Drug Law Midterm

"Prescription" under the CSA would include which of the following? A. An order for a controlled drug dispensed to a patient at a community pharmacy. B. An order for a controlled drug dispensed in a hospital for immediate administration to a patient C. A controlled drug administered directly by a physician to a patient D. A certification for medical cannabis (marijuana)

A

The landmark case Gonzales v. Oregon (decided by the US Supreme Court) A. Established limits on the ability of the DEA, thru the Attorney General, to define "legitimate medical purpose" B. Established that FDA could not impose regulations, or its authority, over dietary supplement manufacturers C. Established that the FDA's unapproved "new drug" policy was inconsistent with the Drug Efficacy (Kefauver-Harris) amendments requiring proof of efficacy D. Established that restraint/prohibition of advertising by pharmacies violated First Amendment Free Speech rights

A

Which of the following would not be considered adulterated. A stock bottle of medication that contains a feather A bottle of medication containing filthy or putrid contents A bottle of medication that was stored for an extended period at temperature beyond what is recommended for that product A bottle of medication that was packaged in a clear container instead of the recommended light-resistant container

A stock bottle of medication that contains a feather

"Dispense" under the Controlled Substances Act includes which of the following: A. Administering a controlled substance (e.g., injection) B. Prescribing a controlled substance C. Dispensing from a community pharmacy D. Distribution by a wholesaler E. Production by a manufacturer

A, B, C

You discover that the physical inventory for diazepam 5mg tablets is five short of what you should have after subtracting records of dispensing from records of receipt. What factors are relevant to determine whether this is "significant". A. The volume of diazepam 5mg dispensed in your pharmacy B. Patterns associated with shortages of other controlled substances C. Strange behavior by co-workers D. Significance does not matter, you are required to report this

A, B, C

Central fill pharmacies ("CFP") filling prescriptions for controlled substances A. May also be community pharmacies in addition to their central fill functions B. May dispense "central fill" prescriptions directly to the patient C. Must have an operating agreement with the dispensing pharmacy D. CFP prescriptions must be filled by a licensed pharmacist

A, C, D

The "public interest" standard, as applied by the Department of Justice through the DEA A. Is the lens used for reviewing applications for registration (Form 224) B. Is the lens used for reviewing the DEA-222 form C. Would take into account the presence of a 'supporting' state license D. Would take into account the ability to participate in Medicaid and/or Medicare E. Would take into account any act that is inconsistent with the public interest

A, C, D, E

Medication assisted therapy (MAT) for opioid dependence with buprenorphine A. Maximum allowable dose of buprenorphine of 24 mg/day B. Buprenorphine/naloxone tablets be prescribed unless the patient requests plain buprenorphine C. Buprenorphine/naloxone tablets prescribed unless the patient is pregnant D. Prescription for buprenorphine may only be dispensed through an Opioid Treatment Program (OTP) E. Prescribers must have a waiver from SAMSHA and an "X" DEA number

A, C, E

To approve a therapeutically equivalent generic drug the manufacturer must submit New drug application Abbreviated new drug application Supplemental new drug application Investigational new drug application

Abbreviated new drug application Investigational new drug application

The investigational new drug exemption is an exemption from: Income taxes Clinical trials Pharmaceutical equivalence "New drug" liability

"New drug" liability

A patient approaches you to transfer a prescription for carisoprodol (Soma) from another community pharmacy (these are not in the same chain). A. This is permissible under federal law, but only one refill at a time B. This is permissible under federal law, but only once and all refills must be transferred C. This is not permissible under any circumstances D. This is permissible but only when there is a shared database

B

A pharmacist, Phillipe, fills a new written prescription and two refills for acetaminophen with codeine (Tylenol #3), a controlled substance. A couple months later, Phillipe learns from drug enforcement agents that the prescription was altered by the patient to receive refills that were never authorized by the prescriber. Could Phil be held responsible under the CSA by allowing the patient to receive the unauthorized refills? A. Yes, the RPh violated the Controlled Substances Act when filling the refills. B. Yes, but only if she/he knew or should have known that the refills were not authorized. C. No, there is no special duty to be alerted for altered prescriptions. D. No, pharmacists are exempt from violating the CSA in circumstances such as this.

