pharmacy law exam 1

what is stare decisis/precedent?

decisions made in prior cases are followed in current cases and will be followed in future cases with same facts

allows anticipation for how courts will decide

lower courts must follow higher court decisions IN THE SAME JURISDICTION

EX: court A from one state can consider the decision made by court B in a different state, but doesn't have to follow the decision

Does a court have to follow a decision from another state?

No, courts must follow binding precedent in their own jurisdiction

why is stare decisis important?

It creates consistency and continuity and makes judicial decisions more efficient

disadvantages of stare decisis

cases may have factual differences and circumstances may change overtime

what is a conflict between hierarchy of government

when laws make it so you comply with state law but violate federal law in the process

(always follow the stricter law)

is this a conflict: marijuana is considered illegal by the federal government, but New Jersey 😍 made it legal

yes it is a conflict

because the state law is conflicting with federal law

is this a conflict: federal law says you can have 5 refills on a CIV substance, but New Jersey law states that you can only have 3 refills on CIV substances.

NOT A CONFLICT. state laws can be stricter than federal laws without being a conflict

Hierarchy after constitution

1) federal statutes

2) state constitutions (state supreme courts)

3) state legislation

4) ordinances

what are ordinances?

a law enacted by a municipality or county under authority delegated by the state

why were administrative agencies created?

to enforce and implement laws/policies when the legislature cannot perform the functions itself

examples of administrative agencies

FDA, DEA, CMS, State Board of Pharmacy

adminstrative agenices can pass ______&_______, not laws (even though they have force of law)

rules and regulations

What legal force do administrative regulations have?

valid regulations have the force of law and must be obeyed

3 tests for valid regulation for an administrative agency

1) regulation must be within the agency's scope of authority

2) must be based on a statute giving the agency authority to regulate

3) must relate to public health, safety and welfare

the 10th amendment states that

states have the power to legislate in all areas except those prohibited or given to by Congress by the Constitution

civil vs administrative vs criminal action

Civil Action: one private party sues another private party alleging injury

- EX: patient sues pharmacist for dispensing a substance that the patient was allergic to and causing injury; pharmacist had knowledge of allergy but simply forgot

Administrative Action: Action taken by an administrative agency to enforce its regulations. Examples include a

state board of pharmacy action against a professional license or a DEA action against a registrant.

Criminal Action: Involves criminal charges by the government against the pharmacy/pharmacist for

violating a law with criminal penalties.

- EX: selling prescription-controlled substance without prescription

the main intent of the FDCA law is to __________

protect consumers from adulterated or misbranded products (food, drugs, cosmetics, devices)

no new drug may be marketed/sold without being proven safe and effective and approved by FDA

drug definition

Drug means...

1) articles recognized by the official US Pharmacopoeia, official Homeopathic Pharmacopoeia, or official National Formulary

2) INTENDED FOR USE in the diagnosis, cure, mitigation, treatment, or prevention of disease (in man/animals)

3) INTENDED TO AFFECT THE STRUCTURE/FUNCTION of the body

-- EX: pregnancy is not a "disease" but drugs to prevent pregnancy affect the function of your body

if a _______________ or ______________ claim is made for an article, that article is a drug, no matter what disclaimers the manufacturer includes in the labeling

therapeutic or structure/function claim

EX: if we produce alfalfa drugs for humans and claim they will cure ulcers, but label specifies that these are not drugs --> court will likely consider it a drug

device definition

instrument, apparatus, machine, contrivance, implant, in vitro reagent or similar/related article including any component/accessory that is

1) recognized by the official US Pharmacopoeia, official Homeopathic Pharmacopoeia, or official National Formulary

2) intended for use in the diagnosis of disease/conditions or in the cure, mitigation, treatment or prevention of disease

3) intended to affect the structure/function of the body

cosmetic

articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering appearance

food definition

articles used for food/drink for man/animals

chewing gum

articles used for components of such articles

2 FDA specialized categories of foods where the labeling CAN have health claims

special dietary foods

medical foods

special dietary food definition

special dietary foods supply a dietary need that exists by reason of physical, pathological, physiological or other condition, but not limited to conditions of disease, convalescence, pregnancy, lactation, infancy, food allergies, underweight, overweight or controlling sodium intake

EX: infant formulas, artificial sweeteners, caloric supplements

medical food definition

includes foods formulated for oral/enteral use under the supervision of a physician that are intended for specific dietary management of a disease/condition for which distinctive nutritional requirements are established by medical evaluation

