12 AAC 52.150, Inspection of pharmacies – Again this has the same issue with the
290 “high risk pharmacy” and another overarching issue is we seem to be requiring
291 more from an out‐of‐state pharmacy than what we require of in‐state pharmacies
and this is not allowable. Mr. Holm explained to AAG Araujo that the reason we
293 require an inspection report from out‐of‐state pharmacies is that whenever we
294 license a pharmacy from out of the state we are relying that pharmacy is being
295 regulated properly and efficiently by their particular board in their home
296 jurisdiction. The inspection report is the only way we can put the responsibility on
297 their home state Board of Pharmacy to regulate and make sure their pharmacies are
298 in compliance and have an inspection. This is the reason why we require the report.
299
300 Pharmacies in our state we can and do inspect at any time. We do not have the
301 funds or the man power to inspect out‐of‐state pharmacies.
302
303 Mr. Cotter stated that the aspect on the “high risk” component is as Mr. Holm stated
304 that out‐of‐state pharmacies just have to provide an inspection report, all the in305
state “high risk” pharmacies are going to be required to be inspected. They both will
306 be inspected per a regulatory period it is just by slightly different methods. One
307 from the out‐of‐state pharmacy that has to provide a report and the in‐state
308 pharmacies will be inspected by us. Mr. Cotter then stated he does not see a
309 discrepancy in that.
310
311 Mr. Holm agreed that there isn’t a discrepancy if anything there is more required of
312 in‐state pharmacies because they are going to be required to pass an inspection. We
313 are only asking for an inspection report from the out‐of‐state pharmacy. It is the
314 only way we know if there are any issues with an out‐of‐state pharmacy.
315
316 AAG Araujo then asked if the physical inspection that is contemplated in 12 AAC. 52
317 150(b) will also be required of in‐state pharmacies prior to licensing? Mr. Holm
318 answered no, but you have to pass an inspection before you can renew your license
319 before the next licensing renewal period. Ms. Giessel then stated we are trying to
320 capture all of them into inspection, it hasn’t been there previously. Mr. Holm stated
321 we have a problem with getting pharmacies inspected in a timely fashion so that
322 licenses are not held up. The in‐state “high risk” pharmacies are being flagged so
323 our investigator who does the inspections knows what pharmacies have priority for
324 inspection. Our investigator is being trained now on how to inspect a “high risk”
325 pharmacy.
326
327 AAG Araujo then restated his concern that under 12 AAC. 52 150(b) the difference
328 between in‐state and out‐of‐state is still an uneven playing field by requiring a
329 current inspection report prior to licensing but do not require the same from in330
state pharmacies prior to licensing.
Mr. Holm stated we have to start some place and that most states do inspections on
333 a regular basis of all their pharmacies and so we are asking for the most current
334 inspection report. Mr. Holm then advised that in‐state pharmacy inspections have
335 not been done in Alaska for almost 30 years when they were performed it was the
336 actual board members who did the inspections. Since then we operated under an
337 honor system by having in‐state pharmacies complete a “Self Inspection” report.
338 Under the current circumstances with what is going on in the country we can no
339 longer rely on that and since we are moving into a new realm if you will, we will
340 have a problem only with the upcoming license renewal period this June. There is
341 no way that our investigator can complete a physical inspection before licensure
342 this time. Going forward it is the board’s intent to require a pharmacy inspection be
343 done before a pharmacy opens and the license is issued.
344
345 With the renewal licensing period coming up so quickly and due the current
346 regulations changes not ready for implementation, the Board with AAG Araujo
347 agreed to level the playing field and eliminate the discrepancy between in‐state and
348 out‐of‐state with a regulation change that will now require an inspection for in‐state
349 pharmacies before licensing for the next renewal period.quoted from here
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