Federal Requirements for PTCB Practice Test

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• Trace wastes in hazardous drug disposal are placed in which container color?
• When converting a 10-digit NDC to 11 digits for billing, what format is required?
• Schedule III and IV controlled substances expire after how many months?
• Which of the following is an example of a Schedule IIIN non-narcotic?
• Schedule III prescriptions: which statement is correct?
• Hazardous pharmaceutical waste under RCRA can be generated from which sources?
• Which is an acceptable disposal pathway under the final rule?
• What is the recommended disposal approach for FDA flush-list medications when there is no take-back program nearby?
• What form must a pharmacy file to report the theft or significant loss of controlled substances to the DEA?
• Which copy does the pharmacy retain?
• Which substances are subject to sealing and labeling requirements when imported into or exported from the United States?
• In an emergency dispensing scenario for Schedule II medications, which of the following must appear on the face of the oral authorization?
• Which agency has the authority to regulate the sale and use of drugs under the CSA?
• Which REMS component is responsible for monitoring ETASU implementation within the health care system?
• For Schedule III, IV, and CV prescriptions, what are the limits on time to fill and number of refills?
• Which of the following is NOT listed as a REMS criterion?
• Which statement is true about transfer of prescription information for refills between pharmacies?
• RCRA stands for which act?
• Which drug requires enrollment in the iPLEDGE program before dispensing?
• What is DEA Form 106 used for?
• What is the maximum number of different items that may be ordered on a single Form 222?
• To which schedule does the 90-day supply regulation apply?
• What is the maximum number of refills permitted for Schedule III and Schedule IV prescriptions?
• Which action could be included in a REMS communication plan?
• Which office must be notified in writing within one business day after theft or significant loss?
• What license is required to prescribe opioid treatment medications to patients fighting narcotic addiction?
• What is the name of the REMS program associated with thalidomide?
• Where are Medication Guides typically provided in REMS contexts?
• Which action is NOT considered a 'Correction' in device recalls?
• Which agency enforces the Controlled Substances Act and may initiate proceedings to add or remove drugs from schedules?
• Trace wastes include which of the following items?
• Restricted drug programs may include restricted distribution networks designed to implement safe use. Which option illustrates such networks?
• Which drugs require a DEA Form 222 for transfer?
• Who enforces the Federal Food Drug and Cosmetic Act?
• What must be included on the written prescription when it accompanies an emergency oral order?
• Transfer between pharmacies for Schedule III-V prescription information for refill purposes is permissible on a one-time basis.
• Which statement describes ETASU as a REMS component?
• Which statement is true about recalls and device and drug definitions?
• What do the first 5 digits of an NDC number represent?
• How do you fill out a new DEA 222 form?
• What form is used to request permission from the DEA to destroy controlled substances?
• What is true about the final rule's take-back program?
• What best describes a reverse distributor?
• What happens when you enter an NDC number in the system?
• Which item must appear on the label of a controlled substance under federal requirements?
• What is a primary purpose of REMS?
• What is the primary purpose of DEA Form 41?
• Who is authorized to fill out a DEA Form 222 for Schedule I and II substances?
• What is the primary purpose of DEA Form 222?
• In an NDC, what do the middle four numbers identify?
• Which information must be retrievable by prescription number for refills?
• Hazardous waste NOT a characteristic?
• Trace wastes are defined as wastes containing less than what percent by weight of the original quantity?
• Do NDC numbers expire?
• The Controlled Substances Act is the statute establishing federal U.S. drug policy governing what?
• If a non-registrant requests disposal of controlled substances, what must they submit?
• What does the EPA encourage the public to use for safe disposal of prescription or OTC drugs?
• What is required to store controlled substances legally?
• Which statement about Schedule I research is true?
• What is a general requirement to safeguard stored controlled substances?
• Under the 2007 regulation, a prescriber may issue multiple prescriptions to total up to a 90-day supply for which schedule of controlled substances?
• What is a reverse distributor?
• Prescriptions by Schedule: Schedule III rules state that such prescriptions are valid for up to how many days or refills?
• Which entities can act as reverse distributors?
• What does the federal Controlled Substances Act do?
• Which copy must the supplier retain?
