MPJE GUIDE CHAPTER 1

<p>Prescription drugs must have adequate directions for safe and effective use.</p> Signup and view all the answers

<p>A drug that is not packaged or labeled accordingly is considered adulterated.</p> Signup and view all the answers

<p>Promoting a compounded drug that is false or misleading.</p> Signup and view all the answers

<p>An expired drug product in a manufacturer's bottle is considered adulterated.</p> Signup and view all the answers

<p>Storing medication on a pharmacy shelf instead of in the refrigerator as required</p> Signup and view all the answers

<p>Misbranding of the product</p> Signup and view all the answers

<p>Dispensing a medication in a child-resistant container when required</p> Signup and view all the answers

<p>Medical gases</p> Signup and view all the answers

<p>All of the above</p> Signup and view all the answers

<p>6 years</p> Signup and view all the answers

<p>All of the above</p> Signup and view all the answers

<p>Outsourcing facilities must label their products as compounded drugs.</p> Signup and view all the answers

<p>The bulk drug substance must be accompanied by a valid certificate of analysis.</p> Signup and view all the answers

<p>5%</p> Signup and view all the answers

<p>The pharmacy must limit the distribution to 2% of the total prescription orders.</p> Signup and view all the answers

<p>Medicare Prescription Drug Improvement and Modernization Act of 2003</p> Signup and view all the answers

<p>To establish a framework for a uniform track and trace system for prescription drugs throughout the supply chain</p> Signup and view all the answers

<p>Outsourcing facilities can compound sterile products without patient-specific prescriptions, while compounding pharmacies can only compound products pursuant to an individual prescription or medication order</p> Signup and view all the answers

<p>To ban the reimportation of prescription drugs and insulin products produced in the United States</p> Signup and view all the answers

<p>Having a wholesale distribution license</p> Signup and view all the answers

<p>Dispensing product to another dispenser on a patient-specific basis</p> Signup and view all the answers

<p>An entity that provides or coordinates warehousing or other logistics services of a product</p> Signup and view all the answers

<p>All of the above</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>The products would be adulterated.</p> Signup and view all the answers

<p>The product will be adulterated.</p> Signup and view all the answers

<p>It would be considered misbranding.</p> Signup and view all the answers

<p>Outsourcing facilities are required to label products with a statement identifying them as a compounded drug and other specified information about the drug.</p> Signup and view all the answers

<p>The drug product can be compounded if the bulk drug substance appears on the 503B bulks list or if the drug product compounded from such bulk drug substance appears on the FDA's drug shortage list at the time of compounding, distribution, and dispensing.</p> Signup and view all the answers

<p>Section 503A limits interstate distribution of compounded drugs to 5% unless the compounder is located in a state that has entered into a memorandum of understanding (MOU) with the FDA.</p> Signup and view all the answers

<p>Pharmacies that are distributing drugs must have a wholesale distribution license and pass DSCSA transaction data with that distribution.</p> Signup and view all the answers

<p>The purpose of the Federal Food, Drug, and Cosmetic Act (FDCA) is to establish the FDA and serve as the primary federal law dealing with food, drug, cosmetic, and medical device safety.</p> Signup and view all the answers

<p>The major amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) include the Durham-Humphrey Amendments of 1951, which established two classes of drugs (prescription and over-the-counter), and the Kefauver-Harris Amendments of 1962, which required new drugs to be proven safe and effective for their claimed use and increased safety requirements for drugs.</p> Signup and view all the answers

<p>A drug is considered adulterated if it contains any filthy, putrid, or decomposed substance, if it has been prepared, packed, or held under unsanitary conditions, if it is the product of a container that is composed, in whole or in part, of any poisonous or deleterious substance, or if it is a drug and its container is composed, in whole or in part, of any unsafe substance that may render the contents injurious to health.</p> Signup and view all the answers

<p>The purpose of the DSCSA is to provide a uniform national framework for an electronic track and trace system for prescription drugs as they move through the supply chain and to set national standards for states to license drug wholesaler-distributors.</p> Signup and view all the answers

<p>A third-party logistics provider (3PL) is an entity that provides or coordinates warehousing or other logistics services on behalf of a manufacturer, wholesaler, or dispenser of a product but does not take ownership of the product.</p> Signup and view all the answers

<p>A drug is considered adulterated if it contains any filthy, putrid, or decomposed substance; has been prepared, packed, or held under insanitary conditions; its container is composed, in whole or in part, of any poisonous or deleterious substance; or its strength, quality, or purity falls below the standards set forth in its official compendium.</p> Signup and view all the answers

<p>If pharmacies receive a notification of an illegitimate product, they must verify the product identifier of the product in question and notify the FDA using Form FDA 3911. They must also notify their trading partners within 24 hours.</p> Signup and view all the answers

<p>The purpose of the Drug Quality and Security Act (DQSA) of 2013 is to address two primary topics: large-scale compounding by pharmacies and the establishment of a framework for a uniform track and trace system for prescription drugs throughout the supply chain.</p> Signup and view all the answers

<p>According to the text, a drug is considered adulterated if it contains any filthy, putrid, or decomposed substance.</p> Signup and view all the answers

<p>The main difference between outsourcing facilities (503B facilities) and compounding pharmacies (503A facilities) is that outsourcing facilities are permitted to compound sterile products without receiving patient-specific prescriptions or medication orders, while compounding pharmacies may only compound products pursuant to an individual prescription or medication order.</p> Signup and view all the answers

<p>According to the text, the requirement for a pharmacy to distribute compounded drug products out of the state in which they are compounded in states that have not entered into a memorandum of understanding (MOU) with the FDA is that interstate distribution of compounded drugs is limited to 10%, unless the compounder is located in a state that has entered into an MOU with the FDA.</p> Signup and view all the answers

<p>The labeling requirements for prescription drugs dispensed by pharmacists do not have to contain all the elements required for the manufacturer's container, except for requirements for patient package inserts and medication guides. State prescription drug labeling requirements would dictate what is required on the label.</p> Signup and view all the answers

<p>OTC products must have adequate directions for safe and effective use and must include the content and format of OTC product labeling in the 'Drug Facts' panel format, which includes active ingredients, purpose, use(s), warnings, inactive ingredients, and optional questions followed by a telephone number.</p> Signup and view all the answers

<p>A drug can be considered adulterated if: it is liable to deterioration unless it is packaged or labeled accordingly, the container is made, formed, or filled so as to be misleading, the drug is an exact imitation of another drug or offered for sale under the name of another drug, it is dangerous to health when used in the dosage or manner suggested in the labeling, or it is packaged or labeled in violation of the Poison Prevention Packaging Act.</p> Signup and view all the answers

<p>A drug can be considered misbranded if: it is dispensed without authorization, it is not packaged in a child-resistant container when required, it is filled with the wrong drug, strength, or directions for use, it is subject to a Risk Evaluation and Mitigation Strategy (REMS) and is prescribed or dispensed without meeting the REMS requirements, the advertising or promotion of a compounded drug is false or misleading, or it is expired and the strength cannot be assured.</p> Signup and view all the answers

