PTCB Supply Chain and Inventory Management Practice Test

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• Under country-of-origin rules, which agency uses the country of origin where the active ingredient was made?
• When storage requirements are not established for a prescription drug, it is appropriate to store it:
• In Value Driven Systems, VALUE equals:
• What OTC products do some wholesalers carry?
• Which term best describes a product that is counterfeit, diverted, or adulterated and unfit for distribution?
• Schedule II inventory requirement?
• What is the term for actions such as removing a product from distribution, returning it, disposing, or retaining a sample for analysis?
• Which statement best describes a third-party logistics provider (3PL)?
• Which of the following is correct about the bolting requirement for safes or cabinets?
• Which agency is primarily responsible for verifying CGMP compliance at outsourcing facilities?
• Schedule IV substances have which characteristics?
• Which action is prohibited under federal law regarding interstate commerce of foods and drugs?
• Which statement best describes distributor sourcing?
• For Schedule III through V transfers to a reverse distributor, which details must be included in the record?
• What must a pharmacy keep if they send a controlled substance to a reverse distributor for destruction?
• When issued a DEA registration, initial inventory must be an actual physical count of all controlled substances; if there is no stock on hand, the registrant should make a record showing zero inventory.
• What feature do primary wholesalers often provide to pharmacies for ordering?
• List 1 chemicals include which of the following?
• Which option is NOT listed as a type of wholesaler?
• Can Schedules III, IV, and V controlled substances be stored with Schedule II controlled substances?
• Which term refers to the regular inventory needed to fulfill orders?
• The Kefauver-Harris Amendments were inspired by which tragedy?
• In a group of five pharmacies, if a schedule III drug is in short supply and unavailable from primary or secondary wholesalers, how should you fulfill the prescription?
• When can a New Drug Application (NDA) be filed?
• Which accomplishment is attributed to the Kefauver-Harris Amendments of 1962?
• A patient requests a refill and the primary wholesaler cannot supply; a nearby independent pharmacy has the product in stock. How should this be handled?
• Creditable waste is defined as which of the following?
• Which statement about 503B outsourcing facilities is true?
• The drug with no storage requirements should be stored at which condition?
• How do health care facilities obtain an EPA identification number?
• In broad terms, which category of waste does RCRA focus on managing?
• Which statement accurately describes Phase 3 and Phase 4 trial roles?
• In which method is inventory inspection carried out at timed intervals (e.g., weekly, monthly, annually)?
• The role of a hazardous waste transporter in pharmaceutical waste management is to:
• Invoices or packing slips from CIII-CV controlled substance orders must be retained by the purchaser for how long?
• Strengthening America's Supply Chain and National Security Act directed the DoD to determine the extent of its dependency on foreign sources of drugs. Which department is referenced?
• The Kefauver-Harris Amendments were inspired by which tragedy?
• Besides manufacturers, distributors, and pharmacies, which entities may be involved in the pharmaceutical supply chain?
• Which formula correctly calculates the Inventory Turnover Ratio (ITOR)?
• How does Gold Bagging differ from standard bagging?
• ANDA stands for which of the following?
• What must a health care facility provide to the EPA if it does not receive a signed shipping document?
• A Class II recall refers to a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Which class is described?
• What is the role of Virtual Manufacturers and Wholesalers?
• Which of the following is NOT a Schedule II substance?
• In a multi-pharmacy group, how should you fulfill a Schedule III prescription when a local wholesaler cannot supply the drug?
• Which document is not required when using CSOS?
• Which statement about pharmacy inventory strategies is true?
• Which document serves as the official proof of registration with the DEA that a pharmacy must display?
• If a drug is labeled with only a US address, how would the FDA and CBP classify it?
• Which of the following is true about batch identifiers?
• Which act would require the DoD and the Department of Veterans Affairs to only purchase US-made drugs and vaccines?
• Which statement best describes the handling of hazardous waste pharmaceuticals?
• If COGS is 400,000 and average inventory is 100,000, ITOR equals?
• Which term best describes a product that is counterfeit, diverted, or adulterated and unfit for distribution?
• Which action is associated with State Boards after inspections?
• If the transaction data has been verified as complete, what is the appropriate status for the product?
• A Class I recall is defined as a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Which recall class is this?
• Intentionally adulterated describes a product that would cause which of the following outcomes?
• The DEA was established by which president and in what year?
• Which statement describes Manufacturer Sourcing?