B

The landmark case Gonzales v. Raich (decided by the US Supreme Court) A. Determined that it is unconstitutional for the federal government to impose its cannabis laws on state medical cannabis programs B. Determined that the Congress was acting within it power over interstate commerce to enact and enforce its cannabis laws under the Controlled Substances Act C. Determined that it is inconsistent with the statute (the Controlled Substances Act) for the federal government to impose its cannabis laws on state medical cannabis programs D. Determined that the federal government should take a 'hands-off' approach (prosecutorial discretion) in connection with state medical cannabis programs

B

According to the regulatory scheme created by Congress, outsourcing facilities A. Must meet standards of USP 797 (sterile products) and USP 795 (non-sterile) B. Must be properly registered with FDA and comply with other regulations to enjoy a "safe harbor" C. May dispense products to hospitals, medical clinics, and other purchasers without a prescription D. Are primarily established for sterile products, but may also produce non-sterile products E. Are permitted to dispense directly to patients under the "outsourcing facility" registration

B, C, D

In Virginia, outsourcing facilities i. Must maintain all required records for at least two (2) years ii. Are in business to compete with traditional pharmaceutical manufacturers iii. Must be registered/permitted with both FDA and VBoP, to do business here (whether located here or not) A. i only B. iii only C. i &iii only D. ii &iii only E. i, ii, &iii

C

The nurse practitioner phones you from the clinic next door to your pharmacy in Anywhere, USA requesting a 30-days supply of a hydrocodone 5mg/acetaminophen 325mg stating that "I have just seen the patient and she will be right over". The prescriber has access to electronic prescribing and the state's official prescription, but wants you to dispense without either of those. Which of the following are true. (Please do not add or ignore any facts) A. The law permits you to dispense this as an oral order B. The law permits a maximum 72-hour supply on this order C. You may not dispense this, it is not an emergency D. You may only dispense this if it is delivered by fax

C

With regard to controlled substance inventories A. A complete count is required with each inventory B. It is permissible to estimate the count in partial packages in all schedules C. It is permissible to estimate the count in partial packages on the condition that it is not CI or CII, and the initial package size is 1,000 units or less D. It is permissible to estimate the count in partial packages on the condition that it is not CI or CII, and the package size is greater than 1,000 units

C.

A new dietary supplement called "Williams Extract" (tincture of dandelion) places the following on the label: "For the treatment of Alzheimer's Disease". This claim: Is not subject to FDA approval Is a structure/function claim causing this product to be characterized as a "drug", giving FDA authority to regulate Causes this product to become a "new drug" and the manufacturer must prove safety and efficacy to the FDA Is a qualified health claim which does not require FDA approval Will cause FDA to characterize this product "adulterated"

Causes this product to become a "new drug" and the manufacturer must prove safety and efficacy to the FDA

Concerning Chapter 797 of USP, which of the following is true Covers all places where sterile products are prepared Relates to the preparation and modification of hazardous medication Requires environmental monitoring and personnel testing Establishes guidelines for assigning beyond use dates

Covers all places where sterile products are prepared Requires environmental monitoring and personnel testing Establishes guidelines for assigning beyond use dates

Chapter 800 of USP Creates a quality control process for sterile compounding Creates a quality control process for non-sterile compounding Creates a mandate for organization to assess risk for hazardous medication Creates a quality control process for outsourcing facilities

Creates a mandate for organization to assess risk for hazardous medication

The Drug Efficacy Study implementation ("DESI") A. Was required by the Food, Drug, and Cosmetic Act B. Concerned medication that had never been approved by FDA C. Is ongoing today D. Concerned medication approved by FDA between 1938 and 1962

D

Which of the following is/are C-IV (select all correct answers) Pregabalin Diazepam Tramadol Carisoprodol Butalbital with aspirin Butalbital with acetaminophen Phenobarbital

Diazepam Tramadol Carisoprodol Phenobarbital

The Drug Price Competition and Patent Term Restoration Act (also known as Waxman-Hatch)(Please choose each correct answer) Enacted the Abbreviated New Drug Application process Established a regulatory process for samples Established informed consent as a requirement to admitting patients into clinical trials Was the first attempt by Congress to regulate compounding Required therapeutic equivalence for admission of generic medication to the market

