervision for certain conditions

Answer 5

OTC drugs

“a drug that is (a) not subject to 353(b) of this title; and (b) not subject to approval in an application submitted under section 355 of this title

Question 6

____________ ____________ is “a drug or other substance, or immediate precursor, included in schedule I, II, III, IV or V” “a drug that has dependence liability and/or the potential for abuse”

Answer 6

Controlled substance

Question 7

________ ______ “are used for a condition that affects less than 200,000 persons in the United States or a condition that affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the US a drug for such a disease or condition will be recovered from sales in the US of such drug”

Answer 7

orphan drugs

Question 8

___________ __________ is “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate metabolite, constituent, extract, or combination of any ingredient described in clause (a), (b), (c), (d), or (e)

Answer 8

dietary supplement

Question 9

____ _____ is a drug that is not generally recognized as safe (GRAS) and effective for the conditions or in the dosage form it would be prescribed under; or a drug that has been recognized as safe and effective, (GRAE) but has not been used in the condition(s) or in the dosage form for a sufficient amount of time.

Answer 9

new drug aka has not yet completed the pre-market approval process (phases of clinical trials)

Question 10

_____ ________ ______ is the application that you send to the FDA once all clinical trials and data have been collected on a new drug in order to have the drug approved for marketing

Answer 10

new drug application (NDA)

Question 11

_________ _________ _______ application is the application that you send to the FDA asking them for an exemption to the NDA requirements in order to investigate and conduct clinical trials on the new drug.

Answer 11

investigational new drug (IND)

Question 12

_________ _____ _____ _________ is an application used by generic manufacturers to show proof of bioequivalence and proof of acceptable manufacturing practices and controls

Answer 12

abbreviated new drug application

Question 13

________ _______ is the “applicable official name designated pursuant to section 358 of this title; or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium… the common or usual name, if any, of such drug or such ingredient…”

Answer 13

established name

Question 14

________ is any printed, written, or graphic material on the actual product container

Answer 14

label (narrow term referring only to the stick or printed material on the container itself)

Question 15

_________ is all labels and written, printed, or graphic material on the container, container wrapper, or accompanying the product.

Answer 15

labeling (broader and contains all printed information that accompanies a product - definition of labeling includes the label)

Question 16

___________ ___________ is “packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.

Answer 16

Special packaging

Question 17

Special packaging is focused only on kids under the age of ______

Answer 17

5

Question 18

Special packaging – who shouldnt have an issue using the packaging?

Answer 18

normal adults

Question 19

special packaging – who should struggle with opening the packaging?

Answer 19

kids under age 5

Question 20

special packaging – kids under the age of 5 MAY still be able to get into the packaging but it prevents…?

Answer 20

prevents kids under the age of 5 from obtaining a toxic or harmful amount in a reasonable time.

Question 21

______________ ___________ are products with the same active ingredient, same dosage form, and same strength

Answer 21

pharmaceutical equivalents

• may differ in some ways, such as look, release mechanism, expiration time, and within limits, labeling

Question 22

____________ ____________ are pharmaceutical equivalents that are likely to have the same clinical and safety profile

Answer 22

therapeutic equivalents

• determined based on the bioequivalence studies submitted with the application for FDA approval

Question 23

a _______ is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the United States Pharmacopeia, National Formulary, or any supplement of them, and (2) intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animal, and (3) intended to affect the structure or any function of the body in man or other animal, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose.”

Answer 23

device :-)

*note! definition is very similar to drug

Question 24

What are the most notable differences between the definition of device vs drug?

Answer 24

1- device does not use chemical action or does not need to be metabolized by the body to achieve its primary intended purpose

2- device does not include the official compendium (devices are only listed in the USP-NF, so there are no homeopathic devices)

Question 25

_______________ “includes individual, partnership, corporation, and association”

Answer 25

the term person as defined in the law – so when you see the term person, it may not just mean an individual!

Question 26

A _________ is defined as “any State or Territory of the US, DC, and the commonwealth of Puerto Rico”

Answer 26

State

Question 27

___________ means “any __________ or possession of the US, including the DC, and excluding the commonwealth of PR and the Canal Zone”

Answer 27

Territory

Question 28

Which act was the government’s best effort at establishing laws for adulteration and misbranding, and is still in place today?

