Pharmacy Law (Exam 1)

Durham-Humphrey Amendment of 1951

Made the distinction between prescription and non-prescription Required warning label that drugs can only be dispensed legally with authorization of a health professional

What are the 3 ways a prescription drug can be switched to OTC?

Manufacturer can request a switch - SNDA Manufacturer can petition the FDA FDA can add or amend OTC monograph

What is this an example of: A drug manufacture/repackager fails to register with the FDA

Misbranding

Child resistant package

designed or constructed to be significantly difficult for children under 5 to open or obtain a harmful amount of the contents within a reasonable time Must also not be difficult for normal adults to use properly

Label

display of written material on the product's container and on the outside container or wrapper

Authorized distributor of record

distributor that has an "ongoing relationship" with a manufacturer to distribute the manufacturer's product

Price advertising

exempt from FDA regulation (reminder advertising) provides info on price and not drug safety, efficacy or indications Price in advertisement must include all charges to consumer

Package (in reference to PPPA)

immediate container or wrapping in which any household substance is contained for consumption, use or storage in or about the household

ETASU

Elements to Assure Safe Use May require health care providers/facilities to have special training/certifications or drugs to be dispensed with safe use conditions (i.e. lab results)

Which source of law takes priority? Federal administrative regulation vs. State constitution

Federal Administrative Regulation Where there is conflict between federal and stat, federal law prevails

Which source of law takes priority? Federal statute vs. State constitution

Federal Statute When there is a conflict between federal and state, federal law prevails

Which source of law takes priority? State constitutional amendment vs. Federal administrative regulation

Federal administrative regulation Where there is conflict between federal and stat, federal law prevails

Preemption Doctrine

(Based on supremacy clause) Federal law preempts state law, even when the laws conflict

What is the usual dosage of Ipecac syrup?

15 mL

GATT/TRIPS system allows patents to last for how long from the earliest effective filling date claimed in the application?

20 years (for applications filed on or after 6/8/95)

How many clinical trial phases are there in the drug approval process?

3

What quantity of Ipecac syrup may be sold without a prescription?

30 mL (1 fluid ounce)

What are the three new pregnancy/lactation labels?

8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential

Stare Decisis

A doctrine under which judges "stand on decided cases" or follow the rule of precedent, in deciding cases

What must be on the label of Ipecac syrup for sale without a prescription?

A statement that is boxed and in red letters stating that it is for emergency use to cause vomiting in poisoning and before use to call a physician, the poison control center or hospital ER immediately for advice Also a warning stating to keep out of reach of children, do not use in unconscious persons, and do not use if strychnine, corrosives and strong acids have been ingested

Which application is used to approve generic products after the brand patent has expired?

ANDA

Examples of drugs included in PPPA regulations

APAP ASA Controlled drugs Diphenhydramine IBU Fe containing drugs/supplements Lidocaine Minoxidil Mouthwash Naproxen Oral Rx drugs

What is this an example of: A pharmacist drops pills on the floor, picks them up and puts them in a vial to be packaged for patient use.

Adulteration

What are the two FDCA prohibited acts?

Adulteration Misbranding

Is an NDA submitted before or after clinical trials are done?

After

Orphan Drug Act of 1983

Allowed drugs intended to treat rare dx and conditions to be designated as "orphan drugs" and provides pharmaceutical manufacturers tax and licensing incentives to develop them

Poison Prevention Packaging Act 1970

Allows CPSC to set rules requiring child resistant packaging for specific product types customarily used in or around the household if the product presents risk of serious injury/illness to children under 5 and technology exists or can be developed to produce child resistant packaging for the product

Nutrition Labeling and Education Act

Allows the use of FDA approved health claims on food labels Health claims are limited to claims about dx risk reduction

Prescription Drug Marketing Act of 1987

Amends FDCA to require states to license drug wholesalers Bans reimportation of rx drugs except by the manufacturer or for emergency use Established sales restrictions, storage, handling and record keeping requirements for drug samples

Injunction

An order which legally prevents something; stops the violators illegal activity

How often is the CFR published? Who updates it?

Annually Updated by the Federal Register

Orphan drugs

Drugs that treat a condition with a relatively small number of sufferers

cosmetic

Articles intended to be rubbed, poured, sprinted 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 Does NOT include soap

Drug

Articles recognized in the official USP/NF or Homeopathic Pharmacopoeia, or any supplement to any of them. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of dx in man or other animals Articles other than food intended to effete the structure or function of the body of man or other animals

Food

Articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article

Selling beverage alcohol at retail must conform to the licensing and tax requirements established by which organizations?

Bureau of Alcohol Tobacco and Firearms (BATF) IRS

Remedy of civil vs. criminal law

Civil - money damages Criminal - prison and/or fines

Civil vs. Criminal Law

Civil law - spells out rights, duties and relief available for injury to private parties Criminal law - injury to society as a whole

What are the three levels of recalls?

Class I: reasonable probability that use of product will cause serious ADE or death Class II: use of product may cause temporary or reversible ADE Class III: use of product is not likely to cause ADE

CFR

Code of Federal Regulations

What kind of speech is drug advertising?

