Pharmaceutical Waste Clause Samples
The Pharmaceutical Waste clause defines the responsibilities and procedures for the proper disposal of unused, expired, or contaminated pharmaceutical products. It typically outlines the methods of collection, storage, and removal of such waste, ensuring compliance with relevant environmental and safety regulations. For example, it may require the use of certified disposal vendors or mandate documentation of waste handling. The core function of this clause is to ensure safe, legal, and environmentally responsible management of pharmaceutical waste, thereby minimizing health risks and regulatory liabilities.
Pharmaceutical Waste. Any viable product which does not result in credit for the Member will be considered pharmaceutical waste and will not be limited by Vendor. Pharmaceutical waste will be disposed of according to applicable federal, state, and local guidelines and charged per pound, regardless of controlled schedule. Vendor will provide a certificate of destruction within 60 business days from the time the product was received and properly destroyed. The Vendor will become the waste generator and assume responsibility for the legal handling of all non-returnable products. A separate waste report shall be generated and available for controlled non-creditable products, non- controlled non-creditable products, and for hazardous non-creditable products.
Pharmaceutical Waste. 4.6.1 Pharmaceutical waste includes, but is not limited to, expired, unused, spilt, and contaminated pharmaceutical products, drugs, vaccines, and sera that are no longer required and need to be disposed of appropriately.
4.6.2 Pharmaceutical waste also includes, but is not limited to, discarded items contaminated from use in the handling of pharmaceuticals, such as bottles or boxes with residues, gloves, masks, connecting tubing, syringe bodies and drug vials.
4.6.3 Memorandum 07-01 divides medicines into three broad groups: • Cytotoxic and cytostatic; • Pharmaceutically active, but not cytotoxic and cytostatic; and • Not pharmaceutically active and possessing no hazardous properties (examples include saline and glucose).
4.6.4 Pharmaceutical waste is listed in both Chapter 18 and Chapter 20 of the European Waste Catalogue (EWC). The term “cytotoxic and cytostatic” relates to the classification of waste medicines in the EWC.
4.6.5 Only cytotoxic and cytostatic medicines are classified as a hazardous waste, although other medicines often possess hazardous properties and therefore require appropriate treatment and disposal.
4.6.6 A cytotoxic and cytostatic medicine is a medicinal product possessing any one or more of the hazardous properties: • H6: Toxic; • H7: Carcinogenic; • H10: Toxic for reproduction; and • H11: Mutagenic.
4.6.7 Medicines other than cytotoxic and cytostatic medicines may have hazardous properties that should be identified to subsequent holders for the purposes of Duty of Care and for transport.
4.6.8 To establish whether a medicinal product has the above mentioned hazardous characteristics, pharmacists should refer to the products’ material safety data sheets (MSDS; sometimes referred to as “COSHH sheets”).
4.6.9 In England, Wales and Northern Ireland, the Hazardous Waste Regulations place prohibitions on producers mixing waste types. The mixing of a cytotoxic and cytostatic medicine with any other medicine, including other cytotoxic and cytostatic medicines, is prohibited where they are chemically incompatible or the necessary treatment/disposal of the waste is affected.
Pharmaceutical Waste. Pharmaceutical waste is defined as non-creditworthy pharmaceutical product, and may include repackaged, unit dose, and blister packed products that may contain patient information. If pharmaceutical waste contains patient information, Vendor will follow all applicable provisions to safeguard this information under the Health Insurance Portability and Accountability Act (HIPAA). Vendor may not limit the amount of waste returned by the Member. All non-credit worthy product will be disposed of according to applicable federal, state, and local guidelines and charged per pound, regardless of controlled schedule. Vendor will provide a Certificate of Destruction on the web portal within 10 business days from when the product was received and properly destroyed. The Vendor will become the waste generator and assume responsibility for the legal handling of all non-returnable products. Vendor’s representative shall witness the destruction of all controlled and non-controlled pharmaceutical products. A separate waste report shall be generated and available for controlled non-creditable products, non-controlled non- creditable products, and for hazardous non-creditable products.