federal regulation of medications: development, production, and marketing - ch 2

based on the LOs someone else did <3

____ provides for the comprehensive regulation of all drugs introduced into interstate commerce

FDCA

FDCA: the intent is to protect consumers from __________ products

adulterated or misbranded

T/F according to FDCA: no new drug may be marketed and sold unless it has been proved both safe and effective for its intended use and approved by the federal FDA

TRUE

the FDCA is oriented towards:

A. consumers

B. prescribers

C. manufacturers

C. manufacturers

T/F the FDCA has absolutely nothing to do with pharmacists

false

it controls the products RPh’s dispense

they must still be concerned with the law and specific sections apply

what was the catalyst for FDCA?

sulfanilamide elixir tragedy

the compounding amendment was passed after…

the New England Compounding Center tragedy of 2012

the primary enforcement of the FDCA is vested in the ____; component of ____

FDA

DHHS

www.fda.gov has laws and other resources set by the FDA

there are regulation and guidance documents…how are they different?

regulations: legally enforceable rules; compliance is mandatory; noncompliance can result in penalties, fines, or legal action

guidance: recommendations; not legally binding

what is the most important FDA office/center for pharmacy practice?

CDER

T/F FDA only uses inside opinion to provide advice on specific topics

False

uses various outside standing committees and experts

is the following referring to: food, drug, dietary supplement, cosmetic, or device?

articles recognized in the official US Pharmacopoeia, official Homeopathic Pharmacopoeia of the US, or official National Formulary, or any supplement to any of them

and articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals

and articles (other than food) intended to affect the structure or any function of the body of man or other animals

and articles intended for use as a component of any articles specified in the clauses above

DRUG

is the following referring to: food, drug, dietary supplement, cosmetic, or device?

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals

intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal 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 any of its principal intended purposes

DEVICE

is the following referring to: food, drug, dietary supplement, cosmetic, or device?

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

COSMETIC

what is antidandruff shampoo considered: food, drug, dietary supplement, cosmetic, or device?

DRUG and COSMETIC

drug: intended to treat dandruff

cosmetic: shampoo, cleansing

what is the critical issue in the determination of whether a product is a drug?

if the supplier made a therapeutic or helath claim, or a structure/function claim

T/F a supplier cannot cancel out a therapeutic or structure/function claim for a product by saying that the product is not a drug

TRUE

what act gave the FDA authority to regulate tobacco products?

this includes the regulating the contents, disclosure of contents, prohibiting certain additives, requiring effective warnings, and strictly controling/prohibiting marketing and sales campaigns

Family Smoking Prevention and Tobacco Act - June 2009

what does the 2016 FDA regulation on tobacco products require?

may not sell to those under 18

must verify age with photographic identification, unless over 26

companies must warn consumers that nicotine is addictive

must submit new and existing products for FDA approval

the FDA has established 2 special categories of foods where labeling can have health claims. what are they?

special dietary foods

medical foods

what are special dietary foods?

supply a special dietary need that exists by reason of a physical, physiological, or other condition

ex: infant formulas, artificial sweeteners, caloric supplements

what are medical foods?

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

ex: foods formulated without the amino acid phenylalanine for phenylketonuria; folic acid, B6, B12 combination products for hyperhomocysteinemia

DHSEA mandates FDA regulate dietary supplements more as a _____

more as a food than a drug

what is a dietary supplement?

product intended for ingestion, intended to supplement the diet, and contains one or more of: vitamin, mineral, herb, amino acid, etc.

DHSEA allows 4 types of nutritional (structure/function) statements and the FDA won’t consider it a drug

what 4 kinds of statements are allowed? what disclaimer is required?

1. product will benefit a classical nutrient deficiency disease, discloses prevalence in US

2. describe the role of the dietary supplement in affecting the structure or function of the body

3. characterize the documented mechanism by which a dietary supplement acts to maintain structure or function

4. describe general well-being from consumption

DISCLAIMER: this statement has not been evaluated by the FDA; product not intended to diagnose, treat, cure, or prevent any disease

DHSEA allows limited health or disease claims that describe relationship between product and disease. what is required if it is an unqualified health claim? qualified health claim?

unqualified health claims: no disclaimer needed; allowed by means of FDA regulation and met significant scientific agreement test

qualified health claims: needs disclaimer so it does not mislead; does not meet scientific agreement test

what are the 2 major offenses prohibited by FDCA?