• Which is a Schedule IV example?
• What types of products does the FDA regulate?
• Which term describes wholesale distribution of drug products without taking physical possession of the drug?
• Clear Bagging is described as which of the following?
• Which statement best describes why a pharmacy would enter into a contract with a primary wholesaler?
• In Value Driven Systems, which two components determine VALUE?
• Which statement about PK and PD definitions is true?
• Which term describes an arrangement that pools the buying power of pharmacies to obtain better prices and discounts from vendors?
• Stock Out Cost is the cost of not having a product on the shelf when needed.
• How often do primary wholesalers typically deliver products?
• Which statement about transaction data forms is accurate?
• When a wholesaler purchases directly from the manufacturer, what designation does the wholesaler have?
• Which term defines the activity of sale, purchase, trade, delivery, handling, storage, or receipt of a product, excluding dispensing under prescription?
• Phase 4 clinical trials are conducted for what primary purpose?
• Which legislation did the EPA enact in 1976 to address waste management?
• In a chain warehouse model, how often are deliveries typically made?
• Which provision describes the Securing America's Critical Minerals Supply Chain Act?
• How long must a pharmacy keep all controlled substance forms?
• What is transaction data commonly referred to as?
• What does consignment in pharmacy entail?
• MedWatch's primary function is to publish safety alerts for FDA-regulated products. Which statement best reflects this?
• What is the cost of not having a product on the shelf when a patient needs it?
• For Schedule III, IV, or V inventories, what type of count is allowed for an open bottle containing not more than 1000 tablets or capsules?
• Do some wholesale drug distributors perform both wholesaling and drop shipping?
• Phase 3 trials enroll approximately how many volunteers with the disease or condition?
• In terminology describing the movement of products, which term denotes a product that has left the US supply chain and is reintroduced or is intended for sale outside the US and brought back into the US?
• Which term refers to the graphic that includes the SNI, lot number, and expiration date of a product, displayed as a linear or two-dimensional representation?
• How long must health care facilities keep a copy of the signed shipping document?
• If a received product appears damaged or suspect, what should you do first?
• What is a common disadvantage of a hospital formulary?
• Which entities are typically included in the drug supply chain path from manufacture to the end user?
• Which item must accompany all shipments of hazardous waste pharmaceuticals, as required by EPA and DOT?
• If storage requirements are not established for a prescription drug, it should be stored where?
• Which arrangement could be described as essentially the same as a GPO but designed to serve smaller pharmacies?
• Who is responsible to ensure that safety and efficacy rules are followed?
• Which approach is recommended for managing an expensive specialty drug used by a single patient?
• What form is required for all shipments of hazardous waste pharmaceuticals?
• What must a Transaction Statement convey?
• How frequently may products from secondary or specialty wholesalers be ordered?
• If DEA Form 222 is stolen, what must a pharmacy do?
• Which method defines a minimum and maximum level of inventory to maintain?
• Pharmacy Buying Groups are essentially the same as a GPO except that they can work with smaller organizations. Which option correctly describes this?
• Who is required to provide medications at reduced rates to 340B-eligible institutions?
• Under the Drug Quality and Security Act, which criteria define an outsourcing facility?
• What is a common consequence of a primary wholesaler contract related to purchasing volume?
• Which of the following is included in Carrying Costs?
• Which statement is true about pharmacokinetics and pharmacodynamics?
• For a drug without specified storage requirements, indicate the acceptable storage condition:
• When storage requirements are not established, the recommended storage is:
• In addition to the stated retention time, which entity may require a longer retention time for CIII-CV order documents?
• What graphic includes the SNI, lot number, and expiration date of a product, displayed as a linear or two-dimensional representation?
• Which substance is a Schedule II example among the following?
• Which term describes a sealed case containing only product that has a single NDC number belonging to a single lot?
• What information must a pharmacy provide when reporting a stolen DEA Form 222?
• Which factor would most likely indicate a suspicious inventory?
• Inventory record for Schedule III through V must include
• What best describes White Bagging?
• What is the primary purpose of Setting Order Points?
• What must a health care facility do if it does not receive a signed shipping document within 60 days?
• Acquisition Cost is defined as the price the pharmacy pays for the product.
• Which term is defined as the price the pharmacy pays for the product?
• What is a 503B outsourcing facility?
• Which of the following is NOT required in an Abbreviated New Drug Application (ANDA)?
