Pharmacy Law Exam 1 (Federal)

Who determines and regulates which drugs are considered over the counter and what drugs require a prescription?

The FDA

What did the sulfanilamide disaster cause the government to do?

The FDA was created by the government as a way to make more regulations and ensure more safety

The FDA originally only required what?

-The drug to be proven safe

-Directions for use

-Adequate warnings

What do Current Good Manufacturing Practices help explain?

The rules and regulations as to how to safely manufacture

What is a 503 (b) pharmacy?

A pharmacy that is allowed to compound in bulk

Who must comply with current good manufacturing practices? (There is 3)

-Manufacturers

-Distributors

-Outsourcing pharmacies

True or False: Retail pharmacies such as Rite Aid, CVS, Giant Eagle, etc. have to comply with CGMP?

False

Explain what it means if a drug was "grandfathered".

If a drug was "grandfathered", it means that it was around before the FDA was created, so instead of having to go through the long process, the drug approval process, they were exempt.

What did the Durham-Humphrey amendment do?

Created a distinction between prescription and OTC drugs.

What is a "legend drug"?

A legend drug is a drug that requires a prescription

What did the Kefauver-Harris amendment do?

Required that drugs must not only show that they are safe, but also effective; started what is now the process of clinical trials; defined Current Good Manufacturing Practices

What is the definition of a device?

An instrument, apparatus, implant, etc. that has no chemical action

What are examples of devices that would be in Class 1?

Needles, scissors, stethoscopes, toothbrushes

Devices such as insulin syringes, electronic heating pads, and thermometers would fall into which device class?

Class 2

Which device class requires that the device have pre-market approval due to the fact that they are life sustaining?

Class 3

What are examples of devices that fall into class 3?

Pacemaker, replacement heart valve

What did the Drug Price Competition and Patent Term Restoration Act of 1984 do?

-Extended the ANDA to generic manufacturers

-Extended patent life for brand drugs

What did the ANDA mean for generic manufacturers?

They did not need to go through clinical trials to prove safety and efficacy; They only had to prove bioequivalence and bioavailability, therefore shortening the time it takes to go to market

An extended patent allowed the brand drug manufacturers to do what?

Make the money back that they used to manufacture the drug. Since the brand only has exclusivity for 20 years, and it usually takes a good amount of time before the product actually hits the market, they are given a 5 year extension

True or False: A drug may not be on market for longer than 14 years

True

What is the life of the patent?

20 years from the date of the first filing of the patent application

What did the Prescription Drug Marketing Act of 1987 do?

Bans the sale of drug samples

If a pharmacy is charging for a drug that was given to them as a sample which act are they violating?

The Prescription Drug Marketing Act

What is an example of a pharmacy selling sample drugs?

Giant Eagle received a sample of Atenolol and then dumped it into their stock bottles and sold, and still charged their patients a copay

Which act encourages development of products used for rare diseases or conditions?

The Orphan Drug Act

What did the Drug Efficacy Study Implementation (DESI) do?

Tested the effectiveness of drugs that were approved from 1938-1962

Why did DESI specifically focus on drugs that were approved between 1938 and 1962?

The FDA originated in 1938; however, did not require that drugs be tested for effectiveness until 1962 when the Kefauver-Harris Act was implemented...So, the drugs approved in between 1938 and 1962 were not yet deemed effective

What are the two parts of the Drug Quality an Security Act?

-The Drug Supply Chain Security Act

-The Compounding Quality Act

What is the Compounding Quality Act?

It describes the conditions under which certain compounded human drug products are entitled to exemptions from the Food, Drug, and Cosmetic Act

Who is required to register with the FDA?

Manufacturers and distributors

True or False: A pharmacy wants to act as a manufacturer

False

What are the two types of compounders who do not need to register as manuacturers?

-503 A

-503 B

What is a 503 A pharmacy?

A traditional compounding pharmacy. This would be your everyday retail pharmacy

What is a 503 B pharmacy?

An outsourcing facility that compounds in bulk amounts

True or False: 503 A pharmacies compound in bulk

False

If a pharmacy is not acting as a manufacturer or a distributor, what three things are they exempt from?

