Section Ph 404.08 - Compounding Procedures(a) Each compounder shall ensure that all personnel adhere to the following when they are in the LAFW or buffer areas: (1) No smoking, food, drink, or chewing gum shall be allowed in the buffer area at any time;(2) No jewelry shall be worn on the hands or wrists and there shall be no visible piercings;(3) No make-up shall be worn in the buffer area as it can shed particles;(4) Before putting on gloves, the nails shall be cleaned, and the hands, wrists, and forearms shall be washed thoroughly for at least 30 seconds with warm water and antimicrobial skin cleanser;(5) Personnel shall appropriately utilize gowns, masks, gloves, hair covers, and shoe covers;(6) No paper, pens, labels, or trays shall be placed in the workbench; and(7) No objects that shed particles shall be brought into the buffer area such as cardboard cartons, paper towels, and cotton items.(b) Each compounder shall ensure when cleaning and disinfecting the interior work surfaces of the LAFW it is done from top to bottom, back to front, away for the HEPA filter.(c) Each compounder shall ensure personnel check the quality, purity, amount, and identity of all ingredients.(d) Each compounder shall ensure all personnel use the correct compounding procedures when compounding sterile products, and periodically disinfect gloves with sterile 70% isopropyl alcohol and allow them to dry thoroughly before continuing.(e) Each compounder shall ensure that open and partially used containers are properly labeled and stored.(f) Each compounder shall ensure the following:(1) CSP has an appropriate BUD that is identified on all product labels;(2) When the BUD exceeds USP standards, it is based on scientific criteria;(3) Packaging is appropriate for sterility and stability;(4) Product labels are appropriate and complete for safe use; and(5) Products are visually inspected for physical integrity during and after compounding, and a final check of the CSP is performed.(g) Each compounder shall ensure any deficiencies in compounding procedures can be rapidly identified and corrected.(h) Each compounder shall ensure that finished compounded products are maintained in a separate area away from the active compounding area, and that no more than 2 entries into any one sterile container or sterile administration device.(i) Each compounder shall ensure all compounding activity only involves closed or sealed packaging systems.(j) In the absence of stability and sterility testing of any CSP the compounder shall use BUD based on USP standards as defined for the following CSPs: (1) Low risk compounded product storage shall not exceed 48 hours at room temperature, 14 days at cold temperature or 45 days in a frozen state if the stability of the product allows;(2) Medium risk compounded product storage shall not exceed 30 hours at controlled room temperature, 9 days at cold temperature or 45 days in a frozen state;(3) High risk compounded product storage shall not exceed 24 hours at room temperature, 3 days at cold temperature or 45 days in a frozen state.N.H. Admin. Code § Ph 404.08
#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.Amended by Volume XLII Number 23, Filed June 9, 2022, Proposed by #13388, Effective 5/25/2022, Expires 11/21/2022