<p>A drug is considered adulterated if it contains any filthy, putrid, or decomposed substance; it has been prepared or held under unsanitary conditions where it may have been contaminated; the methods of manufacture do not conform to current Good Manufacturing Practices (cGMPs); it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment, and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection or refuses to permit entry or inspection; the container is composed of any poisonous or deleterious substance which may contaminate the drug; it contains an unsafe color additive; it purports to be a drug in an official compendium, and its strength differs from or its quality or purity falls below the compendium standard unless the difference is clearly stated on the label; it is not in a compendium, and its strength differs from or its quality falls below what it represents (i.e., what is on its label); it is mixed or packed with any substance that reduces its strength or quality, or the drug has been substituted in whole or in part.</p> Signup and view all the answers

<p>A drug is considered misbranded if its labeling is false or misleading in any particular way; it is a prescription drug, and the manufacturer's label fails to contain the following information: the name and address of the manufacturer, packer, or distributor; brand and/or generic name of the drug or drug product; the net quantity (weight, quantity, or dosage units); the weight of active ingredient per dosage unit; the federal legend, “Rx only.”; if not taken orally, the specific routes of administration (e.g., for IM injection); special storage instructions if appropriate; manufacturer's control number (lot number); expiration date; adequate information for use (package insert and medication guide or patient package insert if required); this includes other information required (e.g. cautionary statements, warnings, contraindications, etc.).</p> Signup and view all the answers

<p>The exceptions to having a distribution license and passing transaction data for pharmacies are: (1) when the distribution is between two entities that are affiliated or under common ownership; (2) when a dispenser is providing product to another dispenser on a patient-specific basis; (3) when a dispenser is distributing under emergency medical reasons; or (4) when a dispenser is distributing “minimal quantities” to a licensed practitioner for office use.</p> Signup and view all the answers

<p>A third-party logistics provider or 3PL is an entity that provides or coordinates warehousing or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product but does not take ownership of the product, nor have a responsibility to direct the sale or disposition of the product.</p> Signup and view all the answers

<p>Federal Food, Drug, and Cosmetic Act (FDCA) = Established the FDA and is the primary federal law dealing with food, drug, cosmetic, and medical device safety today Poison Prevention Packaging Act (PPPA) = Requires child-resistant packaging for certain medications Kefauver-Harris Amendments of 1962 = Required new drugs be proven safe and effective for their claimed use. Increased safety requirements for drugs and established Good Manufacturing Practices (GMPs) for manufacturing of drugs Durham-Humphrey Amendments of 1951 = Established two classes of drugs: prescription and over-the-counter (OTC)</p> Signup and view all the answers

<p>Insulin products = Some are nonprescription, while certain others, such as Lantus° and Humalog°, are prescription-only products Ibuprofen 200 mg = Does not require a prescription Ibuprofen 400 mg, 600 mg, and 800 mg = Require a prescription Prescription drugs = Always require a prescription</p> Signup and view all the answers

<p>Adulterated = A drug is considered adulterated if it does not meet the required quality or purity standards Misbranded = A drug is considered misbranded if its labeling is false or misleading Prescription drugs = Drugs that can only be dispensed with a valid prescription Over-the-counter (OTC) drugs = Drugs that can be purchased without a prescription</p> Signup and view all the answers

<p>Prescription Drug Marketing Act of 1987 (PDMA) = Bans the reimportation of prescription drugs and insulin products produced in the United States (except by the manufacturer) Medicine Equity and Drug Safety (MSDS) Act of 2000 and the Medicare Prescription Drug Improvement and Modernization Act of 2003 = Allow the importation of drugs under specific conditions Drug Quality and Security Act (DQSA) of 2013 = Addresses large-scale compounding by pharmacies and the establishment of a framework for a uniform track and trace system for prescription drugs Durham-Humphrey Amendments of 1951 = Established three classes of drugs: prescription, over-the-counter (OTC), and nonprescription</p> Signup and view all the answers

<p>503A facilities or 503A pharmacies = Compounding pharmacies that may only compound products pursuant to an individual prescription or medication order Outsourcing facilities or 503B facilities = Facilities that are permitted to compound sterile products without receiving patient-specific prescriptions or medication orders FDA Section 505 = New drug provisions that outsourcing facilities are exempt from FDA Section 582 = Drug track and trace provisions that outsourcing facilities are exempt from</p> Signup and view all the answers

<p>FDA Section 505 = Outsourcing facilities must be exempt from this provision FDA Section 502(I)(1) = Outsourcing facilities must be exempt from the adequate directions for use requirement FDA Section 582 = Outsourcing facilities must be exempt from the drug track and trace provisions cGMPs = Outsourcing facilities are primarily regulated by this FDA requirement</p> Signup and view all the answers

<p>503A facilities or 503A pharmacies = Compounding pharmacies that are primarily regulated by the states and are subject to USP Chapter 797 quality standards for sterile compounding Outsourcing facilities or 503B facilities = Facilities that are primarily regulated by the FDA and are subject to the FDA's current Good Manufacturing Practices (cGMPs) PDMA = An act that bans the sale, trade, or purchase of prescription drug samples DQSA = An act that addresses large-scale compounding by pharmacies and the establishment of a framework for a uniform track and trace system for prescription drugs</p> Signup and view all the answers

<p>Registration = Report to the Secretary of HHS upon registering, and every six months thereafter, the drugs sold in the previous six months Inspection = Be inspected by the FDA according to a risk-based inspection schedule and pay annual fees to support it Adverse Events = Report serious adverse event experiences within 15 days and conduct a follow-up investigation and reporting similar to current drug manufacturers Labeling = Label products with a statement identifying them as a compounded drug and other specified information about the drug</p> Signup and view all the answers

<p>503B bulks list = The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need FDA's drug shortage list = The drug product compounded from such bulk drug substance appears on the FDA's drug shortage list at the time of compounding, distribution, and dispensing Certificate of analysis = Bulk drug substances must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with the FDA USP or National Formulary monograph = If an applicable United States Pharmacopeia (USP) or National Formulary monograph exists, bulk drug substances must comply with the monograph</p> Signup and view all the answers

<p>5% Limit = In states that have not entered into an MOU with the FDA, a pharmacy may not distribute (or cause to be distributed) compounded drug products out of the state in which they are compounded in quantities that exceed 5% of the total prescription orders dis- pensed or distributed by such pharmacy MOU with FDA = In states that have entered into an MOU with the FDA, a pharmacy is considered to have distributed an inordinate amount of compounded drug products in interstate commerce if the number of prescription orders for compounded human drug products that the pharmacy distributed interstate during any calendar year is greater than 50% of the sum of: the number of prescription orders for compounded human drug products that the pharmacy sent out of(or caused to be sent out of) the facility in which the drug products were compounded during that same calendar year; plus the number of prescription orders for com- pounded human drug products that were dispensed (e.g., picked up by a patient) at the pharmacy during that same calendar year</p> Signup and view all the answers