Answer 28

Food, Drug, and Cosmetic Act (FDCA) of 1938

Question 29

These additional laws passed by congress are addressing which provisions?

• Controlled substances Act
  -Durham-Humphrey Amendments
• Poison Prevention Packaging Act

Answer 29

Adulteration and Misbranding

Question 30

In Indiana, what is the name of their adopted version of the FDCA?

Answer 30

Uniform Drug Act

Question 31

Adulterated or Misbranded?
a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it
has been prepared, packed, or held under insanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a
drug and the methods used in, or the facilities or controls used for, its manufacture, processing,
packing, or holding do not conform to or are not operated or administered in conformity with current
good manufacturing practice… or (3) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it
bears or contains, for purposes of coloring only, a color additive which is unsafe…

Answer 31

Adulterated

Question 32

Adulterated or Misbranded?
(b) If it purports to be or is represented as a drug the name of which is recognized in an official
compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in
such compendium… No drug defined in an official compendium shall be deemed to be adulterated
under this paragraph because it differs from the standard of strength, quality, or purity therefor set
forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly
stated on its label…

Answer 32

Adulterated

Question 33

Adulterated or Misbranded?
(c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or
its purity or quality falls below, that which it purports or is represented to possess.

Answer 33

Adulterated

Question 34

Adulterated or Misbranded?
(d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality
or strength or (2) substituted wholly or in part therefore

Answer 34

Adulterated

Question 35

Adulterated or Misbranded?
(j) If it is a drug and it has been manufactured, processed, packed, or held in any factory, warehouse,
or establishment and the owner, operator, or agent of such factory, warehouse, or establishment
delays, denies, or limits an inspection, or refuses to permit entry or inspection.”

Answer 35

Adulterated

Question 36

T or F?
A drug is considered adulterated if it’s in conditions where it MAY have been contaminated

Answer 36

True -
there does not actually need to be something wrong with a drug for it to be adulterated; it only needs to be prepared, packed, or held in conditions where it may have been contaminated, exposed to a container that may have contaminated it, or manufactured under conditions that don’t conform to current good manufacturing practice (cGMP).

Question 37

Who are the main focus of adulterated provisions?

Answer 37

the drug manufacturer; however, ALSO pharmacies/pharmacists!

ex:
– air conditioning breaks in the pharmacy and temps reach 95F and temp exceeds max excursion temp for most products in the pharmacy
– a pharmacy intern counts tablets on a counting tray but does not clean the tray before counting the next prescription drug; residue from the prev counted drug gets on the tablets of the current medication
- an rph reconstitutes a face gel with ethyl alcohol instead of the purified water specified in the recon. instructions
…etc

Question 38

__________________________ is a set of regulations that establish the minimum requirements for manufacturing drug products for administration to humans or animals.

Answer 38

current good manufacturing practice (CGMP)

Question 39

CGMP regulations assure:
1)
2)
3)

Answer 39

1) proper design
2) monitoring
3) control of manufacturing processes and facilities

Question 40

CGMP regulations apply to who?

Answer 40

manufaturers of drug products but NOT pharmacies, UNLESS the pharmacy engages in manufacturing

(fyi, manufaturers must be regustered with the FDA and go through an inspection process at least every two years)

Question 41

_________ practices help prevent instances of contamination, mix-ups, deviations from protocol, failures and overal errors, to assure drug products meet quality standards.

Answer 41

CGMP

– applies to all facilities manufacturing products in the US OR FOR USE in the US; aka moving a facility overseas does not exclude them

Question 42

Adulterated or misbranded?
(a) If its labeling is false or misleading in any particular. Health care economic information provided
to a formulary committee, or other similar entity, in the course of the committee or the entity carrying
out its responsibilities for the selection of drugs for managed care or other similar organizations, shall
not be considered to be false or misleading under this paragraph if the health care economic
information directly relates to an indication approved…for such drug and is based on competent and
reliable scientific evidence…Information that is relevant to the substantiation of the health care
economic information presented pursuant to this paragraph shall be made available to the Secretary
upon request. In this paragraph, the term “health care economic information” means any analysis that
identifies, measures, or compares the economic consequences, including the costs of the represented
health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or
to no intervention.