Enacted the Abbreviated New Drug Application process Required therapeutic equivalence for admission of generic medication to the market

"GRASE" (for generally recognized as safe and effective), is the standard for new drug approval. GRASE is determined by Pharmacists Physicians Pharmacologists Experts engaged by FDA

Experts engaged by FDA

A state seeks to place an anabolic steroid-like substance from bee pollen in its controlled substance Schedule II, but a federal law (the Dietary Supplement Health Education Act, "DSHEA") includes this as a dietary supplement which prohibits state regulation. Which jurisdiction's law is controlling? State law because it is more strict State law because the US Constitution elevates state law over conflicting federal laws Pharmacists are licensed by the state and do not need to comply with conflicting federal laws Federal law controls over conflicting state law

Federal law controls over conflicting state law

The policy of the federal government with regard to medical cannabis Was explicitly ruled unconstitutional in the case Gonzales v. Raich Continues to be "zero tolerance" with regard to state medical cannabis programs Has resulted in changing cannabis from Schedule I to Schedule II Has become more flexible in recent years with regard to state-regulated programs, even though it is still in Schedule I

Has become more flexible in recent years with regard to state-regulated programs, even though it is still in Schedule I

You have received a prescription for a controlled substance from Lucretia P. Driftwood, a (female) Nurse Practitioner. Her DEA number is MH7251376 I. The DEA number is invalid because the check digit does not match the 7th digit II. The DEA number is invalid because the second letter does not match the first letter of her last name III. The DEA number is invalid because the first letter is incorrect. I only III only I and III II and III I, II, and III

I

"Labeling" under the FDCA includes which of the following: I. The label; II. The package insert; III. Brochures available to patients in medical clinics and other public areas * I only I and II only II and III only I, II, and III only III only

I, II, and III only

The substitution process by pharmacists for biosimilars (select all that apply) Is created by state law Requires "therapeutic equivalence" Is created by federal law Generally, is based on FDA's rating of "interchangeable"

Is created by state law Generally, is based on FDA's rating of "interchangeable"

"Off-label" prescribing Is unlawful, the prescriber is guilty of prescribing misbranded medication Is unlawful, the pharmacist who dispenses is guilty of dispensing an adulterated product Is permissible to prescribe/dispense (the practice of medicine doctrine) May only be prescribed and dispensed when guided by a REMS

Is permissible to prescribe/dispense (the practice of medicine doctrine)

Concerning pseudoephedrine regulation: It may be sold only in pharmacies Sales are restricted to 3.6 grams/day and 9 grams/month by mail order It must be sold in "blister packs" or pouches in units of 2 The restrictions relate only to liquid forms of the medication

It must be sold in "blister packs" or pouches in units of 2

Which of the following is/are C-V (select each correct answer) Meprobamate Lacosamide Buprenorphine Epdiolex Tapentadol Camphorated tincture of opium Loperamide

Lacosamide Epdiolex

Consumer Medication Information (or "CMI") (leaflets that we dispense with prescriptions) Is regulated by the Internal Revenue Service Is regulated by the Department of Justice Is regulated by the Federal Trade Commission May be regulated by the Food and Drug Administration

May be regulated by the Food and Drug Administration

Elements to assure safe use ("ETASU") Are included in the 1984 Waxman Hatch amendments (also known as the Drug Price Competition and Patent Term Restoration Act) May incude a Medguide or Patient Package Insert May include prescribing restrictions May be part of a REMS May include a restricted distribution program

May include prescribing restrictions May be part of a REMS May include a restricted distribution program

Concerning "improved generics":(Please select each correct answer) May receive a period of market exclusivity These are generics marketed by the NDA holder Often include new dosage forms Are generic products that have the best inactive ingredients

May receive a period of market exclusivity Often include new dosage forms

Which of the following statements about requirements for Medication Guides for drugs with REMS is correct MedGuides are required when patient adherence to directions for use is crucial to proper usage MedGuides are required for all drug products with REMS MedGuides are not considered part of the FDA-approved labeling MedGuides are not required when drug products are used on an outpatient basis

