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Board clarifies disaster and closure rules, requires timely reporting of fires/floods and data loss
Summary
The board approved proposals clarifying what qualifies as a disaster that allows temporary pharmacy closure (up to 90 days) and added a 10-day reporting requirement for loss of data or fire/flood events affecting drug integrity.
The Texas State Board of Pharmacy voted to propose amendments clarifying required notifications and operation rules related to disasters and data loss.
Staff presented amendments to rule 291.3 and 291.11 to specify that a pharmacy experiencing a fire, flood or natural disaster that may have affected the strength, purity or labeling of drugs must report the event to the board within 10 days. The rules would allow a pharmacy to discontinue operations for up to 90 days following such an event if the board is timely notified; otherwise the licensee risks needing to obtain a new license after 90 days of closure.
Staff also proposed adding a requirement that significant loss of information from a pharmacy’s data processing system be reported in writing to the board within 10 days of discovery, with the change aligning record requirements across pharmacy classes.
Board members said the intent is to restore a narrow focus on events that affect drug integrity rather than commercial or operational disruptions (for example, loss of clientele or a computer glitch was not meant to qualify as a disaster permitting a 90-day closure). The board approved the proposal for publication.
What happens next: Staff will send the proposed amendments out as part of the rulemaking process; the board approved moving the changes forward for public comment.
