Pharmacy Law Exam 1 Liz

Federal Food, Drug, and Cosmetic Act

Protects consumers against misbranded or adulterated food, drugs, medical devices, or cosmetics (must be both SAFE and EFFECTIVE)

Pure Food and Drug Act of 1906

Prohibit the manufacturer, sale or transportaion of mis-brandished and adulterated foods and drugs (hard to enforce because the government would have to prove that someone intentionally wrongly to put the false statement on the label)

Sulfanilamide Tragedy of 1937

Led to the passage of the Food, Drug, and Cosmetic Act of 1938, more than 100 people died after the use of sulfanilamide. Dissolved sulfanilamide into diethylene glycol (antifreeze). Produced the drug in an elixir form with diethylene glycol.

Food, Drug, and Cosmetic Act of 1938

indicated that mis-branding and adulteration of drug is illegal. It also required manufacturers to provide package inserts and to follow FDA guidelines to present evidence of safety for new drugs before marketing. Labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs. This law also gives the FDA authority to issue food standards and inspect factories/

Durham-Humphrey Amendment of 1951

• Created a distinction between "OTC" and "Legend Drugs or Prescription drugs".

provided that the labels of prescription drugs need not contain "adequate directions for use" so long as they contain the legend "Caution: federal law prohibits dispensing without a prescription."

-also authorizes oral prescriptions (telephone prescription from doctor) and refills of prescription drugs

Food Additives Amendment of 1958

-First law that directly affected packaging

-Anything that directly or indirectly becomes part of the food, is considered an additive - includes packaging components; they must receive premarket approval for safety

Color Additive Amendments of 1960

Required manufacturers to establish the safety of color additives in food drugs and cosmetics.

Thalidomide

A mild tranquilizer that, taken early in pregnancy, can produce a variety of malformations of the limbs, eyes, ears, and heart.

-Due to the FDA refusal to allow marketing of the drug in the US, the number of birth defects in the US was low

Kefauver-Harris Amendment of 1962

• Also known as the "Drug Efficacy Amendment".

• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .

EFFICACY REQUIREMENT

ESTABLISHED GOOD MANUFACTURING PRACTICES

• Required drug advertising to be more closely regulated and disclose accurate information about side effects

Medical Device Amendment of 1976

Requires life-sustaining and life-supporting devices to have premarket approval from the FDA, classification of devices according to their function, establishment of performance standards, adherence to record and reporting requirements, conformance with GMP regulations

Orphan Drug Act of 1983

Provided tax and exclusive licensing incentives for the development of orphan drugs for treatment of rare diseases

Drug Price Competition and Patent Term Restoration Act of 1984

Waxman Hatch Amendment

-streamline a generic approval process while giving patent extensions, in some circumstances, to innovator drugs

-make generic drugs more readily available to the public while providing incentives to manufacture new drugs

Prescription Drug Marketing Act of 1987

Prevents re-importation of a drug into US

Prohibited hospital and healthcare entities from reselling their pharamaceuticals

-establishes sales restrictions and record keeping requirements for prescription drug samples

Safe Medical Devices Act of 1990

FDA additional authority over medical devices. Postmarketing approval. Require health care facilities to report problems to FDA. FDA new authority to recall.

Generic Drug Enforcement Act of 1992

Occurred when some FDA staff accepted bribes from generic drug industry personnel in order to facilitate the approval process of certain generic drug products.

?FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.

?Imposes severe civil penalties for any false statements, bribes, failures to disclose material facts and other related offenses.

Prescription Drug User Fee Act of 1992

requires manufacturers to pay fees for the applications and supplements when the FDA must review clinical studies

Fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA review

Nutrition Labeling and Education Act of 1990 (NLEA)

mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations

Dietary Supplement Health and Education Act of 1994

defines dietary supplements and permit manufacturers to make certain claims that otherwise would have been illegal under the FDCA (regulate dietary supplements more as foods than as drugs)

Food and Drug Administration Modernization Act of 1997

streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices

Creates fast track approval process for drugs intended for serious or life threatening diseases, establishes a database of information on clinical trials, authorizes scientific panels to review clinical investigations, and expands the rights of manufacturers to disseminate unlabeled use information

Medical Device user fee and modernization act of 2002

established user fee requirement for premarket reviews of medical devices and also established performance goals for many types of premarket reviews, inspections that can be conducted at establishments by accredited third parties and new regulatory requirements for reprocessed single use devices

