Section Draft Recommendation Evidence Impact/Notes 17.15 (1a) Buffer Room Remove entirely the square footage requirement of Current USP There is currently no standard for the size of a buffer room. (a) A buffer room shall be at least 144 square feet. 144 square feet. <797> The state of control is regulated by the HVAC, SEC and PEC, ASHP Sterile which are fined tuned to the size of the room built. The room Compounding should be built to the size needed to perform the necessary Guidelines. operations, and not be dependent on a fixed number. For example, one 3’ hood in a room this size vs five 4’ hoods and carts and staff and the supplies needed to support this implied volume of work. It is not evidence based to assume a pharmacy cannot demonstrate a state of control in a room of 130 square feet without an additional 14 square feet. 17.15 (2d) Ante Room Remove the requirements for specific square footage Current USP There is currently no standard for the size of an ante room. (d) An ante room shall be at least 100 square feet. <797> The size of the room should be dependent on the work space requirement. ASHP Sterile occurring within and the available space to implement a Compounding buffer room or cleanroom suite operation of a given size. Guidelines. 17.18 (7) A pharmacy shall operate and monitor the HVAC Remove the requirement or add language USP <797> The purpose and scope of these proposed regulations, as “where systems that supply conditioned air to the non- prescription medications are handled and stored”. stated in 17.01, to establish minimum professional “…is classified areas of the pharmacy 24 hours per day, standards for sterile compounding in order to safeguard the seven days per week. public health and welfare.” Establishing HVAC requirements for pharmacy personnel offices, customer waiting areas, rest rooms, conference rooms, office supply storage areas, and non-sterile compounding areas fall outside the scope of these proposed regulations.
Section Draft Recommendation Evidence Impact/Notes 17.15 (1a) Buffer Room (a) A buffer room shall be at least 144 square feet. Remove entirely the square footage requirement of 144 square feet. Current USP <797> ASHP Sterile Compounding Guidelines. There is currently no standard for the size of a buffer room. The state of control is regulated by the HVAC, SEC and PEC, which are fined tuned to the size of the room built. The room should be built to the size needed to perform the necessary operations, and not be dependent on a fixed number. For example, one 3’ hood in a room this size vs five 4’ hoods and carts and staff and the supplies needed to support this implied volume of work. It is not evidence based to assume a pharmacy cannot demonstrate a state of control in a room of 130 square feet without an additional 14 square feet. 17.15 (2d) Ante Room (d) An ante room shall be at least 100 square feet. Remove the requirements for specific square footage space requirement. Current USP <797> ASHP Sterile Compounding Guidelines. There is currently no standard for the size of an ante room. The size of the room should be dependent on the work occurring within and the available space to implement a buffer room or cleanroom suite operation of a given size. 17.18 (7) A pharmacy shall operate and monitor the HVAC systems that supply conditioned air to the non- classified areas of the pharmacy 24 hours per day, seven days per week. Remove the requirement or add language “where prescription medications are handled and stored”. USP <797> The purpose and scope of these proposed regulations, as stated in 17.01, “…is to establish minimum professional standards for sterile compounding in order to safeguard the public health and welfare.” Establishing HVAC requirements for pharmacy personnel offices, customer waiting areas, rest rooms, conference rooms, office supply storage areas, and non-sterile compounding areas fall outside the scope of these proposed regulations.