Throughout history physicians and pharmacists have prepared, or compounded, drugs from
raw ingredients. Some pharmacists still do.

Legally in the US pharmacists can presemtly compound drugs that are made from
substances that are on what is called a bulk drug list.
In the early part of 1999 I was asked to present written and oral testimony to an
FDA advisory committee on pharmacy compounding that was considering adding Mild Silver
Protein (MSP)to the bulk drug list. Compounding pharmacists had proposed that it be
added for "ophthalmic use". However, had it been placed on the list, it 
could have been used for any indication. In other words, its use would not have 
been restricted to the eyes alone.

For more information go to the Federal Register:
Check off "1999" and "proposed rules" in the appropriate boxes.
Use "pharmacy compounding"   as the search term.  Include the " ".
Two hits come up.  Click on:
TEXT under "List of Bulk Drug Substances That May Be Used in Pharmacy"

I submitted written comments to the committee
and also attended the two day meeting in Rockville, MD at which they heard oral 
testimonies on the drugs being considered for placement on the list from the 
compounders, the public and other interested parties. MSP was considered on the second

Both an FDA ophthalmologist and I gave oral presentations on MSP.  In concluding my 
talk I asked the compounders if they were ignorant like my MD,quacks like my 
pharmacist or if they had evidence that I hadn't seen. If so I wanted to see it.  In 
fact, I told them that if they could demonstrate to my satisfaction that ingesting 
silver is benefical for something and that the benefits outweigh the risks I will 
endorse it and also support their request to have it added to the bulk drug list.  
There was no response.  To date no one has shown me or the FDA any evidence indicating
that ingesting silver in any form, amount or particle size benefits anyone other than 
the quack who sells it.

The compounders had a non-voting representative on the committee who had attended the 
session on the first day when he and his colleagues saw me in person. Since committee 
members had received my written comments in advance, I believe that their non-voting 
representative had seen them and guess that he must have shown them to his colleagues 
as well.

Another of the compounders' representatives gave oral presentations explaining their 
reasons for requesting that various individual substances be added to the list.  She 
was scheduled to give just such a presentation on MSP but didn't show up until after 
the FDA doctor and I had given our presentations and the vote had been taken. 
The committed voted unanimously not to add MSP to the list of drugs that pharmacists
are permitted to compound. Their non-voting rep didn't show up at all the second day.
He never heard my oral presentation although he may later have heard a recording of it
since I believe that there was at least one compounder in the audience taping it.

After my talk, a committee member asked who had proposed MSP for the bulk list.  
The answer was IACP, the International Academy of Compounding Pharmacists.  It had 
been their rep, Gina Ford, who had been scheduled to speak but who hadn't appeared 
until after all the testimony had been presented and the vote had been taken.

Larry Sasich, the Parm. D from Public Citizen, was present for the meeting on the 
first day.  He gave an oral presentation in which he pointed out that a visit to one
of the compounders' websites contained links to some of the worst quacks in medicine.
When PC requested more information, they were sent similar material snail mail.
These are the compounders webpages:
Check them out for yourselves.   
The committee also voted unanimously not to permit hydrazine sulfate to be added to 
the bulk list.  HS & MSP are also sold legally as unregulated dietary supplements.	

While I was in Rockville attending the meeting, FDA gave out more pink slips.  More
budget cuts.  Fewer employees. Less protection for Americans.

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