MPJE 2022 Chapter 1

If the container is made, formed or filled to be misleading: A. The drug is adulterated B. The drug is misbranded

B. The drug is misbranded

If the drug is an exact imitation of another drug or offered for sale under the name of another drug: A. The drug is adulterated B. The drug is misbranded

B. The drug is misbranded

What ammendment established Good Manufacturing Practices (GMP)? A. Durham-Humphrey B. Food, Drug and Cosmetic Act C. Kefauver-Harris D. Prescription Drug Marketing

C. Kefauver-Harris

What are 503B facilites?

Outsourcing facilities

What is meant by a "dispensing pharmacy"?

Providing a drug to the patient/consumer

Per the DCQA, when do outsourcing facilities have to report serious adverse events?

Report serious adverse events within 15 days

What is required by the FDCA to be on the labeling of Isoproterenol inhalation preparations?

Requires warning not to exceed dose prescribed and to contact physician if difficulty in breathing persists

What is required by the FDCA to be on the labeling of OTC pain reliever: Acetaminophen?

1. Must have acetaminophen prominently displayed 2. Must warn about liver toxicity 3. Must warn not to use with other products containing acetaminophen an to talk to a doctor or pharmacist before taking with warfarin

What is required by the FDCA to be on the labeling of OTC pain reliever: NSAIDs?

1. Must include term "NSAID" prominently on label 2. Must contain "stomach bleeding" warning

What is required by the FDCA to be on the labeling of OTC products containing Iron in solid dosage form?

1. Must provide following "Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately 2. This warning requiremet also applies to dietary supplements containing iron 3. FDA previously had a rule that required unit-dose packaging for iron-containing dietary supplements

What are the exceptions that allow an outsourcing facility to compound a product that includes a bulk drug substance?

1. The bulk drug substance appears on a list of bulk drugs where there is a clinical need 2. The bulk drug is on the FDA's drug shortage list at the time of compounding, distribution and dispensing

What are the exceptions to a distributing pharmacy obtaining a wholesale distributio license?

1. When distribution is between two entities under the same company 2. When a dispenser is providing to another dispenser on a patient specific basis 3. When a dispenser is distributing under emergency medical reasons 4. When a dispenser is distributing "minimal quantities" to a licensed practitioner for office use

When was the FDCA enacted and why?

1938 following the deaths caused by Sulanilamide exlixir in 1937

When was the Durham-Humphrey Amendment passed and what did it establish?

1951 Established 2 classes of drugs: Prescription and OTC Authorized verbal prescriptions and prescription refills

When was the Kefauver-Harris Amendment passed and why was it needed?

1962 Prior to this amendment, new drugs only had to be safe. With this amendment new drugs are required to be safe AND effective

When was the Prescription Drug Marketing Act passed and what did it establish?

1987 Bans the re-importation of prescription drugs and insulin products produced in the US (except by the manufacturer) Bans the sale, trade, or purchase of prescription drug samples Mandates the storage, handling, and recordkeeping requirements for prescription drug samples Prohibits the resale of prescription drugs purchased by hospitals or healthcare facilities

When was the Drug Quality and Security Act (DQSA) passed and what did it enact?

2013 Two primary topics: large scale compounding by pharmacies and establishment of a framework for a uniform track-and-trace system for prescription drugs throughout the supply chain to prevent counterfit drugs

Per the DCQA what is required on all products made by an outsourcing facility?

