FL CDR Exam Questions and Complete Solutions Graded A+

FL CDR Exam Questions and Complete Solutions Graded A+ Active pharmaceutical ingredient - Answer: includes any substance or mixture of substances intended, represented, or labeled for use in drug manufacturing that furnishes or is intended to furnish, in a finished dosage form, any pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or to affect the structure or any function of the body of humans or animals. "Advertisement" - Answer: any representation disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of drugs, devices, or cosmetics. "Affiliate"* - Answer: a business entity that has a relationship with another business entity in which, directly or indirectly: (a) The business entity controls, or has the power to control, the other business entity; or (b) A third party controls, or has the power to control, both business entities. "Affiliated party"** (KNOW THIS) - Answer: means: (a) A director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant; (b) A person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant; (c) A person who has filed or is required to file a personal information statement pursuant to s. 499.012(9) or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(8); or (d) The five largest natural shareholders that own at least 5 percent of the permittee or applicant. "Applicant" - Answer: means a person applying for a permit or certification under this part. "Certificate of free sale" - Answer: means a document prepared by the department which certifies a drug, device, or cosmetic, that is registered with the department, as one that can be legally sold in the state. "Chain pharmacy warehouse" - Answer: means a distributor permitted pursuant to s. 499.01 that maintains a physical location for prescription drugs that functions solely as a central warehouse to perform intracompany transfers of such drugs between members of an affiliate. "Closed pharmacy" - Answer: means a pharmacy that is licensed under chapter 465 and purchases prescription drugs for use by a limited patient population and not for wholesale distribution or sale to the public. The term does not include retail pharmacies. "Color" - Answer: includes black, white, and intermediate grays. "Color additive" - Answer: means, with the exception of any material that has been or hereafter is exempt under the federal act, a material that: (a) Is a dye pigment, or other substance, made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral, or other source; or (b) When added or applied to a drug or cosmetic or to the human body, or any part thereof, is capable alone, or through reaction with other substances, of imparting color thereto. "Cosmetic" - Answer: means an article, with the exception of soap, that is: (a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or (b) Intended for use as a component of any such article. "Department"* - Answer: means the Department of Business and Professional Regulation.(DBPR) "Device" - Answer: means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including its components, parts, or accessories, which is: (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, or any supplement thereof, (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or (c) Intended to affect the structure or any function of the body of humans or other animals, and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. "Distribute" or "distribution"** - Answer: means to sell, purchase, trade, deliver, handle, store, or receive. The term does not mean to administer or dispense. REMEMBER THAT DISTRIBUTION DOES NOT REQUIRE MONEY TO CHANGE HANDS NOR DOES IT REQUIRE TOUCHING THE DRUG. THEREFORE, VIRTUAL ENTITIES OR BROKERS STILL DISTRIBUTE AS DEFINED HERE "Drug" - Answer: means an article that is: (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications; (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals; (c) Intended to affect the structure or any function of the body of humans or other animals; or (d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. "Establishment" - Answer: means a place of business which is at one general physical location and may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. Where multiple buildings are under common exclusive ownership, operation, and control, an intervening thoroughfare does not affect the contiguous nature of the buildings. For purposes of permitting, each suite, unit, floor, or building must be identified in the most recent permit application. "Federal act" - Answer: means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq. "Freight forwarder" - Answer: means a person who receives prescription drugs which are owned by another person and designated by that person for export, and exports those prescription drugs. EDITORS NOTE: you must know the definition of freight forwarder and understand when you use a freight forwarder vs a 3PL vs a common carrier "Health care entity" - Answer: means a closed pharmacy or any person, organization, or business entity that provides diagnostic, medical, surgical, or dental treatment or care, or chronic or rehabilitative care, but does not include any wholesale distributor or retail pharmacy licensed under state law to deal in prescription drugs. However, a blood establishment is a health care entity that may engage in the wholesale distribution of prescription drugs under s. 499.01(2)(h)1.c. "Health care facility" - Answer: means a health care facility licensed under chapter 395. "Hospice" - Answer: means a corporation licensed under part IV of chapter 400. "Hospital" - Answer: means a facility as defined in s. 395.002 and licensed under chapter 395. "Immediate container" - Answer: does not include package