Senate working under the “cover of darkness”?

I got this email from NCPA (National Community Pharmacists Assoc) today. Admittedly, I don’t really have a dog in this fight.. but.. if it affects pharmacy/Pharmacists.. it should be important to all of us.

To further regulate pharmacy compounding, the US Senate is attempting to pass legislation through a process known as “Unanimous Consent” before they adjourn for August recess next week, AND IT COULD HAPPEN AS SOON AS TODAY! The final bill S. 959, the Pharmaceutical Compounding Quality and Accountability Act, was produced behind closed doors, yet this procedure prevents any debate on the bill, prohibits amendments, and no Senator is forced to go on the record and affirmatively support the bill. However, it takes only ONE SENATOR to SAY NO to force regular order.
Despite great strides to improve the bill we still have serious substantive concerns with the legislation in addition to our procedural concerns, including:

• Requiring individual pharmacies to report directly to the Food and Drug Administration (FDA) when compounding a medication that is in shortage.

• Allowing FDA to unilaterally establish a “do not compound” list
• Exempting hospital pharmacies from these regulatory burdens

• Not adequately addressing the concept of office use of compounded medications

Due to these serious concerns, this bill is not non-controversial and deserves full fair and open debate. Urge Senators Coats and Donnelly to consider the impact on community pharmacies by OBJECTING TO THE UNANIMOUS CONSENT REQUEST.

There is a old saying on “The Hill”… “horror stories don’t make good policy.. but.. they do make policy”… IMO.. this is a direct result the of the mess around NECC and all that fungal contaminated methylprednisolone using for spinal injection… and the nearly 100 people that died.. and hundreds that have gotten and/or still sick and suffering… and what has seemingly been a direct cause/effect of the lack of oversight by the MA BOP.

There are rumors roaming around that there is another east coast state.. where the state’s BOP has been following in the foot steps of the MA BOP in regards to oversight and soon find themselves in the spotlight of scrutiny by Congress and the FDA…

IMO.. we are in a continuing period of the federal bureaucracy looking for areas to expand their oversight and authority.. About the only place left is to take more and more authority away from the states.. With the general focus of most BOP’s on drug diversion and little else… they are laying the ground work for when horror stories like NECC come to the forefront… to step in and “solve” the problem.

As has been stated before.. “you should never let a crisis to go to waste ”


One Response

  1. There is one thing…for sure…when government works under the cloak of secrecy, nothing good will come from it.

Leave a Reply

Discover more from PHARMACIST STEVE

Subscribe now to keep reading and get access to the full archive.

Continue reading