• Under Part 1302, which statement about labeling symbols for schedules is true?
• Which item cannot be changed when dispensing controlled substances?
• Which elements must be included on a prescription for dispensing controlled substances?
• What are the four parts of a prescription?
• What is the pharmacist's corresponding responsibility regarding controlled substances?
• Which element is required on all prescriptions for controlled substances?
• Who is authorized to write a prescription for a controlled substance?
• CSOS is the only electronic method allowed for ordering Schedule I and II controlled substances.
• What form is used to destroy controlled substances?
• Which of the following is a Schedule II drug used for pain relief?
• What is the function of the Implementation System in REMS?
• In an NDC number, which segment identifies the drug product?
• Which statement correctly describes Schedule I controlled substances?
• Where can a current list of medications with REMS programs be found?
• Which schedules are included in the six-month and up to five refills rule for prescriptions?
• Which statement accurately describes the NDC number?
• Under the disposal rule, where can community pharmacies maintain receptacles for disposal?
• The 2007 regulation allows issuing multiple prescriptions to total up to 90 days for which schedule?
• Can Schedule II prescriptions be dispensed via fax to a pharmacy?
• Who assigns the labeler code in the National Drug Code (NDC) number?
• Which form is used for new applicants to obtain a DEA registration?
• Where must inventory records for controlled substances be stored?
• What is the minimum frequency for REMS assessments after launch?
• Who authorizes disposal of controlled substances and what documentation is used?
• What is the mission of the DEA?
• What is the primary purpose of a REMS?
• What is a key practice in maintaining compliance when dispensing controlled substances?
• Which statement best defines a Risk Evaluation and Mitigation Strategy (REMS)?
• Which statement best defines a voluntary recall?
• Which of the following is an example of a Schedule I drug?
• Which disposal method is recommended for Non-Hazardous Pharmaceutical Waste?
• Which is a serious side effect associated with Lotronex?
• Which statement about ETASU is correct?
• Which item is required for controlled substances prescriptions?
• Which method can be used to order Schedule I and II controlled substances electronically?
• Which DEA form is used to destroy damaged, outdated, or unwanted controlled substances?
• As of July 2016, how many REMS incorporate ETASU?
• Within which timeframe must theft or significant loss be reported to the DEA?
• How many days early can you fill a Schedule III/IV prescription?
• Recalls can be initiated as what type of removal?
• Which program provides a mechanism to dispose of unwanted medications in the Military Health System?
• When disposing a controlled substance by destruction, what documentation must a reverse distributor submit?
• Which form is used to report theft or loss of listed chemicals?
• What is the form used to report theft or loss of controlled substances to the DEA?
• What is the National Drug Code (NDC) used for?
• Which statement about the DEA Form 222 is true?
• Recalls may be conducted by which sources?
• What is the primary function of the National Drug Code (NDC)?
• In the National Drug Code (NDC), which segment identifies the product?
• Which of the following is a Schedule I drug example?
• Which storage requirement applies to Schedule I and II substances?
• Which statement best describes a Risk Evaluation and Mitigation Strategy (REMS)?
• Are electronic orders allowed for Schedule II substances?
• Schedule IV and V prescriptions: which statement is true?
• When was the U.S. Food and Drug Administration established?
• Which of the following is a Schedule V substance?
• Which drug is a Schedule V substance?
• What is DEA Form 510 used for?
• Which of the following is an example of a Schedule II/IIN stimulant?
• Under federal law, do Schedule II prescriptions have an expiration?
• What identifier does the DEA use to track controlled substances and listed chemical products reported as lost or stolen?
• Which drug is mentioned as intended for patient administration under direct observation in REMS context?
• Which statement best describes the prevalence of REMS among medications?
• What does the FDA regulate?
• For Schedule III, IV, and V substances, which storage method is listed as the preferred method?
• Which statement about Schedule II stimulants is true?
• In an NDC number, which segment identifies the packaging?
• Which statement about REMS is true?
• Medication Guides may be required as part of REMS.
• What is the primary safety goal of the STEPS program for thalidomide?
• What does DoD Directive 5124.02 establish?
• Under recall criteria, when is a drug recalled due to health risk?