liners. "Label" - Answer: means a display of written, printed, or graphic matter upon the immediate container of any drug, device, or cosmetic. A requirement made by or under authority of this part or rules adopted under this part that any word, statement, or other information appear on the label is not complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any, of the retail package of such drug, device, or cosmetic or is easily legible through the outside container or wrapper. "Labeling" - Answer: means all labels and other written, printed, or graphic matters: (a) Upon a drug, device, or cosmetic, or any of its containers or wrappers; or (b) Accompanying or related to such drug, device, or cosmetic. "Manufacture" - Answer: means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic. "Manufacturer" - Answer: means: (a) A person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or a license issued under s. 351 of the Public Health Service Act, 42 U.S.C. s. 262, for such drug or biologics, or if such drug or biologics are not the subject of an approved application or license, the person who manufactured the drug or biologics; (b) A co-licensed partner of the person described in paragraph (a) who obtains the drug or biologics directly from a person described in paragraph (a), paragraph (c), or this paragraph; (c) An affiliate of a person described in paragraph (a), paragraph (b), or this paragraph that receives the drug or biologics directly from a person described in paragraph (a), paragraph (b), or this paragraph; or (d) A person who manufactures a device or a cosmetic. The term does not include a pharmacy that is operating in compliance with pharmacy practice standards as defined in chapter 465 and rules adopted under that chapter. "Medical convenience kit" - Answer: means packages or units that contain combination products as defined in 21 C.F.R. s. 3.2(e)(2). "Medical gas" - Answer: means any liquefied or vaporized gas that is a prescription drug, whether alone or in combination with other gases, and as defined in the federal act. "New drug" - Answer: (EDITORS NOTE: a new drug is an unapproved drug) means: (a) Any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of that drug; or (b) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under certain conditions, has been recognized for use under such conditions, but which drug has not, other than in those investigations, been used to a material extent or for a material time under such conditions. "Nursing home" - Answer: means a facility licensed under part II of chapter 400. "Official compendium" - Answer: means the current edition of the official United States Pharmacopoeia and National Formulary, or any supplement thereto. "Permittee" - Answer: means any person holding a permit issued under this chapter. "Person" - Answer: means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any other group or combination of the foregoing. "Pharmacist" - Answer: means a person licensed under chapter 465. "Pharmacy" - Answer: means an entity licensed under chapter 465. "Prepackaged drug product" - Answer: means a drug that originally was in finished packaged form sealed by a manufacturer and that is placed in a properly labeled container by a pharmacy or practitioner authorized to dispense pursuant to chapter 465 for the purpose of dispensing in the establishment in which the prepackaging occurred. "Prescription drug" - Answer: means a prescription, medicinal, or legend drug, including, but not limited to, finished dosage forms or active pharmaceutical ingredients subject to, defined by, or described by s. 503(b) of the federal act or s. 465.003(8), s. 499.007(13), subsection (31), or subsection (47), except that an active pharmaceutical ingredient is a prescription drug only if substantially all finished dosage forms in which it may be lawfully dispensed or administered in this state are also prescription drugs. "Prescription drug label" - Answer: means any display of written, printed, or graphic matter upon the immediate container of any prescription drug before it is dispensed to an individual patient pursuant to a prescription of a practitioner authorized by law to prescribe. "Prescription label" - Answer: means any display of written, printed, or graphic matter upon the immediate container of any prescription drug dispensed pursuant to a prescription of a practitioner authorized by law to prescribe. "Proprietary drug," or "OTC drug," - Answer: means a patent or over-the-counter drug in its unbroken, original package, which drug is sold to the public by, or under the authority of, the manufacturer or primary distributor thereof, is not misbranded under the provisions of this part, and can be purchased without a prescription. "Repackage" - Answer: includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic. "Repackager" - Answer: means a person who repackages. The term excludes pharmacies that are operating in compliance with pharmacy practice standards as defined in chapter 465 and rules adopted under that chapter. "Retail pharmacy" - Answer: means a community pharmacy licensed under chapter 465 that purchases prescription drugs at fair market prices and provides prescription services to the public. "Veterinary prescription drug" - Answer: means a prescription drug intended solely for veterinary use. The label of the drug must bear the statement, "Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian." "Wholesale distributor" - Answer: means a person, other than a manufacturer, a manufacturer's colicensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution. 