2.2: Defining and Distinguishing Drugs from Foods, Dietary Supplements, Devices, & Cosmetics

Federal Drug Regulation is the

Protection of the public health by ensuring drug products (human and veterinary) are safe and effective

Federal Drug Regulation has a balance of

"Direct regulation" and "Indirect regulation"

Direct regulation for Federal Drug Regulation

FDA Rulemaking authority

Indirect regulation for Federal Drug Regulation

Issue Guidance Documents

The Federal Food and Drug Administration (FDA) is an agency within the

Department of Health and Human Services (DHHS)

Authority for administering the FDCA is vested in the

Secretary of DHHS.

The _________ appoints a commissioner of the FDA who is accountable to the Secretary

President

There are _____ Headquarter offices within the FDA

13

3 example of Headquarter offices in the FDA

Office of Regulatory Affairs

Office of Operations

Office of Import Operations

FDA consists of ___ Center level organization

9

Notice and Consent Rulemaking allows for public input on proposed regulation _________ the FDA issues a final regulation

before

Notice and Consent Rulemaking falls under what title

Title 21 of the Code of Federal Regulations (CFR)

who has a voice in the rulemaking process?

experts, stakeholders, and public

T/F

FDA regulations are federal laws but they are not part of the FDCA

true

FDA issues ________ ____________ which is a less formal way of regulation that describes the agency's current thinking on a regulatory issue

Guidance documents

T/F

Guidance documents

FALSE

FDA incorporates advice from standing committees of outside experts such as

physicians, pharmacists, nurses

What does the FDA regulate?

Foods, drugs, biologics, medical devices, electronic products that give off radiation, cosmetics, veterinary products, and tobacco products

T/F

FDA approves animal drugs and food additives for use in food for animals

true

A drug is recognized by what three organizations

United States Pharmacopeia (USP) or official homeopathic pharmacopeia, or official National Formulary

Establishing that an article is a drug, as opposed to a food, dietary supplement, or cosmetic, provides the FDA with considerably more ________ over the article.

authority!

What established prescription and OTC drugs

Durham-Humphrey Amendment of 1951

Two things in order to change the status of a drug from OTC to prescription

1. the ______ and __________ of use require physician supervision

2. ___________ measures for use require physician supervision

toxicity, method

Collateral

_____has authority to categorize Rx drugs; unsafe for use except under the supervision of a practitioner due to toxicity, method of use, or collateral measures necessary to use the drug

FDA

Rx Drugs are subject to

New Drug Application

a product is a drug if it was intended to diagnose, cure, mitigate, treat, or prevent a disease, or (for articles other than food) was intended to affect the body __________ or ____________

structure

function

A product is a drug if __________ or ____________ claims are made no matter what the disclaimers are in the labeling

therapeutic

structure/function

A product is a drug if the manufacturer cannot ___________ a therapeutic or structure/function claim for a product by proclaiming an article is not a drug

mitigate

A product is a drug if it is the __________- intended use of a product NOT the ____________ intended use

manufacturer

purchaser

Something is a food if it is used for its ordinary ___________ and in an ordinary _________ (people use food for taste, aroma, or nutritive value)

purpose

manner

Foods are excluded in what part of the definition of a drug because it will naturally affect structure of function of the body

Part C- Articles (other than food) intended to affect the structure or any function of the body in man or animals

Two special categories of foods created by the FDA:

Special dietary foods

Medical Foods

Special Dietary Foods are recognized under the ________ and supply dietary need that exists by reason of a _________, _____________ or ___________ condition

FDCA

physical, physiological, pathological

examples of conditions that need supply of dietary need

convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or need to control intake of sodium

Medical Foods include food formulated for ________ or _________ use under the supervision of a physician and that are intended for the specific dietary management of a disease or condition for which distinctive ___________ requirements are established by medical evaluation

oral, enteral

nutritional

Examples of a medical food are foods formulated without the amino acid ____________ for people with phenylketonuria

phenylalanine

Medical Foods must be specially formulated, NOT ____________ occurring, and must provide nutritional requirements that would be impossible for the patient to meet through a _________ diet

naturally

normal

______________ and ____________ foods are VAUGE definitions that are NOT specifically defined by law

Nutraceuticals

functional

Functional Foods have been enhanced with

dietary supplements

Example of functional food or neutraceuticals

OJ with Vit D

foods with probiotics

FDA does not approve :

- medical foods

- infant formula

- dietary supplements

- the food label or nutritional facts panel

- structure-function claims on dietary supplements

DA has battled with food manufacturers who have made

health claims for their products

If a manufacturer makes a claim on a food label that fits the definition of a drug, then the FDA may recognize that the manufacturer is claiming that the product can

treat, diagnose, prevent, or cure disease

T/F

FDA can take action against a manufacturer if its claims a product is a drug when its not

true

This act created a new category of FOOD called dietary supplements

Dietary Supplement Health and Education Act of 1994 (DSHEA)

