Compliance Inspection Report Page 8
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Requirements
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NO
N/A
Comment / Observation
No.
Non-Sterile Compounding, con’t.
65
Adequate hand and equipment washing facilities shall be easily accessible to the compounding areas. Such facilities
shall include, but are not limited to, hot and cold water, soap or detergent, and lint free single-use towels (Best Practice).
(247 CMR 9.01 (3)) (USP Chapter <795>)
66
Compounding facilities shall have an adequate space that is specifically designated for compounding of prescriptions
and is suitable for its intended purpose. This space shall provide for the orderly placement of equipment and materials to
prevent mix-ups among ingredients, containers, labels, in process materials, and finished preparations and is designed,
arranged, and used to prevent adventitious cross-contamination. (247 CMR (247 CMR 9.01 (3)) (USP Chapter <795>)
67
The areas used for compounding shall be maintained in clean, orderly, and sanitary conditions and shall be maintained
in a good state of repair. (247 CMR 9.01 (3)) (USP Chapter <795>)
68
All equipment used in compounding is clean, properly maintained, and used appropriately. (247 CMR 9.01 (3)) (USP
Chapter <795>)
69
Compounding ingredients are purchased from reliable sources and are properly stored according to manufacturer
specifications or USP standards. (247 CMR 9.01 (3)) (USP Chapter <795>)
70
Purified Water (see Purified Water monograph) shall be used for compounding non-sterile drug preparations when
formulations indicate the inclusion of water. (247 CMR 9.01 (3)) (USP Chapter <795>)
71
In the absence of stability information that is applicable to a specific drug and preparation (maximum BUDs
recommended for non-sterile compounded drug preparations that are packaged in tight, light-resistant containers and
stored at controlled room temperature, unless otherwise indicated):
• For Non-aqueous Formulations—The BUD is not later than the time remaining until the earliest expiration date of any
API or 6 months, whichever is earlier.
• For Water-Containing Oral Formulations—The BUD is not later than 14 days when stored at controlled cold
temperatures.
• For Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations—The BUD is not later than 30
days.
Per USP <795>: When a manufactured product is used as the source of the API for a nonsterile compounded
preparation, the product expiration date cannot be used solely to assign a BUD for the compounded preparation. (247
CMR 9.01 (3)) (USP Chapter <795>)
72
For components that do not have expiration dates assigned by the manufacturer or supplier, the compounder shall label
the container with the date of receipt and assign a conservative expiration date, not to exceed one year after receipt to
the component. (While not mandated by USP Chapter <795>, the Board of Registration in Pharmacy expects this “Best
Practice” to be followed.) (247 CMR 9.01 (3)) (USP Chapter <795>)
73
A Master Formulation Record shall be followed each time that preparation is made. (247 CMR 9.01 (3))
(USP Chapter <795>)
74
A Compounding Record is completed each time a preparation is compounded. (The Board's interpretation of the
language in USP <795> mandates this standard be followed.) (247 CMR 9.01 (3)) (USP Chapter <795>)
75
Material Safety Data Sheets (MSDSs) shall be readily accessible to all employees working with drug substances or bulk
chemicals located on the compounding facility premises. (247 CMR 9.01 (3)) (USP Chapter <795>)
76
The labeling indicates that “this is a compounded preparation”. (The Board's interpretation of the language in USP
<795> mandates this standard be followed.) (247 CMR 9.01 (3)) (USP Chapter <795>)
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