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For those customers who renew their prescriptions regularly, Mr. Roberge said he keeps a supply of the compounded medication on hand.
The F.D.A. said in June that after obtaining and testing 13 samples of the compounded drug, it had found no significant quality problems.
K V hired a corporate intelligence firm to obtain and test samples of the compounded version, 17P, for potency and purity.
Instead, Dr. Carome said, the group suggested answers "for which the implicit, if not explicit message was to stonewall and obstruct" the F.D.A.'s attempt to assess the quality of the compounded drug.
Large-scale pharmacy compounding has greatly expanded since the early 1990s, partly because hospitals are increasingly outsourcing the making of the compounded drugs that they need and also because of widespread shortages of medicines made by the big drug manufacturers.
When the F.D.A. was given the data last fall, the agency decided to take its own samples of the compounded version, prompting the International Academy of Compounding Pharmacists, the trade organization, to offer its members advice on how to respond to F.D.A. requests, in an e-mailed member alert titled, "F.D.A. Calling Compounders about 17-P".
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