misbranding

adulteration

violations of FDCA prohibited acts are a __________ - no intent or knowledge required

strict liability nature

list the ways the FDA can enforce the FDCA

-injunctive action

-criminal proceedings against violator

-seize adulterated or misbranded products in interstate commerce

-warning letters as first step

-go after corporate officers when other employees violate the FDCA

T/F FDA has recall authority for limited products and can prescribe procedures for recall

true

T/F if a pharmacist dispenses a recalled product they can face FDCA enforcement and civil actions if patient injured

TRUE

pharmacist is responsible for keeping up to date on recalls

3 classes of recalls

class I: reasonable probability that the product will cause serious adverse health consequences or death

class II: temporary or medically reversible adverse health consequences, probability of serious adverse consequences is remote

class III: not likely to cause adverse health consequences

what makes something adulterated?

consists in whole or in part of any filthy, putrid, or decomposed substance

or if was prepared, packed, or held under unsanitary conditions where it may have been contaminated

or the methods used do not conform to CGMPs

or container is composed of any deleterious substance

or if it contains an unsafe color additive

or if it purports to be a drug recognized in an official compendium, but strength, quality, or purity differs from those standards

T/F a drug may be adulterated but actually pure because of how it “may” have been prepared, packed, held, exposed, etc. improperly

TRUE

regulates the facility and the production means as well

can pharmacies violate adulteration provisions? how?

yes!

ex: pharmacy counts tablets on a dirty tray

ex: pharmacy repackages drugs stored in containers that may contaminate the product

T/F drugs can only be adulterated or misbranded; they cannot be both at the same time

FALSE

drugs can be adulterated and misbranded at the same time

what are Current Good Manufacturing Practices (CGMPs)?

regulators giving minimum requirements for manufacturer’s methods, facilities, and controls for making, packaging, holding products

manufacturers must register with the FDA and are inspected ______

every 2 years

what is misbranding?

false or misleading labeling or HCEI is not accurate and reliable

imitation drugs

must contain adequate directions for use (OTC) or adequate information for use (RX)

dispensing prescription drug without a prescription

not providing required patient information

not meeting PPPA

products not meeting REMS requirements

so basically anything that isn’t giving the patient the right info about the product

regarding misbranding, what adequate directions for use are required for OTCs?

labeling where product can be used safely by a lay person for purposes intended

regarding misbranding, what adequate information for use are required for RXs?

labeling directed towards practitioner for safe use (prescribing)

T/F pharmacists that repackage or relabel OTC products must comply with manufacturing labeling requirements

true

what amendment allows drugs that do not require professional supervision (RX only/legend) can be sold OTC (nonlegend)?

Durham Humphrey amendment

____ application can request OTC status or RX drugs can be switched to OTC

NDA

nonprescription drug labeling requires

-statement of identity of product

-name/address of manufacturer, packer, or distributor

-quantity of contents

-cautions and warnings

-adequate directions for use

-drug facts panel

-normal dose for intended purposes

-frequency of use

-administration information

-required prep for use

for OTCs, what is required in the drug facts panel?

-active ingredient: therapeutic substance in product; amount of active ingredient per unit

-uses: symptoms or diseases the product will treat or prevent

-warnings: when not to use the product; conditions that may require advice from a doctor before taking the product; possible interactions or side effects; when to stop taking the product and when to contact a doctor; if you are pregant or breastfeeding, seek guidance from a healthcare professional; keep product out of children’s reach

-inactive ingredients: such as colors or flavors

-purpose: product action or category

-directions: specific age categories, how much to take, how to take, and how often and how long to take

-other info: how to store, required info about certain ingredients

-questions/contact phone number

T/F drugs can only be approved as RX or OTC

FALSE

can be approved as both RX and OTC

label vs labeling

label: label affixed to container

labeling: label plus accompanying information; written for healthcare professional

list the requirements on commercial labels of prescription drugs

• Name and address of manufacturer, packer, or distributor  

• Established name of drug product  

• Ingredient information, including the quantity and proportion of each active ingredient 

• The quantity in terms of weight or measure  

• The net quantity of the container  

• A statement of the recommended or usual dosage, or reference to the package insert  

• The symbol “RX Only” or the legend: “Caution: Federal law prohibits dispensing without a prescription”  

• The route of administration, if it is not for oral use  

• An identifying lot or control number 

• A statement directed to the RPh specifying the type of container to be used in dispensing the drug 

• The expiration date, unless exempted; When listed as month/year, use last day of the month

list the requirements for unit dose labeling

• Established name of drug 

• Quantity of active ingredient in each dosage unit  

• Expiration date (for repackaged – look to state and USP guidance; may be termed BUD)  

• Lot or control number  

• Name or place of business of manufacturer/packer/distributor  

• Any special statements required by compendia  

what expiration date do you use when it comes to unit dose labeling?