MedGuides are required when patient adherence to directions for use is crucial to proper usage

Which of the following are Schedule II medications Meperidine Phenobarbital Butalbital with acetaminophen Cocaine ophthalmic drops Strattera Secobarbital injection Pentobarbital suppositories

Meperidine Cocaine ophthalmic drops Secobarbital injection

You receive a prescription at your community pharmacy for methadone and the patient informs you that it is to prevent immediate withdrawal from addiction to heroin. There are nother indications. Can you legally fill this prescription? Yes, methadone is approved for this purpose Yes, there are no legal restrictions regarding methadone No, methadone is a C-I controlled substance and is only permitted to be used in research No, methadone may be dispensed from the pharmacy for analgesic purposes, but not to prevent immediate withdrawal

No, methadone may be dispensed from the pharmacy for analgesic purposes, but not to prevent immediate withdrawal

Which of the following is the beyond use date for a non-sterile, non-aqueous compounded product Not later than 30 days, or the expiration date of any API Not later than 6 months, or the expiration date of any API Not later than 14 days when stored at controlled cold temperatures Thirty (30) hours at controlled room temperature, or 9-days in the refrigerator, or 45 days in the freezer

Not later than 6 months, or the expiration date of any API

Which of the following is both adulterated and misbranded? Medication dispensed in the absence of proper CRP (child-resistant packaging) A medication that is clearly decomposed, contaminated, or putrid Oral, solid medication dispensed without an identifying code on each tablet/capsule Prescription-requiring medication dispensed without "adequate directions for use"

Oral, solid medication dispensed without an identifying code on each tablet/capsule

The "corresponding responsibility" of pharmacists Relates to the requirement that an offer to counsel the patient is made Permits only prescriptions that are issued in the usual course of professional practice Requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose Requires pharmacists to fill controlled substance prescriptions precisely as written, without question

Permits only prescriptions that are issued in the usual course of professional practice Requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose

Which of the following is/are "mid-level" practitioners for DEA registration purposes Podiatrist Pharmacist Optometrist Nurse midwife Dentist

Pharmacist Optometrist Nurse midwife

According to the regulatory scheme created by Congress, the Drug Quality and Security Act (Select All That Apply) Requires outsourcing facilities to produce sterile products via the traditional prescription process, or based on historical volumes Prohibits resale (wholesale) of outsourcing facility products once delivered to the purchaser Requires outsourcing facilities to conduct sterile product production under current good manufacturing practices Requires pharmacies to conform sterile product production to current good manufacturing practices

Prohibits resale (wholesale) of outsourcing facility products once delivered to the purchaser Requires outsourcing facilities to conduct sterile product production under current good manufacturing practices

The two-dose regimen of levonorgestrel form of "emergency contraception" is currently available without prescription to Purchasers over 17 years of age, only in pharmacies Purchasers over 18 years of age, only in pharmacies Purchasers over 17 years of age, without 'point-of-sale' restrictions Any purchaser without regard to age, without 'point-of-sale' restrictions

Purchasers over 17 years of age, only in pharmacies

What is the standard of evidence required to prove safety and effectiveness for approval of a new drug application * Substantial evidence Clear and convincing evidence Beyond reasonable doubt Preponderance of the evidence

Substantial evidence

Which provision in the United States Constitution is the foundation for virtually all medication-related legislation by Congress The Supremacy clause The Interstate Commerce clause The Due Process clause in the 14th Amendment The Santa Clause The Free Exercise (of religion) clause

The Interstate Commerce clause

Which of the following is the primary concern of FDA in approving "biosimilars" (generic biological products) Adequate pricing of these products The low cost of conducting additional clinical trials The need for patient information protection The need to ensure safety and effectiveness

The need to ensure safety and effectiveness

A pharmacist fails to dispense prescription medication with required "child-resistant" packaging. Which one of the following is correct This may be characterized as a new drug This may be characterized as adulterated This may be characterized as misbranded This may be characterized as adulterated and/or misbranded

This may be characterized as misbranded

Which one of the following FDA programs are "compassionate use" providing patient access to medication outside of clinical trial (select all that apply) Treatment IND Parallel track Paper NDA Right to try law Prescription drug user fee

