Chapter 1 Flashcards
(36 cards)
What is the name of the law governing the Florida drug distribution companies?
Florida Drug and Cosmetic Act
What is the purpose of the Florida Drug and Cosmetic Act?
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.
What is “active pharmaceutical ingredient”?
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.
“Affiliate”
means a business entity that has a relationship with another business entity in which, directly or indirectly:
The business entity…
…controls, or has the power to control, the other business entity;
A third party controls…
…or has the power to control, both business entities.
“Affiliated party” means…
-A director, officer, trustee, partner…
-A person who has filed or is required to file a personal information statement …
-The five largest natural shareholders that own at least 5 percent of the permittee or applicant.
“Contraband prescription drug” 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”
…without authorization, bears the trademark, trade name, or other identifying mark, imprint…which thereby falsely purports or is represented to be the product…
“Department”
means the Department of Business and Professional Regulation.
“Distribute” or “distribution”
means to sell, purchase, trade, deliver, handle, store, or receive. The term does not mean to administer or dispense.
“Drug” means an article that is:
Recognized in the current edition of the United States Pharmacopoeia and National Formulary…
“Establishment” 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.
“Labeling”
means all labels and other written, printed, or graphic matters:
“Manufacturer” means:
-A person who holds a New Drug Application, an Abbreviated New Drug Application
-A co-licensed partner of the person described in paragraph
-An affiliate of a person described in paragraph (a), paragraph (b)
-A person who manufactures a device or a cosmetic.
“Medical convenience kit”
means packages or units that contain combination products as defined in 21 C.F.R. s. 3.2(e)(2).
“Medical gas”
means any liquefied or vaporized gas that is a prescription drug
“New drug”
Unapproved drug
“Repackage”
includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic.
“Repackager”
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.
When can a wholesaler repackage?
Can’t in any way.
“Wholesale distribution” means
the distribution of a prescription drug to a person other than a consumer or patient, or the receipt of a prescription drug by a person other than the consumer or patient, but does not include:
-charitable organization
-The distribution of a prescription drug among hospitals or other health care entities that are under common control
-federal, state, or local government agency
-emergency medical reasons
-reverse distributions or destruction
the hospital or health care entity that distributes prescription drugs pursuant to this subparagraph must reconcile all drugs distributed and returned and resolve any discrepancies in a timely manner.
-Intracompany distribution of any drug between members of an affiliate or within a manufacturer.
-distribution of prescription drug samples
-distribution of a prescription drug by a third-party logistics provider
-The distribution of an intravenous prescription drug that, by its formulation, is intended for the replenishment of fluids and electrolytes, such as sodium, chloride, and potassium or calories, such as dextrose and amino acids.
-The distribution of an intravenous prescription drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions.
-The distribution of a prescription drug that is intended for irrigation or sterile water, whether intended for such purposes or for injection.
-The distribution of an exempt medical convenience kit pursuant to 21 U.S.C. s. 353(e)(4)(M).
-A common carrier that transports a prescription drug, if the common carrier does not take ownership of the prescription drug.
-The distribution of medical gas pursuant to part III of this chapter.
“Authorized absence”
the physical absence of the designated representative 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 and to care for the newborn child; the placement of a child with the employee for adoption or foster care; the care of a family member (child, spouse, or parent) with a health condition, where the employee is needed to care for the family member; or the employee’s own serious health condition makes the employee unable to perform the functions of the designated representative.