Answer 42

Misbranded

Question 43

Adulterated or misbranded?
(b) If in package form unless it bears a label containing (1) the name and place of business of the
manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in
terms of weight, measure, or numerical count…

Answer 43

misbranded

Question 44

Adulterated or misbranded?
(c) If any word, statement, or other information required…on the label or labeling is not prominently
placed thereon with such conspicuousness…and in such terms as to render it likely to be read and
understood by the ordinary individual under customary conditions of purchase and use.
…

Answer 44

misbranded

Question 45

Adulterated or misbranded?
(e)(1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name
(except the applicable systematic chemical name or the chemical formula) (i) the established name (as
defined in subparagraph (3)) of the drug, if there is such a name; (ii) the established name and
quantity or, if determined to be appropriate by the Secretary, the proportion of each active ingredient,
including the quantity, kind, and proportion of any alcohol, and also including whether active or not
the established name and quantity or if determined to be appropriate by the Secretary, the proportion
of any bromides, ether, chloroform, acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine,
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin,
strychnine, thyroid, or any derivative or preparation of any such substances, contained therein, except
that the requirement for stating the quantity of the active ingredients, other than the quantity of those
specifically named in this subclause, shall not apply to nonprescription drugs not intended for human
use; and (iii) the established name of each inactive ingredient listed in alphabetical order on the
outside container of the retail package and, if determined to be appropriate by the Secretary, on the
immediate container, as prescribed in regulation promulgated by the Secretary, except that nothing in
this subclause shall be deemed to require that any trade secret be divulged, and except that the
requirements of this subclause with respect to alphabetical order shall apply only to nonprescription
drugs that are not also cosmetics and that this subclause shall not apply to nonprescription drugs not
intended for human use. (B) For any prescription drug the established name of such drug or
ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or
ingredient is used) shall be printed prominently and in type at least half as large as that used thereon
for any proprietary name or designation for such drug or ingredient…(3) As used in subparagraph (1),
the term “established name”… means (A) the applicable official name… or (B) if there is no such
name and such drug…is an article recognized in an official compendium, then the official title thereof
in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph applies, then the
common or usual name…

Answer 45

misbranded

Question 46

Adulterated or misbranded?
(f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against
use in those pathological conditions or by children where its use may be dangerous to health, or
against unsafe dosage or methods or duration of administration or application, in such manner and
form, as are necessary for the protection of users, except that where any requirement of clause (1) of
this paragraph, as applied to any drug or device, is not necessary for the protection of the public
health, the Secretary shall promulgate regulations exempting such drug or device from such
requirement…

Answer 46

misbranded

Question 47

Adulterated or misbranded?

(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is
packaged and labeled as prescribed therein…

(h) If it has…to be a drug liable to deterioration, unless it is packaged in such form and manner, and
its label bears a statement of such precautions…

(i) (1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an
imitation of another drug; or (3) if it is offered for sale under the name of another drug.

Answer 47

misbranded

Question 48

Adulterated or misbranded?
(j) If it is dangerous to health when used in the dosage or manner, or with the frequency or duration
prescribed, recommended, or suggested in the labeling thereof.

Answer 48

misbranded

Question 49

Adulterated or misbranded?
(m) If it is a color additive the intended use of which is for the purpose of coloring only, unless its
packaging and labeling are in conformity with such packaging and labeling requirements..

Answer 49

misbranded

Question 50

Adulterated or misbranded?
(n) …unless the manufacturer, packer, or distributor includes in all advertisements and other
descriptive printed matter…a true statement of (1) the established name…printed prominently and in
type at least half as large as that used for any trade or brand name thereof, (2) the formula showing
quantitatively each ingredient of such drug…and (3) such other information in brief summary relating
to side effects, contraindications, and effectiveness…

Answer 50

misbranded

Question 51

Adulterated or misbranded?
(p) If it is a drug and its packaging or labeling is in violation of an applicable regulation of the Poison
Prevention Packaging Act of 1970

Answer 51

misbranded

Question 52

Adulterated or misbranded?
(y)If it is a drug subject to an approved risk evaluation and mitigation strategy…and the responsible
person…fails to comply with a requirement of such strategy…

Answer 52

misbranded

Question 53

Adulterated or misbranded?
(bb) If the advertising or promotion of a compounded drug is false or misleading in any particular.

