Law Exam 1 - Review

What does the 1st series of numbers in the NDC identify?

Manufacturer

Describe the three classes of drug recalls

- Class I: recalls are issued when there is a reasonable probability that the product will cause serious, adverse health consequences or death - Class II: recalls occur when the product may cause temporary or medically reversible health consequences, but the probability of serious adverse consequences is remot - Class III: recalls apply to products that are not likely to cause adverse health consequences

Provide an example of a pharmacy situation that addresses the following; criminal act, civil act and administrative act?

- Criminal act: diverting of a controlled substance. And you can go to jail for that. Ibuprofen 800mg is a schedule 6 in MA so you need to have a Rx for it. By taking ibuprofen 800mg could be diverting of a control substance. In federal it is schedule 1-5 and in MA it is schedule 1-6. it is beyond reason with doubts - Civil act: negligence- someone is hurt by taking the wrong med a pharmacist dispensed. Preponderance of the evidence - Administrative action: loss of license, suspension of license. E.g. going in front of the board of pharmacy.

Poison Prevention Packaging Act of 1970

- Requires use of child-resistant containers for prescription and nonprescription drugs-To guide healthcare professionals on which drugs come in easy off caps: -On page 10 there's a list of drugs that are exempt from having the child resistant cap so our number 1 drug that always has the easy off cap is the SUBLINGUAL dosage form of nitroglycerin (not the caps or patches) -You also have sublingual and chewable forms of isosorbide dinitrate of dosage form of 10mg or less -The erythromycin ethyl succinate often found in the fridge of the pharmacy also has easy off cap on it not the child resistant cap -Anhydrous cholestyramine powder is the generic for questran and it doesn't come in the child resistant cap bc it looks like sand and most probably as child will not ingest it -You also have potassium supplements in unit dose forms including individually wrapped effervescent tabs -You have sodium fluoride drug preparations including liquid and tab form containing no more than 264 mg of sodium fluoride package -Betamethasone tabs, your methylprednisone tabs, your pancrelipase preparations, you have your prednisone tabs no more than 105mg of drug

Provide 2 examples of relating to pharmacy of an adulterated drug

- Tablet falls on the floor and pharmacist returns the table to the stock bottle after it was covered in dirt - Prepared, packed or held in conditions where it may have been contaminated; exposed to a container that may have contaminated it, manufactured under conditions that do not confirm the current CGMP

How many classes of drug recalls are there? Which class is most serous?

- Three levels - Class one is the most serious

Provide 2 examples of a combination product

1. EpiPen 2. Drug Eluding Stent

Provide 2 examples of a REMS that you have seen in the pharmacy

1. Medication Guides 2. iPledge

List 4 types of market failures

1. Natural monopolies 2. Public goods 3. Externalities 4. Information asymmetry

Which of the following amendments to the Federal Food, Drug and Cosmetic Act required that a drug be effective as well as safe before it could be marketed in the U.S.A.? A. Kafauver-Harris B. Durham-Humphrey C. Clinton-Gore D. Prescription Drug User Fee Act

A. Kafauver-Harris

List that are exempt from child resistant caps

1. Sublingual dosage forms of nitroglycerin 2. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 milligrams or less 3. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8 grams or the equivalent of erythromycin. 4. Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin. 5. Anhydrous cholestyramine in powder form. 6. Potassium supplements in unit dose forms, including individually wrapped effervescent tablets, unit dose vials of liquid potassium, and powdered potassium in unit dose packets, containing not more than 50 milliequivalents per unit dose 7. Sodium fluthan 264 milligrams of sodium fluoride per package 8. Betamethasone tablets packaged in manufacturers' dispenser packages containing no more than 12.6 milligrams betamethasone. 9. Mebendazole in tablet form in packages containing not more than 600 milligrams of the drug. 10. Methylprednisolone in tablet form in packages containing not more than 84 milligrams of the drug. 11. Colestipol in powder form in packages containing not more than 5 grams of the drug. 12. Pancrelipase preparations in tablet, capsule, or powder form. 13. Cyclically administered oral contraceptives in mnemonic (memory-aid) dispenser packages which rely solely upon the activity of one or more progestogen or estrogen substances. 14. Prednisone in tablet form when dispensed in packages containing no more than 105 milligrams of the drug. 15. Conjugated estrogen tablets when dispensed in mnemonic dispenser packages containing not more than 32.0 milligrams of the drug. 16. Norethindrone acetate tablets in mnemonic dispenser packages containing not more than 50 milligrams of the drug. 17. Medroxyprogesterone acetate tablets 18. Sacrosidase (sucrase) preparations in a solution of glycerol and water. 19. Hormone Replacement Therapy products that rely solely upon the activity of one or more progestogen or estrogen substances.oride drug preparations, including liquid and tablet forms, containing no more

