FL CDR Latest Update with Verified Solutions

FL CDR Latest Update with Verified Solutions 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. "Advertisement" 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"* 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) 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" means a person applying for a permit or certification under this part. "Certificate of free sale" 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" 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" 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" includes black, white, and intermediate grays. "Color additive" 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" 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"* means the Department of Business and Professional Regulation.(DBPR) "Device" 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