Specialty Compounding provides an efficient solution for patients, doctors, hospitals, clinics and ambulatory surgery centers. Our pharmacy processes meet or exceed the industry standards and guidelines established by the Texas State Board of Pharmacy and United States Pharmacopeias. Specialty Compounding is a PCAB accredited and a licensed DEA drug manufacturing facility.
quoted from here and accessed on August 15, 2013
1 comment:
PCAB Accreditation just means "you paid enough money to get a piece of paper". Nothing more.
IACP membership means "you belong to a trade organization whose main focus is to decrease your regulatory burden and increase your profit making potential." Nothing more.
Having a state license "in good standing" (even though you had a FDA 483 inspection letter with severe deficits means "The state Department of Health Bureau of Enforcement is so inept, they can't protect patients from their own rogue compounding pharmacies (and certainly can do nothing about all the non-resident compounding pharmacies located in distant states, but shipping drugs (perhaps tainted, misbranded, adulterated) into the state)." Nothing more.
"Snake oil" remedies that actually contained opium (getting patients addicted), but were not labeled as containing this addictive narcotic, caused the U.S. Congress to enact thr Pure Food and Drug Act of 1906. Elixir Sulfixinomide poisonings caused the U.S. Congress to enact the Federal Food, Drug, and Cosmetic Act. "Doctors dispensing speed (amphetamines) for profit" caused the U.S. Congress to crest the Drug Enforcement Agency and regulate amphetamines as Schedule II drugs (no refills allowed, physical prescription required each time, etc.). Each of these regulations (among others) was in response to an industry gone amok with a significant minority of the industry hurting patients physically and exploiting them for financial gain.
The IACP and PCAB did nothing to self-regulate the compounding pharmacy industry (and actually helped protect rogue pharmacies by challenging laws in the courts, lobbying heavily to prevent better regulation to protect patients, and providing "political cover" with their "PCAB accreditation diploma mill". Although the "good compounding pharmacies will face increased regulatory burdens by s. 969 (or other laws that get passed), these new FEDERAL regulatory laws are necessary to reign in an industry thst a significant portion of it has "gone rogue".
Kenneth Woliner, M.D.
www.holisticfamilymed.com
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