Commercial speech

Who enforces the PPPA?

Consumer Product Safety Commission (CPSC)

Which words were defined under the FDCA?

Drug Device Cosmetics Labeling

What are 'behind the counter, nonprescription drugs'?

Drug that is OTC, but could jeopardize patient health unless a pharmacist provides consultation

Which two agencies are responsible for drug advertising?

FDA - prescription Federal Trade Commission (FTC) - non prescription

What is the Orange Book?

FDA published book of approved drug products with therapeutic equivalence (AB ratings)

Drug Efficacy Study Implementation Program

FDA to retroactively treat generic drugs as new drugs and requires manufacturers to prove efficacy Created the ANDA

T or F: Dietary supplements are not regulated by the FDA

False

T or F: Items covered under PPPA regulations that are used in hospitals must also follow the same regulations as the items that would be found in a household

False

T or F: Medicines that are made with tax free alcohol can be sold to outpatients

False

T or F: Retail pharmacies are permitted to receive drug samples

False

T or F: Soap (lye) is considered a cosmetic

False

T or F: The FDCA definition of a drug makes a distinction between prescription and non-prescription

False

T or F: The FTC regulates drug advertising for prescription drugs

False

T or F: Under the Pure Food and Drug Act, drugs are required to have pre-market approval

False

T or F: For a package to be child resistant, a total of 95% of the children tested according to procedure must not open the package during a 5 minute testing

False 80% of children 10 minute testing

T or F: Med guides must be given to patients only with new prescriptions

False All new and refilled prescriptions

T or F: A commercial container label is meant to be seen by the consumer

False It is only for the health care professional

T or F: Refills can be authorized by oral or written consent from a prescriber or their medical assistant

False Prescriber only

T or F: Manufacturers must include a habit forming warning on the label for drugs that are habit forming

False Up to manufacturer discretion, but they are required to describe the habit forming characteristics in the package insert

What are the three parts of an NDC code?

First 5 numbers: Manufacturer Next 4 numbers: Drug Last 2 numbers: Package size

Examples of substances included in PPPA regulations

Fluoride Furniture polish Glue removers Kindling/Illuminating preps Solvents for paint Sulfuric acid Turpentine

Medical Device Amendment of 1976

Gave FDA more oversight for medical devices -premarket approval required -GMP required -ADE reporting

GMP

Good Manufacturing Practices Set of regulations that establishes minimum requirements for the methods, facilities, or controls used in manufacture, processing, packaging or holding of a drug product

What is the first application that is submitted in the drug approval process?

IND

Supremacy Clause

If a conflict exists between federal and state law, federal law prevails

What is the exception that would allow the FDA to regulate the practice of pharmacy?

If the pharmacist ventures into drug manufacturing

Which amendment to the FDCA made it so that generic drugs could not be sold as expensive drugs under new trade names?

Kefauver-Harris Amendment

Which amendment to the FDCA required manufacturers to prove drug efficacy?

Kefauver-Harris Amendment

Misbranding

Labeling of a product that is false or misleading; label information must include directions for use; safe and/or unsafe dosages; manufacturer, packer, or distributor; quantity; and weight Imitation drugs

Natural Monopoly

Occurs when the fixed costs of providing a good are high relative to the variable cost; so the average cost declines over the time the good is provided

PPI is required for which drugs?

Oral contraceptives Estrogens

Tamper resistant packaging

Packaging that has an indicator or barrier to entry which if breached/missing can provide visible evidence to the consumer that it has been tampered with

When would expanded access be granted for an investigational drug?

Patient has serious dx whose life is immediately threatened by said dx There is no comparable alternative therapy to diagnose, monitor or treat the dx It is not possible to enroll the pt in clinical trial Potential benefit justifies potential risks of treatment Providing the drug will not interfere with investigational trials that would support market approval for the tx indication

Is Arizona a mandatory or permissive substitution state in regards to generic substitution?

Permissive

Medicare Prescription Drug Improvement and Modernization Act of 2003

Pharmacists can receive fees for providing MTM services to patients with multiple chronic dx and who take multiple covered drugs; these patients will likely exceed annual drug costs

What are the three categories of ad content and which ones are subject to regulations?

Product claim ads (drug + condition) - Subject to regulation Reminder ads (drug only, does not state use) Health Seeking Ads (educational and only names company, not product; informs about dx only)

1906 Pure Food and Drug Act

Prohibited marketing of adulterated and misbranded food and drugs

What is the Federal Register?

Proposed rules and regulations that updates the CFR

What are the three main areas of OBRA 90?

Rebates Funded demonstration projects DUR

Which drugs require medication guides?

