Law Exam 1

USP Chapter <800>, which became effective December 1, 2019, requires entities that handle hazardous drugs (HDs) to maintain at a minimum the following:

a. A list of HDs; b. Proper facility and engineering controls; c. Competent personnel; d. Safe work practices; e. Proper use of appropriate Personal Protective Equipment (PPE); and f. Policies for HD waste segregation and disposal.

Under section 503A of the FDCA, a pharmacy cannot compound "regularly or in inordinate amounts" any drug products that are ________ of commercially available drug products. A commercially available drug product is any marketed drug product, except drug products discontinued or no longer marketed and products appearing on the FDA drug shortage list.

"essentially copies"

When healthcare providers prescribe and dispense drugs for indications other than those listed on the approved labeling, this is considered ________ use, which the FDA recognizes as acceptable medical practice in general.

"off-label, unlabeled, or unapproved"

Pursuant to the Drug Quality and Security Act of 2013, a compounder of sterile products may voluntarily register to become an _______ under section 503B of the FDCA.

"outsourcing facility"

The Orphan Drug Act of 1983 provided tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of _________ (defined as those affecting fewer than 200,000 Americans).

"rare diseases or conditions"

The FDA requires that manufacturers produce and that pharmacies dispense MedGuides for drugs that pose a

"serious and significant concern to public health"

The USP states that unless specified otherwise in an individual monograph or in the absence of stability data to the contrary, the beyond-use date (BUD) on the label of a dispensed drug product shall not be later than ________, whichever is earlier.

(a) the expiration date on the manufacturer's container, or (b) 1 year from the date the drug is dispensed

The Poison Prevention Packaging Act (PPPA) requires the use of child-resistant containers for packaging most OTC drugs and nearly all prescription drugs. These containers must be manufactured such that _____ of children less than _____ years of age cannot open them, whereas at least ______ of adults can.

80%, 5, 90%

Almost any food can be considered a drug if what claim is made for it?

A therapeutic or health claim

The FDA approved Femstipril (fictitious) in 2014. How could Femstipril become a new drug in 2021? a. The manufacturer adds a new indication in the labeling b. The manufacturer changes the enteric coating c. The manufacturer changes the recommended dose d. All of the above

All of the above

The Drug Supply Chain Security Act: a. preempts the state pedigree laws b. requires pharmacies to quarantine, investigate, and notify the FDA of suspect products c. requires pharmacies to receive a transaction history with the drug product d. All of these are correct

All of these are correct

Which of the following statements regarding Medication Guides (MedGuides) is correct?: a. The FDA can require manufacturers to publish MedGuides only for drugs that pose a serious and significant concern b. Since the enactment of the FDAAA, the FDA has considered every new MedGuide to be part of a REMS c. A MedGuide is required the first time a drug is dispensed to a healthcare professional d. All of these are correct

All of these are correct

Phase II trials

Determine the efficacy of the drug and the dosages at which the efficacy occurs.

Phase III trials

Drug is tested for safety and efficacy in hundreds or even thousands of patients.

The ______ regulates prescription drug advertising under the FDCA and the _______ regulates nonprescription drug advertising under the FTC Act.

FDA, FTC

A proposed FDA regulation to set new labeling requirements for prescription drugs would be published in the: a. the Federal Register b. The Code of Federal Regulations c. both the Federal Register and the Code of Federal Regulations d. neither

Federal Register

The FDA is a component of the Department of.....

Health and Human Services

A pharmacist submitted fraudulent prescription drug claims to Medicaid and was ultimately caught. The Board of Pharmacy became involved to determine whether the pharmacist's license would be revoked. How will the board likely proceed?: a. Hold a hearing pursuant to its judicial function b. Hold a hearing pursuant to its legislative function c. Issue a regulation pursuant to its legislative function d. Proceed either by means of a hearing or regulation

Hold a hearing pursuant to its judicial function

Second segment of NDC

Identifies specific strength, dosage form, and formulation

Which of the following statements best describes the 1938 FDCA as enacted?: a. It is the nucleus for today's FDCA b. The law required that new drugs must be proven safe and effective prior to marketing c. The catalyst for the law was the thalidomide tragedy d. The law did not include devices