• Which method creates a monthly buying budget based on planned sales?
• Which description best fits Schedule I controlled substances?
• What is the main purpose of clinical trials in drug development?
• Which statement describes VFC Eligible Children?
• Which are examples of products sourced from secondary or specialty wholesalers?
• Vaccines for Children (VFC) program was created and became operational in which time frame?
• CSOS program is administered by which agency?
• Which president signed Executive Order 13944?
• A medical device safety alert is issued when?
• Phase 4 trials are conducted after what milestone?
• Which scenario illustrates a permissible 503A compounding?
• Your year-end purchases total 6,500,300 and year-end inventory is 450,700. Approximately how many inventory turns does this represent?
• Which statement about FDA registration renewal is correct?
• Which statement correctly describes the expiration criterion for creditable waste?
• Which term refers to the portion of inventory that is regularly used to fulfill orders?
• Carrying Costs include which items?
• DEA Form 106: Completed for theft or significant loss of any controlled substance, they must notify the local DEA Diversion Field Office in writing within 1 business day.
• If 12,500 tablets were dispensed in a year and you have 200 tablets on hand, approximately how many days of supply does the on-hand inventory represent?
• What is true about country of origin for pharmaceuticals?
• Scheduling an order ten days before a patient's next refill is an example of:
• If a drug lists a US address but uses a foreign-made active pharmaceutical ingredient, is this compliant?
• What does the FTC Act specify about the phrase 'Made in the USA'?
• What is the primary role of a distributor in sourcing?
• Cash discounts are offered for which purpose?
• When receiving DSCSA products, which action should pharmacy staff take?
• A batch of a drug will have the same lot number and expiration date. What is true about serial numbers?
• What happens if a pharmacy exceeds the agreed-upon percentage of purchases from other sources?
• Which is an example of a Schedule I substance?
• Which of the following best describes a specialty distributor?
• Which statement best defines Inventory Management?
• Which of the following is an example of a Trading Partner?
• Schedule III substances have moderate potential for abuse, potential for moderate physical dependence, and an accepted medical use.
• When evaluating foreign sourcing for a drug, which factor must be considered?
• What must health care facilities handling non-creditable hazardous waste pharmaceuticals obtain?
• Procurement Costs cover which activities?
• What is the purpose of DEA Form 224B?
• Which item is included in Transaction Information?
• The FAERS database supports post-market surveillance by collecting which of the following?
• When closing a pharmacy, to whom should unused DEA Form 222 order forms be returned?
• What standards does the EPA impose through the Resource Conservation and Recovery Act?
• Before starting clinical research, which application must be submitted to the FDA?
• Which statement about Schedule II controlled substances transfer is true?
• What is required if the inventory of controlled substances will not fit in a safe or cabinet?
• What term describes the set of numbers or characters used to uniquely identify each package or homogenous case, comprising the NDC and a unique alphanumeric serial number up to 20 characters?
• What is the 340B Drug Pricing Program?
• What does the FDA registration approval process include?
• Which data elements does the EPCIS framework capture to enable supply chain visibility?
• What is the role of the FDA?
• Which key concept under RCRA is embodied by the requirement for tracking and permitting?
• The Sentinel Initiative was launched in 2008 to monitor safety of approved medical products using real-time data from electronic health records and claims databases. Which statement best describes its goal?
• Which sequence accurately describes the required flow for hazardous waste pharmaceuticals?
• Which of the following best describes traditional distributors?
• Which term refers to an entity that repacks and relabels a product for sale or distribution without engaging in any further transaction?
• Which statement best describes typical P&T committee membership?
• Under DSCSA, a 'product' refers to what?
• Wholesaler is defined as which of the following?
• Which FDA reporting system collects adverse event reports, medication error reports, and product quality complaints?
• Which item is included on the IND application? (to describe studies?)
• Which statement best describes 503A compounding?
• To keep prescription drug costs down, which approach is safest?
• How must pharmacies store Schedule II controlled substances?
• Which form serves as the Certificate of DEA Registration?
• DEA Form 41: Recording breakage or spillage does not constitute a loss because the registrant can account for the controlled substances and requires 2 witnesses.
• Purpose of Phase 1 Clinical Drug Trial
• The days' supply is calculated by which of the following formulas?
• Which of the following may indicate the product is suspicious and should be quarantined?
• What problems did the Resource Conservation and Recovery Act address?
