No more need for compounded BLT in aesthetics!

B enzocaine, L idocaine, T etracaine

Yes! It is finally here! A FDA Regulatory Compliant option to replace the high risk, high cost compounded BLT option!

You have worked exceedingly hard to build your successful practice and reputation. Why put your business and good name at risk for the benefit of one product in your practice?

As we are ALL aware the procurement and use of multi-use compounded BLT ordered for one patient but used on many is a truly high risk proposition none of us appreciate (The FDA and DEA call this practice DIVERSION!). However, we all know that adequate pain management is absolutely necessary for nearly all of our effective procedures!

The risks of using compounded BLT abound!

• Regulatory non-compliance - prescription diversion
• Cross contamination - non sanitary multi-use jars
• Under dosed or overly concentrated product procurement due to mislabeling
• Lengthy product duration on skin leading to increased cumulative entry into the system and potential adverse events
• Use of expired product

Why take the risk when there are now safe and equally if not more effective alternatives currently available?

Many are being told by a small handful of unscrupulous compound pharmacies that they are able to procure and use compounded BLT and Lidocaine23%/Tetracaine7% (as well as other combinations) suppliers that compounded products can be used on multiple patients if labeled "for office use only" multi-use jars. This practice is, in fact, not legitimate and may bring unwanted FDA and other regulatory office scrutiny into medical and quasi-medical practices.

According to FDA policies, compounds MUST be written by a single practitioner for a single patient in limited amounts. They may not be provided on a bulk basis whether for one patient or for office use on a Federal and State level. Anything compounders are saying to the contrary is false, misleading and highly risky to practice integrity and patient safety. The issue occurs (and is then irreversible) when some problem arises due to the use of the compound. Once this occurs  the medico-legal risk comes into play and all practices are examined potentially including medication prescribing and uses practices.

Please see below:

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm376733.htm

https://www.accessdata.fda.gov/scripts/cderworld/index.cfm?action=compliance:main&unit=5&lesson=2&topic=15&page=2

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469119.pdf

https://www.fda.gov/NewsEvents/Testimony/ucm327667.htm  SEE RISK-Based Framework

https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339771.htm  -  Warning letters, investigations and other actions

https://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=2383

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108793.htm 

Sambria Pharmaceuticals has launched its' NeuroMed BLT Variety Package! Your comprehensive pain management solution.

This product line includes benzocaine 20%, lidocaine 4% and tetracaine 2% each in a proprietary formulation designed to improve onset of action, API delivery, efficacy and limited systemic entry into the blood (IRB approved study of its lidocaine product demonstrated no traceable amounts of lidocaine or its active metabolite MEGx entering the blood of the study's human test subjects after repeated applications in an 8-hour period).

Your advantages switching to this product line include:

• Single-use metered dose package for application precision
• Sanitary single-use packaging to limit risk of cross contamination
• FDA regulatory compliant acquisition, and multi-clinician and multi-patient use
• Application flexibility - all three API's are included separately for your convenience - use as deemed appropriate on a case by case basis
• Cost effective - savings
• 2-year FDA guidelines shelf life
• Light and creamy consistency allows for easy application and quick, non-oily, non-gritty removal
• Formulated to reach peak effect in no more than 15 - 20 minutes with an initial onset of 5 - 10 minutes!

Don't wait! Your compounded multi-use jar is a Petri dish creating a high risk of cross contamination! One adverse event could open you up to medico-legal and other risks you may not yet foresee.

250 total grams of the combined products is only $199! That is only $0.80 per gram of all the products contained within the packages! Compare cost and reduced risk and call or email us NOW!

Regulatory Compliant Packaging below!

NeuroMed BLT Variety Package - Your comprehensive pain management solution!

At the very least, switching from compounded multi-use containers anesthetics to this alternative is your insurance policy against cross-contamination risk and regulatory entanglements.

For additional info go to:

https://www.slideshare.net/MichaelGreenspan1

To get started now using a sanitary, regulatory compliant, safe and effective topical numbing cream call:

888.246.6601

or email:

[email protected]

www.sambriapharma.com