True of False

FDA cannot require premarket approval of "Dietary Supplements

TRUE

FDA must prove what of a dietary supplement before removing it from the market

that it is unsafe

What is the disclaimer on every label of dietary supplement

"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease

___________ permits manufacturers to make limited health claims that describe the relationship of a food substance and disease

DSHEA

FDA must approve the claim made by these manufacturers by regulation pursuant of the _____________________ standard

"significant scientific agreement

what claims dont require a disclaimer if it meets the significant scientific agreement

unqualified health claims

What claims require the disclaimer when a claim does not meet the significant scientific agreement

qualified health claims

DSHEA provides that a dietary supplement is adulterated if it presents a significant or unreasonable risk of _______ or ______ under the conditions of use recommended or suggested in the labeling or under ordinary conditions of use

illness or injury

This act shows Adverse event reporting requirements for Dietary Supplement manufacturers and non-prescription drug manufacturer

The Dietary Supplement and Nonprescription Drug Consumer Protection Act 2006

Manufacturers, packers, or distributors whose name appears on the label MUST submit to the ______________ program any report of a serious ADR within 15 business days

MedWatch

A device differs from a drug because it does not achieve its primary purpose through a ____________ action and not dependent on ___________ for its primary purpose

chemical

metabolism

Some devices are ____________ products that contain drug

combination

A cosmetic can become a drug if the seller makes a health or ______________ claim

structure/function

T/F

FDA does not approve cosmetics

true

___________ prohibits the distribution of cosmetics that are adulterated or misbranded in interstate commerce

FDCA

Some products may be a cosmetic and a drug if a product has

2 intended uses

Can a cosmetic make the following claim?

Cleanses skin and alters appearance

YES

Can a cosmetic make the following claim?

treats acne, eczema or increases collagen

NO

Label means a display of written, printed or graphic matter upon the ___________ container of an article

immediate

Labeling means ALL labels and written, printed or graphic matter upon

any article, its containers or wrappers accompanying it

If the literature is deemed to _______________ the product, it is labeling

accompany

If the literature is deemed NOT to accompany a product, it is

ADVERTISING

Prescription drugs are labeled for the ____________________ not the ______________

healthcare professional

patient

What label exception of a prescription drug is actually for the patient

Medication guide

patient instructions

Regulated specific information required on the commercial label

name/address of Mfr, packer, distributor

name, quantity, proportion of each active ingredient

New package insert requirements

Highlights at the beginning of table of contents

Full Prescribing info

patient counseling information

pamphlet that must"accompany" the drug product and contains the essential scientific and medical information needed for safe and effective use of the drug by healthcare professional

package insert

T/F

package inserts can be promotional in nature

FALSE

Where are package inserts found for reference

DailyMed

Labeling may also include Instructions for

use or medication guides

Pharmacists are required to include FDA approved ______________________ every time a drug is dispensed to help ensure the safe use

medication guides

Medication Guides are _____________ labeling that is part of the FDA approved prescription drug labeling for certain prescription drugs

Patient

Patient labeling could prevent serious __________________

adverse reactions

A drug will be considered misbranded or adulterated under the FDCA if it is not recognized in

USP-NF

Homeopathic Pharmacopeia

__________________ is a private org independent of the FDA created by physicians and pharmacist in 1820 who were concerned about the potency, quality, and composition of medicinal agents and ingredients

USP Convention

_______________ contain the approved titles, definitions, descriptions, and standards for identity, quality, strength, purity, packaging, stability and labeling for a drug

Monographs

The FDA does not subject homeopathic drugs to ______________ approval or require proof of safety or efficacy

pre-market

Patient Package Inserts are required for

oral contraceptives and estrogens

T/F

PPIs are patient information and patient labeling that is FDA approved as drug labeling

true

Nonprescription Drug Labeling must be in a ____________- format stating the principle intended use, cautions, warnings, and adequate directions for use and "Drug Facts" panel

User-friendly

Some drugs exists as both OTC and prescription, depending on the _____________ for use

indication

Some indications can be labeled with ______________ directions for use

adequate

It is important for pharmacists to communicate the information on the label for nonprescription drug products accurately and never recommend use for _______________ purposes that are not on the nonprescription drug label or ____________ doses that recommended on the label

unintended

higher

if a patient has a condition that can not be treated by the OTC version of a drug then what is necessary?

guidance of a healthcare professional

Is it unsafe for a patient to use the OTC version product for a condition found on the prescription labeling on the product ?

YES could delay treatment