• The DSCSA of 2013 amended the FDCA to enhance safety by mandating development of what?
• If no storage requirements have been established, the drug should be stored:
• Which approach is considered safest and most cost-effective for obtaining prescription medications?
• The FDA requires which facilities to report medical device problems that result in serious illness, injury, or death?
• Schedule II substances are characterized by which combination?
• How often must 340B covered entities recertify their eligibility?
• What type of incentives does the Act provide?
• What do State Boards of Pharmacy license besides pharmacy personnel?
• What is the DSCSA’s track-and-trace requirement specifically focused on?
• DEA's CSOS allows for secure electronic transmission of Schedule I-V orders without the supporting paper Form 222. Where can CSOS orders be accessed?
• Early-phase trials focus on which aspects?
• If no storage requirements have been established for a prescription drug, where should the drug be stored?
• What is an example of a virtual distributor in pharmaceutical distribution?
• Pharmacy Buying Groups are essentially the same as a GPO but can work with smaller organizations. Which option best reflects this statement?
• Who else must register with the FDA besides manufacturers?
• Which scenario may put you at risk for purchasing counterfeit products?
• What is DEA Form 222 used for?
• Which of the following is NOT a Schedule IV example?
• What term describes sale, purchase, trade, delivery, handling, storage, or receipt of a product; does not include dispensing pursuant to a prescription?
• Which item is included in a New Drug Application (NDA) submission?
• A serial discount refers to which pricing practice?
• Which statement best describes state licensing requirements for 3PLs?
• Which statement about state licensing for controlled substances is accurate?
• Which statement about product types handled by wholesalers is true?
• Which group creates and maintains hospital formularies?
• What is the function of the manifest form?
• CSOS can be used to order which schedules?
• What term is used for a formulary that restricts drug choices to a pre-determined list?
• If a health care facility does not receive the signed shipping document, what must it provide to the EPA?
• Non creditable waste is defined as which of the following?
• Which of the following is a Schedule III example?
• What is true about customs brokers?
• Market withdrawal is described as what?
• Under DSCSA, what is a key purpose of product labeling and documentation for tracking and reporting?
• What must a health care facility do if it does not receive a signed shipping document within 60 days?
• For Schedule II medications, which statement about record retention is correct?
• What is the relationship between a 3PL and ownership of products?
• When was the Compounding Quality Act established?
• When are wholesale drug and device distributors required to report to the FDA?
• Which statement best describes how importation of pharmaceutics is regulated?
• What is a responsibility of State Boards of Pharmacy regarding complaints?
• If signed shipping documents are not received within the specified timeframe, which agency should be notified?
• Under the Compounding Quality Act, which statement about 503A pharmacies is true?
• Which statement best describes buffer stock or safety stock?
• Which of the following is a Schedule II substance?
• What types of products do some wholesalers handle?
• What is a key advantage of hospital formularies?
• Which statement about REMS products is true?
• Which of the following is a Schedule V example?
• The DEA biennial inventory:
• The primary purpose of the DEA is to enforce which act?
• In the context of pharmaceutical distribution, what is drop shipping?
• Which data element is explicitly listed as an element of Transaction Information?
• What should pharmacy staff do to verify the validity of each transaction when receiving DSCSA products?
• What is the DSCSA’s requirement for 503B Outsourcing Facilities regarding DSCSA documentation?
• Which statement best describes SNI in the context of DSCSA?
• Affirmation of Compliance Codes (A of C Codes) indicate:
• In a typical primary wholesaler arrangement, what share of prescription products is purchased from the primary wholesaler?
• Which entity coordinates warehousing or other services of interstate commerce on behalf of a manufacturer but does not own the product or direct its sale?
• Incompatible hazardous waste pharmaceuticals commingled in a container, what must a health care facility do?
• What must FDA approval prove?
• What must domestic and foreign facilities that manufacture, repack, or relabel human or veterinary drug products do?
• Which products are commonly included by secondary or specialty wholesalers?
• Which inventory system is computerized and measures inventory in real time?
• For a drug without storage requirements, store it:
• If a container holds more than 1000 units for Schedule III-V, the inventory must be what?
• Which statement correctly describes Schedule V substances?
• Which action should health care facilities take to obtain EPA identification numbers?
• When must transaction data be available for each DSCSA product?
• What must registered facilities report to the FDA?
• FAERS is a database that contains which types of reports submitted to the FDA?
• What led to the establishment of the FDA?
