Excellent Blog about Pharmacy Operations

I know its been a while since I posted last… summer is finally kicking into gear here in Seattle and life seems to get so much busier! I just got back from a camping trip with my wife and 3 daughters. But you’re not here to read about my personal life…

I highly recommend you check out the Community Forum that Pharmacy OneSource has recently started. Among other topics, it has a great section on Pharmacy Operations that includes lots of Q&A about USP 797, and usually the answers come directly from Eric Kastango. Check the forums here.


USP 797 FAQ: How large does the ante-room need to be?

From USP’s FAQ on USP 797 page:

126. Is a large ante-room required, or would a small vestibule for hand washing and donning of protective garb be sufficient? In other words, could there be an IV work room that is unclassified where the computer input, unboxing and storage of IVs takes place outside of an ante-room to reduce the square footage of space required to be ISO 7 or 8? The IVs would still pass into the buffer area through the vestibule that is the ante-room.

USP does not define the process flow requirements. A small ante room that simply facilitates hand hygiene and gowning is adequate.

California Compounding Regulations FAQs Being Sought

Just received this email from the California State Board of Pharmacy:

Compounding Regulations FAQs Are Being Sought

The California State Board of Pharmacy announces that at its Enforcement Committee Meeting  on June 16 in Sacramento,  a question and answer session will be held to discuss the Board’s Implementation of 16 California Code of Regulations Sections 1735-1735.8, Pharmacies That Compound, and Sections 1751-1751.8, Pharmacies That Compound Sterile Injectable Medications.  These requirements will go into effect on July 6, 2010.

Questions for the Board’s Enforcement Committee to answer about the compounding regulations may be submitted in advance to Susan.Williams@dca.ca.gov.  Questions and anwers developed will be posted on the board’s Web site in the future, so those individuals submitting questions do not need to attend the meeting.  Not every question submitted may be answered by the committee.

Please click on this link to view the Enforcement Committee Meeting agenda:


22% of Hospitals Currently Meet USP 797 Regulations

From Pharmacy Purchasing & Products annual State of Pharmacy Compounding Survey for 2010 based on 322 pharmacy director responses:

  • 22%   Meet/exceed all requirements
  • 56%   Meet most requirements
  • 15%   Meet some requirements
  • 4%    Plan to address
  • 3%    No plan for compliance

With less than a quarter of pharmacies currently fully compliant, here is the projected timeline to compliance for those not there yet:

  • 31%   Within 6 months
  • 32%  6 months – 1 year
  • 23%  1-2 years
  • 5%    2-3 years
  • 9%   No plans for compliance

What if your loved one was the recipient of the next CSP you make?

Would you do anything differently if you knew that the next CSP you are preparing was for your mother or your child? Eric Kastango recommends that the the “Loved-one Rule” be part of your training program:

Any compliance approach should integrate the ‘loved-one’ rule, where staff are asked to picture loved ones as the recipient of the final CSPs, making the patients they may never meet more real.