Which one of the following alphabet letters used in the "Orange Book" indicates that drug products are considered to be therapeutically equivalent to the reference drug product? A B C D

A

Which of the following provides tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for rare conditions. A. Orphan Drug Act B. Kefauver-Harris Amendment C. Prescription Drug Marketing Act D. Food and Drug Administration Modernization Act E. Durham Humphrey Amendment

A. Orphan Drug Act

The National Drug Code (NDC) Number means a nationally recognized standard which identifies drug products using a unique number issued by the United States Food and Drug Administration. The NDC number has three components the first component identifies the _____. A. Drug Manufacturer B. Product C. Package Size D. Date of Drug Approval

A. Drug Manufacturer

This Amendment to the Food, Drug, and Cosmetic Act clarifies and strengthens FDA oversight over pharmacies engaged in large scale compounding and shipping of sterile products to other licensed entities A. Drug Quality and Security Act of 2013 B. Food and Drug Administration Amendments Act of 2007 C. Patient Protection and Affordable Care Act of 2010 D. FDA Safety and Innovation Act of 2012 E. Food and Drug Administration Modernization Act of 1997

A. Drug Quality and Security Act of 2013

Which of the following was responsible for establishing two classes of drugs - prescription and over-the-counter? A. Durham-Humphrey Amendment B. Kefauver-Harris Amendment C. Prescription Drug Marketing Act D. Food and Drug Administration Modernization Act

A. Durham-Humphrey Amendment

The DEA falls under which branch of the federal government? A. Executive B. Legislative C. Judicial D. None of the above

A. Executive

Drug product Z is new to the market, and is required by the manufacturer to be stored in the refrigerator. Pharmacist Phil is unaware of this, and stores the product on the shelf at room temperature. A couple weeks after receiving the product, Phil dispenses it to a patient. Which of the following statements would be most accurate? A. Phil could be found to have violated the Food Drug and Cosmetic Act, the product has been adulterated. B. Since Phil did not intend to improperly store the drug product, he can not be found to have violated the Food Drug and Cosmetic Act. C. Since Phil is not a manufacturer, Phil can not be found to have violated the Food Drug and Cosmetic Act. D. The Food Drug and Cosmetic Act would not apply to this situation. E. None of the above are correct.

A. Phil could be found to have violated the Food Drug and Cosmetic Act, the product has been adulterated.

Which amendment to the FDCA clarified and strengthened the FDA's authority over large-scale sterile compounding pharmacies and shipping of sterile products to other licensed entities? A. The Drug Quality and Security Act B. Kefauver-Harris Amendment C. Food and Drug Administration Modernization Act D. Food and Drug Administration Amendments Act

A. The Drug Quality and Security Act

Which of the following is not required to be included on the label of a dispensed drug under the FDCA? A. The lot number of the drug B. The name and address of the dispenser C. The prescription serial number D. The prescriber name

A. The lot number of the drug

Which statement about the "beyond use date" on the label of a dispensed multiple-unit drug container by a pharmacy is correct? A. USP guidelines allow the earlier of the manufacturer's expiration date, or one year from the date of dispensing. B. FDA guidelines allow the earlier of the manufacturer's expiration date, or two years from the date of dispensing. C. All state laws mandate that the pharmacist must type the same date that is on the manufacturer's label. D. None of the above are correct.

A. USP guidelines allow the earlier of the manufacturer's expiration date, or one year from the date of dispensing

Pharmacist Phil receives a prescription for Mrs. Smith for Drug X. Drug X is approved by the FDA to GERD. However, recent peer reviewed journal articles have indicated that Drug X may also be helpful in treating certain types of skin disorders. Mrs. Smith informs Phil that she was prescribed Drug X for her skin disorder. The dose of Drug X for the skin disorder is the same as for GERD. Could Phil fill the prescription for Mrs. Smith? A. Yes. The off-label indication for Drug X does not appear to create an unreasonable risk for Mrs. Smith. B. Yes. Phil has an obligation to the fill all legal prescriptions, regardless of the indication and level of risk to the patient. C. No. It is illegal for drugs to be prescribed and dispensed for off-label uses. D. No. Phil has an obligation to Mrs. Smith not fill any prescription that may cause any potential risk to Mrs. Smith.