Required for products that have serious or significant public health concern for which patient info is necessary to ensure safe and effective use

Federal Food, Drug and Cosmetic Act of 1938

Required manufacturers to demonstrate safety of new drugs prior to marketing Also allowed the FDA to inspect manufacturing facilities and allowed FDA to enforce Defined drug, device, cosmetics and labeling

Kefauver-Harris Amendment of 1962

Required manufacturers to prove drug efficacy before going on the market and report serious side effects afterwards Required efficacy to be based on adequate clinical studies Gave FDA 180 days to approve an NDA Allowed FDA to set GMP for industry Gave FDA control of rx drug advertising Controlled marketing of generic drugs to keep them from being sold as expensive meds under new trade names

PMDA Amendment of 1992

Requires companies to account for disposition of drug samples and prohibits reimportation of drugs exported to foreign countries. "Pedigree" requirement

REMS

Risk Evaluation and Mitigation Strategies Requires risk management plans that use risk minimization strategies beyond professional labeling to ensure that the benefits outweigh the risks

Functions of the Federal administrative agencies

Rule making Investigation and enforcement Adjudication

Pedigree Requirement

Rx drug wholesalers wo are not the "authorized distributor of record are required to provide a pedigree with each wholesale distribution of the drug

What three things are required under OBRA 90's DUR prospective review?

Rx must be screened before dispensing Pharmacist must counsel patient (patient can refuse) Pharmacist must document relevant info

Which application is used when there are changes in synthesis, production measures, manufacturing location, packaging, labeling and indications for a drug?

SNDA

Dietary Supplement Health and Education Act of 1994

Says that dietary supplements are exempt from FDCA food additive provisions Places burden of proving supplements are unsafe on the FDA rather than the manufacturer FDA established labeling requirements and cGMP for supplements

What two things must LTCF provide?

Service consultation from a pharmacist Comprehensive care plan for each resident

Which source of law takes priority? State statue vs. Common law of the state

State Statute Any area not covered by state statutes is governed by state case law (common law)

Food and Drug Administration Modernization Act of 1997

Streamlined approval for certain new drugs/devices by exempting some from pre-market notification processes Use of expert panels in drug approval process Federal requirements regarding compounding

Waxman Hatch Amendment

Streamlined the generic drug approval process Created market and patent exclusivity periods for both brand and generic drug companies Allowed a patent term extension to adjust for delays in the FDA approval process

FDA Anti-Tampering regulations

Tamper resistant packaging for cosmetic liquid or oral hygiene products, vaginal products, contact lens solution and most OTCs

What are the requirements that exempt a pharmacy from registering with the FDA under the FDCA?

The pharmacy must be in compliance with the local law The pharmacy must be regularly engaged in the practice of dispensing rx drugs/devices, upon prescription of practitioners licensed to administer such drugs/devices to patients under their care in the usual course of professional practice The pharmacy cannot manufacture, prepare, propagate, "compound" or process drugs/devices for resale other than in the regular course of their business of dispensing or selling at retail

T or F: Bioequivalence requirements are not adequate for narrow therapeutic index drugs or narrow therapeutic ration drugs

True

T or F: Devices have the intent to diagnose or treat diseases

True

T or F: Labeling includes drug advertisements and package inserts

True

T or F: Under OBRA 90, manufacturers are required to provide pharmaceuticals to Medicaid at their "best price"

True

T or F: A patient or prescriber can request for their oral medications to not have child resistant packaging

True Recommended to get this request in writing, but not required

T or F: Food labels can not have claims about the diagnosis, cure, mitigation and treatment of disease

True Per NLEA 1990

Which source of law takes priority? Federal statute vs. U.S. Constitution

U.S Constitution Supreme law of the land

Uniform laws

When adopted by a state legislature, they become statutory law in that state

Counterfeit drug

a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer or distributor other than the person or persons who in fact manufactured, processed, packed or distributed such drug

Dietary Supplement

a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet

Labeling

all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article Includes: package insert, drug advertisement, information in publications, promo materials

Prescription Drug User Fee Act of 1992

allows the FDA to accept user fees from drug and biologic companies in return for committing to review new drug and biologic applications within certain time frames.

Device

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory Intended to diagnose or treat diseases

Adulteration

making unpure poorer in quality Prepared in unsanitary conditions where it can become contaminated with filth container is composed of any poisonous substance contains color additive that is unsafe

What is mandatory substitution?

must substitute less expensive generic drug for the brand name drug unless prescriber writes DAW

What is permissive substitution?

pharmacy may choose to substitute if the prescriber issues prescription in a way that permits substitution

What is a seizure in regards to removal of a drug from the market?

physical isolation of a drug while the FDA or state agency files a civil lawsuit

What is the FDA responsible for?

regulating all aspects of manufacturing and, to a lesser extent, wholesale distribution of prescription and non-prescription drugs

What are the three parts of DUR?

retrospective review educational programs prospective review

pedigree

statement of origin that identifies each prior sale, purchase or trade of the drug including the date of those transactions and the names and addresses of all parties to them

Recall

the correction or removal and notification to the company of a product that is in violation of the law

What is the penalty for adulteration or misbranding?

up to 1 year imprisonment and/or $1000 fine (first offense)

Off label use

use for indications other than those approved by the FDA

"ongoing relationship"

written agreement