Section Ph 2003.01 - Standards of Practice and Requirements for Outsourcing Facilities(a) Outsourcing facilities shall maintain a human drug compounding outsourcing facility registration from the United States Food and Drug Administration (FDA) when compounding or manufacturing drugs for sale in New Hampshire.(b) Outsourcing facilities shall be in compliance with applicable United States Drug Enforcement Administration (DEA) regulations.(c) Outsourcing facilities shall be required to test all lots or batches of finished drug products compounded from bulk active pharmaceutical ingredients (API) to determine whether they meet final product specifications for sterility, endotoxin, and potency before their release for distribution. No products shall be released for use until this testing is conducted and the results confirm that the finished drug product meets specifications. Copies of the test results shall be readily available and included with each batch sent to New Hampshire customers and available for inspection by the pharmacy board.(d) Outsourcing facilities compounding drug products from sterile, commercially available raw materials shall be required to test all lots or batches of finished drug products to determine whether they meet final product specifications for sterility, endotoxin, and potency before their release for distribution. No products shall be released for use until this testing is conducted and the results confirm that the finished drug product meets specifications. Copies of the test results shall be readily available for each batch sent to New Hampshire customers and available for inspection.(e) All facilities at which sterile drugs are compounded shall provide storage areas that ensure adequate lighting, ventilation, temperature, sanitation, humidity, equipment, and security conditions. All sterile compounded products shall be stored at appropriate temperatures per label requirements or in compliance with the latest edition of the official United States Pharmacopeia (USP) compendium requirements to help ensure that the identity, strength, quality, and purity of the products are not affected. If no temperature requirements are listed, compounded products may be stored at room temperature. A separate storage section shall be provided for compounded products that are deteriorated, outdated, misbranded, or otherwise adulterated.(f) All buildings at which sterile drugs are compounded shall be of a size, construction, and location that facilitates cleaning and maintenance. The buildings shall meet all applicable federal, state, and local standards. A facility shall not be located in a residence. All facilities shall be located in an area that is commercially zoned.(g) Each outsourcing facility shall be equipped with an internal alarm system to detect entry after hours. The alarm system shall be of the type that transmits a signal directly to a central station protection company, to a local or state police agency that has a legal duty to respond, or to a 24-hour control station operated by the outsourcing facility.(h) Outsourcing facilities shall ensure that all access from outside their premises is secure. This shall include, but not be limited to, the installation of adequate lighting at the outside perimeter of the premises that deters unauthorized entry into the premises.(i) Internal security policies shall be developed by the outsourcing facility to provide protection against theft by personnel.(j) No outsourcing facility shall distribute sterile compounded drugs directly to a consumer or a patient, or operate in such a manner as to endanger the public health.(k) Any person who compounds sterile drugs in violation of RSA 318:51-d or the provisions of Ph 2000 shall be subject to disciplinary action as provided in RSA 318:29.N.H. Admin. Code § Ph 2003.01
Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, Effective 7/22/2017, Expires 7/22/2027.