A. Yes. The off-label indication for Drug X does not appear to create an unreasonable risk for Mrs. Smith.

A pharmacist counts tablets on a dirty counting tray, or tray where the residue of the previous drug counted remains on the tray. This is an example of: A. Misbranding B. Adulteration C. Product Tampering D. A and B

B. Adulteration

The legislative powers of the federal government shall be vested in: A. Administrative agencies B. Congress C. Judges D. The President of the United States

B. Congress

In part, antibiotics are regulated as prescription-only products because their indiscriminate use could lead to increased resistance in the population. This reason to regulate antibiotics can best be described under the market failure of: A. Public goods B. Externalities C. Natural monoplies D. Information asymmetry E. None of the above

B. Externalities

This Amendment to the Food, Drug and Cosmetic Act strengthen the new drug approval process requiring drugs to prove not only safe but also effective A. Durham-Humphrey B. Kefauver-Harris Amendment C. Prescription Drug Marketing D. Orphan Drug Act E. Food and Drug Administration Amendments Act of 2007

B. Kefauver-Harris Amendment

A pharmacist in State A receives a prescription for Drug X. Under federal law, Drug X is allowed to have refills. However, a law in State A prohibits any refills for Drug X. If a prescriber were to authorize 3 refills on the prescription, should the pharmacist allow the patient to receive the refills? A. Yes, federal law controls over stricter state laws B. No, stricter state laws not conflicting with federal laws must be followed

B. No, stricter state laws not conflicting with federal laws must be followed

A new health food company plans to sell oat tablets. The company would like to promote and advertise that the product decreases cholesterol levels (cures a disease). Which of the following would be the most accurate regarding this statement: A. The statement about the product would likely not cause concern with the FDA B. The FDA may classify this as a drug C. The FDA may classify this as a supplement D. None of the above are correct

B. The FDA may classify this as a drug

An example of a narrow therapeutic drug is/are: A. Metformin B. Warfarin C. Ibuprofen D. Codeine

B. Warfarin

The label of a prescription drug has the following expiration date 03/2018. What is the actual date of expiration for this prescription drug? A. March 1, 2018 B. March 15, 2018 C. March 31, 2018 D. None of the Above

C. March 31, 2018

The ___________ prohibit(s) pharmacies from storing, dispensing, or purchasing prescription drug samples and requires state board of pharmacy to license drug wholesalers. A. Poison Prevention Packaging Act B. Price Competition and Patent Restoration Act C. Prescription Drug Marketing Act D. Kefauver-Harris Amendment E. Orphan Drug Act

C. Prescription Drug Marketing Act

A situation in which there is a reasonable possibility that the product will cause serious, adverse health consequences or death. To which class of drug recall does this statement apply? Class I Class II Class III Class IV

Class I

The amendment requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics. Under this amendment the FDA can approve a color for one use but not for others (e.g. external use only).

Color Additive Amendments

Regarding manufacturer expiration dates on the label of a prescription drug. If the label has an expiration date of 6/20 when does the product expire? A. 6/1/20 B. 5/15/20 C. 6/20/20 D. 6/30/20 E. None of the above

D. 6/30/20

The FDA's attitude about the practice of the prescribing of approved drugs for off-label indications is that it: A. Regards the practice as illegal. B. Frowns on the practice but tolerates it. C. Encourages the practice. D. Accepts that the practice is appropriate and rational. E. None of the above

D. Accepts that the practice is appropriate and rational.

Pharmacist Phil has been refilling prescriptions for patients without getting proper authorization from the prescriber for controlled substances. One of the patients who was receiving the unauthorized refills was harmed by the drug. Which of the following could Phil be subjected to regarding his actions? A. A civil suit from the harmed patient B. An administrative action from the state board of pharmacy C. A criminal proceeding from a law enforcement authority D. All of the above

D. All of the above

A drug such as Accutane or Thalidomide, contains a contraindication section which states that the drug "May cause fetal harm when administered to a pregnant woman." To which Pregnancy Warning category might this statement apply? A. Category A B. Category B C. Category D D. Category X

D. Category X

Which of the following was enacted to streamline the generic approval process while giving patent extensions, in certain circumstances, to innovator drug companies? A. Durham-Humphrey Amendment B. Kefauver-Harris Amendment C. Prescription Drug Marketing Act D. Drug Price Competition and Patent Term Restoration Act E. The Generic Drug Enforcement Act