<p>Withdrawal = A lawsuit filed by some compounding pharmacies has caused the FDA to withdraw the October 2020 MOU Development of new MOU = FDA will now develop an MOU through the rulemaking process</p> Signup and view all the answers

<p>Misbranding = Failing to dispense a medication in a child-resistant container when required Adulteration = Storing a medication on a pharmacy shelf instead of in the refrigerator as required</p> Signup and view all the answers

<p>Failing to dispense a medication in a child-resistant container when required = Misbranding Counting a medication on a tray that has residue from another medication = Adulteration Storing a medication on a pharmacy shelf instead of in the refrigerator as required = Adulteration Dispensing a prescription without authorization = Misbranding</p> Signup and view all the answers

<p>A misfilled prescription involves the wrong strength of the drug prescribed = Adulteration A drug is subject to a Risk Evaluation and Mitigation Strategy (REMS) and it is prescribed or dispensed without meeting the requirements of the REMS = Misbranding The advertising or promotion of a compounded drug that is false or misleading = Misbranding An expired drug product in a manufacturer's bottle is used = Adulteration</p> Signup and view all the answers

<p>Adulteration = The container is made, formed, or filled so as to be misleading Misbranding = The drug is dangerous to health when used in the dosage or manner suggested in the labeling</p> Signup and view all the answers

<p>Adulteration = The act of making a drug impure or unwholesome by adding extraneous, improper, or inferior ingredients Misbranding = The act of labeling a drug incorrectly or in a way that is false or misleading Outsourcing facility = A facility at one geographic location or address that is engaged in the compounding of sterile drugs Third-party logistics provider (3PL) = An entity that provides or coordinates warehousing or other logistics services with respect to a product in interstate commerce</p> Signup and view all the answers

<p>Storing inventory in a room with inadequate temperature control = Adulteration of the products Failing to dispense a medication in a child-resistant container when required = Misbranding Storing a medication on a pharmacy shelf instead of in the refrigerator as required = Adulteration of the product Dispensing a prescription without authorization = Misbranding, even if it is labeled correctly by the pharmacist</p> Signup and view all the answers

<p>Prescription Drug Marketing Act of 1987 (PDMA) = Bans the reimportation of drugs produced in the United States and then exported Kefauver-Harris Amendments of 1962 = Increased safety requirements for drugs and established Good Manufacturing Practices (GMPs) for manufacturing of drugs Medicine Equity and Drug Safety (MSDS) Act of 2000 and the Medicare Prescription Drug Improvement and Modernization Act of 2003 = Allow the importation of drugs under specific conditions Federal Food, Drug, and Cosmetic Act (FDCA) = Established the FDA and is the primary federal law dealing with food, drug, cosmetic, and medical device safety today</p> Signup and view all the answers

<p>Adulteration = A drug is adulterated if it contains any filthy, putrid, or decomposed substance, or if it has been prepared or held under unsanitary conditions where it may have been contaminated, among other conditions Misbranding = A drug is misbranded if its labeling is false or misleading in any particular way, or if it is a prescription drug and the manufacturer's label fails to contain certain required information, among other conditions Outsourcing Facility (503B) = An entity that prepares compounded drugs or repackages drugs and meets certain requirements Third-Party Logistics Provider (3PL) = An entity that provides or coordinates warehousing or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product but does not take ownership of the product</p> Signup and view all the answers

<p>Adulteration = Manufactured, processed, packed, or held in any factory, warehouse, or establishment, and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection or refuses to permit entry or inspection</p> Signup and view all the answers

<p>Misbranding = A prescription drug, and the manufacturer's label fails to contain the net quantity (weight, quantity, or dosage units)</p> Signup and view all the answers

<p>Adulteration = A drug is adulterated if it contains an unsafe color additive, or if it purports to be a drug in an official compendium, and its strength differs from or its quality or purity falls below the compendium standard unless the difference is clearly stated on the label, among other conditions Misbranding = A drug is misbranded if it is a prescription drug, and the manufacturer's label fails to contain the federal legend, “Rx only,” or if it is a prescription drug and not taken orally, the specific routes of administration are not mentioned on the label, among other conditions Outsourcing Facility (503B) = An entity that prepares compounded drugs or repackages drugs and meets certain requirements Third-Party Logistics Provider (3PL) = An entity that provides or coordinates warehousing or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product but does not take ownership of the product</p> Signup and view all the answers

<p>Transaction Information = Includes the product's name, strength, and dosage form; NDC number; container size and number of containers; date of transaction; and name and address of the person from whom ownership is being transferred and to whom ownership is being transferred Transaction History = A paper or electronic statement that includes prior transaction information for each prior transaction back to the manufacturer Transaction Statement = A paper or electronic statement by the seller that the seller is authorized (licensed), received the product from an authorized (licensed) person, received the transaction information and transaction history from the prior owner if required, did not knowingly ship a suspect or illegitimate product, has systems and processes to comply with verification requirements, and did not knowingly provide false transaction information Product Identifier = A standardized graphic with three elements: the product's standardized numerical identifier (SNI), which comprises the NDC Drug Code plus a unique alphanumeric serial number; a lot number; and an expiration date</p> Signup and view all the answers

<p>Suspect Product = Products that one has reason to believe are potentially counterfeit, diverted, stolen, subject of a fraudulent transaction, intentionally adulterated, or appear otherwise unfit for distribution such that they would result in serious adverse health consequences or death to humans Illegitimate Product = Products for which credible evidence shows that the product is counterfeit, diverted, stolen, subject of a fraudulent transaction, intentionally adulterated, or appears otherwise unfit for distribution such that it would result in serious adverse health consequences or death to humans Pharmacy Investigation = As part of the investigation, a pharmacy must verify the product identifier of at least 3 products or 10% of the suspect product, whichever is greater, or all of the packages if there are fewer than 3 Illegitimate Product Notification = If a product is illegitimate, pharmacies must notify the FDA using Form FDA 3911 and notify trading partners within 24 hours</p> Signup and view all the answers

<p>Transaction Data = Data that must be maintained for 6 years by each supply chain partner and includes Transaction Information, Transaction History, and a Transaction Statement Pharmacy Requirement = Pharmacies may only receive drugs with product identifiers. Pharmacies are not yet required to authenticate (scan) those product identifiers Manufacturer Requirement = Manufacturers are required to provide “Transaction Data” for each product sold Wholesaler Requirement = Wholesalers are required to receive transaction data upon purchase and subsequently provide transaction data to the buyer (pharmacies or other wholesalers)</p> Signup and view all the answers