A label with a statement identifying them as a compounded drug along with additional specific information

In states that have not entered into a MOU, what is the percent they are not allowed to exceed of a compounded drug? A. 5% B. 6% C. 7% D. 10%

A. 5% They are not allowed to exceed 5% of the total prescription orders dispensed or distributed

If the pharmacist placed a beyond use date that is after the medication's expiration date of the drug, that would be considered: A. Misbranded B. Adulterated

A. Misbranded

If a drug is subject to a REMS and it is prescribed or dispensed without meeting the requirements of the REMS, is it: A. Misbranded B. Adulterated

A. Misbranded The REMS program is part of the official labeling of the drug

If a pharmacist fails to dispense a medication in a child-resistant container when required, this would be: A. Misbranding B. Adulteration

A. Misbranding

Misfilling a prescription with the wrong drug, strength, or directions for use, will ALWAYS be: A. Misbranding B. Adulteration

A. Misbranding

The advertising or promotion of a compounded drug that is false or misleading would be considered: A. Misbranding B. Adulterated

A. Misbranding

4. It has been manufactured, processed, packaged or held in any establishment that refuses to permit entry or inspection A. The drug is adulterated B. The drug is misbranded

A. The drug is adulterated

If a drug has been prepared or held under insanitary conditions where it may have been contaIt has been prepared or held under insanitary conditions where it may have been contaminated: A. The drug is adulterated B. The drug is misbranded

A. The drug is adulterated

If a drug product contains any filthy, putrid, or decomposed substance the drug is considered: A. The drug is adulterated B. The drug is misbranded

A. The drug is adulterated

If the container is composed of any poisonous or deleterious substance which may contaminat the drug: A. The drug is adulterated B. The drug is misbranded

A. The drug is adulterated

If the drug contains an unsafe color additive: A. The drug is adulterated B. The drug is misbranded

A. The drug is adulterated

If the drug is mixed or packed with any substance that reduces its strength or quality or the drug has been substituted in whole or in partminated: A. The drug is adulterated B. The drug is misbranded

A. The drug is adulterated

If the methods of manufacture do not conform to current cGMPs, the drug is considered: A. The drug is adulterated B. The drug is misbranded

A. The drug is adulterated

If the strength, quality or purity falls below the compendium standard: A. The drug is adulterated B. The drug is misbranded

A. The drug is adulterated

True/False: A community pharmacy that is not affiliated with a healthcare entity may not be in possession of prescription drug samples. A. True B. False

A. True

Under the Drug Quality and Security Act (DQSA), what was the Drug Compounding Quality Act (DCQA) passed in response to?

An outbreak of fungal meningitis in over 20 states in the fall of 2012. It was traced back to a contaminated injectable steroid produced by the New England Compounding Centerresulting in 60 deaths and over 750 cases of infection

What is required by the FDCA to be on the labeling of Wintergreen oil (methyl saicylate) or products containing Wintergreen oil?

Any drug containing more than 5% methyl salicylate (often used as flavoring agent) must include warning that any use other than directed may be dangerous and that the article should be kept out of reach of children

What medication must contain a warning in "precautions" section of labeling to the following effect: Phenylketonurics: contains phenylalanine __mg per dosage unit

Aspartame

What is required by the FDCA to be on the labeling of Salicylates?

Aspirin and other salicylate drugs must have special warnings for use in children, including a warning regarding Reye's syndrome. Retail containers of 11/4 grain (pediatric) aspirin cannot be sold in containers holding more than 36 tablets

How many of the "suspect products" must a pharmacy investigate to verify the product identifier?

At least 3 products or 10% of the suspect product, whichever is greater, or all the packages if there are fewer than 3.

How long must transaction data be maintained by each supply chain carrier? A. 5 Years B. 6 Years C. 10 Years D. 11 Years

B. 6 Years

If a pharmacist counts a medication on a tray that has residue from another medication, the product would be considered: A. Misbranded B. Adulterated

B. Adulterated

If a pharmacist stored a specific product incorrectly, such as stocking a medication on a pharmacy shelf instead of in the refrigerator as required, this will lead the product to being: A. Misbranded B. Adulterated

B. Adulterated

If a pharmacist stored inventory in a room or refrigerator, where the temperature is not adequately controlled, the products would be considered: A. Misbranded B. Adulterated

B. Adulterated

An expired drug product in a manufacturer's bottel is: A. Misbranded B. Adulterated