D. Drug Price Competition and Patent Term Restoration Act

Which of the following is considered the "daily newspaper" of US federal agencies? A. The Boston Globe B. Code of Federal Regulations C. Government Manual D. Federal Register

D. Federal Register

Which Amendment to the Food, Drug and Cosmetic Act was a result of a scandal that occurred when some FDA staff accepted bribes from the generic drug industry personnel in order to facilitate the approval process of certain generic drug products? A. Kefauver-Harris Amendment B. Prescription Drug Marketing Act C. Durham Humphrey Amendment D. The Generic Drug Enforcement Act

D. The Generic Drug Enforcement Act

While picking up a new prescription from Friendly Pharmacy, Mrs. Nelson requests to receive the package insert. Can the pharmacy provide this information to the patient? A. No. The Food Drug and Cosmetic Act only allows health care practitioners to view this information B. No. Only prescribers are allowed to provide the package insert to the patient; pharmacies are prohibited from doing so. C. Yes. Pharmacies are mandated to provide the package insert with each new prescription D. Yes. Pharmacies are not prohibited from providing the package insert to patients

D. Yes. Pharmacies are not prohibited from providing the package insert to patients

What is the federal register?

Daily publication where federal agencies post proposed regulation for notice and comment. It is a daily newspaper

This act defines dietary supplements and permits manufacturers to make certain claims that otherwise would be illegal under the FDCA. Under this Act FDA regulates dietary supplements more as foods than as drugs.

Dietary Supplement Heath and Education Act

What does the second series of numbers in the NDC identify?

Drug

What does DEA stand for?

Drug Enforcement Administration

Also called the Waxman-Hatch Amendment, that act was enacted to streamline the generic drug approval process while giving patent extensions, in certain cases, to innovator drugs.

Drug Price Competition 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.

Drug Quality and Security Act

This amendment established two classes of drugs-prescription and OTC- and 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". This amendment also authorizes oral prescriptions and refill of prescription drugs.

Durham - Humphrey Amendment

An example of an administrative agency affecting pharmacy practice is A. The centers for Medicare and Medicaid services B. The food and drug administration C. Congress: legislative D. Supreme court: falls under judicial E. A and B

E. A and B

Pursuant to the Food, Drug and Cosmetic Act, for which of the following reasons is a drug considered adulterated? A. Contains any filthy or putrid substance B. Is stored under unsanitary conditions C. Does not meet compendia standards D. Methods used in the manufacture do not conform to Good Manufacturing Practices E. All of the Above are correct

E. All of the Above are correct

A drug may be considered a "new drug" if changes occur in which of the following? A. Dosage form B. Indication for use C. Duration of action D. Route of administration E. All of the above

E. All of the above

True or False: The FDA spent over 10 years analyzing the effectiveness of prescription drugs marketed between 1938 and 1962 on a case-by-case basis under the Drug Efficacy Study Implementation (DESI) review. The FDA took the same approach with OTC drugs

False

True or False: The only way for a drug to be switched from prescription to OTC status is by the manufacturer petitioning the FDA for the switch.

False

True or False: There are five classes of drug recalls.

False

What branch of government does the DEA fall under?

Executive.

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

FDA Reauthorization 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.

FDA Safety and Innovation Act

True or False: If a patient requests the pharmacist to authorize conventional, easy to open packaging, the pharmacy must have the patient sign a waiver, oral authorization is not permitted under the Poison Prevention Packaging Act.

False

True or False: Nitroglycerin oral capsules are exempt from the safety closure packaging when dispensed by the pharmacist.

False

True or False: The Delaney Clause transferred jurisdiction of prescription drug advertising from the Federal Trade Commission to the FDA.

False

Provide an example of relating to pharmacy of a misbranded drug

Focus on representations made by manufacturer on the label or labeling. Wrong NDC number - not calling MD for refills and pharmacist refills

What if there is a conflict between the state and federal law?

Follow the stricter of the law

This amendment requires that components added to food products receive premarket approval for safety. Also contain in this law is the anticancer provision (Delaney Clause) which prohibits the approval of any food additive that might cause cancer.

Food Additives Amendment

The abbreviation "FDA" refers to:

Food and Drug Administration

What does the abbreviation FDA stand for?

Food and Drug Administration

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.

Food and Drug Administration Modernization 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 drug and administration amendment act (FDAAA)

This law along with amendments forms the nucleus of todays' law. It provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA. This law also expanded the definitions of misbranding and adulteration, requiring that labels must contain adequate direction for use and warning about the habit-forming properties of certain drugs.

