Science

Senate Holds Hearing on Compounding Pharmacies

July 16th, 2013

On Tuesday, July 16, in Washington, a Senate health subcommittee is holding a legislative hearing entitled Reforming the Drug Compounding Regulatory Framework.

Safety and secrecy issues regarding the use of a compounding pharmacy led to yesterday’s stay of execution for Georgia death row inmate Warren Lee Hill, Jr.

The state is using a compound pharmacy to supply the drug Pentobarbital that will be used in lethal injections.

WABE’s Rose Scott reports on the good and bad of compound pharmacies.

Last year a Massachusetts company shipped more than 17-thousand vials of an injectable steroid solution to 23 states.

But the vials were from three contaminated lots and 50 people died.

More than 7-hundred would become ill.

Reports indicate the deaths were due to complications associated with fungal meningitis.

This clip is from the CBS news show 60 minutes.

The man you’re about to hear, Willard Mazure, he received a tainted injection.

“I’m on 60 mg of morphine a day with no cure in sight. There is no cure in sight for me”

Compounded drugs are specifically made for a particular patient and require a prescription.

For example, someone may have an allergy to an ingredient in a commercially produced drug and would require custom-made drug.

David Ball admits the tragedy in Massachusetts was unfortunate, but he’s also adamant that compounding pharmacies and pharmacists provide a great deal of service to the medical community and people.

“They keep people healthy. They keep them out of the hospital. In some cases they’re the only option. Take the person who can’t swallow medication or on a feeding tube or they need liquid therapy. If you didn’t have compounders you wouldn’t be able to take drugs that are only made in pill form and have them orally.”

Ball is spokesperson for the International Academy of Compounding Pharmacists or (IACP).

He is not a pharmacist.

But Ball says every precaution is taken to ensure compounded drugs and the facilities meet standards set by state boards of pharmacies.

IACP Executive President and CEO David Miller is scheduled to testify at the Senate hearing.

Right now the FDA has no regulatory authority over compounding pharmacies.

Georgia law prevents the identity of the manufacturer or supplier of the state’s drug Pentobarbital from been made public.

Georgia Governor Nathan Deal supports the law.

“I think there are good reasons why you would not want someone to be harassed simply because they are complying with a contract that the state has, even though it may be in a distasteful area.”