B. Adulterated After the expiration date, the strength cannot be assured.

Which of the following insulin products can be obtained OTC? A. Lantus B. Novolin 70/30 C. Humalog D. Toujeo

B. Novolin 70/30

If a drug is liable to deterioration unless it is packaged or labled accordingly: A. The drug is adulterated B. The drug is misbranded

B. The drug is misbranded

If it is dangerous to health when used in the dosage or manner suggested in the labeling: A. The drug is adulterated B. The drug is misbranded

B. The drug is misbranded

If it is packaged or labeled in violation of the Poison Prevention Packaging Act: A. The drug is adulterated B. The drug is misbranded

B. The drug is misbranded

If the labeling does not contain: the name and address of the manufacturer, packer, or distributer, brand and/or generic name of the drug/product, the net quantity, the weight of active ingredient per dosage unit, the federal legend "Rx only", specific route of administration (unless oral), special storage instructions if appropriate, manufacturer's control number (lot number), expiration date AND adequate information for use: A. The drug is adulterated B. The drug is misbranded

B. The drug is misbranded

If the labeling is false or misleading: A. The drug is adulterated B. The drug is misbranded

B. The drug is misbranded

What is required by the FDCA to be on the labeling of Ipecac Syrup?

Boxed and in red letters: "For emergency use to cause vomiting in poisioning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice The following warning: "Keep out of reach of children. Do not use in unconcious persons." The dosage of the medication must appear. The usual dosage is 1 tablespoon (15mL) in individuals over 1 year of age. May only be sold in 1 oz (30mL) containers

Manufacturers are required to provide "transaction data" for each product sold under what specific act? A. Drug Compounding Quality Act (DCQA) B. Drug Quality and Security Act (DQSA) C. Drug Supply Chain Security Act (DSCSA) D. Food, Drug and Cosmetic Act

C. Drug Supply Chain Security Act (DSCSA)

Which amendment gave the FDA jurisdiction over prescription drug advertising? A. Food, Drug and Cosmetic Act B. Durham-Humphrey C. Kefauver-Harris D. Prescription Drug Marketing

C. Kefauver-Harris

What is a 503A Facility/Pharmacy?

Compounding pharmacy that is not registered with the FDA as an outsourcing facility and are only allowed to compound products based off of a prescription

What is Florida's rules with imported samples?

Consistent with federal law however is distringuished from "starter packs" or "initial dose packs" or "stock samples". They are usually given to the pharmacy by a manufacturer at no cost but not intended to be free to the consumer and require prescription

Which of the following doses of Ibuprofen requires a prescription? A. 100 mg B. 200 mg C. 300 mg D. 400 mg

D. 400mg

Outsourcing facilities that meet the DCQA requirements are exempt from which of the following? A. Good Manufacturing Practices B. Obtaining a Special Sterile Compounding Permit C. USP Chapter 797 D. Premarket approval requirements

D. Premarket approval requirements

Under the DQSA, what does the Drug Supply Chain Security Act (DSCSA) enact?

DSCSA also identified as track and trace: Provides universal framework for an electronic track and trace system for prescription drugs as they move through the supply chain and sets national standards for states to license drug wholesaler distributers

What color dyes must disclose presence and provide waring in "precautions" section of the label that may cause allergic reation in certain susceptible persons?

FD&C Yellow #5 (tartrazine) and #6 (21 CFR 201.20)

Per the DCQA, who inspects outsourcing facilities?

FDA according to a risk-based inspection schedule and pay annual fees to support it

Under the Drug Supply Chain Security Act (DSCSA), what form must the pharmacy file if a product is illegitimate? Who else do they inform?

Form FDA 3911 and notify trading partners within 24 hours

Who generally receives lower prices for medications, community or hospital pharmacies? What act is responsible for preventing price diversion because of this?

Hospital Prescription Drug Marketing Act

In what scenario would a misfilled prescription also be considered adulterated?

