FLORIDA MPJE EXAM 2024/2025 QUESTIONS & ANSWERS (VERIFIED Q&A) LATEST UPDATE GRADED A+, Exams of Pharmacy

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FLORIDA MPJE EXAM QUESTIONS &

ANSWERS (VERIFIED Q&A) LATEST

UPDATE GRADED A+

Sherman Antitrust Act Correct Answer: This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act Correct Answer: This act states: No adulterated or misbranded drugs in interstate commerce Adulteration Correct Answer: Gross - Think inside the capsule Misbranded Correct Answer: Improperly labeled - think outside the bottle FDCA Correct Answer: This act requires:

2 ingredients are disclosed on bottle drug must be proven safe before marketing authorizes FDA inspection of manufactures and distributors Public Health Service Act Correct Answer: This act:

• biologic drugs approved under BLA not NDA
• reviewed for purity, potency, and safety Durham- Humphrey Labeling Amendments to FDCA Correct Answer: This act:
• allows for refills
• establishes Rx and OTC OTC requirements of Durham-Humphrey Correct Answer: This act states:
• must be labeled with adequate directions for use (drug facts label)
• pregnancy/ breast feeding warning
• domestic contact information to receive ADR report
• OTC drugs approved under OTC monograph or NDA

Rx requirements of Durham-Humphrey Correct Answer: This act states:

• Rx must be labeled with adequate info for use (package insert)
• Rx approved under NDA - grandfathered pre 1938 Durham-Humphrey Act established Pregnancy Categories What are they? Correct Answer: A - safe in humans B - safe in animals - no data in humans C - Unknown safety in humans D - unsafe in humans - benefits may outweigh risks X - unsafe in humans - risks always outweighs benefits Unit Dose Drugs - Labeling requirements Correct Answer: These items are required on which labels?
• generic name or brand - not both
• strength
• dosage form
• exp date (1 yr or earlier if manufacturer is sooner)
• Lot number
• business name of packager
• qty

2 -Rx only + Cautionary statement (if applies) ** directions for use are not required on dose but should be stored where can be accessed easily Kefauver-Harris Drug Efficacy Amendments to FDCA Correct Answer: This act states:

• drugs must be proven effective before marketing
• creates NDA and SNDA Phase I, II, and III research - studies require informed consent and IRB approval
• IND required to test new drugs in humans (FDA has 30 days to issues "clinical hold" or else study can proceed
• mandates informed consent in clinical research
• ADRs must be reported to FDA on Med Watch Form Manufacturers are required to report ADRs Healthcare professionals and patients are voluntary
• All drug labels must have brand and generic name
• Advertising FDA for Rx FTC for OTC
• Establishes cGMP - current good manufacturing practices
• Manufacturers must register facility and be inspected every 2 years
• If not registered - drugs are Misbranded
• If a facility produces substandards of strength, quality or purity drugs are adulterated

Advertising of Rx drugs is by Correct Answer: FDA Advertising of OTC drugs is by Correct Answer: FTC ADRs must be reported on which form Correct Answer: Med Watch Form If a Manufacturer is not registered the drugs are considered Correct Answer: Misbranded If a facility produces substandards of strength, quality, or purity drugs are considered _________? Correct Answer: Adulterated Pharmacies that compound large amounts of drug not based on an individual's Rx must register with the FDA as a _____________? Correct Answer: Manufacturer and meet cGMP Poison Prevention Packaging Act Correct Answer: This act states:

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• Pharmacy must dispense drugs using Child-resistant containers (exceptions: sl nitro, chloestyramine, erthyromycin, prednisone)
• may use reversible caps
• cannot reuse containers
• Patient may make a blanket request for non child resistant containers (verbal request is ok)
• Physician may request an individual Rx be non child resistant but cannot make a blanket request
• Hospitals are exempt
• Manufacturers may market one size as non child resistant Identify some drugs that are exempt from PPPA Correct Answer: - sl nitro
• chloestyramine
• erythromycin
• prednisone Who may make a blanket request from non child resistant containers? Correct Answer: Patient - may give verbal auth Can a physician give a blanket approval for non child resistant containers for a patient? Correct Answer: No

May however give auth for an individual Rx Federal Anti-Tampering Act Correct Answer: This act stipulates that OTC products must be in tamper resistant packaging Orphan Drug Act Correct Answer: This act gives incentives to companies to create drugs for rare diseases - must still submit an NDA Federal False Claims Act Correct Answer: This act stipulates that you are not allowed to falsely bill Medicaid or Medicare. Whistleblowers are allowed 25% Hatch Waxman Amendment to FDCA Correct Answer: This act is also known as Drug Price Competition and Patent-Term Restoration Act Hatch Waxman Amendment to FDCA stipulates Correct Answer: This act:

• establishes abbreviated drug approval process for generics based on bioequivalence.
• added patent term equal to drug development review by FDA

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• establishes Orange Book - lists all FDA approved drugs - cross reference with generics. AB rated may be substituted BX/BC/BE are generics that may NOT be substituted National Childhood Vaccine Injury Act Correct Answer: This act:
• reports involving vaccines must be reported using VAERS form
• FL pharmacists can vaccinate Prescription Drug Marketing Act Correct Answer: This act:
• prohibits sale /trade/ purchase of drug samples
• states must license drug wholesalers
• patients cannot bring/order foreign drugs into US - requires prescription drugs to bear the legend "Rx Only" any drug without this legend is Misbranded. Omnibus Budget Reconciliation Act is also known as? Correct Answer: OBRA 90 Omnibus Budget Reconciliation Act

Correct Answer: This act mandates pharmacists conduct a prospective drug use review and counsel all Medicaid Patients. Prescription Drug User Fee Act Correct Answer: This act states that manufacturers must pay a user fee along with each drug that is marketed, facility that manufacturers drugs, and each app from approval. The money is used to hire drug reviewers and facilitate the drug approval process. Dietary Supplement Health and Education Act Correct Answer: This act allows dietary supplements to be categorized as food and are not required to be proven safe or effective, must follow cGMP FDA Export Reform and Enhancement Act Correct Answer: This act allows export of FDA approved drugs if label meets other country's requirements. Allows export for clinical investigation. Health Insurance Portability and Accountability Act (HIPAA) Correct Answer: This act limits disclosure of patient health information to what is minimally necessary. May disclose for treatment, payment or regular healthcare operations. May provide to patients upon request (verbal auth ok). Employees must be

2 trained. There need to be procedures and safeguards. Should appoint a responsible individual. Patient must authorize use of PHI for marketing. FDA Modernization Act Correct Answer: This act is a manufacturer friendly set of laws. Allows fast track approval of life saving drugs. Drug Addiction Treatment Act Correct Answer: This act allows authorized physicians to treat drug addiction with buprenorphine (subutex/subuoxne) in office based practice where pharmacist dispenses drugs. There is a 30 patient limit - can go up to 100 with meet special requirements. Authorized physician unique provider number starting with X. Methadone may be prescribed for pain OR opioid addiction (40mg tablets for addiction only) Medicare Prescription Drug Improvement and Modernization Act is also known as? Correct Answer: Medicare Part D Medicare Prescription Drug Improvement and Modernization Act Correct Answer: This act provides prescription drug coverage to Medicare patients with copays and donut hole. Excludes: weight loss, fertility, cosmetic, hair growth, barbiturates, OTC, cold and cough relief. It does reimburse pharmacists for MTM. Staff must have annual training on fraud, waste and abuse.

Combat Methamphetamine Act Correct Answer: This act restricts the sales of pseudoephedrine (PSE). 3.6g per person per day 9g per person per 30 day period Mail order may send 7.5g per person per 30 day period Must be 18 years old, show ID, sign log book Must be blister packed with no more than 2 per blister Must be behind pharmacy counter, secured in pharmacy Must show picture ID Maintain logbook x 2 years Products packaged for individual sale that contain less than 60mg PSE are exempt from log book requirements. Pharmacy personnel must have training and certifications. Dietary Supplement and Non Prescription Drug Consumer Protection Act Correct Answer: This act requires manufacturers report serious ADRs to FDA for OTC and supplements FDA Amendments Act Correct Answer: This act is a group of drug laws that focused on drug safety. It establishes risk evaluation and mitigation strategies (REMS) for drugs with important health risks. Requires all prescription drugs to have side effects statement.

2 Ryan Haight Online Pharmacy Consumer Protection Act Correct Answer: This act prohibits internet prescriptions for controlled substances without in person medical evaluation. Family Smoking Prevention and Tobacco Act Correct Answer: This act grants limited authority to FDA involving tobacco (from ATF). Bans flavored cigarettes. Must disclose all ingredients. Prohibits youth based marketing. Biologics Price Competition and Innovation Act Correct Answer: This act establishes generic approval pathway for biologics (BLA). Plan B OTC Correct Answer: This allows Plan B to be available Rx and OTC. OTC only for patients 17 and older with valid ID. Overtime Pay Not Required Correct Answer: This establishes that Pharmacists are considered professionals and not entitled to overtime pay under the FLSA. Define Drug Recalls

Correct Answer: Voluntary removal or correction of marketed product. Class I Recall Correct Answer: Reasonable probability that the use or exposure to a product WILL cause serious adverse health consequences or death. Class II Recall Correct Answer: May cause temporary or medically reversible adverse health consequences - possibility of severe effect is remote. Class III Recall Correct Answer: Not like to cause adverse health consequences. Recall Strategy Correct Answer: Consumer / Retail / Wholesale Must use "urgent" for Class I & II bold red type "drug recall". Who may initiate a Drug Recall? Correct Answer: By the manufacturer or Government (FDA, State Board of Health) Federal Labeling Requirements or is Misbranded: Glandular Preparations Correct Answer: Label must read: No scientific evidence