Answer 53

misbranded

Question 54

Adulterated or misbranded?
(cc) If it is a drug and it fails to bear the product identifier as required…”

Answer 54

misbranded

Question 55

While ________ focuses more on the drug product (strength, purity, quality, manufacturing process), _________ focuses more on the label and labeling of a drug product

Answer 55

adulteration
misbranding

Question 56

All labeling is approved as part of the FDA drug approval process and any deviation from approved labeling on the part of a ___________, ________________, or _____________ is misbranding

Answer 56

manufacturer, manufacturer representative, pharmacy

Question 57

What MUST be included on the label of the drug?**** (hint: 5 items!)

Answer 57

1. The name of the manufacturer, packer, or distributor.
2. The amount of drug in the package.
3. The established name of the product.
4. The established name and quantity of active ingredients.
5. The established name and quantity of inactive ingredients listed in alphabetical order.

ALSO - it MUST be easily read and understood by the ordinary customer!

**the established (generic) name must be prominently placed on the label in type at least HALF as large as the proprietary (brand) name; safety reasons

Question 58

If the labeling company cannot include adequate directiosn for use and adequated warnings against use where applicable, the FDA classifies the drug as…

Answer 58

a prescription drug, and therefore exempts the drug from these requirements

the labeling accompanying rx drug products, like package insert, is meant for healthcare professionals and not patients.

Question 59

T or F this is misbranding:

EX: ibuprofen is available as a 200mg OTC product and 400mg, 600mg, or 800mg prescription product. based on the package insert and our drug information resources, the osteoarthritis the max dose of ibuprofen is 3200mg per day. the OTC labeling for ibuprofen, it says not to take more than 1200mg (6 tablets) in a day. you tell a patient to take more than six tablets in a day…. is this misbranding?

Answer 59

YES! misbranding; that maximum dose is for when the drug is used under the supervision of a prescriber.

This is illegal. we do not have prescribing privileges in outpatient setting.

Question 60

____________ drugs are exempt from CGMP, misbranding, and new drug requirements if the product is for an individual patient, based on the receipt of a valid prescription from a physician or other licensed practitioner, and compounded by a licensed rph or licensed dr

Answer 60

compounded drugs

Question 61

Compounds MUST be compounded with bulk drug substances or ingredients that comply with the standards of a ____ or NF monograph if available and cannot be compounded with a drug that has been withdrawn or removed from the market.

Answer 61

USP or NF monograph.

the compound can’t essentially be a copy of a commercially available product UNLESS compounded occassionally and not in inordinate amounts. (ex: an rph may compound a product for a pt if pt is unable to take a commercial product due to an ingredient in that product)

Question 62

T or F:
Pharmacists may NOT compound a product before the receipt of a prescription.

Answer 62

FALSE!

Pharmacists MAY compound a product before receipt of a prescription

• the compound must be made in limited quantities and the decision MUST be based on a history of receiving prescriptions for the compounded product.

The purpose is to reduce the amount of time it takes for the pt to get the product.

Question 63

Compounding does OR does not include mixing reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling?

Answer 63

DOES NOT.

this is important because this means these activities dont count toward the amount the pharmacy has compounded.

Question 64

Pharmacies cannot compound AND distribute more than ___% of the TOTAL prescriptions dispended or distributed unless there is an understanding between the pharmacy’s state and the FDA.

Answer 64

5%

Question 65

__________ _________ for compounding require more requirements on how they compound medications and what they can compound.

Answer 65

Pharmacies that classify themselves as outsourcing facilities

• have specific labeling requirements for their products, which are different than prescription labels

SO, if a pharmacy doesnt follow all of the rules listed for pharmacy compounding (ALL THE RULES), that pharmacy is automatically classified as an outsourcing facilitiy by the FDA and MUST meet all of those requirements.

