Designated Prescription Drug Prescribers and Pharmacies We may limit your selection of a pharmacy to a single pharmacy location and/or a single prescribing provider or practice. Those members subject to this designation include, but are not limited to, members that have a history of: • being prescribed prescription drugs by multiple providers; • having prescriptions drugs filled at multiple pharmacies; • being prescribed certain long-acting opioids and other controlled substances, either in combination or separately, that suggests a need for monitoring due to: o quantities dispensed; o daily dosage range; or o the duration of therapy exceeds reasonable and established thresholds.
label Prescription Drugs This plan covers off label prescription drugs for cancer or disabling or life-threatening chronic disease if the prescription drug is recognized as a treatment for cancer or disabling or life-threatening chronic disease in accepted medical literature, in accordance with R.I. General Law § 27-55-1.
Prescription Drugs This plan covers prescription drugs and diabetic equipment or supplies. When they are purchased from a pharmacy, prescription drugs and diabetic equipment or supplies are covered as a pharmacy benefit. In most cases, when the prescription drug requires administration by a provider other than a pharmacist (or the FDA approved recommendation is administration by a provider other than a pharmacist), the prescription drug is covered as a medical benefit referred to as “medical prescription drugs”. See subsection B: Medical Benefits - Prescription Drugs Administered by a Provider (other than a pharmacist) below for further information. Please see Pharmacy Benefits subsection A and Medical Benefits subsection B below for information about how these prescription drugs are covered. Prescription drugs and diabetic equipment or supplies are covered when dispensed using the following guidelines: • the prescription must be medically necessary, consistent with the physician’s diagnosis, ordered by a physician whose license allows him or her to order it, filled at a pharmacy whose license allows such a prescription to be filled, and filled according to state and federal laws; • the prescription must consist of legend drugs that require a physician’s prescription under law, or compound medications made up of at least one legend drug requiring a physician’s prescription under law; • the prescription must be dispensed at the proper place of service as determined by our Pharmacy and Therapeutics Committee. For example, certain prescription drugs may only be covered when obtained from a specialty pharmacy; and • the prescription is limited to the quantities authorized by your physician not to exceed the quantity listed in the Summary of Pharmacy Benefits.
FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.