EX: foods formulated w/o amino acid phenylalanine for phenylketonuria

dietary supplements vs drugs

DSHEA created category of dietary supplements and mandated that dietary supplements should be regulated more as a food than a drug

dietary supplements do NOT require pre-market approval (unlike drugs)

manufacturer CAN make function/structure claims (same with drugs)

CANNOT claim to diagnose/treat/cure/prevent disease

4 types of structure/function claims that dietary supplements CAN make

1) structure/ function claims

- EX: calcium HELPS maintain strong bones

2) nutrient-deficient claims

- can state that a supplement helps with classical nutrient deficiency diseases

3) moa

- EX: supports calcium absorption in the body

4) general well-being claims

- EX: promotes energy

Disclaimer for dietary supplements

"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

unqualified vs qualified health claims

unqualified: no disclaimer needed bc it met significant scientific agreement test

qualified: needs disclaimer, did not meet scientific agreement test

FDA can enforce the FDCA in what ways (4)

- injunctive action (telling violator to cease activity)

- criminal proceedings (fines, imprisonment)

- seizing adulterated/misbranded products

- warning letters (minor violations)

Can the FDA mandate recalls on drugs?

the FDA cannot mandate, but they can request the manufacturer to do a recall

if the manufacturer does not respond to their request, the FDA can seize/take injunctive action

manufacturers can do voluntary recalls as well

3 classes of recalls

Class I - reasonable probability that product will cause SERIOUS HEALTH CONSEQUENCES OR DEATH

Class II - TEMPORARY OR MEDICALLY REVERSIBLE adverse health consequences (probability of serious AE is low)

Class III - not likely to cause adverse health consequences (EX: finding something impure, but safe)

most product recalls are _____________ products

adulterated/misbranded products

adulteration definition

drug/device will be deemed adulterated if...

- includes filthy/putrid/decomposed substance

- may have been prepared/packaged in unsanitary conditions

- methods for manufacturing/packaging/processing do not conform to cGMP

- container contains poisonous or deleterious substance

- includes unsafe color additive

- strength/quality/purity falls below standards UNLESS this difference is stated on the label

- packaged/mixed with substance that would reduce quality/strength

examples of adulteration

pharmacies counting on dirty trays

room temp is not controlled

unsafe color additive

in what circumstance can a drug be deemed adulterated if it is actually pure?

because of how it "may" have been prepared

better to regulate facility/production vs the product itself

What are CGMPs? (current good manufacturing practices)

regulations giving minimum requirements for manufacturers' methods, facilities, and controls for making, packaging, holding products - inspected by FDA every 2 years

may apply to outsourcing facilities as well

misbranding definition

FDA must approve the exact wording of a drug's label

labeling cannot be false/misleading

package must contain name/place of manufacturer business and an accurate statement of quantity of contents

words/statements cannot be placed conspicuously on the label

container cannot be misleading (imitating another drug, looks like it has more product than it actually does)

cannot violate Poison Prevention Act 1970

T or F: all OTC drugs, cosmetics and devices need to be manufactured in tamper-evidence packaging

False

OTC labeling directions for use are intended to inform _______

consumers

RX adequate information for use is intended to inform ________

practitioners

OTC adequate directions for use must include

quantity/dose for each intended use

frequency

duration

time of administration (in relation to meals/sx/etc)

route of administration

if preparation is necessary (shaking)

RX adequate information for use must include

indications, SE, dosages, routes, methods, frequency, duration, contraindications, warning/precautions

imitation drugs

count as misbranding

a drug is an imitation drug if...

- Identical in shape, size and color to another drug

- Identical in gross appearance

- Similar in effect to controlled substances

- Sold under the name of another drug

EX: dispensing a placebo and labeling it is a certain drug

dispensing RX drugs without a prescription counts as _______

misbranding

OTC specific labeling requirements

name/address of manufacturer, packer, distributor

Location of expiration date

lot/batch code

Statement of product's identity (established name, pharmacological category, intended actions)