<p>Product Identifier = A standardized graphic with three elements: the product's standardized numerical identifier (SNI), a lot number, and an expiration date Pharmacy Action = Pharmacies must investigate and properly handle suspect and illegitimate products. Pharmacies must also verify any illegitimate product in response to a notification of an illegitimate product from the FDA or a trading partner Illegitimate Product Handling = If a product is illegitimate, pharmacies should also work with the manufacturer to prevent illegitimate products from reaching patients Illegitimate Product Notification = If a product is illegitimate, pharmacies must notify the FDA using Form FDA 3911 and notify trading partners within 24 hours</p> Signup and view all the answers

<p>Syringes</p> Signup and view all the answers

<p>Not all medical devices require a prescription.</p> Signup and view all the answers

<p>Animal drugs have to be approved by the FDA as safe and effective.</p> Signup and view all the answers

<p>FDA</p> Signup and view all the answers

<p>FTC</p> Signup and view all the answers

<p>The product has serious risks relative to benefits.</p> Signup and view all the answers

<p>All of the above</p> Signup and view all the answers

<p>Distributing a side effects statement</p> Signup and view all the answers

<p>To manage the known risks of a drug</p> Signup and view all the answers

<p>Monitoring patients using the drug</p> Signup and view all the answers

<p>A program for registering pharmacies that can dispense isotretinoin</p> Signup and view all the answers

<p>21 CFR 201.20</p> Signup and view all the answers

<p>Aspartame</p> Signup and view all the answers

<p>Sulfites</p> Signup and view all the answers

<p>Allow refills</p> Signup and view all the answers

<p>30-day supply</p> Signup and view all the answers

<p>Complete a Thalomid Patient-Physician Agreement Form</p> Signup and view all the answers

<p>7 days</p> Signup and view all the answers

<p>FDA Orange Book</p> Signup and view all the answers

<p>Drug products in identical dosage forms and route(s) of administration</p> Signup and view all the answers

<p>The pharmaceutical equivalence of the drug</p> Signup and view all the answers

<p>A biological product that is highly similar to the reference product, with no clinically meaningful differences</p> Signup and view all the answers

<p>Sexually transmitted diseases (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.</p> Signup and view all the answers

<p>Must warn about liver toxicity. Must warn not to use with other products containing acetaminophen and to talk to a doctor or pharmacist before taking with warfarin.</p> Signup and view all the answers

<p>Must include the term “NSAID” prominently on the label. Must contain “stomach bleeding” warning.</p> Signup and view all the answers

<p>Must provide the following warning: '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.'</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>Class I, Class II, Class III</p> Signup and view all the answers

<p>Dental floss</p> Signup and view all the answers

<p>The highest level of regulatory control</p> Signup and view all the answers

<p>The label must disclose the presence of FD&amp;C Yellow No. 5 and No. 6 and provide a warning in the 'precautions' section that the drug may cause an allergic reaction in certain susceptible persons.</p> Signup and view all the answers

<p>The label must contain a warning in the 'precautions' section that the product contains phenylalanine, with the amount specified in milligrams per dosage unit, and that it is not suitable for individuals with phenylketonuria.</p> Signup and view all the answers

<p>The label must include an allergy warning in the 'warnings' section for prescription drugs containing sulfites, which are often used as preservatives.</p> Signup and view all the answers

<p>The prescription drug labeling requirements would apply and would include the prescriber's directions for use.</p> Signup and view all the answers

<p>The FDA regulates the advertising of prescription drugs.</p> Signup and view all the answers

<p>A drug requires a Medication Guide if patient labeling could prevent serious adverse effects, if the product has serious risks relative to benefits, or if patient adherence to directions is crucial.</p> Signup and view all the answers

<p>PPIs must be given to patients in the community setting when new and refill prescriptions for certain products are dispensed, such as oral contraceptives and estrogen-containing products.</p> Signup and view all the answers

<p>FDA Orange Book</p> Signup and view all the answers

<p>'Pharmaceutical equivalents' are drug products in identical dosage forms and route(s) of administration that contain identical amounts of the identical active drug ingredient. 'Therapeutic equivalents' are approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.</p> Signup and view all the answers

<p>The FDA Purple Book lists biological products that are considered biosimilars and provides interchangeability evaluations for these products.</p> Signup and view all the answers

<p>A biosimilar product is highly similar to the reference product, with no clinically meaningful differences in terms of safety, purity, and potency. An interchangeable product is a biosimilar product that has been shown to produce the same clinical result as the reference product in any given patient.</p> Signup and view all the answers

<p>Requires warning regarding nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts.</p> Signup and view all the answers

<p>The following statement (boxed and in red letters) must appear: “For emergency use to cause vomiting in poisoning. Before using, call the physician, the poison prevention center, or the hospital emergency room immediately for advice.” The following warning must appear: “Warning: Keep out of reach of children. Do not use in unconscious persons.”</p> Signup and view all the answers

<p>Must contain a warning about possible kidney damage when taken in large amounts or for a long period of time.</p> Signup and view all the answers

<p>Aspirin and other salicylate drugs must have special warnings for use in children, including a warning regarding Reye's syndrome. Retail containers of1'Z‹ grain (pediatric) aspirin cannot be sold in containers holding more than 36 tablets.</p> Signup and view all the answers

<p>The purpose of the iPLEDGE Program is to prevent pregnancy and birth defects in patients taking isotretinoin.</p> Signup and view all the answers

<p>Pharmacists must obtain authorization from iPLEDGE, verify that the patient is registered and has received counseling, and confirm that the patient is not pregnant.</p> Signup and view all the answers

<p>Prescribers must enroll and become certified with Celgene, counsel patients on the benefits and risks of thalidomide, provide contraception counseling, verify negative pregnancy tests for female patients, complete a Thalomid Patient-Physician Agreement Form, and complete applicable mandatory confidential surveys.</p> Signup and view all the answers

<p>Pharmacies must be certified in the Thalomid REMS program, accept prescriptions with an authorization number and patient risk category, obtain a confirmation number prior to dispensing, dispense within 24 hours of obtaining the confirmation number, and provide counseling to patients.</p> Signup and view all the answers

<p>REMS are strategies to manage a known or potentially serious risk associated with a drug, drug class, or biological product. FDA requires a REMS if it finds that it is necessary to ensure that the benefits of the drug, drug class, or biological product outweigh the risks of the product.</p> Signup and view all the answers

<p>Elements to ensure safe use may include special training, experience, or certification of healthcare practitioners prescribing the drugs; special certification for pharmacies, practitioners, or healthcare settings that dispense the drug; dispensing drugs to patients only in certain healthcare settings such as hospitals; dispensing drugs to patients with evidence or other documentation of safe use conditions such as laboratory test results; monitoring patients using the drug; or enrolling each patient using the drug in a registry.</p> Signup and view all the answers

<p>The side effects statement is provided to enable consumers to report the side effects of prescription drugs to the FDA. It must read, 'Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.'</p> Signup and view all the answers

