Changes to Sterile Preparations Starting May 1, 2014

May 01, 2014
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This is an important message in regards to upcoming standardizations that will be made to our sterile preparations including testosterone cypionate, cyanocobalamin, methylcobalamin, glutathione and HCG (human chorionic gonadotropin).

MedQuest continues to lead the charge to deliver high quality, consistent, and appropriately priced compounded preparations. We know your practice and your patients expect the highest level of assurance that our compounds meet and exceed all the standards set forth in USP Chapter 795 (non-sterile compounding) and USP Chapter 797 (sterile compounding).

STERILITY TESTING IS OF PARAMOUNT IMPORTANCE

Sterility testing of our injectable preparations is our highest priority item for patient safety.

The new compounding law: Drug Quality and Security Act of 2013 continues to be debated as to the effect on prescribers, compounding pharmacies, and ultimately: patients.

Regulatory agency interpretations of the law will have a profound impact on sterility testing of injectable compounds. Such interpretations have made it economically impossible for us to continue offering the many alternative combinations of strength and vial sizes. Testing costs are truly prohibitive for only but a narrow band of more common options.

Our dedication to be in compliance, exceed industry standards, and to continue to provide affordable injectable preparations for you to prescribe to your patients has only increased our focus on this important area.

NECESSARY CHANGES

We will be standardizing the strengths and vial sizes of our sterile preparations in order to remain compliant while preserving economic viability for your patients. This will allow us to keep testing costs from severely impacting the price of the preparation. Prescribers will still have sufficient choices to customize the dose for each individual patient. However, the dose will now, of necessity, be more dependent on the volume to inject to achieve the optimal dose.

The following preparations are scheduled for our formulary revision, and will take effect on May 1, 2014:

Testosterone Cypionate
Base – sesame or grape seed oil
Strengths – 200mg/ml, 100mg/ml, 50mg/ml
Vial Sizes – 2 ml, 5ml, or 10ml vials only
Cyanocobalamin
Strength – 1000mcg/ml (when commercially unavailable)
Vial Sizes – 4ml and 5ml vials only
Methylcobalamin
Strength – 1000mcg/ml
Vial Sizes – 4ml and 5ml vials only
Glutathione
Strength – 200mg/ml
Vial Sizes – 10ml and 30ml vials only
HCG (human chorionic gonadotropin)
Strength – 2000 IU/ml
Vial Sizes – 2ml and 4ml vials only

Strength – 8000 IU/ml
Vial Sizes – 3ml and 5ml vials only

Strength – 4000 IU/ml
Vial Sizes – 2ml vial only