Tuesday, September 24, 2013

This is another whoa moment for me-- Jim Smith, president of PCCA, said, “The sponsors of S. 959 claim that this legislation will not affect community pharmacies. In fact, 41% of the respondents to this survey meet the bill’s criteria for ‘manufacturing.’ T

What does this comment actually tell us?  Really, 41% would meet the definition for manufacturing.  So does this mean the definition is too broad or that we have a lot more serious problem than we ever dreamed and that are potentially a lot more NECC outbreaks that are possible if 41% are "manufacturing."  Does this also mean that state boards of pharmacy have done a lot worse job than one could have imagined by not inspecting, enforcing and regulating these types of compounding pharmacies?  Readers help me out?  What does this statement really mean?

1 comment:

Kenneth Woloner, MD said...


It means that state boards of pharmacy (and each State's Bureau of Enforcement are Ill-equipped to deal with manufacturers who hide under the guise of their pharmacy license. Consider each of the following actions and ask yourself, "Is it the practice of pharmacy?" or "Is it manufacturing?"

- producing a drug without having a prescription from a physician (anticipatory compounding)

- marketing this drug you just produced for indications not approved by the FDA to physicians and veterinarians across the entire country a with national sales force with sales reps making $200,00+ a year, just to generate interest in prescribing this new drug you produced (not just trying to divert business from a competitor to your own business)

- selling drugs wholesale to physicians/veterinarians for them to further dispense/distribute to their patients for self-administration at their own homes

- offering split-fee /patient-brokering arrangements with prescribers where patients pay their physician a "retail price", the prescriber faxes the script to that specific pharmacy only (denying the patient choice of his or her own pharmacy), the pharmacy then drop-ships the drugs to the patient at his/her home, and at the end of the month, the pharmacy will send a bill to the prescriber for all the meds prescribed in this manner, but at a lower "wholesale price", and both the pharmacy and prescriber make tons of money by exploiting the patient for financial gain. 

Based upon these actions, I consider these pharmacies to not just be manufacturers but also criminal racketeers. What do you think?

Ken Woliner, MD
www.holisticfamilymed.com