Net quantity in package

Tamper-evidence labeling

Cautions and warnings

Adequate directions for use

**Drug facts panel (next flashcard)

Inactive ingredients in alphabetical order

Normal dose for each intended use (ages, and conditions)

frequency/duration

Administration time

Route

Any preparation

drug facts panel for OTC labeling consists of

active ingredient (and the amount per unit)

uses

warning

inactive ingredients

purpose (antihistamine, cough suppressant)

directions

other information (how to store, required info about certain ingredients)

questions contact

RPhs that repackage or relabel OTC products must ____________

comply with manufacturing labeling requirements

drugs that are both RX and OTC

labeling will vary for RX and OTC indications

EX: ibuprofen 200 is OTC for mild-moderate pain indication, while the RX strength is for rheumatoid and osteoarthritis

EX 2: omeprazole is OTC for reflux, but Rx for ulcers

what is a RX drug label

defined as the label affixed to the container

what is RX drug labeling

defined as label PLUS accompanying information (package insert accompanies product)

labeling for RX drugs is written for the ________

healthcare professional, but we can convey it to patients who request it

RX drug commercial container label requirements

- name/address of manufacturer/packer/distributor

- name of drug product & statement of identity (generic and proprietary names)

- ingredient info (with quantity and proportion of each active ingredient

- inactive ingredients listed alphabetically

- quantity (mg)

- net quantity of container (# of tablets)

- recommended dosage or reference to package insert

- Rx only

- route of administration if not oral

- lot/control number

- if type of container must be specified (light-sensitive)

- expiration date

what is unit dose labeling

used in hospitals for direct administration to patient

may come from manufacturer or repacked at location

requirements for unit dose labeling

since package size is small, only a few requirements

- name of drug

- quantity of active ingredient

- expiration date

- lot/control number

- name of man/packer/distrib

- compendia special statements (official name)

- # of dosage units/strength per unit

- controlled drug symbol if needed

NDC (national drug code)

unique 10 digit number

EX: 60575-4112-01

first segment: manufacturer identification

2nd segment: strength/dosage form

3rd: package size

postmarketing surveillance

manufacturer continues to monitor drug after it reaches market; must submit to FDA reports of any serious adverse drug reactions and any new info regarding drug's safety and efficacy

REMS

helps manage known or potential serious risks of a product/class

EX: opioids

examples of REMS procedures

Distribution of Medication Guides

Patient package insert

Communication plan for healthcare professionals

Restricted distribution plans

Special training for providers

postmarket labeling

FDA can compel safety-related labeling changes when FDA becomes aware of serious drug risks

EUA (emergency use authorization)

HHS can declare EUA when appropriate for the nation's public health during public health emergencies

EX: COVID vaccine

Manufacturers decide to submit EUA request to FDA

DESI (Drug Efficacy Study Implementation) program

Implemented by FDA in 1962, requiring that drugs be effective as well as safe

Applied DESI retroactively to any drug passed after 1938

also made it so generic drugs were regarded as new drugs and required generic manufacturers to prove efficacy

rated drugs from 1 (effective) to 6 (ineffective)

ANDA vs NDA

Abbreviated New Drug Application: created by the FDA so approved generic drugs would not require an NDA

Would only have to prove bioequivalence/acceptable manufacturing methods

DESI: OTC drug review

instead of examining each OTC drug one by one (like they did with Rx), OTCs were evaluated based on therapeutic category and their active ingredients

rated category 1 (GRASE) to 3 (insufficient data)

what's the purpose of ACNU (Additional Condition for Nonprescription Use)

FDA wanted to make more drugs available as OTC, but promote safe consumer use

Could make consumer do the following tasks in order to purchase:

1) Answer questions to determine whether the drug is appropriate (self-selection test)

2) Watch an educational video

3) Confirm that they watched/read the instructions

4) Read additional information on a website or app

how can an unapproved drug be on the market legally?

pre-1938 (DESI)

pending final determination of efficacy under DESI

these drugs are legal, even though they are unapproved

what is the MedWatch Voluntary Reporting Program?

FDA's safety information and adverse event reporting program

NOT JUST for RX

voluntary, but moral obligation

healthcare professionals/patient can report

pharmacy must provide patients with MedWatch Number (sticker on container, preprinted vial cap, separate paper, PMI, Medguide)

if you do not provide MedWatch phone # with patient Rx, it is considered _____________

misbranded

3 classes of medical devices

I: least regulation (needles, scissors, exam gloves, toothbrush)

II: must meet additional controls to ensure safety and efficacy before marketing (insulin syringes, infusion pumps, thermometers, tampons)

III: life-supporting or life-sustaining devices (pacemaker, contact lenses, replacement heart valves)

cosmetics do not require __________

pre-market approval (unless for color additives)

FDA may take action to remove a cosmetic product if its _________

misbranded, adulterated, or health hazard

Modernization of Cosmetics Regulation Act

Facilities must register with FDA and provide list of products

GMP: FDA must issue GMP rules for facilities to ensure cosmetic products are not adulterated

MCRA requires adverse event reporting within specific timeframes

what are biologics?