It is the nucleus for today's FDCA

The Drug Quality and Security Act had what effect on the traditional compounding of community pharmacies pursuant to prescriptions?: a. It reinstated the constitutional provisions of Section 503A enacted in 1997 by the FDAMA b. It shifted enforcement authority from state pharmacy boards to the FDA c. It established that pharmacy-compounded drugs are new drugs d. It prohibited pharmacies from compounding in anticipation of prescriptions

It reinstated the constitutional provisions of Section 503A enacted in 1997 by the FDAMA

What two classes of drugs did the Durham Humphrey Act establish?

OTC and prescription

To guide healthcare professionals in evaluating biologics, the FDA electronically publishes the _______, where biosimilars are noted with a "B" and, if interchangeable, with an "I".

Purple Book

Pursuant to the Poison Prevention Packaging Act, a community pharmacy may: A. dispense a non-child-resistant container if, in the pharmacist's professional judgement, it is appropriate B. dispense a non-child-resistant container upon a patient's request, but only if the request is in writing C. reuse a child-resistance glass container with a new closure D. All of these are correct

Reuse a child-resistance glass container with a new closure

What 2 categories of special food did the FDCA create?

Special dietary foods and medical foods

Prospective DUR has three components under the OBRA '90 mandate

a. A screen of prescriptions before dispensing, b. Patient counseling by the pharmacist, and c. Pharmacist documentation of relevant information.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a dietary supplement is defined as a product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following:

a. A vitamin; b. A mineral; c. An herb or other botanical; d. An amino acid; e. A dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or f. A concentrate, metabolite, constituent, extract, or combination of the previous.

The "Drug Facts" panel on a nonprescription drug must contain the following information in the following order:

a. Active ingredient(s) (including dosage unit and quantity per dosage unit); b. Purpose (general pharmacological category or principal intended action); c. Uses; d. Warnings; e. Directions; f. Other information; g. Inactive ingredients (listed in alphabetical order); and h. Questions? Or Questions and Comments.

When compounding medications, if a pharmacy meets all of the conditions set forth in section 503A of the FDCA, it is exempt from registering as a manufacturer and is exempt from three specific requirements of manufacturers:

a. Adequate directions for use; b. CGMP; and c. New drug requirements (section 505 of the FDCA).

Two key provisions of the Durham Humphrey Act

a. Legalization of the verbal transmission of prescriptions. b. Legal right for pharmacists to honor refill authorizations indicated by physicians in the initial prescription.

The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) contains a number of significant provisions, but most involve one of three major areas:

a. Rebates, b. Demonstration Projects, and c. DUR.

3 parts of the DUR process

a. Retrospective Review, b. Educational Programs, and c. Prospective review.

The plaintiff must show two things in order to prove their standing:

a. The challenged conduct has caused the plaintiff injury. b. The plaintiff's interest is a legally protectable interest.

Section 503A of the FDCA permits a drug product to be compounded in two situations: (1) based on the receipt of a valid prescription order for an identified individual patient or (2) in limited quantities before the receipt of a prescription for an identified individual patient. The FDA has concluded that a compounder does not exceed a "limited quantity" if:

a. The compounder holds for distribution no more than a 30 day supply supply of the compounded drug product to fill the prescriptions it has yet to receive; and b. The amount of the supply is based on the number of valid prescriptions that the compounder has received for identified patients in a 30-day period over the past year.

Three ways to switch a prescription to OTC status

a. The manufacturer may request the switch by submitting a NDA or supplemental application to its approved NDA (SNDA). b. The manufacturer or other parties may request an OTC switch through a citizen petition to the FDA. c. The FDA or industry may add or amend an OTC monograph. This process was changed by the CARES Act in 2020 from a rulemaking process to an administrative order process.

What three legal tests must a regulation meet to be valid?

a. The regulation must be within the scope of the agency's authority. b. The regulation must be based on a statute that give the agency the authority to promulgate the regulation. c. The regulation must bear a reasonable relationship to the public health, safety, and welfare.

HIPAA targets four aspects of health information

a. Transaction and code sets, b. National provider identities, c. Security, and d. privacy.