• Which channels are listed for notifying a Trading Partner?
• Which method requires staff to manually inspect inventory?
• Wholesaler Sourcing commonly includes backorder programs and what other service?
• Verification involves determining whether the product identifier matches which data?
• What is the Environmental Protection Agency (EPA)?
• Which of the following is regulated by the FDA according to the material?
• What is the primary driver of rising drug costs?
• Which statement best defines a repackager in the pharmaceutical supply chain?
• Unfit For Distribution refers to a prescription drug whose sale would violate the FDCA and is likely to cause serious harm. Which of the following is included in this category?
• The inventory record field 'Whether the inventory was taken at the beginning or close of business' indicates what?
• Trading partners are required to retain transaction records for how many years?
• Which document is associated with confirming the transfer of ownership between trading partners under DSCSA?
• What challenge does the lack of licensing or registration for OTC-only wholesalers create?
• Phase 2 of Clinical Trial for New Drug Approval
• Which category of products is regulated by the Drug Supply Chain Security Act (DSCSA)?
• Which statement best describes a primary wholesaler?
• Which of the following is a true statement about storage of controlled substances?
• How long must health care facilities keep a copy of the signed shipping document?
• Which of the following is a type of distributor in the pharmaceutical supply chain?
• Date of shipment is required under DSCSA if the shipment occurs more than 24 hours after the transaction date.
• Which item is included on the IND application?
• A drug with a domestically manufactured active pharmaceutical ingredient can claim 'Made in the USA' under which condition?
• Which term refers to ordering inventory via the internet?
• A prescription drug without established storage requirements should be kept:
• What are the requirements for containers holding hazardous waste pharmaceuticals?
• Which organization is notified by Form FDA 3911?
• A hospitalized patient is on a specialty medication delivered to the hospital from home by their family. This is an example of:
• Which statement about the relationship of state programs to federal standards is correct?
• MedWatch safety alerts cover which of the following FDA-regulated products?
• Setting Order Points involves determining how much and how often products should be ordered.
• In the pharmaceutical supply chain, which entity provides warehousing but does not take ownership or direct sales?
• Which statement best describes a Group Purchasing Organization (GPO)?
• What must health care facilities ensure about their personnel regarding hazardous waste?
• Where could a hospital legally obtain IV medications when standard distributors are unable to supply?
• Which option is an exemption from DSCSA transaction data requirements?
• Which entity owns or operates an establishment that dispositions or processes saleable or nonsalable product received from an authorized trading partner so the product may be processed for credit or disposed of for no further distribution?
• How many days before operating must a drug establishment be registered with the FDA?
• What must pharmacies contracted with the 340B program demonstrate?
• Phase 2 Purpose
• Which of the following is explicitly listed as a basis for suspending or revoking a DEA registration?
• Do transferring pharmacies need to provide product tracing information?
• The Compounding Quality Act established two types of pharmacies: 503A and 503B. What distinguishes these two categories?
• Which of the following is a Schedule III example?
• Costs associated with purchasing the product (e.g., checking inventory, placing orders, receiving orders, stocking the product, paying invoices) are called?
• Which pharmacy type is permitted to compound in bulk?
• For a drug with no specified storage requirements, choose the appropriate storage condition:
• For a prescription drug with no specified storage requirements, which storage condition is acceptable?
• Which scenario best illustrates a market withdrawal?
• If transaction data for a specialty medication order is not provided by the wholesaler, what is an appropriate immediate action?
• Which action would confirm a product is not suspicious?
• Which form is used to notify the FDA under tracing requirements?
• Which describes Brown Bagging?
• Phase 3 clinical trials are primarily conducted to evaluate which of the following?
• Which statement best describes Phase 4 trial scope?
• What term describes when a patient brings a prescription from home to be used in a hospital setting?
• What document serves as the certificate confirming a practitioner is registered with the DEA?
• Which metric is commonly used to determine how well inventory is managed?
• What is the formal definition of Demand Planning in supply chain management?
• If a DEA Form 222 or CSOS order has errors or omissions, what happens?
• Which program helps obtain vaccines for eligible children?
• How often must a registrant register with the FDA?
• Which act specifically targets government procurement policies to favor US-made drugs and vaccines in federal purchases?
• Which term is not described in the material?
• Who is required by FDA to report adverse events through MedWatch?
• How soon are Schedule II orders filled by wholesalers reported to the DEA?