<p>The iPLEDGE Program is a program for the safe use of isotretinoin (Accutane). Only doctors registered in iPLEDGE can prescribe isotretinoin. Doctors registered with iPLEDGE must assume the responsibility for pregnancy counseling of female patients of childbearing potential. Prescribers must obtain and enter into the iPLEDGE system negative test results for those female patients of childbearing potential prior to prescribing isotretinoin. Only patients registered in iPLEDGE can be prescribed isotretinoin. In addition to registering with iPLEDGE, patients must comply with a number of key requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for the safe use of the drug, and, for women of childbearing potential, complying with required pregnancy testing and use of contraception. Only pharmacies registered in iPLEDGE can dispense isotretinoin. To register in iPLEDGE, a pharmacy must select a Responsible Site Pharmacist who must obtain iPLEDGE program information and registration materials via the internet (<a href="http://www.ipledgeprogram.com">www.ipledgeprogram.com</a>) or telephone (1-866-495-0654) and sign and return the completed registration form. To activate registration, the Responsible Site Pharmacist must access the iPLEDGE program via the internet (<a href="http://www.ipledgeprogram.com">www.ipledgeprogram.com</a>) or telephone (1-866-495-0654) and attest to the following points: I know the risk and severity of fetal injury/birth defects from isotretinoin. I will train all pharmacists on the iPLEDGE program requirements. I will comply and seek to ensure that all pharmacists comply with iPLEDGE program requirements. I will obtain isotretinoin from iPLEDGE-registered wholesalers.</p> Signup and view all the answers

<p>Class I = Low risk and subject to the least regulatory controls Class II = Higher risk and require greater regulatory controls Class III = Generally the highest-risk devices and subject to the highest level of regulatory control Class IV = Not mentioned in the text</p> Signup and view all the answers

<p>Dental floss = Class I Syringes = Class II Replacement heart valves = Class III Contact lenses = Not mentioned in the text</p> Signup and view all the answers

<p>Medical devices achieve their primary purpose through chemical action within or on the body = False Class I devices are subject to the highest level of regulatory control = False Not all medical devices require a prescription = True Animal drugs are not regulated by the FDA = False</p> Signup and view all the answers

<p>Prescription Drug = A drug that, because of its potential harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer it Over-the-counter (OTC) Drug = A drug that is safe and effective for use by the general public without seeking treatment by a healthcare professional Class I Recall = Reasonable probability that the product will cause either serious adverse effects on health or death Class III Recall = Not likely to cause adverse health consequences</p> Signup and view all the answers

<p>Accutane = Isotretinoin Coumadin = Warfarin sodium Epogen = Epoetin alfa Lotronex = Alosetron hydrochloride</p> Signup and view all the answers

<p>Reminder Advertising = Advertising of prescription drug prices under FDA regulations, where the only purpose is to provide information on price, not information on the drug's safety, efficacy, or indications for use Misleading Advertising = Advertising that includes false or misleading information about the drug or its uses Professional Services = Additional services that can be mentioned in the advertising, as long as they are not misleading Drug's Strength = Information that must be included in the advertising of prescription drug prices, along with the proprietary name, generic name, dosage form, and price charged for a specific quantity of the drug</p> Signup and view all the answers

<p>Isotretinoin = Dispensed in blister packages that cannot be broken Antidepressants in children and teenagers = Potential for serious adverse effects Coumadin = Has serious risks relative to benefits Lindane shampoo and lotion = Potential for serious adverse effects</p> Signup and view all the answers

<p>A = Pharmaceutically equivalent and therapeutically equivalent B = NOT pharmaceutically equivalent and therapeutically equivalent</p> Signup and view all the answers

<p>Biosimilar = A biological product that is highly similar to the reference product, with no clinically meaningful differences in terms of safety, purity, and potency Interchangeable = A biological product that has been shown to be biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient</p> Signup and view all the answers

<p>AB1, AB2, AB3 = Multiple pharmaceutically equivalent reference drugs that have not been determined to be bioequivalent to each other AA = Products with no known or suspected bioequivalence issues</p> Signup and view all the answers

<p>AA = Conventional dosage forms AN = Solutions and powders for aerosolization</p> Signup and view all the answers

<p>21 CFR 201.20 = FD&amp;C Yellow No. 5 and No. 6: Must disclose the presence and provide a warning that the drug may cause an allergic reaction in certain susceptible persons 21 CFR 201.21 = Aspartame: Must contain a warning about Phenyl-ketonuria and the amount of phenylalanine per dosage unit 21 CFR 201.22 = Sulfites: Prescription drugs containing sulfites must contain an allergy warning 21 CFR 201.303 and 201.314(g)(1) = Wintergreen Oil (methyl salicylate): Any drug containing more than 5% methyl salicylate must include a warning about dangerous use and keeping it out of reach of children</p> Signup and view all the answers

<p>FD&amp;C Yellow No. 5 and No. 6 = Must disclose the presence and provide a warning that the drug may cause an allergic reaction in certain susceptible persons Aspartame = Must contain a warning about Phenyl-ketonuria and the amount of phenylalanine per dosage unit Sulfites = Prescription drugs containing sulfites must contain an allergy warning Wintergreen Oil (methyl salicylate) = Any drug containing more than 5% methyl salicylate must include a warning about dangerous use and keeping it out of reach of children</p> Signup and view all the answers

<p>21 CFR 201.307 = Sodium Phosphates: Limits the amount in oral solution and requires specific warnings 21 CFR 201.302 = Mineral Oil: Requires warning to only be taken at bedtime and not be used in infants unless under the advice of a physician 21 CFR 201.21 = Aspartame: Must contain a warning about Phenyl-ketonuria and the amount of phenylalanine per dosage unit 21 CFR 201.303 and 201.314(g)(1) = Wintergreen Oil (methyl salicylate): Any drug containing more than 5% methyl salicylate must include a warning about dangerous use and keeping it out of reach of children</p> Signup and view all the answers

<p>Prescriber enrolls and becomes certified = Thalomid REMS program Prescriber obtains an authorization number and writes it on every prescription = Thalomid REMS program Prescriptions can only be accepted with an authorization number and patient risk category = Thalomid REMS program Prescriber verifies negative pregnancy tests for all female patients of reproductive potential = Thalomid REMS program</p> Signup and view all the answers

<p>Product is dispensed in blister packages, which cannot be broken = Isotretinoin distribution A 30-day supply is the maximum quantity that can be dispensed = Isotretinoin distribution No refills are allowed = Isotretinoin distribution Prescription must be written for a 4-week (28-day) supply or less = Thalomid distribution</p> Signup and view all the answers

<p>First 4 to 5 digits = Labeler code Next 3 to 4 digits = Specific drug, strength, and dosage form Last 1 to 2 digits = Package size The leading zero is inserted into one of the segments = To make the NDC 11 digits for billing and claims submissions</p> Signup and view all the answers

