Throughout history physicians and pharmacists have prepared, or compounded, drugs from raw ingredients. Some pharmacists still do. http://www.quackwatch.com/01QuackeryRelatedTopics/compounding.html 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: http://www.access.go.gov/su_docs/aces/aces140.html 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 http://homepages.together.net/~rjstan/msp.html 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 day. 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: http://www.thecompounders.com/ http://www.ijpc.com/ http://www.iacprx.org/ 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. http://homepages.together.net/~rjstan/rose14.html While I was in Rockville attending the meeting, FDA gave out more pink slips. More budget cuts. Fewer employees. Less protection for Americans. Return to Index