Question of the Day August 28, 2013 In light of the issues at Front Range Laboratories Inc. and the estimate that it tested compounds for 100 compounding pharmacies in 32 states will Congress act quickly in September to help give the FDA the much needed resources to get this enormous problem with compounding preparations under control?

As we are seeing there are issues on the front end of compounding with the bulk powders, issues with the actual compounding (sterility and potency) and now with the testing laboratories with  blurred or no lines as to who oversees what it.  Compounding pharmacists who feared what federal regulation would do to their business now have far greater concerns-lack of trust by the public, liability issues, etc. with potential federal regulation being the least of the worries and potentially a blessing to the good compounders doing it right.  With these overwhelming and out-of-control issues in the compounding world, Congress would be doing a grave injustice to the American people if it does not pass some form of federal legislation. 

We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds

on August 27, 2013

The expected backlash to attempts by the FDA to crackdown on compounding pharmacies has begun, threatening public safety.
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.

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Safety Alerts for Human Medical Products Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination

Safety Alerts for Human Medical Products Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination

URGENT AND IMPORTANT!! Sterility Concerns at Three More Pharmacies Prompt Recalls

Three more compounding pharmacies are recalling products due to concerns that some of their products may not be sterile, the US Food and Drug Administration (FDA) has announced.

Front Range Laboratories, in Loveland, Colorado, are at the center of 2 of the recalls.

On Monday, JCB Laboratories recalled 6 lots of sterile drug products to the user level because of concerns about sterility assurance following a recent FDA inspection of Front Range Labs, one of the contract testing labs used by JCB. The products, lot numbers and expiration dates are:

Product	Lot # (expiration date)
Sodium thiosulfate 25% (250 mg/mL)	130701@9 (12/28/13) 130709@6 (1/5/14) 130717@2 (1/13/14)
Sodium citrate 4% solution injection, 30 mL multiple-dose vial	130710@4 (1/6/14)
Sodium citrate 4% w/gentamicin, 320 mcg/mL multiple-dose vial	130620@2 (12/17/13)
Acetylcysteine, 20% solution for inhalation, 4 mL single-dose vials	130627@5 (8/26/13)

 

The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8 through August 20, 2013.

After an inspection of Front Range Labs, the FDA issued an alert to pharmacies on August 21 stating that "the methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."

"Out of an abundance of caution, JCB has discontinued its relationship with Front Range and is now testing products at a different laboratory," the company said.

JCB has not received any reports of adverse events related to this recall to date, the company said. However, if there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

JCB is notifying its customers by telephone, email, fax, and mail. To return product or request assistance related to this recall, users should contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8 AM. and 5 PM CDT.

Similar Concerns at Second Pharmacy

Concerns at Front Range Labs has also prompted Wellness Pharmacy, Inc, in Birmingham, Alabama, to recall 6 products. They are:

Product	Lot #	Expiration date
dexpanthenol 250 mg/mL	130605@52	12/2/2013
magnesium sulfate 50%	130613@38	12/10/2013
methylcobalamin 1 mg/mL	130612@49	12/9/2013 10/19/2013
sodium phenylbutyrate 200 mg/mL SDV PF	130621@28	10/19/2013
R.L. glutathione 100 mg/mL SUV PF	130710@27	1/6/2014
ascorbic acid (cassava) 500 mg/mL PF SUV	130711@13	1/7/2014

 

The recalled medications were distributed to individual patients and to physician offices nationwide. These liquid medications are in either clear or amber sterile vials ranging in size from 1 mL to 50 mL, the company said. The medications can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size.

Wellness Pharmacy is notifying its customers by telephone and regular mail of this recall. "Patients andphysicians should immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy," the company advises.

To return medication or request assistance related to this recall, patients and physicians should contact Wellness Pharmacy at 205-879-6551 or 800-227-2627, Monday through Friday, between 9 AM and 4 PM CDT.

Testing Issues at Third Pharmacy

On Friday, Park Pharmacy & Compounding, in Irvine, California voluntarily recalled to the consumer level 2 lots of methylcobalamin 5 mg/mL 30 mL amber vials with lot # 06132013@1 and an expiration date of 12/10/2013.

The company also recalled multitrace-5 concentrate 10 mL amber vials for injection with lot # 05212013@20 and an expiration date of 11/17/2013, to the consumer level.

This recall was also prompted by a recent FDA inspection of the laboratory used by this pharmacy, although the laboratory was not named in the company release posted on the FDA Web site.

The prescription preparations were sold during June and July of 2013, in California, Florida, New Mexico, and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).

"To date there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products. We are voluntarily recalling the products as a precautionary measure for the safety of our patients," the company said.

Park Pharmacy & Compounding is notifying its customers by phone and mail and is arranging for return of all recalled product lots. Customers with product being recalled should stop using it and contact Park Pharmacy & Compounding to arrange for return of the unused product. Customers with questions regarding this recall can contact Park Pharmacy & Compounding at 949-551-7195 Monday through Friday, 9 AM to 5 PM PST, or at info@parkrx.com.