The FDA has the right to categorize as prescription drugs those that are......

a. Unsafe for use except under the supervision of a practitioner because of the toxicity, the method of use, or the collateral measures necessary to use the drug. b. Subject to the new drug application (NDA) approval process.

The HIPAA privacy rule allows pharmacies to use and disclose Protected Health Information (PHI) for three things

a. treatment, b. Payment, and c. operations.

A breach of PHI is defined as "the _______, _______, ______, or _____" of PHI in an unpermitted manner that "compromises the security or privacy of the PHI," meaning that it poses a significant risk of financial, reputational, or other harm to the individual.

acquisition, access, use, or disclosure

Section 502(e) of the FDCA requires the listing of any _______ for both prescription and nonprescription drugs and the quantity of each.

active ingredient

A legislature may create an ______ to administer a body of substantive law when the legislature itself cannot perform these functions.

administrative agency

The FDA can remove a dietary supplement from the market on the basis of public safety only if the agency can prove the product is......

adulterated

The FDCA establishes two major offenses:

adulteration and misbranding

The Pure Food and Drug Act of 1906 prohibited the _______ and ______ of foods and drugs in interstate commerce.

adulteration, misbranding

In order for a live educational program for pharmacists to be considered independent and objective, and not subject to the advertising and labeling laws of the FDCA, the program should not: a. accept any funding from a drug manufacturer b. allow the drug manufacturer to influence the content c. provide free meals to pharmacist attendees d. include a speaker recommended by a drug manufacturer

allow the drug manufacturer to influence the content

MedWatch

allows healthcare professionals as well as patients to report any serious adverse events and other suspected medical product problems directly to the FDA.

Public goods

are those necessary and beneficial commodities that private entities will not supply because there is no incentive for a private entity to supply them. Orphan drugs are an example.

Opinions issued by a court are ________ on lower courts within the same jurisdiction and are persuasive in other jurisdictions.

binding

Pharmacists are responsible for ensuring that a substituted generic drug product is ______ to the prescribed product, which basically means that the products display comparable bioavailability (rate and extent of absorption) at the site of action under similar circumstances.

bioequivalent

The Drug Price Competition and Patent Term Restoration Act of 1984 (PTRA; Hatch-Waxman amendment) statutorily created the Abbreviated New Drug Application (ANDA). When considering an ANDA for a generic drug, the FDCA establishes a presumption that if the products are ________, then the generic drug is as safe and effective as the innovator drug.

bioequivalent

When the use of a drug may lead to death or serious injury, the FDA may require the warning of the special problem in the package insert to be placed within a prominently displayed box. This is known as a ________

black box warning

The label of a drug product not listed in the USP states that the drug is 0.25 mg. In actuality, the product strength is 0.50 mg. This product is: A. Adulterated B. Misbranded C. Both adulterated and misbranded D. Neither adulterated nor misbranded

both adulterated and misbranded

The Medical Device Amendments of 1976 (MDA) differentiates devices from drugs by stating that a device does not achieve any of its principal intended purposes through ________ and is not dependent on being _______ for the achievement of any of its principal intended purposes.

chemical action, metabolized

The Prescription Drug User Fee Act of 1992 (PDUFA) requires manufacturers seeking approval of a New Drug Application (NDA) to pay fees for applications and supplements when the FDA must review ________

clinical studies

The body of law developed from judicial opinions is called _______

common law

The issue of whether a pharmacist has a right to refuse to dispense prescriptions to which the pharmacist has moral or religious opposition has been labeled as one of.....

conscientious objection

The term "labeling" means all labels and other written, printed, or graphic matter upon any article or any of its _______ or accompanying such article.

containers or wrappers

Phase I trials

determine safety and adverse effects

Dispensing is a comprehensive activity that incorporates ________ as well as ______

drug therapy monitoring and patient education, drug distribution

The United States Pharmacopoeia of the United States (USP) establishes ______ standards and the Homeopathic Pharmacopoeia of the United States (HPUS) establishes _______ product standards.

drug, homeopathy

The Kefauver-Harris Amendment of 1962 required that drugs be proved not only safe, but also _______

effective

Externalities

exist when the production or consumption of a good affects someone who does not fully consent to the effect and when the costs of a good are not fully incorporated into the consumer price.

