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| In March of 2018 the FDA issued a draft guidance for the “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act”. This guidance document outlines the process by which the FDA will determine which drug substances will be added and maintained on the 503B bulks list. The guidance also describes the FDA’s general policy regarding the use of bulk drug substances by 503B facilities. The draft guidance is open for public comment under Docket ID: FDA-2018-D-1067-0002 until May 25, 2018.
As your contract laboratory, DYNALABS understands the significant time and financial commitment that you, as a 503B facility, have made to establish and maintain a compliant operation. As part of our commitment to advocate for the compounding industry, we intend to submit a public comment to the FDA supporting the use bulk drug substances in compounding. If you have concerns regarding this draft guidance, we invite you to submit your comments to consulting@dynalabs.us by May 15, 2018. We will use your comments and concerns to tailor our response to the guidance.
Thank you in advance for your help in this critically important exercise.
Kristopher Le, PharmD. | VP & Principal Consultant |
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Effective May 1, 2018, DYNALABS is adding gel-clot technique to our Endotoxin testing methodology. This allows for the testing of suspensions and opaque solutions. This also allows for better investigations of endotoxin OOS. Per USP <85>, when in doubt or dispute of Endotoxin testing, the final decision is based upon the gel-clot limit test unless otherwise indicated in the monograph for the product being tested.
Effective May 1, 2018, DYNALABS performs and reports pH testing on all Endotoxin samples. For Endotoxin samples USP <85> states, “If necessary, adjust the pH of the solution to be examined (or dilution thereof) so that the pH of the mixture of the lysate and Sample Solution falls within the pH range specified by the lysate manufacturer, usually 6.0–8.0.” |
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As part of DYNALABS’ commitment to continuous investigation of internal procedures, improvements to some sample particulate count calculations were implemented on May 1. Both the new and the old calculations are shown below.
Previous Small Volume Injectable Calculation
Updated Small Volume Injectable Calculation
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Previous Ophthalmic Calculation
Updated Ophthalmic Calculation
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To improve sterility testing of pellets, DYNALABS is now using sterile funnels to place the pellets into media |
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FDA guidance requires purchased standards to be from the USP/NF, or another official source (e.g., CBER, 21 CFR 610.20). DYNALABS follows this guidance, and purchases available reference standards from USP. |
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Effective July 1st, 2018, Transfer Methods – Dexamethasone Acetate, Midazolam, Betamethasone Sodium Phosphate, Glycopyrrolate, Apomorphine, Dexmedetomidine.
PLEASE NOTE:
Any customer needing extension will need to be submitted by then.
New Methods Now Available at DYNALABS– Tacrolimus and Apomorphine
Methods Being Transferred to New Instruments May 1st Betamethasone Acetate, Bumetanide, Methohexital Sodium, Dexamethasone Sodium Phosphate. |
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Investigation Reports are now available for download from myDYNALABS. Completed samples that underwent an Out of Specification Investigation at DYNALABS will receive an Investigation Report.
These completed reports can be downloaded from Sample Tracking 24-7. In a future release, In-Process Investigation Reports will be made available as well.For questions regarding the investigation process, please email sales@dynalabs.us or follow this link: https://www.dynalabs.us/products-services/dynalabs-oos-process/ |
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The update has ended support for Windows XP/Internet Explorer 8 users. If you are currently using a Windows XP workstation, you will not be able to access the DYNALABS secured website. Make sure your browser and operating systems are up to date!
Changes made to DYNALABS’ website security include:
* TLS 1.0 is no longer supported
* TLS 1.1 is no longer supported
* TLS 1.2 is supported using AES 128/128 and AES 256/256 ciphers only
What is TLS?
Transport Layer Security (TLS) is a protocol that provides privacy and data integrity between two communicating applications. It’s the most widely deployed security protocol used today and is used for web browsers when data is to be securely exchanged over the internet. TLS 1.2 is the newer and more secure version, and, to ensure the security and data integrity of our customers’ information we are disabling TLS 1.0 and TLS 1.1 on our website.
If you are having issues after the May 1, 2018, security update, please initially consult with your IT professional to update your computer. If you have questions or other issues, please do not hesitate to contact your DYNALABS Customer Support Specialist. sales@dynalabs.us |
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We will resume our normal business schedule Tuesday 05/29/2018. Please make all the necessary shipment arrangements to have the samples arrive on or before Friday 05/25/2018 or on or after Tuesday 05/29/2018.
Have a fun and safe holiday!
Any questions regarding these updates can be directed to customer support by calling 888.396.2522 or sales@dynalabs.us |
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