Our pharmacist Alan just came back from a Veterinary Symposium with a lot of insights into vet compounds. Give us a call to see how we can help your pets as well!
quoted from here
quoted from here
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Well and there it is, just like
the saleswoman said, in #18--maybe the lawyers believed the marketing claim
too. "Compounded done by OmniPlus consists of mixing one or more
FDA-approved ingredients at the direction of the physician to meet the
individual patient's specific needs" on More information on Dan Milosvic
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I note that #16 in the complaint
reads "Compounding pharmacies have the ability to mix multiple
FDA-approved drugs or active ingredients to create a medication specifically
tailored to a patient's needs." The language is misleading. Compounding
pharmacy business models almost exclusively use non-FDA approved chemicals as
starting materials, with the entire industry supported and facilitated by
suppliers to the U.S. market, pharmacies do this to reap exceptionally large
profit margins by dropping the bottom out of acquisition costs. This may be
where some of the payer confusion arises from. At a medical meeting several
years ago, a compounded drug saleswoman stated that although the drug she was
promoting was not FDA approved, the individual ingredients contained in the
drug were approved by FDA. That statement is false--FDA only approves product
s in their finished dosage forms, with packaging and labeling for safe use.
Maybe payers were marketed to also, and believed the on More information on Dan Milosvic
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Check out this prior matter
involving precursors (butanediol) with links to Houston, TX Genapharm:
http://www.fda.gov/downloads/ICECI/.../UCM091464.pdf on Texas man gets 20 years in synthetic
drug deaths - FOX 26 News | MyFoxHouston
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Anonymous
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at
11:56 AM
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By Anthony Clark Carpio, Huntington Beach Independent, Calif. | |
McClatchy-Tribune Information Services |
Network Providers may not produce, distribute, or accept pre-printed or pre-populated prescriptions for Covered Medications that include a controlled substance. This prohibition includes “check the box” order forms. Network Provider acknowledges and agrees that using, accepting,and/or distributing pre-printed or pre-populated prescription forms that include controlled substances constitutes a violation of law, including but not limited to, the Controlled Substances Act and its implementing regulations. PBM may, in its sole discretion, recoup claims and immediately terminate Network Provider for violating this section of the Provider Manual.