Question 66

________ _______ Act amended the FDCA and allowed for the regulation of devices, in 1976

Answer 66

Medical Device Act

Question 67

New devices marketed after 1976 had to be classified by the FDA into one of three classes:

Answer 67

Class I,
Class II,
Class III

(devices on the market before 1976 were allowed to remain on the market as pre-amendment devices “pending classification or other type of action by the FDA”)

Question 68

Which class of device?

is not used for “supporting or sustaining human life or…for a use which is of substantial importance in preventing impairment of human health” and do “not present a potential unreasonable risk of illness or injury.

Answer 68

Class I;
These devices are subject to general controls, which include manufacturers registering the facilities that manufacture the devices, manufacturers listing their products with the FDA, maintaining records and reports, and adhering to good manufacturing practices.

ex: simple devices like stethoscopes, scissors, elastic bandages, and toothbrushes.

47% of medical devices fall under this category, and 95% of these are exempt from the pre-market review process

Question 69

Which class of device?

More serious than the previous class; require special controls to assure the safety and effectiveness of the device. These special controls include “promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendation, and other appropriate actions.”

Answer 69

Class II

EX: syringes, tampons, condoms, powered wheelchairs, and hemoglobin A1C immunoassays.

Question 70

Which class of device?

Requires pre-market approval before marketing. These devices are used for “supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or…presents a potential unreasonable risk of illness or injury.

Answer 70

Class III

10% of medical devices fall into this category and this class III devices include:
pacemakers, replacement heart valves, and soft contact lenses.

ALL NEW DEVICES automatically fall into class III “unless the FDA determines taht they are substantially equivalent to a class I or class II devices.

Question 71

___________ devices require a prescription due to the potential for harm and the need for collateral measures to ensure their proper use - similar to prescription drugs.

Answer 71

restricted devices.

EX: contact lenses and diaphragms

Question 72

___________ devices are ordered by a healthcare professional to fit the needs of a single patient

Answer 72

custom devices.

ex: orthopedic footwear, certain braces after injury, and canes permanently modified for a patient’s height

Question 73

________ devices are devices excluded from the US market.

Answer 73

banned devices

currently (2021), the only banned device is prosthetic hair fibers

Question 74

At times drugs or devices on the market may be adulterated or misbranded and subject to a __________

Answer 74

recall

Question 75

Recalls for devices, biological products, and foods can be:
1) voluntarily issued from the:
2) requested by:
3) mandated by:

Answer 75

voluntarily issued from the manufacturer
requested by the FDA
mandated by the FDA

Question 76

T or F:

The FDA does NOT have the authority to require a manufacturer to recall a drug, which means all drug recalls are voluntarily issued by the manufacturer

Answer 76

TRUE

drugs are voluntary recalls,
devices are MANDATORY recalls

—note that there was a bill introduced to the house in 2017 to make drug recalls mandatory, but it never progressed through committee. So this may change in the future.

Question 77

T or F:

The FDA has the authority to take seizure or injunction action on a product if the FDA believes the product should be recalled and a manufacturer is unwilling to issue the recall

Answer 77

TRUE!

drugs are voluntary recalls,
devices are MANDATORY recalls

—note that there was a bill introduced to the house in 2017 to make drug recalls mandatory, but it never progressed through committee. So this may change in the future.

Question 78

______________ recalls are the most serious recalls and are issued when “there is a reasonable probability that the use of or exposure to a violative product will cause serious consequences or death”

Answer 78

CLASS I RECALL

Question 79

______________ recalls are issued in “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”

Answer 79

CLASS II RECALL

Question 80

____________ recalls are the least serious recalls and are issued in situations “in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”

Answer 80

CLASS III RECALL

Question 81

The depth of recall - consumer level, retail level, or wholesale level - will depend on
1)
2)

Answer 81

hazard of the product
extent of distribution

Manufacturers are responsible for notifying sellers like wholesalers and pharmacies of recalls;

sellers like pharmacies are responsible for notifying consumers.

Question 82

PHARMACISTS ARE RESPONSIBLE FOR KNOWING WHAT DRUG PRODUCTS HAVE BEEN RECALLED & MAY VIOLATE THE FDCA THRU ___________ AND ______________ PROVISIONS IF A RECALLED PRODUCT IS DISPENSED TO A PATIENT***

Answer 82

misbranding and adulteration!