2 Federal Labeling Requirements or is Misbranded: Isoproterenol Correct Answer: Label must read: severe paradoxical bronchoconstriction Federal Labeling Requirements or is Misbranded: OTC sore throat lozenges Correct Answer: Label must read: if severe or persistent call physician, may be severe Federal Labeling Requirements or is Misbranded: Ipecac Correct Answer: Label must read: call for professional advise before using Federal Labeling Requirements or is Misbranded: Nonoxynol 9 Correct Answer: Label must read: does not protect against HIV Federal Labeling Requirements or is Misbranded: Phenindione Correct Answer: Label must read: causes agranulocytosis and hepatitis Federal Labeling Requirements or is Misbranded:

Contains FD&C Yellow No 5 Correct Answer: Label must read: (Tartrazine) as a color additive Federal Labeling Requirements or is Misbranded: Contains FD&C Yellow No 6 Correct Answer: Label must read: as a color additive Federal Labeling Requirements or is Misbranded: Phenylketonurics Correct Answer: Label must read: Contains phenylalanine __mg Aspartame containing drugs Federal Labeling Requirements or is Misbranded: Contains sulfite Correct Answer: Label must read: Systemic antibiotics to reduce the development of resistance use only if proven or strongly suspected Federal Labeling Requirements or is Misbranded: Alcohol and OTC internal analgesics / antipyretics Correct Answer: Label must read: Advises consumers with history of heavy drinking to consult MD especially if have three or more drinks per day. APAP can cause liver damage. NSAIDS - internal bleeding. Combination can cause liver damage and stomach bleeding.

2 Federal Labeling Requirements or is Misbranded: Phytonidione (Vitamin K) Correct Answer: oral and injectable are prescription only. Federal Labeling Requirements or is Misbranded: Epinephrine Correct Answer: injections require prescription Federal Labeling Requirements or is Misbranded: Isotretinoin Correct Answer: 30 day supply only. Females must use two methods of birth control, one month prior and after. Must have two negative pregnancy tests prior to initiation of therapy. Federal Labeling Requirements or is Misbranded: Thalidomide Correct Answer: STEPS program to minimize fetal exposure of drug. Has restricted distribution. Define Misbranding Correct Answer: Label is false or misleading. LIE (misfiled, mislabeled)

Examples of Misbranding Correct Answer: - Label is missing: name of drug, each active ingredient, qty of container ingredients, info for use, name or location of manufacturer, words, statements, info as required by law (Rx Only).

• OTC label lacks adequate directions for use
• drug made in non registered establishment
• failure to include contact info for ADRs
• prescription drug promoted in violation of advertising provisions
• drug is not in accordance with USP NF for sale under another name
• packed in violation of PPPA / FATA
• Not in compliance with REMS
• Health endangering when used as prescribed
• lacking precautionary statement for drugs subject to deterioration. Define Adulterated Correct Answer: Dirty and Wrong Strength Adulteration Examples Correct Answer: - contains any filthy, putrid, or decomposed substance
• contains unapproved / unsafe color additive
• exposed to any unsanitary condition where it may have been contaminated
• involving substandard cGMPs

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• mixed or substituted with another product to reduce its strength
• strength, quality, purity not meeting standards
• used in substitution of another substance
• container is composed of any poisonous or deleterious substance which may render the contents injurious to health. Federal Controlled Substances Act - what did it do? Correct Answer: Created five schedules of drugs based on Medical Use, potential for abuse and dependence. Controlled Substance - CI Correct Answer: - high risk for abuse
• may not be prescribed for medical use
• no currently accepted medical use in the US
• research and investigational use only Controlled Substance - CII Correct Answer: - no refills
• no post dating of Rx
• No Transfers
• 90 day limit max
• oral Rx only in emergency - limits amount - pharmacist writes the Rx (authorization for emergency dispensing) attaches original when it arrives. Must obtain within 7 days. -

fax Rx only ok if - Home infusion IV for pain, Residents of LTCF, or state licensed Hospice facility

• Partial fill ok - complete filling in 72 hours - if can't then notify MD and void remainder. - LTCF partial refills - valid for 60 days from date written. Each fill the RPh must document date of fill, qty dispensed and qty remaining and sign.
• RPh may not change essential element on Rx: (Drug, Patient, Signature). May change address, qty, strength, directions (with auth).
• Order on 222 Forms - may also use to transfer to another pharmacy. May use to send to reverse distributors. What pieces of information may a RPh change on a CII Rx? Correct Answer: Address, Quantity, Strength, Directions with authorization from MD Controlled Substance - CIII-IV Correct Answer: - five refills in six months
• 1 transfer permitted unless share a common database then may transfer as many time as needed as long as there are refills
• partial fills permitted - don't exceed total quantity or six month duration
• In Florida pharmacists AND interns may transfer controlled substance prescriptions
• may be written, oral or faxed (need original)
• may make any changes with consultation of MD
• no special order form - orders kept readily retrievable

