Eight Question of the Day, September 22, 2013, Will the slow progress of Congress in passing legislation to deal with the compounding pharmacy problem have any impacts on whether some in the House and Senate get reelected? Would the passage of federal compounding legislation help them in getting reelected?

Seventh Question of the Day, September 22, 2013, In the interest of transparency why doesn't the FDA make all 483 inspection reports available on its website?

Sixth Question of the Day, September 22, 2013, Which version the House or Senate version of the compounding legislation would be more likely to protect the health and safety of the public?

Fifth Question of the Day September 22, 2013 Which version of the compounding legislation the house or the senate version will help more people be employed? Which version will cause more small, local business owners to close up shop?

Fourth Question of the Day, September 22, 2013 Since there appears to be wide spread corruption and lack of ability to police ones on self among the State Board of Pharmacies when it comes to Compounding Pharmacies and Pharmacists Should Congress Consider Tasking the Department of Justice With a Priority of Criminal Investigations into this Area and Provide It With Dedicated Positions to Handle Pharmacy and Prescription Law Crimes in additon to the already mandated Health Care Fraud Positions.

Third Question of the Day, September 22, 2013 In light of the fact very few state boards of pharmacy have started to strictly and swiftly enforce state compounding laws, regulations and rules against compounding pharmacies and pharmacists, why hasn't Congress taken prompt action to give the FDA much needed clearly defined authority over compounding pharmacies and pharmacists that are a danger to the public safety and health?

Question of the Day: June 4, 2013 How Many Compounding Pharmacists Are Currently In Or Have Been to Prison? What Crimes Where They Charged With? How Many Just Received Probation?

Should more or less have gone to prison?  Certainly attorneys have had their fair share of members go to prison for some really bad crimes?  Are Compounding Pharmacists Any Better or Worse As A Whole Than Any Other Profession When It Comes to Members of the Group Who Give Everyone in the Group a Bad Name?  What can the profession of Compounding Pharmacists do to show the public that it is not protecting the bad members?  Does the FDA or the states have to determine they are bad before the group of compounding pharmacists ( such as IACP) will take action and not allow them to be member? Are does there actually have to be a civil or criminal finding of liability?  And what kind of action should groups like IACP take against bad members?  This is a separate question that what state boards of pharmacies should do once a civil or criminal finding of liability has been made.

Question of the Day: 4/3/2013 What Can the FDA, Congress, State Boards of Pharmacies, and State Legislatures Do to Clear Up the Confusion Regarding Veterinary Compounding law?

Question of the Day: 4/2/2013 Are FDA and State Inspectors Knowledgeable Enough and Consistent Enough Throughout the Nation to Inspect Compounding Pharmacies?

By consistent I mean at the FDA it appears that perhaps each district office is inspecting and writing compounding pharmacies up in an inconsistent manner.  For example, while a pharmacy in Oklahoma might be violating the rules and regulations in the same manner as a pharmacy in South Carolina, the one in South Carolina gets cited for the violation while the one in Oklahoma does not.   Do the inspectors have a clear understanding of all the issues they should be looking for at each compounding pharmacy?  Did they all receive the same training?

Question of the Day: 4/1/2013 In increasing regulations and inspections to rein in bad compounders how do we keep from running off the good compounders who are so essential in both human and animal medicine?

3/31/2013 Question of the Day: Do Unsafe Compounded Veterinary Drugs Poses Just As Great A Public Health Risk As Contaminated Compounded Human Drugs?

 If so, why does the FDA and state boards of pharmacy and others not seem to pay any attention to this area?

Question of the Day: Has the Sky Fallen on Compounders and Compounding Pharmacies Because of Greed or Is it Simply a Failure to Police Ones Own by Enforcing the Laws on the Books or Is it Both?

Question of the Day--A Response to the IACP's New Position

By Sue Tuck Richmond

Why is the IACP and others so critical of the FDA for things such as the failure to follow up on warning letters when there are also examples of the states failing to follow up after issuing warning letters and doing the exact same thing?  For example,  in Texas they have in the past allowed the pharmacies to merely submit a letter stating after a warning letter/violation notice that the pharmacy is now in compliance and has taken the appropriate action rather than reinspecting) or state pharmacy boards  that send the FDA correspondence to local FDA offices rather than finding out the specific and appropriate person in the FDA to address the referral that a pharmacy appears to be manufacturing and furthermore the state does no followup after hearing nothing from the FDA).  Also what about the fact that the states have failed to police these compounding pharmacies that the FDA has now found serious problems with.  It is easy to sit here and point the finger back and forth at the states and the FDA, but this ultimately solves nothing and only creates a further divide between the two.  Rather than blaming shouldn't we all be trying to solve the problem and find the right solution.  I am fairly should if we want to get involved in the blame game there is plenty of blame to go around.

Question of the Day 3/22/2013 Sales Reps/Marketing Directors and Ethics Code

I have been working on a post covering this topic but wanted to go ahead and pose the question.  Should sales representatives, marketing directors or anyone who sales or markets compounds regardless of his or her title be bound by a code of ethics?  By this I mean, other professions have code of ethics--specific rules and regulations that they as a profession must adhere to  or be sanctioned or removed from the profession--shouldn't these folks also have a similar set of rules and regulations, in addition to the pharmacy rules and regulations-setting forth the standards they must maintain and follow.  Just as a pharmacist, doctor, and lawyer must be registered in each state, a person selling or marketing these compounds must also be licenced and registered in the state he or she is selling the compounds in.  There are numerous items these ethics could include--everything from what the person can say when marketing or selling, to prohibited relationships with customers and employees.  To be able to sell compounded medications, an individual would have to pass both an ethics and a knowledge based test appropriate for the type of compounds to be sold.

Question of the Day:

Should a pharmacist who was operating a business under one business name and that business was disciplined be allowed to open a compounding business under another name and continue to compound medications?  See example in comment below which was provided to earlier post.

Kenneth Woliner, MDMarch 21, 2013 at 6:49 PM

But will Illinois be any smarter than Florida?

Florida closed "FRANCK'S LAB, INC" but allowed the same pharmacist/owner, "Paul W. Franck", to open up "Franck's Lab Inc" (corporate name without comma, and not in all caps). So, the same bad apples who compounded bad drugs that blind patients and kill polo horses are still in business.

License Org Name DBA Name Address Profession City
PH22470 Franck's Lab Inc. Trinity Care Solutions 202 C SW 17TH STREET PHARMACY OCALA
PH19761 FRANCK'S LAB, INC FRANCK'S COMPOUNDING PHARMACY 1210 A South West 33rd Avenue PHARMACY OCALA


Kenneth Woliner, MD
www.holisticfamilymed.com