Sunday, April 28, 2013

Question of the Day 4/28/2013 Is the FDA's and some states' Position on Bulk Compounding for Animals Unsound?

There are a number of reasons the FDA's position appears to be unsound in that in some cases in non-food producing animals it is medically necessary.  It can be medically necessary when:
 FDA-approved product is not commercially available, 
 FDA-approved drug is available but the needed compound cannot be prepared from it, or
 The needed drug is not in an FDA-approved, commercially available form.

Fix 'compounding pharmacy' oversight: Our view


he first time most people heard of a "compounding pharmacy" was last fall, when people started dying after getting routine shots produced by one such operation in the Boston area. By early this month, the death toll stood at 53, or 50 more than the marathon bombings.
Among the dead was Douglas Wingate, 47, a Virginia account executive whose only complaint was a pinched nerve in his shoulder. He got a steroid shot and became a victim of a meningitis outbreaktied to tainted injections made by the New England Compounding Center (NECC).
More than 700 people in 20 states have been sickened, and many are still suffering.
In the aftermath of this public health disaster, Republicans and Democrats in Congress are debating two questions: Has the Food and Drug Administration failed to use its existing authority to oversee compounders such as NECC? Or does the FDA need broader powers?
The answers are yes, and yes. The FDA repeatedly dropped the ball. And the agency's authority does need to be clarified and expanded.
For more than a century, traditional compounders have provided a vital service, mixing prescriptions for individual patients who need something customized, such as a liquid for someone who can't swallow pills. By the late 1990s, however, some compounders envisioned big profits in making large batches of medicine and selling to clinics and hospitals all over the country — essentially acting like manufacturers.
The lethal problems range far beyond NECC. In recent inspections, the FDA found dozens of safety problems at large-scale compounders across the USA — from black particles in injectable medicines to rust and mold in supposedly sterile rooms. In a survey, Rep. Edward Markey, D-Mass., said he found compounders going "untracked, unregulated and underinspected" by states.
At the now-shuttered New England Compounding Center, the FDA and Massachusetts health officials knew of problems with company products, including the same medication suspected in the recent deaths, as far back as 2006. But aside from a pair of warnings, little action was taken until people started dying.
This month, FDA Commissioner Margaret Hamburg acknowledged to a House committee that her agency "should have more aggressively applied existing authorities." Last week, she told the USA TODAY Editorial Board that oversight of compounders is at "a critical moment" and that "the system is broken." Large-scale compounders, she said, should have to register with the FDA, meet uniform quality standards, label their products, report any adverse drug reactions and be barred from producing certain medications.
All that makes sense, and on Friday a bipartisan group of senators proposed a measure to reach those goals. But any new law faces hurdles, particularly from House Republicans who are so bent on blaming the FDA that they oppose providing the clarity and tools to ensure public safety.
Twice in the past decade, the Senate looked into mounting problems with compounders. After the International Academy of Compounding Pharmacists, the industry's trade group, opposed proposed solutions, Congress did nothing. A spokesman for the group says its leadership has changed, and it wants to work with the Senate. We'll see what happens this time, now that the deadly consequences of inaction are clear
Quoted from THE USAToday

State of Washington Board of Pharmacy Clarifies Pharmacy Compounding Standards


No. 1135 Clarification of Pharmacy
Compounding Standards
The Washington State Board of Pharmacy discussed pharmacy
compounding standards at the February 21, 2013 business
meeting, specifically WAC 246-878-020(4). The Board has
always read Section (4) in conjunction with other subsections
that specifically require a prescription for a compounded
drug. However, it agreed that Section (4), read independently,
could allow a pharmacy to provide compounded products for
a practitioner to give out to individual patients without a prescription
for a specific patient. Because this has clearly been
the belief of some compounding pharmacies in Washington,
the Board decided it will honor this interpretation of the rule.
On January 10, 2013, the Board authorized rulemaking regarding
compounding practices to ensure appropriate standards
are in place to protect the health and safety of the people of
Washington. The Board will invite stakeholders to participate
after filing the “Intent to Initiate Rulemaking” (CR101).

Quoted from State of Washington Board of Pharmacy April 2013 Newsletter

South Dakota Board of Pharmacy Distinction Between Compounding and Manufacturing


Compounding and Manufacturing
Over the last several months, there have been numerous
communications as to the definition of compounding
versus manufacturing. South Dakota Codified Law 36-
11-2(5) defines compounding “as the preparation, mixing,
assembling, packaging or labeling of a drug or drug
device as a result of a practitioner’s prescription drug
order or an initiative based on the pharmacist/patient/
practitioner relationship in the course of professional
practice,” eg, patient-specific. Manufacturing on the
other hand, as defined by the National Association of
Boards of Pharmacy® is “preparation of non-patient specific
products where the primary focus is on the product;
not the patient.” Organizations that are manufacturing
must be permitted by Food and Drug Administration.

Quoted from South Dakota Board of Pharmacy April 2013 Newsletter