<p>NDC numbers are required for a drug manufacturer to list its product with the FDA = True The FDA suggests NDC numbers be included on the drug's label, but they are not technically required = True An NDC code does not indicate a drug is approved by FDA = True If a dietary supplement or medical device has an NDC number on its label, it would be misbranded = True</p> Signup and view all the answers

<p>Failure to provide a Medication Guide when dispensing a drug that requires one = Causes the drug to be misbranded Pharmacies and pharmacists are required to distribute a side effects statement to patients = When dispensing all new and refill prescriptions in the outpatient setting REMS are strategies to manage a known or potentially serious risk associated with a drug = Drug class, or biological product Isotretinoin (Accutane) iPLEDGE Program = Only doctors registered in iPLEDGE can prescribe isotretinoin</p> Signup and view all the answers

<p>Special training, experience, or certification of healthcare practitioners = Prescribing the drugs Special certification for pharmacies, practitioners, or healthcare settings = That dispense the drug Dispensing drugs to patients only in certain healthcare settings = Such as hospitals Monitoring patients using the drug = Or enrolling each patient using the drug in a registry</p> Signup and view all the answers

<p>Only doctors registered in iPLEDGE can prescribe = Isotretinoin Only patients registered in iPLEDGE can be = Prescribed isotretinoin Only pharmacies registered in iPLEDGE can = Dispense isotretinoin To activate registration, the Responsible Site Pharmacist must = Access the iPLEDGE program and attest to specific points</p> Signup and view all the answers

<p>Consumer Medication Information (CMI) = Not equivalent to or substitutable for FDA-regulated and mandated PPls and MedGuides Risk Evaluation and Mitigation Strategies (REMS) = Strategies to manage a known or potentially serious risk associated with a drug Prescription Drugs: Side Effects Statement = Enables consumers to report the side effects of prescription drugs to the FDA Isotretinoin (Accutane) iPLEDGE Program = Requires doctors, patients, and pharmacies to be registered in the program</p> Signup and view all the answers

<p>Alcohol Warning (21 CFR 201.322) = Requires a warning for persons consuming 3 or more alcoholic beverages per day and to consult with a doctor before taking OTC Products Containing Iron in Solid Oral Dosage Form (21 CFR 310.518(a)) = Must provide a warning about accidental overdose in children under 6 Over-the-Counter Drugs for Vaginal Contraceptive and Spermicide Use Containing Nonoxynol 9 as the Active Ingredient (21 CFR 301.325) = Requires a warning that the product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner OTC Pain Relievers (21 CFR 301.326) = Requires a warning about liver toxicity and not to use with other products containing acetaminophen without consulting a doctor or pharmacist</p> Signup and view all the answers

<p>Ipecac Syrup (21 CFR 201.308) = Requires a warning to keep out of reach of children and not to use in unconscious persons Phenacetin (acetophenetidin) (21 CFR 201.309) = Must contain a warning about possible kidney damage when taken in large amounts or for a long period of time Salicylates (21 CFR 201.314) = Must have special warnings for use in children, including a warning regarding Reye's syndrome OTC Drugs for Minor Sore Throats (21 CFR 201.315) = Must include a warning about when a sore throat may be serious and to consult a physician</p> Signup and view all the answers

<p>Ipecac Syrup (21 CFR 201.308) = The usual dosage is 1 tablespoon (15 ml) in individuals over one year of age OTC Products Containing Iron in Solid Oral Dosage Form (21 CFR 310.518(a)) = Must provide a warning about accidental overdose in children under 6 Potassium Salt Preparations for Oral Ingestions (21 CFR 201.306) = Requires warning not to exceed the dose prescribed and to contact physician if difficulty in breathing persists Phenacetin (acetophenetidin) (21 CFR 201.309) = Must contain a warning about possible kidney damage when taken in large amounts or for a long period of time</p> Signup and view all the answers

<p>Alcohol Warning = Internal analgesics and antipyretics are required to have a warning for persons consuming 3 or more alcoholic beverages per day and to consult with a doctor before taking Sexually transmitted diseases (STDs) alert = OTC drugs for Vaginal Contraceptive and Spermicide Use Containing Nonoxynol 9 must have a warning that the product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner Liver toxicity = OTC Pain Relievers must have a warning about this potential side effect Reye's syndrome = Salicylate drugs must have special warnings for use in children, including a warning regarding this syndrome</p> Signup and view all the answers

<p>Consumer Product Safety Commission (CPSC)</p> Signup and view all the answers

<p>Methyl Salicylate (oil of wintergreen)</p> Signup and view all the answers

<p>4% or more by weight</p> Signup and view all the answers

<p>Every 30 days</p> Signup and view all the answers

<p>14 days</p> Signup and view all the answers

<p>14 days</p> Signup and view all the answers

<p>The Alcohol and Tobacco Tax and Trade Bureau (TTB)</p> Signup and view all the answers

<p>An unauthorized acquisition, access, use, or disclosure of PHI that compromises its security or privacy</p> Signup and view all the answers

<p>Maintain a log of these breaches and notify HHS of these breaches annually</p> Signup and view all the answers

<p>Texas privacy laws require a pharmacy to respond to a request for confidential records by a patient within 15 days</p> Signup and view all the answers

<p>Overhearing counseling performed in a private area</p> Signup and view all the answers

<p>60 days</p> Signup and view all the answers

<p>Designating a Privacy Official</p> Signup and view all the answers

<p>15 days</p> Signup and view all the answers

<p>Preparations for human use in oral dosage forms containing more than 0.045 mg of loperamide in a single package</p> Signup and view all the answers

<p>Unflavored acetaminophen-containing preparations in powder form with no more than 13 grains of acetaminophen per unit dose</p> Signup and view all the answers

<p>Ibuprofen preparations containing 1 gram or more of ibuprofen in a single package</p> Signup and view all the answers

<p>Products containing more than 0.5 mg of dibucaine in a single package</p> Signup and view all the answers

<p>Consumer Product Safety Commission (CPSC)</p> Signup and view all the answers

<p>All of the above</p> Signup and view all the answers

<p>Occupational and Safety Health Administration (OSHA)</p> Signup and view all the answers

<p>Drugs in solid, final dosage form for administration to patients</p> Signup and view all the answers

<p>CPSC</p> Signup and view all the answers

<p>To classify the hazards of chemicals</p> Signup and view all the answers

<p>OSHA</p> Signup and view all the answers

<p>All of the above</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>False</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>Aspirin, Methyl Salicylate, Controlled Drugs, Methyl Alcohol, Iron-Containing Drugs, Dietary Supplements Containing Iron, Acetaminophen</p> Signup and view all the answers

<p>1g</p> Signup and view all the answers

<p>To require child-resistant containers for drugs and substances that could be harmful if ingested by children</p> Signup and view all the answers

<p>reporting adverse events to the FDA, reporting to health oversight agencies, reporting to law enforcement agencies</p> Signup and view all the answers

<p>reply within 15 days</p> Signup and view all the answers

<p>to limit PHI to the minimum necessary to accomplish the intended purpose</p> Signup and view all the answers