Food and Drug administration amendments act of 2007

provides FDA with increased responsibilities and authority to regulate drug safety, label changes related to safety, clinical trial data reporting and registries, requiring postmarked clinical studies to assess risk and requires companies to implement risk evaluation and mitiation strategies

FDA Safety and Innovation Act of 2012

allows FDA to continue to collect fees from manufacturers seeking NDAs or medical device approvals

adds to generic drug user fee act and Biosimilar User Fee Act

reduces drug counterfeiting, blocks the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines

Drug Quality and Security Act of 2013

Compounding Quality Act: clarifies and strengthens FDA oversight over pharmacies engaged in the large scale compounding and shipping of sterile products to other licensed entities

removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMP, labeling and the new drug approval process

adds "track and trace" requirements for all entities in the chain of distribution of pharmaceutical products

The 21st century Cures Act of 2016

streamline and add flexibility and innovation to the drug development and approval process, primarily by creating new clinical trial design options and by accelerating the pathways to market for drugs intended to treat certain serious or life threatening diseases

provides billions of dollars of additional funding to the National Institute of Health

FDA Reauthorization Act of 2017

This act reauthorized the user fee programs and enhanced the goals of the Cures Act and created a new category of OTC hearing aids.

Prescription Drug User Fee Act

The act requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies. The fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and speed up the NDA reviews. In addition, this Act must be reauthorized every 5 years.

The Generic Drug Enforcement Act

This act resulted from a scandal that occurred when some FDA staff accepted bribed from generic drug industry personnel in order to facilitate the approval process of certain generic drug products. This law authorizes the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.

Drug Quality and Security Act

Two titles under this act. Title 1 also called the Compounding Quality Act, clarifies and strengthens FDA oversight over pharmacies engaged in the large scale compounding and shipping of sterile products to other licensed entities. The law also removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMOP, labeling and the new drug approval process. Title II known as the Drug Supply Chain Security Act, adds "track and trace" requirements for all entities in the chain of distribution of pharmaceutical products. Requires manufacturers to provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchasers. The law also mandates an electronic, interoperable product tracing system by 2023, strengthens wholesaler and third party logistics licensure requirements and requires manufacturers to serialize drugs by 2017.

Prescription Drug Marketing Act

Congress enacted this act in response to the growing alarm that a secondary or diversionary distribution system for prescription drugs was threatening the public health and safety. Further this law establishes sales restrictions and record keeping requirements for prescription drug samples and prohibits hospitals and other healthcare entities from reselling their purchases to other businesses and requires the state licensing of drug wholesalers.

Kefauver-Harris Amendment

This amendment is also called the Drug Efficiency Amendment, it strengthen the new drug approval process by requiring that drugs be proved not only safe but also effective. The efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962. In addition, the amendment also transferred jurisdiction of prescription drug advertising form the FTC to the FDA, established GMP requirements and added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions .

Food and Drug Administration Amendments Act

This act reauthorized and amended many drug and medical device provisions that were set to expire, also provided the FDA with new funding and significantly more authority over drug safety. This act allows the FDA broader use of the fees generated by PDUFA, while increasing the fees. The law also provides the FDA with significantly enhanced responsibilities and authorization to regulate drug safety, authority to mandate labeling changes related to safety, require clinical trial data reporting and registries, require postmarket clinical studies to assess risk, and require companies to implement risk evaluation and mitigation strategies (REMS) when necessary.

Food and Drug Administration Modernization Act

This act was passed primarily to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices. The intent of this act is to eliminate backlogs in the approval process and ensure the timely review of applications. This act creates a fast-track approval process for drugs intended for serious or life threatening diseases, establishes a databank of information on clinical trials, authorizes scientific panels to review clinical investigations and expands the rights of manufacturers to disseminate unlabeled use information. This act also expands the FDA's authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients. The law also affects the regulation of medical devices in part by mandating priority review for breakthrough technologies in medical devices and allowing the FDA to contract with outside scientific experts for review of medical device applications.

Orphan Drug Act

Congress passes this Act to provide tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of "rare diseases or conditions (defined as those affecting fewer than 200,000 Americans.)

