Monday, October 15, 2012

Minutes from August 2012 Alabama Board of Pharmacy Meeting Minutes: Discussion Regarind inspection done on sterile compounding pharmacies


inspection.
2 And most states do not let the same person
3 inspect twice in a row. They move it around so
4 that they feel like they get a fresh set of eyes on
5 things and go that route. I did talk to, as it was
6 brought up in a work session earlier, we've looked
7 at states that have all or some pharmacists,
8 inspectors, investigators. It appears that all of
9 the statutes or most of the statutes are written
10 like ours that says that only sworn officers that
11 are certified by the State currently can, I guess,
12 have access to records and that sort of thing.
13 Georgia, South Carolina, quite a few other
14 states actually hire pharmacists and send them to
15 the police academy to do that. One of the things
16 that I've been looking at and NABP has been looking
17 at is how to get a consistent survey, more of a
18 survey than an inspection done on sterile
19 compounding and on compliance with <795> and the
20 laws that relate to retail compounding. And I
21 think we're okay within our proposed budget that
22 we're looking at for the upcoming year to do some
23 analytical and background-type work

many of these places there are and put a number out
2 there as to whether we want to do something like
3 this forever like Texas does where they go out and
4 get samples of product and send it off
5 independently to have analyzed. They have a budget
6 of $100,000 a year to pay analytical labs to test
7 things; whether we want to go to that extent or
8 whether we want to go to more of a -- some of the
9 states charge a fee to inspect places that have a
10 higher level of difficulty to inspect and they send
11 somebody with the sworn officer out to the place
12 and do more of a survey, but they charge the
13 pharmacy for the survey.

Source found here

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