• Which statement about medical device safety alerts is true?
• What is the overarching aim of EO 13944 and related acts?
• What is the most efficient and cost-effective way to manage inventory and ordering of an expensive specialty drug only used by one patient at your pharmacy?
• What additional security feature may be required for a safe or cabinet storing controlled substances?
• Which of the following are the three methods used in inventory management?
• If storage requirements are not established, the drug should be stored:
• Open to Buy Method involves...
• What must a pharmacy do if permanently closing or discontinuing supplying controlled substances?
• Diverted products include which of the following scenarios?
• Phase 1 of Clinical Trial typically enrolls which participants?
• What is required for a pharmacy to receive REMS products?
• Which mechanism does the EPA use to enforce hazardous waste requirements under RCRA?
• What is the primary purpose of 503B outsourcing facilities?
• What is DEA Form 224 used for?
• What forms can transaction data currently take?
• The Sentinel Initiative uses which data sources to monitor safety in real time?
• Which statement best describes a virtual manufacturer?
• MedSun primarily monitors safety and effectiveness of which medical products?
• Which statement describes the regulatory purpose of the IND in the drug development process?
• What labeling requirement does the Tariff Act impose on imported products?
• Which agencies have the power to add, change or remove controlled substances from the schedules?
• Which entities can purchase drugs at reduced rates under the 340B Drug Pricing Program?
• When a product is identified as illegitimate or high risk suspect for illegitimacy, what action must the manufacturer take and within what time frame?
• Which agency oversees the safety and efficacy of the nation's drug supply?
• If the country of manufacture is not shown on a product label, what enforcement concern arises under the Tariff Act and FDCA?
• Which product is subject to DSCSA?
• Which facility compounds preparations for office use?
• What is one purpose of State Boards of Pharmacy?
• During which period do FDA drug establishment registrations renew annually?
• What is a primary wholesaler?
• Which statement is true about outsourcing facilities with respect to CGMP and inspections?
• How often can schedule III through V controlled substances be transferred?
• Pharmacodynamics is the study of how the drug
• The copy of the signed shipping document must be retained for how long?
• Executive Order 13944 signed by President Trump on August 6, 2020 aims to:
• Wholesaler sourcing involves which of the following services?
• Phase 4 trials typically enroll how many volunteers with the disease or condition?
• Which statement correctly reflects how an inventory turn is calculated in the given example?
• Which form is required to order Schedule I or II controlled substances?
• Which statement accurately describes a DEA inventory requirement?
• Which act authorized the FDA to demand safety evidence for new drugs, issue standards for food, and conduct factory inspections?
• Which of the following may indicate a product is suspicious and should be quarantined until investigated?
• Which of the following is a typical Trading Partner role under the DSCSA?
• Which entity conducts inspections of outsourcing facilities to ensure CGMP compliance?
• MedWatch is a program designed to promote public safety by performing which function?
• State Boards license in the supply chain include which groups?
• Pharmacokinetics is the study of
• Which statement best defines a Class III recall?
• Which statement best describes how ordering is supported by primary wholesalers?
• What authority does the Resource Conservation and Recovery Act give to the EPA?
• An outsourcing facility may provide compounded products for use in a health system that are which of the following?
• When distributing to reverse distributor, which document is the reverse distributor responsible for maintaining for destruction?
• Non-creditable waste is described as which of the following?
• What is the requirement for a safe or cabinet weighing less than 750 pounds?
• What additional service may primary wholesalers offer in case of urgent needs?
• Which form is used to renew a DEA registration?
• Which of the following is a List 2 chemical?
• Under FTC rules, when can a product legally bear the phrase 'Made in USA'?
• Which group is explicitly described as handling prescription drugs and devices in the context of FDA registration?
• How often must the DEA Form 224A renewal be completed?
• What transparency measure does the Act introduce?
• Which inventory approach orders products as needed to meet demand?
• What must facilities do with hazardous waste pharmaceuticals?
• Under what conditions can states operate their own hazardous waste programs?
• Dispensers are typically thought of as which group?
• What is a benefit of performing a daily order?
• A drug lacks established storage requirements. The recommended storage is:
• Which act would require federal agencies to purchase drugs made in the US when available?
• What must the pharmacy do if a stolen or lost unused DEA Form 222 is later recovered?
• The Federal Food, Drug, and Cosmetic Act of 1938 was passed in response to which tragedy?