Durham-Humphrey Amendment

Durham-Humphrey Amendment

FDA Safety and Innovation Act

The law allows the FDA to continue to collect fees from manufacturers seeking NDAs or medical device approvals. It also adds the Generic Drug User Fee Act and Biosimilar User Fee Act. The purpose of imposing fees on these manufacturers is to increase resources for the FDA in order to speed the generic drug and biosimilar approval process. The law also contains several provisions directed at reducing drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines. Additionally this law enables the FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites.

False

Procardia XL 30mg and Lasix 40mg tablets are classified under the Federal Controlled Substance as a Schedule IV.

True or False

True

Anabolic Steroids are classified as a Schedule III controlled substance under the Federal Controlled Substance Act.

True or False

Schedule II

Oxycodone is classified under the Federal Controlled Substance Act as a:

Schedule IV

Diazepam is classified under the Federal Controlled Substance Act as a:

III

Acetaminophen with codeine tablets is classified under the Federal Controlled Substance Act as a:

Morphine

Cocaine

Fentanyl

Morphine

Cocaine

Fentanyl

Example(s) of a Schedule II controlled substance under the Federal Controlled Substance Act is/are:

Schedule V

Antitussive preparations that contain codeine is classified under the Federal Controlled Substance Act as a:

True

Acetaminophen 325mg is considered an Over the Counter (OTC) product and can be purchased without a prescription in the United States.

True or False

Alprazolam

Flurazepam

Lorazepam

Meprobamate

Alprazolam

Flurazepam

Lorazepam

Meprobamate

Select all that apply. Example(s) of a Schedule IV controlled substance under the Federal Controlled Substance Act is/are:

Schedule I

Heroin is classified under the Federal Controlled Substance Act as a:

For a patient enrolled in a hospice care program

Which one of the following may a faxed Schedule II Controlled Substance prescription serve as an original prescription under Federal Law?

DEA form 41

Which DEA form would be used to destroy controlled substances?

DEA Form 222

Ordering a Schedule II controlled substance is done utilizing which form?

DEA Form 224

Which DEA Form should be completed to register a new pharmacy?

3

Complete the following DEA number AB123456_

DEA Form 106

Which DEA Form should be completed to report a theft or significant loss of any controlled substance?

DEA Form 222

Which DEA Form should be completed to transfer schedule II substances?

The prescription expires 6 months from the date of issuance

With regard to Schedule III prescriptions, which of the following is correct under federal law?

9

How many grams per month is the sale of OTC pseudoephedrine limited to? Assume this is a retail sale and not mail order.

A pharmacy must conduct a controlled drug inventory every 2 years

With regard to a federal controlled substance inventory, which of the following statements is correct regarding how many times should a controlled drug inventory be taken?

Purple

The ___ book lists biological products, including any biosimilar and interchangeable biological products licensed by the FDA under the Public Health Service Act (PHSA).

Orange book

Evaluates pharmaceutically equivalent products on the basis of bioequivalence.

uses a two-letter rating system; some products use two letters and a number

Pharmacists must comply with state law when substituting and exercise professional judgment substituting B-rated products.

Bioequivalent pharmaceeutical equivalents are generally presumed therapeuticaaly equivalent- having the same clinical safety and efficacy.

Medication Guides

Required for drugs that the FDA has determined as posing "serious and significant concerns"

Required for new prescriptions

Content of the _____ must be approved by the FDA

Required for refill prescriptions

True

Pharmacies compounding for their patients pursuant to a prescription are exempt from FDCA manufacturing provisions.

True or False

Poison Prevention Packaging Act

Intent of the act is to protect chlidren from accidential poisonings due to "household substances".

Administered by the Consumer Product Safety Commission.

The law establishes the standards for child-resistant containers.

Container may not be reused unless glass or threaded plastic and then only with a new closure.

if the patient requests

Sublingual (SL) dosage forms of nitroglycerin

Sublingual (SL) isosorbide dinitrate in dosage strengths of 10 milligrams or less

Anhyrdous cholestyramine in powder form

Exemptions under the Poison Prevention Packaging Act

True

Guidance prohibits supplying compounded drugs for "office use", the drug product being compounded must be for an identified individual patient based on the receipt of a valid prescription order.

True or False

True

The Compounding Quality Act was passed as part of the Drug Quality and Security Act as a response to the New England Compounding Center tragedy.

True or False

True

Compounding "regularly or inordinate amounts" of products that are "essential copies" of "Commercially available products" is prohibited unless a change for an identified patient produces a signifiant difference.

