MS. ALVERSON: All right. As was
mentioned, the Senate passed the compounding bill this week on Monday. Donnie mentioned it
and once that gets implemented, and of course
when things get implemented, what you expect is going to happen doesn't always happen and the agency that writes it comes up with different
quirks in there but I think it's -- this bill is going to put us in a more difficult position in that the bill allows manufacturers -- what we all know to be manufacturers -- to make a choice: Do you want to put yourself under FDA compliance or don't you?
And you might think that most people would say, well, why would I want to be inspected by the FDA but some businesses to be
able to sell what they're manufacturing aregoing to need that FDA certification because
their customers are going to demand it but there will be others that don't and so for our office, it's going to mean much more in-depth inspections going through a lot more paperwork,looking at shipping records, looking at compounding records, all of which we most certainly intend to do but it is going -- it's going to be balancing whether the FDA picks up certain components or if -- or if we pick up those components for manufacturers in the State
and I guess we won't know until we actually see
how that law is implemented.
MR. SANDERS: When -- when do we
3 anticipate that it would be?
4 MS. ALVERSON: I don't know.
5 MR. SANDERS: Yeah.
6 MS. ALVERSON: From my perspective, we
7 have to begin inspecting -- well, we've already
8 started that but we will have to assume that
9 until they go with the FDA that they're going to
10 remain licensed in Alabama and so I think we
11 will have to inspect them as manufacturers even
12 though they remain licensed as a pharmacy and if
13 they go with the FDA, then we can take them off
14 our radar. One component of the legislation
15 though says that those people who do go under
16 FDA have the choice to be a pharmacy or not be a
17 pharmacy and I think we need to have a policy
18 that if you're dispensing prescriptions out of
19 that pharmacy, you are a pharmacy in Alabama.
20 And whether you're with the FDA or not, if
21 you're dispensing drugs to patients, you have to
22 be registered with the Board of Pharmacy.
23
MR. SANDERS: Jim, we probably
wouldn't have to change it --
2 MR. WARD: I don't think so.
3 MR. SANDERS: We should already be
4 protected.
5 MR. WARD: Yeah, I think we're okay.
6 MR. CONRADI: The FDA only gets
7 involved if it's not patient specific and if
8 it's out of state so. The way that law was
9 written, I don't know if it finally passed that
10 way or not. I haven't seen a copy of it but it
11 was nonpatient specific and had to cross the
12 state line before they would get involved.
13 MS. ALVERSON: It's just that we have
14 places that are dispensing prescriptions to
15 patients inside Alabama but 80 or 90 percent of
16 their business comes from shipping out-of-state
17 products that they manufactured.
18 MR. CONRADI: Do they ship it to
19 patients or just like to hospitals and other
20 people or bear with us.
21 MS. ALVERSON: They are primarily
22 selling drugs that they manufactured to
23 physicians' offices.
We have arranged for the inspectors
2 to have a day of training at a hospital -- what
3 goes on in a hospital, what are all the
4 components to look at, to try to help with that
5 inspection, and we've also arranged for a half a
6 day to a day for our inspectors to spend at a
7 nonsterile compounding pharmacy for all of us to
8 be trained on all the equipment and how all of
9 that is being used.
10 And I've asked a group of compounding
11 pharmacists, sterile and nonsterile, to meet
12 with me periodically, so we're going to have our
13 first meeting this afternoon when this meeting
14 disbans. Just so you know that we're doing that
15 because I would like to stay in touch with the
16 pharmacists in the state. Sometimes they've
17 heard of something that we haven't and so on and
18 so forth.
19 For the data system, you've also
20 received a copy of a proposed inspection report
21 for community pharmacy that Henry and I worked
22 on. We have worked with GLS now to begin the
23
process of electronic data inspection
submissions for the inspectors.
2 I'm sure that's going to take four or
3 five months to implement but this is the form
4 that they will see on their laptop or on their
5 iPad or whichever system Henry and the
6 inspectors decide to use. So they will be able
7 to fill this out on their -- as I said their
8 laptop or their iPod -- iPad and then submit it
9 directly to this office through Henry's
10 department and it will populate the data for
11 that particular pharmacy without us having to
12 scan documents, re-enter data, so everything
13 will be done electronically.
14 If you -- what we primarily had to do
15 now was send the format but we have time to
16 change inspection criteria. So if you see
17 something that you like or don't like, your best
18 bet is probably to email Henry and -- and he can
19 tell you why things are in there and why they
20 are not in there.
21 The tech renewal is going well. We're
22 hoping we're not here Christmas Eve working or
23 New Year's Eve working to get everybody
Quoted from Alabama Board of Pharmacy November Minutes
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