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  • jwgilbreath

Regulatory Body Visit (#1)

As many of you have experienced the slight twinge in your stomach when someone presents to the pharmacy and says..."I'm from the Board of Pharmacy coming in for an unannounced visit." Maybe you even feel your stomach drop to your toes!

What can YOU do to help keep your sanity and reduce anxiety for times of visits of regulatory bodies? One thing I absolutely recommend is BE READY AT ALL TIMES!

Being always ready helps put your mind at ease so you can confidently bring that person into your pharmacy space and easily present to them exactly what they are looking for!

So let's discuss some ways (some low hanging fruit) that helps you to be ready for a visit. My plan is to discuss a few topics per post. There will be follow up posts that continue the conversation.

So let's start this!!

First off...make sure to verify that whoever presents to the pharmacy is exactly who they say they are! Don't get scammed!

What type paperwork can you be expected to present?

  1. Inventories.

--does your state require annual inventories?

--does your state require change in Pharmacist in Charge (PIC) inventories?

--does your state only require what the DEA requires related to inventories? I.e., biennial and initial

*****be on the lookout for future seperate post(s) doing more deep dive into inventories!

2. Invoices

--are your C-II invoices separated from your other invoices?

--are your C-III through V invoices separated from other invoices or filed with non-controlled invoices but notated in some way that they can be easily retrievable from the non-controlled inventories? It's generally easier to be separated from non-controlleds though.

3. Are any documents stored offsite from the pharmacy?

--is there proper documentation showing that the DEA was contacted in writing to request?

--has the state approved?

--is the items stored off site only items that are allowed offsite? Example --financial documents. Remember executed 222 forms and inventories MUST be on site! Refer to 21 CFR for more details of what must be maintained on site.

Watch this space for future post!!

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