• Which sentence best describes the primary purpose of the CSA?
• What is the validity period for a paper DEA Form 222 after its execution?
• How many digits does an NDC contain?
• Which statement accurately describes REMS authority?
• If a controlled substance is stolen or lost, which DEA form must be used to report it?
• According to FDA guidelines for prescriptions of controlled substances, which statement is correct?
• Which entity enforces the federal regulations related to foods, drugs, devices, and cosmetics under the Federal Food Drug and Cosmetic Act?
• REMS applies to medications with which characteristic?
• Which statement describes Schedule IV drugs?
• Which facilities were added as authorized collectors in the final rule?
• How may Schedule I and II controlled substances be ordered?
• Which statement about Schedule II inventory is true?
• Which set of elements is required on controlled-substance prescriptions?
• How many jurisdictions have operational PDMPs?
• What is REMS?
• Which schedules may be dispensed to a patient with a faxed prescription?
• What information must be included on a controlled-substance prescription regarding date and signature?
• Which statement about NDC identifiers is true?
• Which statement about FDA recall status updates is accurate?
• Non-hazardous pharmaceutical waste scope: which statement is true?
• Which option best reflects the legal requirements of a prescription?
• For how long must Controlled Substances Inventory logs be kept?
• Is isotretinoin required to be dispensed in the manufacturer's packaging?
• Which statement about voluntary recalls is accurate?
• For Lotronex, which statement about prescription handling is true?
• In the context of FDA device recalls, what does 'Correction' mean?
• Which statement best describes a drug recall?
• Which agencies determine which substances are placed in or removed from the federal schedules?
• RCRA Hazardous Pharmaceutical waste is defined by which characteristics?
• Which information is required on a prescription for a controlled substance?
• In emergencies, which practice is true for dispensing Schedule II substances?
• When dispensing Schedule II via an emergency oral prescription, which of the following is required?
• What was the primary purpose of the Pure Food and Drug Act of 1906?
• What storage method is described for narcotic medications in CVS Pharmacy stores in California?
• When must significant losses of controlled substances be reported?
• Clozapine therapy requires monitoring of which laboratory value due to effects on blood cells?
• What is the purpose of the Prescription Drug Monitoring Program (PDMP)?
• Are community pharmacies allowed to destroy controlled substances under the disposal rule?
• Which distribution describes how copies are sent with a DEA Form 222 when ordering?
• What is the maximum number of refills allowed for a Schedule III or IV prescription?
• Which statement about the CSOS program is true?
• Who can initiate a drug recall?
• Schedule IV and V rules allow which of the following?
• What is the primary destruction standard for controlled substances under the disposal rule?
• Non-Hazardous waste includes which of the following?
• Which statement is true about FDA recall status updates?
• Which professionals may be assigned a DEA registration number?
• In an NDC number, what do the last two numbers identify?
• Is a 90-day supply of Adderall generally permitted for patients, assuming physician approval and state law compliance?
• Which act authorized the FDA to require REMS?
• What is the general storage rule for controlled substances according to DEA guidelines?
• How long must DEA Forms 222 be kept available for inspection?
• Does the National Drug Code (NDC) indicate FDA approval status?
• What form documents the transfer of a C-II to a DEA-registered reverse distributor?
• Which item must be included on a controlled substance prescription?
• Do the symbol labeling requirements under Part 1302 apply to controlled substances imported into the United States?
• For CIII-V substances, what recordkeeping is required when transferring to a reverse distributor?
• Which are examples of Schedule II drugs?
• Which form is required to transfer Schedule II drugs?
• On what date did the regulation take effect allowing up to a 90-day total supply for Schedule II substances via multiple prescriptions?
• Which schedules have a low potential for abuse?
• What does the Disposal of Controlled Substances final rule authorize for community pharmacies?
• Which statement about the CSA schedules is true?
• For RCRA hazardous waste, which lists are most relevant?
• Which provision governs exceptions to the 60-day validity of a paper DEA Form 222?
• How are controlled substances stored?
• Which statement best describes the role of the Drug Enforcement Administration (DEA)?
• Which entities may host a pharmaceutical take-back program according to EPA guidance?