499.06 - Answer: Embargoing, detaining, or destroying article or processing equipment which is in violation of law or rule. It is unlawful for any person to remove, use, or dispose of such detained or embargoed article or processing equipment by sale or otherwise without such permission; and such act is a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 499.062 - Answer: Seizure and condemnation of drugs, devices, or cosmetics. Any person who violates this subsection is guilty of a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 499.0121 - Answer: Storage and handling of prescription drugs; recordkeeping. THIS IS A LONG ONE "Florida Drug and Cosmetic Act." - Answer: This part is intended to: (a) Safeguard the public health and promote the public welfare by protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics. common carriers - Answer: common carriers engaged in interstate commerce are NOT subject to this part (Florida Drug and Cosmetic Act) if they are engaged in the usual course of business Active Pharmaceutical Ingredient (API) - Answer: includes any substance or mixture of substances intended, represented, or labeled for use in drug manufacturing that furnishes or is intended to furnish, in a finished dosage form, any pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or to affect the structure or any function of the body of humans or animals. "Contraband prescription drug" - Answer: means any adulterated drug, as defined in s. 499.006, any counterfeit drug, as defined in this section, and also means any prescription drug for which a transaction history, transaction information, or transaction statement does not exist, or for which the transaction history, transaction information, or transaction statement in existence has been forged, counterfeited, falsely created, or contains any altered, false, or misrepresented matter. "Counterfeit drug" - Answer: means a drug, device, or cosmetic which, or the container, seal, or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug, device, or cosmetic manufacturer, processor, packer, or distributor other than the person that in fact manufactured, processed, packed, or distributed that drug, device, or cosmetic and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, that other drug, device, or cosmetic manufacturer, processor, packer, or distributor. True - Answer: true/false - if an entity doesn't qualify to be the manufacturer under 29(a-d) then they are a wholesaler and will need an additional permit as a wholesaler to distribute those drugs medical convenience kit EDITOR'S NOTE - Answer: a medical convenience kit or just "kit" contains non-Rx items and one Rx product, therefore, these kits are treated as DRUGS even though they are technically devices under Federal law. We will learn that permitting laws apply but these kits are exempt from the definition of "product" under federal law and therefore no track and trace applies... but EVERYTHING ELSE APPLIES Medical gas - Answer: means any liquefied or vaporized gas that is a prescription drug, whether alone or in combination with other gases, as defined in the federal act. EDITORS NOTE: we will learn more about medical oxygen. this is treated as a Rx drug. New Drug - Answer: (EDITORS NOTE: a new drug is an unapproved drug) True - Answer: T/F a wholesaler cannot repackage in any way authorized absence - Answer: means the physical absence of the designated rep from the permitted establishment, for a cumulative 60 calendar days in any 365 calendar day period for situations such as: the birth of the employee's child; the placement of a child with the employee for adoption/foster care; the care of a family member with a health condtion; or the employee's own serious health condition makes the employee unable to perform the functions of the designated rep. authorized recipient - Answer: means a person permitted by or otherwise authorized by Florida law, or by the law of the jurisdiction in which the person receives the prescription drugs, to purchase, own, receive, or possess those prescription drugs. DOES NOT include a Class 1 Institutional pharmacy since it is only authorized to possess dispensed prescription drugs and medical oxygen for administration to it's patients. broker* - Answer: means a person participating in the wholesale distribution of a prescription drug by buying, purchasing, or OTHERWISE TAKING OWNERSHIP of or title to the prescription drug and selling or transferring, or offering to sell or transfer, ownership of or title to the prescription drug to a person other than the patient or the patient's agent WITHOUT TAKING ANY PHYSICAL POSSESSION of the prescription drug. change in ownership - Answer: meant that there has been a transfer or assignment of a majority of direct ownership or controlling interest of a permitted establishment. when someone new gains MORE THAN 50% OWNERSHIP Intracompany transfer - Answer: means a distribution of a specific unit of a prescription drug between two establishments wholly owned and operated by the same business entity. EDITOR'S NOTE: keep intracompany transfer in the back of your mind. It is an exception to T3 and wholesale distribution. notes it's INTRA not INTER. "readily available" or "readily retrievable - Answer: records (hard or electronic) are organized in a manner that they can quickly be retrieved within minutes during an inspection (unless the permitted address is not within the state in which case a 48 hour timeframe is available for producing records the only time a wholesaler can repackage is... - Answer: altering a package of multiple units for sale if the individual unit is a fully labeled self-contained package that is shipped by the manufacturer in multiple units; or by adding the package insert to a fully labeled unit sale - Answer: includes any transfer of title or ownership whether by barter, exchange, or gift.