Treatment IND Parallel track Right to try law

Which of the following is/are official compendia of the United States United States Pharmacopeia DiPiro's Pharmacotherapy Homeopathic Pharmacopeia of the United States FDA's Therapeutic Equivalence Ratings (Orange Book) National Formulary

United States Pharmacopeia Homeopathic Pharmacopeia of the United States National Formulary

Patient package inserts ("PPIs") * Are no longer required because we have MedGuides When required are dispensed with every fill and refill Are required for progesterone Are required for anti-depressants

When required are dispensed with every fill and refill

Which of the following must register with DEA as a "distributor"? * Physician assistant Wholesalers Pharmacies exceeding 5% of total doses of controlled substances in non-prescription sales Community pharmacies Opioid treatment programs

Wholesalers Pharmacies exceeding 5% of total doses of controlled substances in non-prescription sales

You receive a telephone order for a 30-day supply of Oxycontin 80mg "1 tablet 2x daily" from the physician next door for a patient residing in a nursing home; a written prescription could be delivered by office staff, but it is not not convenient. You may fill this prescription as is You may fill not fill this without a written prescription, this is not an emergency You may fill this but only for a maximum 72-hour supply You may fill this as ordered, but an Authorization for Emergency Dispensing (follow-up) is required

You may fill not fill this without a written prescription, this is not an emergency

You receive a fax order for a 30-day supply of methadone 5mg "1 tablet 2x daily" for a patient enrolled in the hospice program. You may fill this but only if it is an emergency, and then only enough for the emergency period You may fill this but only for a 72-hour supply, and a follow-up prescription is required You may fill this; no follow-up prescription is required You may only fill this if it is delivered electronically

You may fill this; no follow-up prescription is required

Under the Food, Drug, and Cosmetic Act, the definition of "drug" includes: * a. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease b. Articles intended to affect the structure or any function of the body c. Products intended to supplement the diet d. Articles that act through mechanical rather than chemical action

a and b

You are the CEO of a pharmacy benefit manager (PBM) and believe that rosuvastatin (Crestor) should be available without a prescription (OTC). You should: a. File a citizen's petition b. File a supplemental new drug application c. File and abbreviated new drug application d. File a regulation

a.

A drug is stored under conditions that may reduce its quality or strength. Under the FDCA, this drug may be deemed to be adulterated misbranded insanitary a "new" drug

adulterated

A primary goal of Congress in connection with the REMS program is a. To prevent the use of drug products with known serious risks b. To avoid market withdrawal of drug products with known serious risks c. To promptly remove from the market drug products with previously undetected serious risks d. To delay marketing of products with known serious risks

b.

A new dietary supplement called "Williams Energy" (vitamins, amino acids, minerals and bee pollen extract) places the following on the label: "Treats depression by restoring purity of essence (PoE). This is not been approved by the FDA". This is an example of: * a. A reminder ad b. A structure/function claim c. A qualified health claim d. An unqualified health claim e. A brief summary

c.

Approval of an Investigational New Drug Application ("IND") a. Permits entry into Phase IV of clinical trails b. Permits marketing of the drug c. Permits clinical trials d. Is for approval of biosimilar products

c.

Before placing a new dietary supplement product on the market, the manufacturer must prove to FDA a. Only that the product is safe b. Only that the product is effective c. The product is both safe and effective d. Proof of safety and efficacy is not required

c.

"Therapeutic equivalence", as defined by FDA, requires all of the following except (that is, which one is not required): a. Product has an approved NDA or ANDA b. Same active ingredients c. Bioequivalent to the reference product d. Same dosage form e. Same inactive ingredients

e.