Food drug and cosmetic 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.

Generic Drug Enforcement Act

Under the current Food, Drug, and Cosmetic Act, the definition of "drug" includes: I. Articles intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of a disease II. Articles (other than food) intended to affect the structure or any function of the body III. Products intended to supplement the diet ** I only I and II only II and III only I, II and III

I and II only

Which of the following statements regarding Patient Package Inserts is/are correct? I. They include information for the patient regarding the drugs' uses, risks, and precautions II. They are required to be provided to the patient for all prescription drugs dispensed III. They are intended to substitute oral counseling from the pharmacist I only I and II only II and III only I, II and III

I only

A drug is misbranded under the Food Drug and Cosmetic Act, if: I. It is missing the quantity of the container contents II. It is missing the name or location of the manufacturer, packer or distributor III. It does not include the established name of the active ingredient I only III only I and II only II and III only I, II and III

I, II and III

Under the FDCA, the definition of "labeling" includes which of the following? I. The label II. The package insert III. Graphic material upon a container I only I and II only II and III only I, II and III

I, II and III

Which of the following statements regarding Medication Guides is/are correct? I. They are intended to substitute oral counseling from the pharmacist II. They are required for all prescription drug products III. They are required by regulation to be given to patients by the dispenser of the drug product **I only III only I and II only II and III only I, II and III

III only

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

Nutrition Labeling and Education Act

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.

Kefauver - Harris Amendment

This amendment requires classification of devices according to their function, premarket approval, establishes performance standards, conformance of GMP requirement and adherence to record and reporting requirements of medical devices.

Medical Device Amendment

This act 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. This also must be renewed by Congress every 5 years.

Medical Device User Fee and Modernization 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.)

Orphan Drug Act

What does the 3rd series of numbers in the NDC identify?

Package size

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.

Prescription Drug Marketing 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.

Prescription Drug User Fee Act

This law prohibited the adulteration and misbranding of foods and drugs in interstate commerce. The law fell short of short of providing that protection that Congress intended, because of a US Supreme Court decision held that the misbranding provision in the law did not prevent false of misleading efficacy claims.

Pure Food and drug act

This act further strengthened the Medical Device Amendment giving the FDA additional authority especially related to post marketing requirements and premarket notification and approval, while expediting the premarket device approval process.

Safe Medical Devices Act

True or False: The Federal Anti-Tampering Act came about as a result of several instances of over the counter (OTC) Tylenol products being intentionally contaminated with a poison

True

This Act was passed in large part to 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. This law also provides for billions of dollars of additional funding to the National Institute of Health (NIH).

The 21st Century Cures Act

True or False: The Food and Drug Administration Modernization Act of 1997 (FDAMA) created a 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.

True

True or False: A pharmacist is responsible for knowing which drug products have been recalled.

True

True or False: An "authorized generic" drug product is a generic copy of the innovator drug product marketed by the innovator manufacturer.

True

True or False: Any time a drug is prescribed for a condition not listed in its official labelling, that use is considered off-label, unlabeled or unproved

True

True or False: Every state has enacted generic drug substitution laws, expanding the scope of pharmacy practice to allow pharmacists to substitute a generically equivalent drug for the prescribed drug, subject to certain requirements and restrictions

True

True or False: If a pharmacy has tax free alcohol on its premises, it must be stored in a securely locked storeroom with the labels and markings on the container intact.

True

True or False: Kefauver-Harris Amendment added more extensive controls for clinical investigations such as informed consent and reporting of adverse drug reactions.

True

True or False: MedGuidelines must be written in nontechnological language and in uniform format, containing the approved uses for the product, circumstances when the product should not be used, serious adverse reactions, proper use, cautions and other general information

True

True or False: Only the patient has the authority to issue a blanket waiver of the child protection requirement under the Poison Prevention Packaging Act.

True

True or False: The Durham-Humphrey Amendment legalized the verbal transmission (oral prescriptions) of prescriptions

True

True or False: The FDA requires that a Medication Guide be issued with prescription strength Motrin (Ibuprofen).

True

True or False: The Prescription Drug User Fee Act requires drug manufacturers to pay fees for applications and supplements when the FDA must review clinical studies. In addition, the fees provide the FDA with resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA reviews.

True

True or False: 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, also known as a black box warning.

True

True or false: Public goods in the drug industry include orphan drugs and vaccines

True