Section Ph 404.04 - Regulatory Requirements for Sterile Compounding(a) A compounder shall have and maintain a permit issued by the board that allows for the compounding of sterile products as defined by the board.(b) When a compounder prepares more than 50 dosage units for non-patient specific preparations the compounder shall be registered as a drug manufacturer or 503B with the FDA.(c) Compounders supplying limited quantities, less than 50 dosage units, to providers for administration use shall have an MOU with the provider for each compounded product they supply to the provider. When a compounder provides a practitioner a non-patient specific preparation, the compounder shall provide the practitioner a copy of the test result for each lot provided to the practitioner.(d) Each batch of a high risk CSP shall be assigned a unique lot number and shall be tested by an independent lab for sterility, potency, and endotoxins. Only a batch that has passed all 3 tests shall be made available to provide to a hospital or practitioner.(e) A compounder shall not compound a sterile product of an FDA-approved product when the product is commercially available.(f) When no commercial source of a sterile product exists, such as being listed on the FDA backorder list, the compounder shall only use USP or other USP recognized grades such as BP, JP, EP, bulk ingredients obtained from a good manufacturing practice compliant supplier. The compounder shall obtain and keep on file for at least 3 years a certificate of analysis and potency testing of all bulk ingredients used to compound each and every compounded product made with a bulk, non-sterile ingredient.(g) A compounder who uses hazardous products shall meet state and federal requirements for handling of hazardous agents.N.H. Admin. Code § Ph 404.04
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05
Amended by Volume XXXV Number 18, Filed May 7, 2015 , Proposed by #10812, Effective 4/18/2015, Expires 4/18/2025.