July 2018 - In This Issue:
ARL now offers lower cost 503A BUD studies
using stability indicating methods. 

 Call today for details  (800) 393-1595
 


Raw Material Vendor Qualification
 
USP and FDA require compounding pharmacists to control the source and quality of the components used to produce compounded preparations. Even though many pharmacists choose to purchase from repackaging facilities, this does not alleviate the requirement to qualify the repackager as a source for raw materials. Below is an overview of how a pharmacist can qualify their component vendors.

503A compounding pharmacists should:
  • Establish a process for auditing and qualifying raw material vendors
  • Monitor FDA documentation (e.g. 483's) for repackaging facilities
  • Examine each CoA and compare it to specifications in current USP monograph
503A pharmacists can reference the 503B draft guidance for information on how to qualify vendors.
 
The 503B draft guidance states component vendors can be qualified by testing active ingredients once every year and other components once every 2 years to make sure that their test results:
  • Match their vendor's test results
  • Confirm that the ingredient meets the applicable USP or NF monograph, if one exists
Testing of active ingredients and other components should be performed using compendial test methods, if available. ARL Bio Pharma routinely performs compendial testing.
Please contact ARL for more information on vendor qualification testing 800-393-1595 or [email protected].
Have you registered for the 2018 Quality Compounding Summit? 

Join us October 5-6, 2018 in Oklahoma City!

The Quality Compounding Summit, presented by ARL Bio Pharma and the American College of Apothecaries, brings together national speakers for a two-day intensive focus on quality in sterile and non-sterile compounding. Industry leaders will speak on key topics selected to build your pharmacy's success including: best practices, safety, facility design, and regulatory issues.



2018 Educational Sessions:
  • Update on the Development and Revision of USP Compounding Chapters - Jeanne Sun, PharmD, United States Pharmacopeia (USP)
  • Current and Future Trends in Pharmaceutical Compounding - Loyd V. Allen, Jr., PhD, RPh, International Journal of Pharmaceutical Compounding
  • Controlled Environments for Sterile and Non-Sterile Compounding - Kenneth S. Latta, BS. RPh, FIACP, FACA, ProPharma Cleanrooms, LLC
  • Scientific and Technical Challenges in Compounding - Thomas C. Kupiec, PhD, ARL Bio Pharma
  • The Practical Use of the USP as a Primary Reference Resource in the Formulation of Sterile and Non-Sterile Compounded Preparations - Kimberly Kieffer
  • 503A/503B, USP/cGMP, BOP/FDA . . . Examples of Government Enforcement and What Not to Do - Tony Park, Pharm.D., J.D., California Pharmacy Lawyers
     
The Quality Compounding Summit will also have a speaker panel session and a round table discussion.

There are 9 hours of CE for this conference.  



Contact ARL for more information 800-393-1595 or  [email protected] . 
ARL and FocusScript Customer Discount Program
ARL Bio Pharma is pleased to announce that FocusScript, an organization that manages pharmacy networks, will offer a $500 discount to ARL clients on FocusScript network application.

FocusScript Network works with health plans, pharmacy benefit managers, and PSAOs to bring the nation's highest performing compounding pharmacies together under a shared set of guidelines by which to maintain their businesses.  

As a FocusScript Network pharmacy, members are part of an elite certified network of leading, accredited and credentialed compounding pharmacies perfectly aligned with payors and physicians on the principles of quality, clinical value, and best practices.

FocusScript member benefits:
  • Access to Payors
  • Pricing Support
  • Flexible Technology
  • Audit Assistance
  • Marketing
  • Clinical and Business Quality
For additional information on FocusScript membership, click here. FocusScript requires pharmacies to submit a recent ARL test result to qualify for the $500 network application discount.  

ARL also offers a customer discount to FocusScript pharmacies. As part of the FocusScript Customer Discount Program, FocusScript pharmacies can earn discounts on services including, but not limited to:
  • Potency Determination
  • Sterility / Endotoxin / Fungal
  • BUD and Stability Studies
  • Microbial Identification
For additional information on ARL FocusScript customer discounts, contact ARL at 800-393-1595 or [email protected]. 
Sample Submission Form
Fast Approaching Deadline - July 31, 2018
ARL will no longer process any samples on old sample submission forms after July 31, 2018. All samples arriving at ARL are required to have a sample submission form or submitted online. 

 

Call 800-393-1595 with questions.
$25 off
Submit this coupon with your next sample for $25 off your next test with ARL. Cannot be combined with discounts or special offers. One-time use coupon. 
Offer Expires 8/31/2018. (July Newsletter)
Have you celebrated ARL's 20 years with 20% off?

To thank you for making our success possible, ARL is offering customers:
  • 20% off USP <71> Sterility Tests method suitability
  • 20% off USP <61> Microbial Enumeration Tests method suitability
  • 20% off USP <51> Antimicrobial Effectiveness Testing method suitability
This discount is good through December 31, 2018. 

To take advantage of these savings, visit  arlokapps.com to submit samples online or  download ARL's sample submission form. 

Contact ARL for more information 405-271-1144 or  [email protected]  to request a quote.