<p>sales representatives or janitorial service members accidentally seeing PHI during the normal course of their jobs, a customer overhearing counseling that is performed discreetly in a private area</p> Signup and view all the answers

<p>They must contain less than 10% acetaminophen with a median lethal dose greater than 5 g/kg of body weight and release at least 85 ml of carbon dioxide per grain of acetaminophen when placed in water.</p> Signup and view all the answers

<p>They must be other than those intended for pediatric use, packaged in unit doses with no more than 13 grains of acetaminophen per unit dose, and contain no other substance subject to the special packaging requirements.</p> Signup and view all the answers

<p>They must be for human use in oral dosage forms containing more than the equivalent of 66 mg of diphenhydramine base in a single package.</p> Signup and view all the answers

<p>They must be for human use in oral dosage forms containing 1 gram or more of ibuprofen in a single package.</p> Signup and view all the answers

<p>The definition of a 'breach' in terms of unauthorized acquisition, access, use, or disclosure of PHI is when it compromises the security or privacy of the information. It does not include inadvertent disclosures within the same organization or instances where the covered entity or B.A. has a good faith belief that the PHI is not further acquired, accessed, retained, used, or disclosed.</p> Signup and view all the answers

<p>For breaches affecting fewer than 500 individuals, covered entities must maintain a log of these breaches and notify HHS of these breaches annually.</p> Signup and view all the answers

<p>For breaches affecting more than 500 individuals, the Secretary of HHS, prominent local media, and the affected individuals must be notified within 60 days after the breach is discovered.</p> Signup and view all the answers

<p>Perform a Medication Regimen Review for all long-term care patients every 30 days and report any irregularities to the attending physician, the facility's medical director, and the facility's director of nursing.</p> Signup and view all the answers

<p>Psychotropic drugs must be limited to diagnosed and documented conditions and when used PRN, they must be limited to 14 days unless the practitioner documents the rationale for extending an order beyond 14 days. PRN orders for psychotropic drugs cannot be renewed unless the attending physician evaluates the patient for the appropriateness of that drug.</p> Signup and view all the answers

<p>Pharmacies may not dispense more than a 14-day cycle of medications to LTCF residents, with limited exceptions.</p> Signup and view all the answers

<p>Controlled substances may be mailed to patients if the prescription container is labeled in compliance with prescription labeling rules, the outer wrapper or container in which the prescription is placed is free of markings that would indicate the nature of the contents, and no markings of any kind are placed on the package to indicate the nature of the contents.</p> Signup and view all the answers

<p>The label must include the name and business address of the manufacturer, packer, distributor, or seller; the common or usual or chemical name of each hazardous ingredient; the signal word 'Danger' for corrosive, extremely flammable, or highly toxic products, and 'Caution' or 'Warning' for all other hazardous products; an affirmative statement of the principal hazard or hazards that the product presents; precautionary statements for user safety; first aid treatment instructions if the product injures someone; the word 'Poison' for highly toxic products, in addition to the signal word 'Danger'; instructions for handling or storage if necessary; and the statement 'Keep out of the reach of children'.</p> Signup and view all the answers

<p>The tamper-evident features must include industry-recognized features designed to prevent unauthorized copying, erasure or modification of information written on the prescription pad, and use of counterfeit prescription forms.</p> Signup and view all the answers

<p>The plan must include a list of hazardous chemicals in the workplace, ensure appropriate labeling and Safety Data Sheets for such products, and provide training on chemical hazards, protective measures, and obtaining additional information.</p> Signup and view all the answers

<p>The prescriptions must have one or more industry-recognized features designed to prevent unauthorized copying, erasure or modification of information, and use of counterfeit forms.</p> Signup and view all the answers

<p>Maintain a log of breaches = Fewer than 500 individuals Notify HHS of breaches = Fewer than 500 individuals Notify the Secretary of HHS and local media = More than 500 individuals Notify affected individuals = More than 500 individuals</p> Signup and view all the answers

<p>TSBP Rule 291.27 = Pharmacy's response to a request for confidential records TSBP Rule 291.28 = Timeline for pharmacy to respond to a request for confidential records HIPAA = Timeline for covered entities to respond to a request for confidential records TSBP Rules = Generally consistent with HIPAA, but with stricter requirements</p> Signup and view all the answers

<p>Covered entity = Report breaches to HHS Business Associate = Report breaches to the covered entity Secretary of HHS = Notified for breaches affecting more than 500 individuals Prominent local media = Notified for breaches affecting more than 500 individuals</p> Signup and view all the answers

<p>Aspirin = Any aspirin-containing preparation for human use in dosage form intended for oral administration Methyl Salicylate (oil of wintergreen) = Liquid preparation containing more than 5% by weight of methyl salicylate unless packaged in pressurized spray containers Methyl Alcohol (methanol) = Household substances in liquid form containing 4% or more by weight of methyl alcohol unless packaged in a pressurized spray container Acetaminophen = Preparations for human use in a dosage form intended for oral administration and containing more than 1 g of acetaminophen in a single package</p> Signup and view all the answers

<p>Controlled Drugs = There are some Schedule V controlled substances available without a prescription under federal law, but this doesn't apply in Texas Iron-Containing Drugs = With the exception of animal feeds used as vehicles for the administration of drugs, noninjectable animal and human drugs providing iron for therapeutic or prophylactic purposes, which contain a total amount of elemental iron equivalent to 250 mg Dietary Supplements Containing Iron = With the exception of those preparations in which iron is present solely as a colorant, dietary supplements that contain an equivalent of 250 mg or more of elemental iron in a single package Acetaminophen = Preparations for human use in a dosage form intended for oral administration and containing more than 1 g of acetaminophen in a single package</p> Signup and view all the answers

<p>Aspirin = Any aspirin-containing preparation for human use in dosage form intended for oral administration Methyl Salicylate (oil of wintergreen) = Liquid preparation containing more than 5% by weight of methyl salicylate unless packaged in pressurized spray containers Methyl Alcohol (methanol) = Household substances in liquid form containing 4% or more by weight of methyl alcohol unless packaged in a pressurized spray container Acetaminophen = Preparations for human use in a dosage form intended for oral administration and containing more than 1 g of acetaminophen in a single package</p> Signup and view all the answers

<p>Federal Hazardous Substances Act of 1966 = Administered and enforced by the Consumer Product Safety Commission to protect consumers from hazardous and toxic substances Federal Hazard Communication Standard = Administered and enforced by the Occupational and Safety Health Administration, requires employers to meet the Hazard Communication Standard for dealing with hazardous materials Centers for Medicare and Medicaid Services (CMS) Requirements = Includes tamper-resistant prescription requirements to prevent unauthorized copying and counterfeiting Federal Food, Drug, and Cosmetic Act (FDCA) = Enforced by the FDA, violation of which is a misbranding violation of FDCA if pharmacist does not comply with PPPA</p> Signup and view all the answers