Biologics are products derived from living organisms (viruses, toxins, blood products), used for prevention/treatment/cure of disease or condition of humans

Does FDA have to approve pre-marketing of biologics?

yes, although they are licensed with Public Health Service

biosimilar def

Biologic product is HIGHLY similar to reference product with no clinically meaningful differences

interchangeable biosimilar def

To interchange products the biosimilar is expected to produce the same clinical results as the reference product without greater risk (better than biosimilar)

the main components of the Durham-Humphrey Amendment 1951

1) distinguished RX from OTC drugs

2) allowed for verbal (in additiona to written) prescriptions and refill authorization

3) labeling of dispensed drugs by pharmacy do not have to meet labeling requirements of manufacturers

under Durham-Humphrey, the FDA categorized RX drugs as___________

drug that is unsafe for use except under supervision of practitioner because of toxicity or method of use

labeling of dispensed drugs under the Durham-Humphrey Amendment

labeling of dispensed drugs are exempt from FDCA requirements for manufacturers, but labeling must not be false/misleading, not be an imitation drug, not sold under another drug's name, and labeling/packaging must comply with compendia and PPPA standards

minimum FDCA info that should be on a PHARMACY label

name/address of dispenser

serial number and date of filling

name of prescriber

name of patient

directions for use/cautionary statements

(doesn't require drug name, but state will)

BUD (beyond-use date) requirements

date after which drug should not be used

according to USP guidelines, BUD should not be later than the manufacturer's expiration date or 1 year from the date the drug is dispensed (choose whichever is earlier)

2 types of labeling mandated by federal law to be given to patients

PPI (patient package insert) and MedGuides

(CMI is written info, but NOT mandated by law/rule)

what are patient package inserts

information required for oral contraceptives and estrogen-containing drugs not intended for oral contraceptive use

How often must PPI be given to patients?

1st fill and every 30 days thereafter (modified in institutional settings)

what are MedGuides?

required by FDA for a product/drug class with serious and significant concern, MedGuides can be apart of REMS

How often must MedGuides be given to patients?

1st fill and every 30 days thereafter (modified in institutional setting)

what is CMI (consumer medication information)

private sector effort to provide useful written information

NOT regulated by FDA

NOT a substitute for PPI or Medguide

should be given out for all dispensed Rx, but not regulated

will a drug ever have both a PPI and Medguide

no

what is PMI (patient medication information)

FDA proposed rule (hasn't happened yet)

1 single easy to read document

FDA stance on off-label indications

drugs may be legally prescribed and dispensed for off-label indications

U800 requires ___________

list of hazardous drugs, proper facility, trained personnel, safe work environment, protective equipment, and policies for waste segregation/disposal

Orange Book

not federal law but is a reference to assist pharmacists in determining bioequivalence/therapeutic equivalence of a drug compared to reference drug

(state law dictates role of Orange Book)

therapeutic equivalence def

pharmaceutical equivalents that are expected to have same clinical and safety effect

Orange Book codes

A: therapeutically equivalent to reference product

B: not equivalent (need new script)

AB: potential/actual bioequivalence problems but have been resolved by evidence

AB1, AB2, AB3: when there are multiple brands and generics specific for one product

can AB1 and AB2 be substituted for one another

no

Purple Book

guidance for the substitution of biosimilars (state law dictates whether to use)

if the purple book rates a biologic as interchangeable ...

no new script is needed

if the purple book states two biologic products are biosimilar ...

may need new script

PDMA: Prescription Drug Marketing Act 1987

Required states to license distributors

Bans reimportation of drugs (unless from original manufacturer or emergency use)

Bans sale, purchase, or trade of drug SAMPLES and coupons

Establishes storage, handling, and recordkeeping requirements for samples

Prohibits resale of drugs purchased by hospitals

drug samples may only be provided to

practitioners licensed to prescribe

OR

hospital pharmacies at the written request of the prescriber