Pharmaceutical Products. Outpatient Pharmaceutical Products, including injectable drugs, and New Pharmaceutical Product, for Covered Health Care Services administered on an outpatient basis in a Hospital, Alternate Facility, Physician's office, or in your home. Benefits are provided for Pharmaceutical Products which, due to their traits (as determined by us), are administered or directly supervised by a qualified provider or licensed/certified health professional. Depending on where the Pharmaceutical Product is administered, Benefits will be provided for administration of the Pharmaceutical Product under the corresponding Benefit category in this Policy. Benefits for medication normally available by a prescription or order or refill are provided as described under Section 10: Outpatient Prescription Drugs. If you require certain Pharmaceutical Products, including specialty Pharmaceutical Products, we may direct you to a Designated Dispensing Entity. Such Dispensing Entities may include an outpatient pharmacy, specialty pharmacy, Home Health Agency provider, Hospital-affiliated pharmacy or hemophilia treatment center contracted pharmacy. If you/your provider are directed to a Designated Dispensing Entity and you/your provider choose not to get your Pharmaceutical Product from a Designated Dispensing Entity, Benefits are not available for that Pharmaceutical Product, unless the provider or its intermediary agrees in writing to accept reimbursement, including copayment, at the same rate as a Designated Dispensing Entity. Certain Pharmaceutical Products are subject to step therapy requirements. This means that in order to receive Benefits for such Pharmaceutical Products, you must use a different Pharmaceutical Product and/or prescription drug product first. You may find out whether a particular Pharmaceutical Product is subject to step therapy requirements by contacting us at xxx.xxxxx.xxx/xxxxxxxx or the telephone number on your ID card. A step therapy requirement may not be imposed if: • The step therapy drug has not been approved by the U.S. Food and Drug Administration (FDA) for the medical condition being treated; or • The prescribing provider provides supporting medical information to us that a Prescription Drug Product: ▪ Was ordered by a prescribing provider for the Covered Person within the past 180 days; and ▪ Based on the professional judgment of the prescribing provider, was effective in treating the Covered Person’s medical condition. • The prescription drug has been ap...
Pharmaceutical Products. 2. (a) If a Party requires, as a condition for approving the marketing of a pharmaceutical product that utilizes a new chemical entity, the submission of undisclosed test or other data necessary to determine whether the use of such products is safe and effective, the Party shall protect against disclosure of the data of persons making such submissions, where the origination of such data involves considerable effort, except where the disclosure is necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use.
Pharmaceutical Products. Emergent shall perform the 3PL Services for the Products that are defined in ARTICLE I of the Agreement (for purposes of this Schedule E, Vials of the Products shall be referred to as the “3PL Vials”).
Pharmaceutical Products. 3.38.1 Schedule 3.38.1 lists each product distributed or sold by PSI or Phoenix during the five-year period ending on January 31, 2005 (collectively, the “Products”). Each Product manufactured by PSI or Phoenix has been manufactured substantially in accordance with (a) the product certificate or other product registration applicable to such Product, (b) the specifications under which the Product is normally and has normally been manufactured and (c) the provisions of all applicable Laws, including, without limitation, the requirements of the Food, Drug and Cosmetic Act of 1938, as amended, and the Food and Drug Administration and any other Agency with jurisdiction over PSI, Phoenix or any of the Products (including, without limitation, with regard to investigational use, premarket clearance, good manufacturing practices, labeling, advertising, record keeping, requisite filings and security). The formulation, development, manufacturing, licensing, packaging, distribution, storage, labeling, promotion, advertising and sale of the Products are in substantial compliance with all applicable Laws, including, without limitation, the requirements of the Food, Drug and Cosmetic Act of 1938, as amended, and the Food and Drug Administration and any other Agency with jurisdiction over PSI, Phoenix or any of the Products (including, without limitation, with regard to investigational use, premarket clearance, good manufacturing practices, labeling, advertising, record keeping, requisite filings and security).
Pharmaceutical Products. 30.01 A change to heading 30.01 from any other heading.
Pharmaceutical Products. A change to 30.01-30.05 heading totalled 30.01 to 30.05 from any other heading; or It does not require a change in tariff classification heading to totalled 30.01 to 30.05, complying with a regional value content requirement according to Article 4.2. A change to 3006.10-3006.40 subheading 3006.10 to 3006.40 from any other heading; or there is a change in tariff classification at the subheading 3006.10 to 3006.40, complying with a regional value content requirement according to Article 4.2. 3006.50 provided that qualifies as originating in accordance with article 4.11. a change to 3006.60-3006.91 subheading 3006.60 to 3006.70 from any other heading; or there is a change in tariff classification at the subheading 3006.60 to 3006.91, complying with a regional value content requirement according to Article 4.2. It does not require 3006.92 tariff classification change to subheading 3006.80 provided that waste and scrap are wholly obtained or produced entirely in the territory of a Party as defined in article 4.26. Article 31. Fertilizers 31.01-31.05 heading to a change to 31.02 31.05 from any other heading; or It does not require a change in tariff classification heading to 31.02 to 31.05, complying with a regional value content requirement according to Article 4.2.
Pharmaceutical Products. The Maximum Reimbursement Allowances for pharmaceutical products shall be as set forth above in 3.1, except the applicable percentage shall be one hundred percent (100%).
Pharmaceutical Products. (a) Schedule 4.24(a) lists each product manufactured, licensed, distributed or sold by the Company (collectively, the "Products"). The Company does not manufacture any Product.
Pharmaceutical Products. Pharmaceutical products and supplies shall be reimbursed based on National Drug Codes (“NDC codes”), excluding the noted exceptions. The Plan will update The Plan’s NDC fee schedule monthly with the price that is in effect at the time of the update. If ASP is unavailable, pharmaceutical products categorized as Exception will be reimbursed as Single Source or Multi Source. When ASP, WAC, MAC and AWP are unavailable, pharmaceutical products categorized as: Exception, Vaccines and Immunizations, Single Source and/or Multi Source will be reimbursed in accordance with The Plan’s NDC fee schedule in effect as of the date of service.
Pharmaceutical Products. Prescription drug products according to a DSHS approved formulary, which includes both legend and over-the-counter (OTC) products. The Contractor’s formulary shall include all therapeutic classes in DSHS’ fee-for-service drug file and a sufficient variety of drugs in each therapeutic class to meet enrollees’ medically necessary health care needs. The Contractor shall provide participating pharmacies and participating providers with its formulary and information about how to request non-formulary drugs. The Contractor shall have policies and procedures for the administration of the pharmacy benefit including formulary exceptions. The Contractor shall approve or deny all requests for non-formulary drugs by the business day following the day of request. Covered drug products shall include:
