A reminder regarding referrals: DaVita Kidney Care to pay $389 million to settle whistle-blower case By Gregg Blesch Posted: October 23, 2014 - 6:15 am ET

DaVita Kidney Care has agreed to pay $389 million to resolve a whistle-blower's allegations that the company induced physicians to steer patients to its dialysis centers for the past decade with opportunities to profit by buying and selling stakes in clinics.

DaVita Kidney Care, the largest division of Denver-based DaVita HealthCare Partners, previously disclosed the sum in financial reports to the Securities and Exchange Commission and has now finalized the agreement with the U.S. Justice Department. 
continue to read here

FDA Law Blog Provides Their Take on the FDA Guidance Regarding Inspections, but Remember They Are Lawyers Making the Arguments To Represent One Side in the Equation: The FDA Guidance is Not Written for the Parties Being Inspected--the Guidance is for the FDA and its employees.

This guidance does give clues to those being inspected as to arguments the FDA is willing to make in court and as to arguments it thinks it has a "reasonable" chance of prevailing on if it goes to court.  In the compounding area, one has to look no further than the Congressional hearings on the NECC outbreak and how some compounding pharmacies refused to allow the FDA to inspect and how some organizations that represented them advised them to refuse to be inspected.  We all know how those played out in court so we do know the FDA has prevailed in the past.   Even if it hadn't, these refusal showed examples of where the FDA tried to get a handle on compounders who were possibly manufacturing but roadblocks were put up by the compounders,  which eventually was used to convince Congress to pass the DQSA.  The lawyers writing the FDA Law Blog do point out that each company/place/business should have its own internal procedures for an FDA inspection and that one should consult an attorney for guidance on these internal procedures.

The FDA Law Blog's take on this guidance can be read at

October 22, 2014

What Can FDA Do During Drug Inspections: Will FDA Apply Its New Guidance to Other Products?

By Jay W. Cormier & Anne K. Walsh –

FDA Enforcement Reports October 22, 2014--Several Veterinary and Drug Issues

Enforcement Reports October 22, 2014

FDA Guidance on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection October 2014

here

Legislator in Missouri Plans to Introduce Prescription Drug Database legislation

here

If you haven't been keeping up on Cafepharma board...you should...One word of Warning Do not Believe Everything Touted to be the law by the people writing those post...but you do have to appreciate the ones speaking up and telling the truth about the industry

here are a few of the comments/claims that I will parapharse

Toxicology and Pain cream compounding is over.

Completely over saturated market

No less than a zillion companies  

It's become a joke.

The PBMS have caught on

One person claims to work for 5 different compounding pharmacies as a sells rep/ says party is not over/ you just need to know how to work the system--send samples of the compounds to the doctors!

claims everyone just needs PCAB accrediation now

claims everyone just needs a W-2 and not 1099 form

claims PCAB accrediations being handed out like candy 

link can be found here

Frank Iannarone of Madison Pharmacy receives 2014 NCPA Prescription Drug Safety Award - DrugStoreNews

Frank Iannarone of Madison Pharmacy receives 2014 NCPA Prescription Drug Safety Award - DrugStoreNews

Competition for pharmacists could rise: Measure 7 could increase service but make hiring more difficult

Competition for pharmacists could rise: Measure 7 could increase service but make hiring more difficult

After Five Year Investigation, Boston Pharmacy father and son plead guilty to drug charges - WALB.com, Albany News, Weather, Sports

Boston Pharmacy father and son plead guilty to drug charges - WALB.com, Albany News, Weather, Sports

Missouri Board of Pharmacy Meeting: October 16, 2014 Report on Meeting

here