2 Controlled Substance - CV Correct Answer: - most are available without a prescription and indicated as cough or antidiarrheal

• Lyrica (pregabalin) requires Rx Controlled Substance - CV - Limits Correct Answer: 120mg Codeine 60mg Dihydrocodeine 30mg ethyl morphine 240mg opium

within a 48 hour period SLCPS Correct Answer: Schedule Listed Chemical Product SLCPS Examples Correct Answer: - Ephedrine, pseudoephedrine, phenylpropanolamine must train staff and keep training records sales limits enforced stored behind counter or in locked cabinet written or electronic log book maintained SLCPS - List 1 Chemicals Correct Answer: Drugs involved in the manufacture of a CS SLCPS - List 2 Chemicals Correct Answer: Solvents involved in the manufacture of a CS Is electronic prescribing of Controlled Substances allowed? Correct Answer: Yes Name the Prescription Filing System Options

1. Three separate files: CII, CIII-V, and non controls Correct Answer:

2. Two separate files: CII, CIII-V and non controls - must stamp a red C >1 inch in lower right corner 3 Two separate files: CII- V, non controls - must stamp CIII-V with a red C in lower right corner How are Controlled Substances Stored? Correct Answer: One of three ways:
3. Locked cabinet
4. Dispersed throughout the pharmacy
5. Combination of both There is no special requirement for CII to be locked up - may be dispersed. Do hospitals need to follow label requirements? Correct Answer: No Can you mail controlled substances? Correct Answer: Yes - in US only. Package must be unmarked regarding contents When do you fill out a DEA Form 106 Correct Answer: Where there is theft or significant loss of a controlled substance. May Midlevel practitioners prescribe Controlled Substances in Florida? Correct Answer:

No. An agent can phone in a prescription at the request of the registrant (ie a receptionist may call it in) including emergency CII prescriptions. Can a Military MD write an Rx for a controlled substance without a DEA number? Correct Answer: Yes. Must use Military number. May fill at a community pharmacy. Can Hospital Interns and Residents write an Rx for a controlled substance without a DEA number? Correct Answer: Yes. May use the hospital DEA number plus their hospital ID number at the end. May fill Rx at community pharmacy and would just use the hospital DEA. Is Central Fill of Controlled Substances permitted? Correct Answer: Yes for CIII-V. Local pharmacy must write date, pharmacist transmitting and Central Fill on the face of prescription along with Central fill pharmacy name, address, DEA #. Store records for two years from date of last fill. Can you Central Fill CII prescriptions? Correct Answer: NO Correct Answer:

What happens when you execute a 222 Form?

• Pharmacy places order and keeps Copy 3
• Copy 1&2 go to the supplier. Supplier fills the order and keeps Copy 1. Completes copy 1&2 and mails copy 2 to the DEA.
• Pharmacy completes copy 3 upon receipt of order with containers and date received. ** Supplier can endorse form to another if unable to complete the order. Controlled Substances Refills? Correct Answer: CII - NO C III-V Yes - 5 in 6 months Controlled Substances Transfer between pharmacies? Correct Answer: CII - NO CIII-V - 1 allowed (unless share same database) Controlled Substances Transfer of bulk drugs / pharmacies? Correct Answer: CII - Requires 222 CIII-V - requires complete invoice Controlled Substances - Oral Rx Allowed? Correct Answer: CII - In emergency CIII - V - Yes Correct Answer:

Controlled Substances - Fax Rx Allowed? CII - Yes to prepare but will need hard copy to dispense CIII - V - Yes to prepare but will need hard copy to dispense Controlled Substances - Electronic Rx Allowed? Correct Answer: CII - Yes subject to security requirments CIII - V Yes Controlled Substances - Partial Fills Allowed? Correct Answer: CII - Generally No but may fill partial if can't supply entire amount. Must complete within 72 hours. Yes for terminally ill and LTCF but must mark "terminally ill" or "LTCF patient" on prescription CIII-V - Yes, just not more than qty or 6 month duration. Controlled Substances - Inventory Requirements Correct Answer: CII - Exact count CIII - V - estimated count unless bottle holds more than 1000 units then will need an exact count. ** Initial inventory required then every two years thereafter. Inventory must have drug name, strength, dosage form, number of units in each container, number of containers (written, typed, or printed - kept on site and includes inventory date and time and opening or close of business). Correct Answer: