PHAR 441 Law 1

Defines the relationships among individuals in society

Defines the limitations on the relationship between the individual and society

State and federal regulations that govern the relationships between govt. and some regulated profession, trade, or industry

Serves as a judicial body to settle disputes related to rule enforcement
Police/enforce compliance with the rules

Interpret new laws from their governing legislature and promulgate rules to implement those laws.
Amend/repeal older rules, create new rules

Notice (proposed rules published)
Opportunity to be heard -(public hearing)
Publication of final rule -(CFR< UAC)

Rule Enforcement
Rule Making
Rule Making Procedure

State law may be stricter, but cannot be weaker

Within the US, territories and possessions ("interstate" and "intrastate" authority)

Within the state ("intrastate" authority)

"The Congress shall have Power to ... regulate Commerce with foreign Nations, and among several States..."

Remedies for wrongs suffered by people who have no formal relationship with those who caused the alleged harm; usually compensated through monetary damages

Battery, assault, false imprisonment, trespass

Abnormally dangerous activities, animals, product liability (pharmaceutical manufacturing liability)

Failing to do something that a reasonable person would do (OMMISSION)

Doing something that a reasonable person would not do (COMMISSION)

Duty
Breach
Causation
Damage

A legal obligation to conform to a specific standard of conduct (standard of care) for protection of another against unreasonable risk of injury

Violation of a legal obligation

Breech is actual and proximate cause of injury

Loss or injury to person or property

(1) Substance recognized in the official US Pharmacopeia (USP), official Homepathic Pharmacopeia of the US, or National Formulary (NF), or a supplement to any of them

(2)Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animials

(3)Substances (other than food) intended to affect the structure or an y function of the body of man or other animals

(4)Substances intended for use as a component of any substances specified in clause (1), (2), or (3); but does not include devices or their components, parts, or accessories

(1) Compostions of drug is not generally recognized as safe and effective

(1/3) A drug intended for use by man which -is a habit-forming drug

(2/3) A drug intended for use by man which -because of its toxicity or other potential for causing a 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 a drug

(3/3) A drug intended for use by man which -is limited by an approved application -to use under the professional supervision of a practioner licensed by the law to administer such a drug

(1/3)Drugs recognized among experts to be safe and effective for use (i.e., non-prescription drug)

(2/3) Must comply with current good manufacturing practices (cGMP)

(3/3) Must contain "Adequate directions for use" -the directions must be written so clearly that a layperson can safely use the drug for its intended purpose(s)

(2/3) Must comply with current good manufacturing practices (cGMP)

(1/3) A procedure for obtaining the FDA pre-marketing approval of a drug which is required by the FDA as a "new drug" FDA approval requires that a drug to be proven safe and effective by means of adequate and well-controlled animal and human studies

(3/3) Must contain "Adequate directions for use" -the directions must be written so clearly that a layperson can safely use the drug for its intended purpose(s)

(2/3) Generally reserved for approval of new chemical entities or new indications/dosage/route of administration for previously-approved drugs

(1/3) A procedure for obtaining the FDA pre-marketing approval of a drug which is required by the FDA as a "new drug" FDA approval requires that a drug to be proven safe and effective by means of adequate and well-controlled animal and human studies

(3/3) May require 18 to 24 months or more for approval

(2/3) Generally reserved for approval of new chemical entities or new indications/dosage/route of administration for previously-approved drugs

(3/3) May require 18 to 24 months or more for approval

(1/3) A procedure for obtaining FDA pre-marketing approval of a (generic) copy of a drug previously approved by the FDA. Applies to all approved drug products upon expiry of patent and/or NDA-exclusivity period.

(1/3) A procedure for obtaining FDA pre-marketing approval of a (generic) copy of a drug previously approved by the FDA. Applies to all approved drug products upon expiry of patent and/or NDA-exclusivity period.

(2/3) Procedure does not require submission of safety and efficacy data, but bioequivalence studies are required for most dosage forms

(2/3) Procedure does not require submission of safety and efficacy data, but bioequivalence studies are required for most dosage forms

(3/3) Usually requires 6 to 8 months for approval

(3/3) Usually requires 6 to 8 months for approval

(1/2) Regulation specifying the conditions (dosage, indications) under which specific active ingredients and combination may be formulated in OTC drug products without prior FDA approval

(1/2) Regulation specifying the conditions (dosage, indications) under which specific active ingredients and combination may be formulated in OTC drug products without prior FDA approval

(2/2) Published for therapeutic classes, e.g. -cough/cold products, analgesics, acne products, etc.

(2/2) Published for therapeutic classes, e.g. -cough/cold products, analgesics, acne products, etc.

