Alaska Board of Pharmacy Discusses Sterile Compounding Inspections at January 2014 meeting

AGENDA ITEM 2 – Sterile Compounding Inspection

544

545 Mr. Cotter presented and reviewed a preliminary Sterile Compounding Inspection

546 Report that he and Lori DeVito another board member who is not in attendance at

547 this board meeting have been working on for the upcoming renewal period.

548

549 Mr. Cotter and Ms. DeVito after reviewing other states inspections forms chose to

550 utilize the state of California’s inspection report as the model from which this

551 preliminary report was created due to it being one of the most comprehensive

552 inspection reports. Mr. Cotter made a table sheet that the left hand column has the

553 California Inspection standards so have the inspection element and the appropriate

554 standard that support the element. On the right hand side is Alaska. The first

555 number of pages has compounding, not sterile compounding information and Mr.

556 Cotter skipped over that. Mr. Cotter started the comparison with element #7

557 Training of Compounding Staff with the Alaska standard next to it. One of the

558 problems Mr. Cotter came across is that every time we quote a standard you can go

559 back to regulation, but when you get into Sterile Product Standards you cannot do

560 the same thing. It simply is an attachment without a numbering system included to

561 get to the line element. Secondly, we have general statements without definitive

562 requirements, i.e. for how many years to keep training records or you have to

563 maintain the temperature of your refrigerator, but it does not specifically state a

564 temperature. More specific standards need to be behind the element so when the

565 investigator goes to inspect a “high risk” pharmacy he/she has a specific standard to

566 be inspecting against. Mr. Cotter’s concern is when we start writing up deficiencies

567 is whether or not there is enough behind in regulations to support it. Upon review of

568 Mr. Cotter’s comparison of the preliminary inspection report, Ms. Giessel stated that

569 our information should be a lot more quantitative for our investigator to acquire

570 good data from an inspection. Mr. Cotter stated that in‐state compounding

571 pharmacies are doing what the California inspection report asks, it is just that

572 Alaska regulations do not drill down to the specifics and they should.

573 The board is in agreement that more specific regulations need to be developed for

574 sterile compounding and will look further into starting it even if it means rewriting

575 the whole section currently used for compounding. Mr. Cotter suggested for the

interim to develop a simplified version 576 of the inspection form that can be used

577 starting this fall and then for the longer term develop an inspection form that is

578 inclusive of more specific standards and also research to include any changes from

579 the recently enacted by HR 3204, the “Drug Quality and Security Act”.

580

581 Mr. Cotter and Ms. DeVito will continue to work on a consolidated version and will

582 have something to present at the next meeting.

583

584 Mr. Holm stated that we may need to work with the Regulation Specialist on how to

585 turn what the compounding pamphlet that is in the regulations now, be utilized for

586 compounding regulations that are more specific and less subjective.quoted from here