The Food and Drug Administration Modernization Act of 1997 (FDAMA) created a _______ approval process for drugs intended for serious or life-threatening diseases.

fast-track

Section 501(a)(1) of the FDCA provides that a drug or device is adulterated if it consists in whole or in part of any _____, putrid, or decomposed substance.

filthy

For new chemical entities approved under an NDA, the market exclusivity provision prevents a generic drug application from being submitted for ______ years from the date of approval of the drug.

five

The FDA is an administrative agency so it can make regulations. It can also follow a less formal avenue by publishing _________ to clarify laws or regulations, to explain how compliance with the laws or regulations may be achieved, and to outline review and enforcement approaches.

guidance documents

In an effort to protect the drug supply chain, the Prescription Drug Marketing Act of 1987 (PDMA) was enacted. One significant provision of the PDMA is that, with certain exceptions, the sale, purchase, or trade of prescription drugs that have been purchased by a _____, ______, or _______ is prohibited.

hospital, healthcare entity, or charitable organization

First segment of NDC

identifies the manufacturer

The FDCA differentiates the definition of label from that of labeling. The term "label" means a display of written, printed or graphic matter upon the ______ of any article.

immediate container

Although registration as an outsourcing facility is voluntary, there is incentive to do so. The registered outsourcing facility can legally compound drugs and ship them interstate without receiving prescriptions for _______ and without _______.

individual patients, quantity limitations

In all three IND clinical phases, the FDCA requires the investigators to secure the _______ of the patient or patient representative.

informed consent

A cosmetic may become a drug if its _______ fits under the drug definition.

intended use

Violations of the FDCA are of the strict liability nature, which means that commission of any of the listed offenses violates the FDCA, regardless of the person's __________

intentions or knowledge

If a practitioner prescribes a drug outside the scope of that practitioner's practice, the prescription would be......

invalid

The supreme law of the United States is the Constitution, and any federal or state statute or regulation that conflicts with the Constitution is ______

invalid

When an applicant seeks to prove the safety and effectiveness of a new drug, the FDA is allowed to exempt such drug from the NDA requirement for the pursuit of clinical investigations. To receive this exemption, the manufacturer must apply for a "Notice of Claimed Investigational Exemption for a New Drug," commonly called an ________

investigational new drug (IND)

Whereas adulteration deals with a drug's strength, purity, and quality, misbranding focuses on misrepresentations made by the manufacturer on the _______

label or labeling

Information asymmetry

leads to market failures when the consumer is uninformed about the true value of a good.

Statutory laws are laws that are made by _____

legislatures

A manufacturer of an industrial solvent promoted that when its product was applied to skin, it would cure eczema. It proclaimed on the label the product was a solvent, not a drug. The FDA investigated. The manufacturer's eczema claim would: a. not likely make the product a drug because this is a structure/function claim b. not likely make the product a drug because of the solvent proclamation on the label c. not likely make the product a drug if it has been commonly used for this purpose d. likely make the product a drug because this is a disease claim

likely make the product a drug because this is a disease claim

Purple Book

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

Biologics are products derived from ___________ and used for the prevention, treatment, or cure of a disease or condition of humans.

living organisms, and include viruses, therapeutic serums, toxins, antitoxins, vaccines, blood and blood components, and derivatives

Physician Payment Sunshine Act

mandate disclosure by drug and device manufacturers and group purchasing organizations of nontrivial payments to physicians and teaching hospitals.