-Complying with CGMP

-The FDA's labeling requirements

-FDA approval prior to marketing

If a 503 A pharmacy wants to avoid being construed as a manufacturer, what must they do?

-Compound ONLY after they have received a patient specific prescription

-Avoid compounding large quantities in advance

-Avoid compounding drugs that have been removed from the market due to safety issues

-Avoid selling compounded products to anyone other than the desired patient

-Avoid compounding for "office use"

-Avoid compounding commercially available drugs

-Have a proper patient-prescriber-pharmacist relationship

-Must comply with the USP standards

-A licensed practitioner must complete the compounding

What does it mean to compound for '"office use"?

Compounding without having an individualized and specific patient receiving the medication

True or False: a 503 B outsourcing pharmacy must comply with CGMP, as well as the FDA's labeling and approval requirments

False; they only have to comply with CGMP

What are some ways a 503 B differs from a 503 A?

-503 B has to comply with CGMP

-503 B do not require a prescription to compound

-503 B are able to compound for "office use"

True or False: a 503 B has to register with the FDA

False, they do not have to, but they can if they want to

How does the FD&C define a drug?

An article recognized in the USP, intended for use in diagnosis, cure mitigation, or prevention of a disease, intended to affect the structure of any function of the body

How does the FDA determine if it will regulate a product as a drug?

-They look at labeling for the products, websites, promotional pamphlets, and other marketing materials

-They look at the intent of the manufacturer or distributor

What exactly is a legend drug?

A drug that requires a prescription due to the toxicity or potential harmful effect is not safe for use unless it is under the supervision of a practitioner that is licensed by the lw to administer such drug

What is a bulk prescription container?

The container that is sent to the PHARMACY by the manufacturer. This does NOT go to the patient

What does a bulk prescription container need to contain?

-Name and address of the manufacturer, packer, or distributor

-The established name of the drug product

-Ingredient information

-If for use other than oral route, the names of all inactive ingredients and route of information

-The quantity in terms of weight or measure

-The net quantity of the container

-A statement of the recommended usual dosage

-"Rx only" or "Caution, federal la prohibits dispensing without a prescription"

-Identifying lot or control number

-Directions for the pharmacist regarding container usage

-The expiration date

-Adequate information use

What defines a new drug?

A drug that has not yet been determined to be both safe and effective for the intended use

What is an over-the-counter drug?

A drug that is both safe and effective for the general public

What characteristics does the FDA expect the OTC product to have?

-A label that allows the consumer to properly self-diagnose, treat, and manage the condition being treated

-It to be safe and effective without the use of a prescribing practitioner overseeing the use

-The benefits of the product should outweigh the risks of the product

-The drug should have a low risk for misuse and abuse

True or False: it is possible for a legend drug to become an OTC drug

True

True or False: A drug can be BOTH a legend and OTC product

True

What is required to be on the label of an OTC drug?

-Active ingredients

-Purpose

-Use, Indication

-Warnings

-Directions

-Other information

-Inactive ingredients

What must the label say if it may affect pregnancy and nursing?

"If pregnant or breast-feeding, ask a health professional before use"

What is special about labeling of sodium, calcium, magnesium, or potassium containing products?

They must contain the content per dosage unit if the single maximum recommended dose of the product is above a specific amount

What does it mean if a drug is adultered?

This means there is something wrong with the drug itself

If a drug has been prepared under unsanitary conditions, is this an example of misbranding or adulteration?

Adulteration

If the pharmacist fills for Atenolol 100 mg when the prescription was written for Atenolol 50 mg, is this an example of misbranding or adulteration?

Adulteration; there is something wrong with the product itself

What does it mean if a drug is misbranded?

There is something wrong with the packaging

If a drug has been sold, dispensed or distributed in violation of the labeling requirements of the FD&C, has the drug been misbranded or adultered?

Misbranded

If a drug is labeled with the incorrect expiration, has it been misbranded or adultered?

Misbranded

If the prescription was written for 200 tablets but the pharmacy fills for 100 tablets is this misbranding or adulteration?

Misbranding

What is an example of both misbranding and adulteration?

A prescription says to fill for atenolol 50 mg, the pharmacy fills for atenolol 100 mg, and then labels it 50 mg

What is a dietary supplement?

