May 2018 - In This Issue:
Extending Beyond Use Dates for Compounded Preparations
Dr. Qiang Liu, Research and Development Laboratory Supervisor
 
A beyond use date (BUD) is the date after which a compounded preparation shall not be used. The BUD is determined from the date the preparation is compounded. This date should be based on drug-specific, scientifically valid studies when possible. Things to consider when assigning BUD include:
  • The drug and its degradation mechanism
  • The dosage form and its components
  • The potential for microbial proliferation
  • The container in which the preparation is packaged
  • The expected storage conditions
  • The intended duration of therapy
USP <797> describes four methods for assigning a beyond use date:
  • Product labeling
  • Commercial product manufacturer consultation
  • Appropriate literature
  • Direct testing
Beyond use dating must be carefully interpreted with respect to the actual compounded formulation and conditions for storage and use. Predictions based on literature are considered theoretical beyond-use dates as the published data introduces varying degrees of assumptions with a likelihood of error or inaccuracy. Pharmacists using literature to assign a beyond use date must look for the exact drug formula, storage conditions, and container/closure to reduce the likelihood of errors. State and federal regulations also require pharmacists to have written justification for a beyond use date assignment.
 
The only truly valid beyond use date is obtained through product-specific studies supported by scientific data. These direct testing studies use stability indicating methods (SIM) to ensure therapeutic effectiveness of compounded drug products.

A SIM is a reliable, meaningful, and specific analytical procedure that accurately and precisely measures active pharmaceutical ingredients (API) by separating the API from its degradation products and excipients.  A SIM must be validated for the exact formulation being tested.  High performance liquid chromatograph (HPLC) is one of the most commonly used techniques for examining the chemical stability of compounded product, but not all HPLC tests are stability indicating. A forced degradation study must be performed on the compounded drug product and not inferred from testing on only the API.


Contact ARL for more information 405-271-1144 or info@arlok.com to request a quote.  

Q&A with Dr. Kupiec, Part 3
Dr. Thomas C. Kupiec, President and CEO
Thank you for joining us over the last few months for our Q&A with Dr. Thomas C. Ku piec, President and CEO. We appreciate our clients and look forward to the next 20 years!
  1. What areas do you expect to see ARL grow and expand in? "ARL continues to diversify and look at other market segments. We are examining new methodologies and exploring various types of testing. There are opportunities in other areas, potentially in the cosmetic industry and natural products. There is also continual growth and expansion of existing market segments such as biologics, protein peptides, drug diversion and others.
     
  2. What are the keys to ARL's future? "To be competitive, we must collaborate! ARL will continue to experience growth and collaborate with industry partners. It's not uncommon for an individual or business to think of segregation. There is a concern of sharing information and someone getting a specific formula or competitive edge, but to be competitive, we must be collaborative. ARL will see more collaborations with industry entities, academic institutions, non-academic institutions, government entities, compounding pharmacies, hospital pharmacies, big pharma, and other areas "
     
  3. What are some of your greatest collaborations? "ARL has a very healthy and strong collaboration with local and national academic institutions. We also have excellent collaborations with non-profit institutions such as United States Pharmacopeia and others. ARL works well with government entities. We have strict confidentiality and do a fair amount of work for government entities, non-government entities, academic institutions, universities, compounding pharmacies, and hospitals."
     
  4. Describe what ARL Bio Pharma means to you, on a personal level, in 15 words or less.  "Exciting, invigorating, tiring, long-hours, great people, and greatness among the people"
     
  5. What is the most valuable thing you have gained from your involvement with ARL Bio Pharma? "Business acumen. I recently gave a talk to a group of individuals and the title was "Science, Synergies, and Success." I am a scientist first that turned entrepreneur and you need both in the pharmaceutical industry. Business decisions are made upon science, truth, and even regulation. Hopefully, regulation and guidance documents are based upon the science, but ultimately in an ideal world, it's where science and compliance are in alignment."
Join us at 2018 Quality Compounding Summit
October 5-6, 2018
Oklahoma City, Oklahoma
2018 Educational Sessions:
  • Update on the Development and Revision of USP Compounding Chapters - Jeanne Sun, PharmD, United States Pharmacopeia
  • 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 10 hours of CE for this conference.
  


Register today at qcsummitrx.org

Contact ARL for more information 405-271-1144 or  info@arlok.com
$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. 
Offer Expires 6/30/2018. (May 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  info@arlok.com  to request a quote.