True or False

Tax-paid alcohol is used in compounding in community pharmacies.

Tax-paid alcohol is obtained from outlets that sell liquor at retail.

Tax-free alcohol (190 proof ethyl alcohol) is available to hospitals for medicinal, mechanical and scientific purposes and in the treatment of patients. May be used only for inpatients.

Tax-free alcohol (190 proof ethyl alcohol) charity clinics may use for medicines for outpatients if they do not charge a fee for the alcohol.

the use of alcohol in pharmacy practice

law

standards for society to act or not act in a certain way

-requirements for human conduct applying to all person's within their jurisdiction

fundamental notion of fairness

custom of history involved

command of a public entity

best balance between conflicting societal interests

Factors taken account when making decisions

market failures

What is the reasons to regulate drugs?

public goods, externality, monopoly, and information asymmetry

What are the four market failures?

public goods

necessary and beneficial commodities that private entities will not supply because there are no incentives

ex. orphan drugs

orphan drugs

safe and effective but less than 200,000 need them , so it is not commercially feasible for a manufacturer to market them. They aren't a major priority or in a company's best interest to create them because they won't make that much money from them.

externality

when the production or consumption of a good affects someone who does not fully consent to the effect

-when the costs of the good are not fully incorporated in the price of a good

ex. antibiotics and misuse of them

monopoly

when the fixed costs of providing a good are high, relative to the variable costs

-ex. patents and market exclusively for new drugs

generic drugs

after patent giving exclusive rights to a company is done or expired, ____________are created

information asymmetry

when the consumer is uninformed about the true value of a good

ex. prescription only drugs; written consumer information for certain drugs--> only healthcare providers are informed

prtecting individual freedoms

deminimis violations (minor)

certain human relationships (families, professions, religious groups)

Examples of limits to the law

De minimis violation

minor violation; okay as long as they dont interfere with patient safety directly

de minimis violation

What would this be an example of?

Your pharmacy states you have a glass graduated cylinder. You accidentally break it; health inspector comes next day with board of pharmacy, they come, inspect it, and finds a violation

U.S. constition which is supreme

legislature

admnistrative agencies

courts

Sources of law

U.S. Constitution

What is the supreme law in that no federal or state laws may conflict with it?

Legislative Branch

Statutory law including U.S. Congress, State constitutions, state legislatures who make state laws, and political subdivisions (ordinances)

U.S. Congress

Who makes federal laws?

House of Representatives and Senate

What are the two parts of Congress?

Administrative agencies

__________ __________ are created by legislatures to administer or enforce the laws(experts to make laws)

Executive branch

Which branch of government enforces laws and make regulations

ex. Board of Pharmacy, FDA, Drug Enforcement Agency

notice-and-comment rulemaking

An administrative rulemaking procedure that involves the publication of a notice of a proposed rulemaking in the Federal Register, a comment period for interested parties to express their views on the proposed rule, and the publication of the agency's final rule in the Federal Register.

1. within scope of board's authority (ex. Board of Pharmacy issues pharmacy laws)

2. based on statutory authority (powers and duties assigned to a government official through a law passed by Congress or state legislature

2 validity tests of a regulation

Judicial Branch

What branch of government interprets laws by rendering decisions pursuant to hearings such as court proceedings

Judicial Review

process where a court will review the record to determine if the decision was based on enough evidence

de novo

If substantial evidence lacking, court will conduct an entirely new trial

Federal Register and Code of Federal Regulations

regulations are published in the ______and______

Federal Register

An official document, published every weekday, which lists the new and proposed regulations and notices of executive departments and regulatory agencies.

Code of Federal Regulations

compilation of final regulations divided and indexed by subject matter

Federal Register

Administrative agency wants to make a law, where would they post their proposed regulation

common law and judicial opinions

law made by courts

stare decisis

Let the decision stand; decisions are based on precedents from previous cases

opinions are binding on lower courts in the same jurisdiction and serve as precedent

stare decisis

What is this an example of?

When a court faces a legal argument, if a previous court ruled on the same or loosely related issue, then the court will make their decision in alignment with the previous court's decision

statue

a written law passed by a legislative body

due process

fair treatment through the normal judicial system, especially as a citizen's entitlement.

-determining legislative intent

-ordinary meaning of words

-rights of the individual

Principles of interpretation