unit dose from manufacturer: use expiration date provided by them

repackaged by pharmacy: determine BUD

list the requirements for package inserts for RX drugs

• Highlight section (boxed warning, recent changes, indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations…), prescribing info, patient counseling information  

• Black box warnings – FDA can require if drug may lead to death or serious injury  

• Pregnancy warnings – no longer A, B, C, D, X categories used for newer drugs; phased out for drugs prior; should be familiar with both old and new requirements. New requires “Pregnancy”, “Lactation”, and “Females and Males of Reproductive Potential”  

the _________ is written for healthcare provider, but no rule against giving to others

package insert (labeling)

what are national drug codes (NDC)?

unique 10 digit, 3 segment number

11 digits used for billing

on OTC and RX drug labels and labeling

what does each segment of an NDC represent?

first segment: manufacturer

middle segment: drug (strength/dosage form)

last segment: package size

what is postmarketing surveillance?

manufacturer to continue to monitor drug after reaches market

must submit to FDA reports of any serious adverse drug reactions and any new information relating to drug’s safety and efficacy (FAERS)

what is REMS?

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

manufacturer develops, FDA approves REMS

can require a variety of procedures

what is postmarket labeling?

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

what is emergency use authorization (EUA)?

declared when appropriate for natioons public health against certain threats

making available the use of medical countermeasures needed during public health emergencies

T/F there are drugs on the market that have not been approved and are being marketed

TRUE

could be old and on the market before the approval process

what are biologics?

derived from living organisms

regulated under PHSA and FDCA

what is medwatch?

FDA’s safety information and adverse event reporting program

voluntary

post-marketing

healthcare professionals and patients can report

pharmacy must provide patients the number

what are class I medical devices? list some examples

least regulation

least potential harm

manufacturers to register facility and list products

examples: needles, scissors, exam gloves, stethoscopes, and toothbrushes

what are class II medical devices? list examples of them

general controls are insufficient to ensure safety and effectiveness

must meet additional standards before they can be marketed

examples: insulin syringes, infusion pumps, thermometers, diagnostic reagents, tampons, electric heating pads

what are class III medical devices? list examples

life-supporting or life-sustaining devices that must have premarket approval

examples: pacemakers, soft contact lenses, replacement heart valves

T/F companies must report to FDA any death or serious injury related to devices

true

does the FDA require pre-market approval for cosmetics?

NO

cosmetics must be labeled with a list of ingredients in _________ order of prominence

descending

T/F some cosmetics must contain warnings

true

example: self-pressurized containers for inhaling can be fatal

practice

cephalosporin bottle contained PCN in it unknown to the pharmacist. is this misbranded/adulterated? is pharmacist responsible under FDCA by FDA?

yes

misbranded and adulterated

pharmacist can be held responsible: no intent or knowledge required

practice

hospital pharmacy receives ampules of community stocked med in pink solution, when it had always been a clear solution previously. pharmacist dispensed. it was contaminated and injured the patient. assume adulterated, has pharmacist violated FDCA and can they face sanctions?

yes!

pharmacist has the responsibility to call the manufacturer and ask if it is supposed to be pink

practice

a class I recall was issued, 2 months later bottles were still in inventory, pharmacy argued it had no knowledge of recall and had no responsibility to remove. Is this a valid argument?

no

pharmacist has responsibility to keep up to date with recalls

practice

cephalosporin counted on tray, contained powder from prior PCN counted, gave it to patient allergic to PCN. is this adulteration?

yes

drug contaminated/prepared on unclean surface

practice

RX sent in for brand name drug, we substituted for the generic but labeled it with the brand name drug. is this misbranding?

yes

label is false

practice

A pharmacy received a bottle of Sinstid, 100 tablets, from the wholesaler. Although Sinstid is only made in 250 mg strength, the label stated 350 mg. No one in the pharmacy noticed the discrepancy and the pharmacy dispensed the product to the patient. The FDA discovered the misbranding and is investigating. Has the pharmacy violated the FDCA? 

a. No, it did nothing wrong.  

b. No, but only if it acted in good faith and it cooperates with the FDA. 

c. Yes, and it will likely face penalties. 

d. Yes, but it will be excused if it acted in good faith and cooperates with the FDA

d. yes, but will be excused if acted in good faith and cooperates with the FDA

practice

which of the following statements about drug recalls is correct?

a. manufacturers are responsible for notifying the FDA, not pharmacies

b. the FDA is responsible for notifying pharmacies

c. pharmacists are responsible for knowing that a product has been recalled

d. class III recalls are the most serious

c. pharmacists are responsible for knowing that a product has been recalled