MedGuides are required for: i. NSAIDS ii. Anti-depressants iii. Oral contraceptives i only iii only i and ii ii and iii i, ii, and iii

i and ii

Pursuant to the FDA's Orange Book which of the following would be correct? i. FDA-approved drugs that are bioequivalent and pharmaceutically equivalent to the reference product are presumed to be therapeutically equivalent ii. Many state generic substitution laws prohibit pharmacists from substituting products not rated as bioequivalent iii. A-rated drugs are not bioequivalent i only iii only i and ii ii and iii i, ii, & iii

i and ii

Prescriptions may be filed as follows: i. Three separate files: CII's, CIII-V's, and non-controls ii. Two separate files: CII-V in one and CVI in another iii. Two separate files: one for CII, and another for CIII-VI (as long as CIII-V are readily retrievable) i only iii only i and iii ii and iii i, ii, and iii

i and iii

The Prescription Drug Marketing Act of 1987: i. Created a process for regulating samples ii. Created a process for regulating compounding iii. Created a process for regulating resales of medication by health care entities i only iii only i and iii only ii and iii only i, ii, and iii

i and iii

To prescribe controlled substances in, "individual practitioners" must be: i. Permitted by the law of their state ii. Registered with the Food and Drug Administration iii. Registered with the Drug Enforcement Administration i only iii only i and iii i and ii i, ii, and iii

i and iii

"Dispense" under the CSA includes which of the following: i. Administering a controlled substance (e.g., an injection) ii. Prescribing a controlled substance iii. Dispensing a controlled substance by a community pharmacy i only iii only i and iii ii and iii i, ii, and iii

i, ii, iii

Which of the following conditions must be met for a controlled substance prescription to be issued? i. the prescriber must be an "individual practitioner" ii. the prescriber must be authorized by state law to prescribe controlled substances iii. the prescriber must be registered with DEA, or qualify under an exception i only iii only i and iii only ii and iii only i, ii, and iii

i, ii, iii

Which of the following require a "user fee" to be reviewed by FDA I. ANDA II. NDA III. Biosimilars i only ii only i and iii ii and iii i, ii, and iii

i, ii, iii

To formally add a new clinical indication to a drug with an approved NDA (or ANDA) the proponent must i. File a New Drug Application (NDA) ii. File an Supplemental NDA iii. Complete additional clinical trials i only iii only i and iii ii and iii i, ii, and iii

ii and iii

Which of the following would be correct regarding records of receipt by a pharmacy for controlled substances i. Invoices are acceptable records for all schedules of drugs ii. DEA Form 222 or CSOS is required for Schedule II medication iii. An invoice is required for Schedules III-V i only iii only i and iii ii and iii i, ii, and iii

ii and iii

The "corresponding responsibility" rule i. relates to the requirement that patients are equally responsible for success in medication therapy ii. relates to the rule that counseling may not be delegated iii. requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose i only iii only i and ii ii and iii i, ii, and iii

iii

An "authorized" generic: i. Is approved under a "505(b)2" NDA ii. Must demonstrate therapeutic equivalence to the brand name product iii. Does not require an Abbreviated New Drug Application (ANDA) i only iii only i and iii ii and iii i, ii, and iii

iii only

With regard to federal food and drug law, which of the following is/are true? i. The Food, Drug, and Cosmetic act, passed in 1938, to regulate compounding by pharmacists ii. The "prescription drug amendment" (or Durham-Humphrey) was passed following the revelations associated with the teratogenic effects of thalidomide iii. The Prescription Drug Marketing Act outlawed the reimportation of drugs from other countries i only iii only i and iii ii and iii i, ii, and iii

iii only

If a Med Guide is not provided when required by law, the product may be characterized as Misbranded Adulterated A "new" drug Unsafe Both adulterated and misbranded

misbranded

If a non-prescription product is dispensed without adequate directions for use then the product is: Misbranded Adulterated A "new drug" A dietary supplement An "outsourced" product

misbranded

Concerning pseudoephedrine regulation: A. It may be sold only in pharmacies B. Sales are restricted to 3.6 grams/day and 9 grams/month by mail order C. It must be sold in "blister packs" or pouches in units of 2 D. The restrictions relate only to liquid forms of the medication E. Sales are restricted to 7.5 grams per month at community pharmacies

need to look up

The "track and trace" provisions in Title II of the Drug Quality and Security Act require transaction history from the manufacturer to the: Manufacturer Wholesaler Pharmacy Patient

pharmacy

The definition of "labeling" under the FDCA includes which of the following: (select all correct choices) the label the package insert advertising in the newspaper advertising on television

the label the package insert advertising in the newspaper