If the misfilled prescription involves the wrong strength of the drug prescribed This is because the definition of adulteration includes when the strength differs from or quality falls belowe that which it represents

What is required by the FDCA to be on the labeling of Internal analgesics and antipyretics products?

Internal analgesics and antipyretics, including acetaminophe, aspirin, ibuprofen, naproxen, ketoprofen, etc. are required to have a warning for persons consumig 3 or more alcoholic beverages per day and to consult with a doctor before taking

What is required by the FDCA to be on the labeling of Sodium Phosphates?

Limits the amount of sodium phosphates in oral solution to no more than 90mL per OTC container. Also requires specific warnings

What allows for drugs to be imported under specific conditions? What is an example of one of these conditions?

Medicine Equity and Drug Safety (MEDS) Act of 2000 and the Medicare Prescription Drug Improvement and Moderinzation Act of 2003 One of those conditions is that the Secretary of Health and Human Services (HHS) must certify to congress that such imports do not threaten the health and safety of the American public and provide cost savings

What is required by the FDCA to be on the labeling of Phenacetin (acetophenetidin)?

Must contain a warning about possible kidney damage when taken in large amounts or for a long period of time

What is required by the FDCA to be on the labeling of sulfite medications?

Must contain an allergy warning in the "warnings" section of the labeling

What is required by the FDCA to be on the labeling for OTC drugs for minor sore throats?

Must include warning "Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician"

What is required for out-of-state 503B facilities to send compounded medications to Florida?

Nonresident Sterile Compounding Outsourcing Facility Permit

What is meant by a "distributing pharmacy"?

Providing a drug to anyone other than the consumer/patient

What is required by the FDCA to be on the labeling of Potassium Salt preparations for oral ingestions?

Requires warning regarding nonspecific small bowel lesions consisting of stenosis, with or without ulceration, associated with the administration pf enteric coated thiazides with potassium salts

Per the DCQA, who do outsourcing facilities report to and how often?

Secretary of HHS upon registering, and every 6 months thereafter, the drugs sold in the previous 6 months

What limits interstate distribution of compounded drugs to 5%? What is the exception?

Section 503A of the DCQA There is an exception if the compounder is located in a state that has entered a memorandum of understanding (MOU) with FDA addressing shortage complaints from the state

In Florida, what is required for an in-state 503B facility to function?

Special Sterile Compounding Permit

What is required by the FDCA to be on the labeling of OTC vaginal contraceptives and spermacide use containing nonoxynol 9 as the active ingredient?

Subject to several warning requirements, including STDs alert: This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner

What constitues a "suspect/illegitimate product" and which act requires pharmacies must investigate and properly handle suspect products?

Suspect products: counterfeit, diverted, stolen, subject to a fraudulent transaction, intentially adulterated or appear otherwise unfit for distribution such that they would result in serious adverse health consequences or death Drug Supply Chain Security Act (DSCSA)

In states that have entered an MOU, what is considered "distributing an inordinate amount" of compounded drug products?

The number of prescriptions distributed interstate is greater than 50% of the sum of the number of prescriptions compounded that same year plus the number of compounded prescriptions dispensed that same year

Who regulates 503A facilities/pharmacies?

The states and are subject to USP Chapter 797 quality standards for sterile compounding

What is considered "transaction data"?

Transaction information, transaction history, and a transaction statement

True or False: Dispensing a prescription without authorization causes the drug to be misbranded even if it is labeled correctly by the pharmacist.

True This is because a prescription drug product is only exempt from the maufacturer's labeling requirements when it is dispensed pursuant to a valid prescription

What is required by the FDCA to be on the labeling of mineral oil or products containing mineral oil?

Warning stating to take at bedtime, not to be used in infants unless under advice of a physician and cannot encourage use during pregnancy

Due to the Drug Compounding Quality Act (DCQA), what regulates 503B facilities?

current Good Manufacturing Practices (cGMPs)