A product intended to supplement the diet, by increasing the dietary intake

Vitamins, Amino acids minerals, and herbs are examples of:

Dietary supplements

If a dietary supplement label contains one of the discussed permissible claims, what statement must the label also contain?

"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease

How soon must dietary supplement manufacturers notify the FDA prior to marketing?

75 days

What must the manufacturer of a dietary supplement include when they notify the FDA of their product prior to marketing?

The basis for concluding that the dietary supplement will reasonably be expected to be safe

How does the FDA define a cosmetic?

Articles intending for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or function

What does it mean if a cosmetic is a drug product?

It is intended to treat or prevent disease or alter a body function

A product that stimulates the person's natural defense system, helps heal illness, and rasies the general level of help is defined as:

A homeopathic drug product

True or False: there are only generics of legend drugs

False; generics exist at legend, OTC, and supplement levels

What is a single source product?

Drug products that are the only product approved by the FDA for that active ingredient, dosage form, route of admin. and strength. Only available from one manufacturer

What is a multi-source product?

Drug products that are manufactured by several manufacturers. Available from multiple manufacturers

What term refers to drug products with the same active ingredients, same dosage form, same route of admin, and identical strength or concentration

Pharmaceutical Equivalence

What term refers to products that are pharmaceutical equivalents and bioequivalent?

Therapeutical Equivalents

What criteria does the FDA use to determine if a drug product is a therapeutic equivalent?

-Approved for safety and effectiveness

-Pharmaceutical equivalent

-Bioequivalent

-Adequate labeling

-Manufactured in compliance with CGMP

What term refers to the rate that the active ingredient of the drug product is absorbed from the product and made available to the site of action?

Bioavailabilty

What term refers to drug products that are pharamceutically equivalent that provide the same results of drug delivery with the same pharmacokinetic properties?

Bioequivalent

When can generic manufacturers file an ANDA?

Upon expiration of the reference list drug (brand drug)

How is bioavailabilty of a generic measured?

It is compared to the brand drug. It must prove that it can provide the same results as the brand drug.

Which term refers to a drug product that contains the same therapeutic action but has is a different salt, ester, or different dosage forms or strengths?

Pharmaceutical Alternatives

What would you find in the orange book?

Approved drug products with therapeutic equivalence evaluations

If a multi-source product has a Code A, what does this indicate?

It is considered to be therapeutically equivalent to other pharmaceutically equivalent products.

What does a code AA indicate?

Products that do NOT present bioequivalnt problems

What does a code AB indicate?

These product DO have potential bioequivalence problems that have been resolved with vivo or in vitro evidence to support bioequivalence

If a multi-source product has a Code B, what does this indicate?

This means the products are not therapeautically equivalent, and can therefore not be substituted

When is not acceptable to substitute AA and AB drug products?

When it is a narrow therapeutic index drug (NTI)

True or False: if a drug is code B it can be substituted

False; code B drug products are not substitutable without contacting prescriber first

What must be considered when substituting products?

-There must be approval from the prescriber

-There must be approval from the patient

-It can not be a NTI

True or False: if the prescriber does not indicate that brand must be used, the pharmacist is allowed to assume that the patient and provider both approve of substitution

True

If substituting products, it is good practice to do what?

Notify and counsel the patient that you have switched their medication to the generic form

True or False: the prescriber does NOT need to be contacted if the patient is being switched from one generic manufacturer to another (Teva to Lannet)

False; the prescriber should be contacted in this case

What exactly is a NTI?

A drug that has an effective dose that is very close to the lethal dose

True or False: there needs to be actual approval (speaking) from the doctor when dealing with NTIs

True

What is a biological product?

Vaccines, various toxoids, skin test substances, blood and blood products for transfusion

What term refers to a unique biological drug from living organisms using recombinant teachnology that is highly similar to the reference product?

Biosimilar

How does a verterinary product gain approval?

A New Animal Drug Application (NADA)

If a veterinary product is used in a food producing animal what must happen?

It needs to be free of unsafe residues due to the fact that humans will be consuming it also

True or false: oral and topical flea control products for animals are regulated the same way

False; oral products are regulated by the FDA and topical products are regulated by the EPA

What is the first step in the drug approval process?

An Investigational New Drug is submitted for approval