The FDCA exempts pharmacies from FDA inspection authority when they do not _____, ______, or ______ _______ or ________ other than in the regular course of their retail business. However, in a 2005 federal case from the Third Circuit, the court held that the FDA has the authority to generally inspect pharmacies to determine if the exemption applies.

manufacture, prepare, or compound drugs or devices

In order to be exempt from registration as a manufacturer, one of the conditions set forth in section 503A of the FDCA states that a compounder must not distribute more than 5% of the total prescriptions dispensed or distributed by the pharmacy absent a _________ between the pharmacy's state and the FDA.

memorandum of understanding (MOU)

Natural monopolies

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

Third segment of NDC

package size

Section 501(a)(3) of the FDCA provides that a drug or device is adulterated if its container is composed, in whole or in part, of any _________ substance which may render the contents injurious to health.

poisonous or deleterious

A civil court case usually involves a dispute between persons or organizations. A civil case begins when a person or entity (the plaintiff) claims that another person or entity (the defendant) has failed to carry out a legal duty owed to the plaintiff. In a civil trial, the plaintiff must establish proof by a _________ of the evidence.

preponderance

State law (called State Practice Acts) defines a practitioner's scope of practice to diagnose and treat, which, in turn, determines the practitioner's scope of....

prescriptive authority

Among other things, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulates the ______ and _______ of health information and authorizes the Department of Health and Human Services (DHHS) to enact regulations to this effect.

privacy, security

Class III recalls

products that are not likely to cause adverse health consequences.

Lanham Trademark Act

prohibits the use of any false description or representation in connection with the sale of any goods or services, allows for a private cause of action and the recovery of monetary damages as well as injunctive relief

Orange Book

rates pharmaceutically equivalent drugs on the basis of therapeutic equivalence using a two-letter coding system, with the first letter either an A or B.

1. A criminal court case involves an action that is considered to be harmful to society as whole. A criminal case begins with an indictment or an arrest. In a criminal trial, the government must prove its case beyond a _________

reasonable doubt

Class I recalls

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

Generally, HIPAA requires an individual's written authorization to use PHI for marketing purposes. However, DHHS has expressly provided an exception for refill reminders and other communications about a drug or biologic currently being prescribed to the individual. This exception is known as the _________ exception.

refill reminder

Administrative agencies accomplish their legislative function through the promulgation of ________, which interpret and define statutes.

regulations

The Food, Drug, and Cosmetic Act of 1938 (FDCA) provided that no new drug could be marketed until proven _______ for use under the conditions described on the label and approved by the Food and Drug Administration (FDA).

safe

The Federal Trade Commission Act establishes a ________ standard for pharmacies that participate in false or deceptive advertising of OTC products, which means that mental state is not an element of violation.

strict liability

DSHEA exempts dietary supplements from part C of the drug definition by permitting ________ claims.

structure/function

Drug A is identical to Drug B, and each is made by a different manufacturer. Drug A is a prescription drug. Drug B is OTC. This is likely because the FDA: a. switched the active ingredient of the drugs to OTC by means of a monograph b. switched drug B from prescription to OTC by means of an SNDA c. switched Drug A from OTC to prescription by means of a monograph d. All of these are correct

switched drug B from prescription to OTC by means of an SNDA

Class II recalls

the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote.

The FDA evaluates OTC products on the basis of _______ rather than individually.

therapeutic category

The Drug Supply Chain Security Act of 2013 (DSCSA) applies to "trading partners" within the prescription drug supply chain. The DSCSA requires that by November, 2023 a full system electronic, interoperable product _____________ be implemented for prescription drugs for human use.

track and trace (pedigree) system

The term "drug" has a broad meaning under the FDCA. The term includes articles intended for use in the diagnosis, cure, mitigation, _______, or prevention of disease in man or other animals as well as articles (other than food) intended to affect the _______ or any ______ of the body of man or other animals.

treatment, structure, function

In the Second Circuit case of United States v Caronia, the court held that _____ and ______ statements regarding off-label use promotion for a lawful purpose are protected under the _____ Amendment.

truthful, non-misleading, first

A narrow therapeutic index (NTI) drug, also known as a narrow therapeutic ratio (NTR) drug, is defined as one where there is less than a _______ difference between the median lethal dose and the median effective dose, or where there is less than a _______ difference between the minimum toxic concentrations and the minimum effective concentrations in the blood.

two-fold, two-fold

A pharmacist may substitute a biosimilar to the prescribed biologic: a. whenever the exercise of professional judgement warrants b. when the biosimilar is "highly similar" to the prescribed biologic c. when the Purple Book designates the biosimilar with an "I" d. All of these are correct

when the Purple Book designates the biosimilar with an "I"