• If a product is backordered from the primary wholesaler, which type of wholesaler would typically supply it?
• What term describes a person who owns or operates an establishment that repacks and relabels a product for sale or distribution without a further transaction?
• What is a third-party logistics (3PL) provider?
• Which agencies require shipments of hazardous waste to be accompanied by a manifest form?
• Which statement best defines anticipatory stock?
• Which statement best describes the EPICS System's purpose in supply chain visibility?
• Which entity is allowed to sell products to a wholesale drug distributor?
• Which statement best describes secondary or specialty wholesalers?
• In a virtual distribution model, who bills the pharmacy for the product?
• Which item is NOT included in a New Drug Application (NDA) submission?
• When ordering from a new supplier, what action is advisable?
• What must wholesale drug and device distributors include in their annual report to the FDA?
• Which term describes a product transfer between persons in which a change of ownership occurs?
• The goal of the 340B pricing program is to:
• Which statement best describes active pharmaceutical ingredients (APIs) in this context?
• Are OTC-only wholesalers that do not carry prescription products required to be licensed or registered?
• If no storage requirements exist, the proper storage is:
• A prescription drug with no storage requirements is best stored at:
• Which statistic reflects how many days, on average, it would take to sell the entire inventory?
• Which statement is true about minimal quantities of product for office use?
• What should a pharmacy report if they cannot provide the order form numbers for a stolen DEA Form 222?
• A prescription drug wholesaler is required to:
• Under FDCA labeling laws, what must appear on a drug label?
• Can some specialty products only be purchased from the manufacturer?
• What benefit does a contract with a primary wholesaler provide?
• Which statement correctly describes CBP's role in drug importation?
• Quantity discounts refer to which of the following?
• The hospital pharmacy is unable to purchase an IV medication from their wholesale distributor and it is in short supply. Which option is appropriate?
• When purchasing a specialty drug from a new wholesaler, authentication will include:
• Which formula expresses ITOR?
• Which of the following describes a permissible secured enclosure for Schedule III–V substances?
• An NDA must include data from studies conducted outside the United States.
• Authentication of an outsourcing facility should include checks with which parties?
• ADR stands for which term in pharmaceutical distribution?
• The Trade Agreements Act (TAA) was enacted to govern trade agreements between the US and foreign countries.
• Who must notify the FDA within 24 hours when illegitimate or high-risk product is identified?
• Which of the following is an environmental benefit of using electronic data interchange (EDI) for controlled substance orders?
• Must the address on a drug label correspond to the place where the drug was manufactured?
• Which statement correctly describes Days of Supply?
• Which of the following is a List 1 chemical?
• A Trading Partner is best described as which of the following?
• What action should be taken if a product shows adhesive residue on the outside of the bottle?
• Where can Schedules III, IV, and V controlled substances be stored?
• What calculation expresses Days on Hand (DOH)?
• How many prescription products does a pharmacy typically purchase from its primary wholesaler?
• What are REMS products?
• What type of entities do State Boards of Pharmacy license in the supply chain?
• What is the Transaction History?
• What is one of the advised methods of authenticating a supplier?
• How does the FDA contribute to national security?
• What does the Just in Time method prioritize?
• Which statement best describes a Third Party Logistics Provider?
• How often must controlled substance inventories be completed?
• The Protecting Our Pharmaceutical Supply Chain From China Act of 2020 aims to track?
• Which standard provides a common language for sharing data to enable supply chain visibility in pharmaceutical tracing?
• Which agency is responsible for ensuring the safety, efficacy, and security of foods, drugs, biologics, radioactive products, medical devices, and cosmetics?
• What may indicate a product is suspicious and should be investigated?
• In emergencies, pharmacies not in the same network may transfer drugs, limited to an annual amount of what percentage of the transferring pharmacy's annual dispensed amount for that drug?
• What is the purpose of the manifest form for hazardous waste?
• Which provisions were authorized by the Federal Food, Drug, and Cosmetic Act of 1938?
• Which data element is NOT listed as captured by the EPCIS/EPICS framework?
• Which agency enforces DSCSA?
• Which supply chain entity is responsible for verifying the authorization of trading partners?
• If a product's transaction history has a whited-out transaction and the supplier will not reveal the trading partner because it is proprietary, what should you do?
• When will the DEA send a reminder to complete DEA Form 224A?
• Which entity is responsible for protecting the rights and welfare of human research subjects in clinical trials?