<p>Tamper-Resistant Prescriptions = Prescriptions that meet certain requirements to prevent unauthorized copying and modification of information Hazardous Communication Plan = A written plan required for pharmacies that deal with hazardous chemicals, includes a list of hazardous chemicals, labeling, and training for workers Safety Data Sheet (SDS) = Contains information about hazardous chemicals, their hazards, and precautions for safe use and handling Third-Party Logistics Provider (3PL) = An entity that provides logistics services to another company</p> Signup and view all the answers

<p>Hazardous Product = A product that is corrosive, extremely flammable, highly toxic, or presents other hazards Immediate Package = The package in direct contact with the hazardous product Hang Tag = A tag that contains the required precautionary information for a hazardous product that does not have a package Principal Hazard = The main hazard that a hazardous product presents</p> Signup and view all the answers

<p>Consumer Product Safety Commission = Enforces the Federal Hazardous Substances Act of 1966 Occupational and Safety Health Administration = Enforces the Federal Hazard Communication Standard Food and Drug Administration = Enforces the misbranding violation of FDCA if pharmacist does not comply with PPPA Centers for Medicare and Medicaid Services = Imposes tamper-resistant prescription requirements</p> Signup and view all the answers

<p>CMS Medication Regimen Review = Requires a consultant pharmacist to perform a review for all long-term care patients every 30 days U.S. Postal Service regulations = Allow mailing of prescription drugs, with specific requirements for controlled substances HIPAA = Requires pharmacies to be a 'covered entity' and comply with certain privacy requirements Federal Hazard Communication Standard = Administered and enforced by the agency responsible for tax-free alcohol regulations</p> Signup and view all the answers

<p>Medication Regimen Review = A review performed by a consultant pharmacist for all long-term care patients every 30 days Tax-free alcohol = Ethanol used for compounding purposes, considered 'tax-free' when used for specific purposes Protected Health Information (PHI) = The HIPAA term for patient-identifiable information Notice of Privacy Practices = A document that pharmacies must provide to patients upon first service delivery, as required by HIPAA</p> Signup and view all the answers

<p>Consultant pharmacist = Performs the review for all long-term care patients every 30 days Attending physician = Must evaluate the patient for the appropriateness of a psychotropic drug before its PRN order is renewed Facility's medical director = Must be reported to by the pharmacist if any irregularities are found during the review Facility's director of nursing = Must be reported to by the pharmacist if any irregularities are found during the review</p> Signup and view all the answers

<p>Transaction Data = Information required by the DSCSA to be maintained by supply chain partners for a specific period of time Outsourcing facility = Type of facility that can compound a drug product that includes a bulk drug substance Interchangeable biological product = Type of biological product that may be substituted for the original reference product by a pharmacist 503A pharmacy = Type of pharmacy that has a limit on interstate distribution of compounded drugs</p> Signup and view all the answers

<p>Minimum Necessary Standard = A pharmacy must make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose Incidental Disclosures = Unintended 'incidental' disclosures are not a violation of the Privacy Rule as long as reasonable safeguards are in place Business Associates (BAs) = Persons or entities, other than members of a pharmacy's workforce, who perform a function or service on behalf of the pharmacy that requires the use or disclosure of PHI Patient Rights and Administrative Requirements = Patients have a right to access and obtain a copy of their PHI, pharmacies must train all employees on privacy policies, pharmacies must designate a Privacy Official and a contact person to receive complaints</p> Signup and view all the answers

<p>Covered Entity = Entity that is subject to HIPAA and must comply with its regulations Business Associate (BA) = Person or entity, other than members of a pharmacy's workforce, who performs a function or service on behalf of the pharmacy that requires the use or disclosure of PHI Privacy Official = Person responsible for the development and implementation of HIPAA-related policies and procedures and compliance Contact Person = Person designated to receive complaints, may also be the Privacy Official</p> Signup and view all the answers

<p>Training = Pharmacies must train all employees on privacy policies Sanctions = Pharmacies must impose sanctions on employees for any violations of privacy policies Compliance = Pharmacies must comply with patient requests for access, copy, amendment, and accounting of disclosures of their PHI Privacy Policies = Pharmacies must establish policies and procedures to protect from accidental or intentional uses and disclosures of PHI</p> Signup and view all the answers

<p>PHI = Protected Health Information - any information about health status, provision of healthcare, or payment for healthcare that can be linked to an individual Covered Entity = Entity that is subject to HIPAA and must comply with its regulations Business Associate (BA) = Person or entity, other than members of a pharmacy's workforce, who performs a function or service on behalf of the pharmacy that requires the use or disclosure of PHI Privacy Official = Person responsible for the development and implementation of HIPAA-related policies and procedures and compliance</p> Signup and view all the answers

<p>Acetaminophen = Effervescent tablets or granules containing less than 10% acetaminophen with a median lethal dose greater than 5 g/kg of body weight and that release at least 85 ml of carbon dioxide per grain of acetaminophen when placed in water Diphenhydramine HCl = Preparations for human use in oral dosage forms containing more than the equivalent of 66 mg of diphenhydramine base in a single package Lidocaine = Products containing more than 5 mg of lidocaine in a single package (includes all dosage forms, including creams, sprays, and transdermal patches) Naproxen = Preparations for human use in oral dosage forms containing 250 mg or more of naproxen in a single package</p> Signup and view all the answers

<p>Ketoprofen = Preparations for human use in oral dosage forms containing more than 50 mg of ketoprofen in a single package Fluoride = Products containing more than 50 mg of elemental fluoride and more than 0.5% fluoride in a single package Minoxidil = Preparations for human use containing more than 14 mg of minoxidil in a single package (includes topical products that must continue to meet requirements once the applicator is installed by the consumer) Imidazolines = Products containing 0.08 mg or more in a single package</p> Signup and view all the answers

<p>Ibuprofen = Preparations for human use in oral dosage forms containing 1 gram or more of ibuprofen in a single package Loperamide = Preparations for human use in oral dosage forms containing more than 0.045 mg of loperamide in a single package Dibucaine = Products containing more than 0.5 mg of dibucaine in a single package (includes all dosage forms, including creams, sprays, and transdermal patches) Imidazolines = Products containing 0.08 mg or more in a single package</p> Signup and view all the answers

<p>Acetaminophen = Unflavored acetaminophen-containing preparations in powder form, other than those intended for pediatric use, that are packaged in unit doses with no more than 13 grains of acetaminophen per unit dose and that contain no other substance subject to the special packaging requirements Ibuprofen = Preparations for human use in oral dosage forms containing 1 gram or more of ibuprofen in a single package Loperamide = Preparations for human use in oral dosage forms containing more than 0.045 mg of loperamide in a single package Dibucaine = Products containing more than 0.5 mg of dibucaine in a single package (includes all dosage forms, including creams, sprays, and transdermal patches)</p> Signup and view all the answers