(Orange Book) Listing of all FDA-approved drug products (NDA or ANDA) by active ingredient(s) and trade name along with patent or exclusivity information. Supplemented monthly

(1/3)A universal product code (UPC) for medications and pharmaceutical aents in the US

(2/3) Part of the Drug Listing Act 1972

(3/3) 3 Sections
-Labeler
-Product
-Packaging

Represent the manufacturer or distributor (Labeler)

Represent the "product"

Represent the "packaging"

Primarily concerned with PHYSICAL CONDITIONS of drugs or devices and the environment of their manufacturer

Primarily concerned with the REPRESENTATIONS made by the manufacturer concerning the drug or device

Prohibited in INTERSTATE commerce drugs that -prepared, packed or held in unsanitary conditions

Prohibited in INTERSTATE commerce drugs that -manufactured not in conformance w/GMP

Prohibited in INTERSTATE commerce drugs that -are in a container composed of poisonous or deleterious materials that may leech

Prohibited in INTERSTATE commerce drugs that -contains or is an unsafe color additive

Prohibited in INTERSTATE commerce drugs that -Varies from an official compendia

Prohibited in INTERSTATE commerce drugs that -is either a new unsafe animal drug or animal feed contiaining a drug

Prohibited in INTERSTATE commerece drugs that -is a class III device without premarket approval

Prohibited in INTERSTATE commerce drugs -an OTC drug not packaged in tamper-resistant packaging

Label or labeling is false or misleading

Label fails to state name and place of business of manufacturer ... and accurate statement of quantity

Label information is not prominently placed

Does not bear adequate directions for use

It is a habit forming substances and does not bear caution "warning: may be habit forming"

Does not bear generic name in type not less than 1/2 size of trade or brand name

Listed in compendia, but not labeled and packed by compendia standards

Package or drug is misleading in the way it is filled or formed or is imitative of another drug

Subject to deterioration if used and label does not warn

Health endangering if used in the manner suggested by the labeling

Insulin or antibiotic drug which is not batch certified

(1/2) "display of written, printed, or graphic matter upon the immediate container of any article

(2/2) If certian information is required to be on the label of a drug, the information must also be on the outside container or wrapper or the inner label must be clearly visible through the outer wrapper

(1/2) All labels and other written, printed or graphic matters either: upon any container or any of its wrappers or accompanying such article

The law requires certian information to accompany the drug, but not necessarily be placed on the actual labe. e.g. -package insert

FDA recall -reasonable probability use will cause serious adverse health consequences

FDA Recall -use may cause temporary or medically reversible adverse health consequences, probability of serious adverse health consequences is remote

FDA Recall -use is not likely to cause adverse health consequences

SEIZURE of product if imminent harm

INJUNCTION/TRO -prevent product from going into commerce

If criminal negligence, or intentional violation of Food and Drug Laws

FBI, ATF, DEA, US Marshals

Required drug safety testing prior to approval

Expanded definitions of adulterated and misbranding
-adequate directions for use
-warning:may be habit forming

Legislation extended to cosmetics and therapeutic devices

Eliminated the Sherley Amendment requirement to prove intent

Authorized factory inspections

Primarily concerned with manufacture and distribution of drugs

Primarily concerned with licensing standard

Exempted certian drugs from labeling requirement by creating "prescription drug exemption"
-Caution: Federal law prohibits dispensing without a prescription
-a.k.a. legend drugs

Required Manufacturers to prove drug efficacy prior to approval

Standard for manufacturer registration
-increased inspection power

Standards for GMP

-New Drug Approval process
-Advertising procedures established

Requires all controlled substances and prescriptions be subject to specail packaging requirements (child-resistant containers)
-many special exceptions
-packaging not required if
1-prescriber authorized
2-patient requests

-Broadened definition of medical devices
-Established Expert panel to review and set standards for review of medical devices

Low risk of harm, no pre-market testing (tongue depressors, bandages, bedpand)

Safety and efficacy must be evaluated (hearing aids, forceps)

Usually life-supporting devices (catheters, stimulators, pacemakers)

-Accelerated mechanism for approving generic versions of approved drugs
-Created the ANDA
-extended certian types of patents from 17 to 20 yrs
(hatch-waxman)

-Provides federal standards for storage, distribution and recordkeeping of drugs
-"Drug Diversoin Act"/"Drug Pedigree Act"
-Bans "re-importation" of drugs originally manufactured in the US

-Provides annual fees on manufacturers and their products
-Fees are appropriated to the FDA for improving the regulatory process and speeding drug approvals

-Designed to overhaul FDA
-Incentives for conducting pediatric clinical studies
-Pharmacy Compounding Regulations
-Labeling requirements liberalized
-New procedures for dissemination of "off-label" information

-Removed dietary supplements from the NLEA
-Essentially deregulated the herbal remedies industry
-Labeling of DS cannont make specific therapeutic claims, but in-store literature not produced by mfg or the store can make therapeutic claims
-Does NOT exempt DS totally from FDA regulations
-DS CANNOT claim to diagnose, cure, mitigate, treat or prevent disease

Benefit a classic nutritional deficiency

Affect structure/function of body

Characterize a documented mechanism by which a DS nutrient acts to maintain structure or function

Statements describing general well being from consuming the DS