ExcelMale
Menu
Home
What's new
Latest activity
Forums
New posts
Search forums
What's new
New posts
Latest activity
Videos
Lab Tests
Doctor Finder
Buy Books
About Us
Men’s Health Coaching
Log in
Register
What's new
Search
Search
Search titles only
By:
New posts
Search forums
Menu
Log in
Register
Navigation
Install the app
Install
More options
Contact us
Close Menu
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Easy breezy question about expiration date on T
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an
alternative browser
.
Reply to thread
Message
<blockquote data-quote="EmpowerPharmacy" data-source="post: 1741" data-attributes="member: 109"><p>This is a great question as there is a lot on confusion on how Beyond Use Dates (BUD) are established with compounded products. All compounders are required to use the United States Pharmacopeia (USP) standards when compounding preparations. USP states that for Oil-Based Products a BUD of 6 months or less shall be used if a stability study isn't available for that specific compound. For Water Based Products a BUD of 14 days or less shall be used if a stability study isn't available for that specific compound.</p><p></p><p>The reason manufacturers can assign 2-3 year Expiration Dates is because they have performed stability studies that take $100,000+ and years to perform. Obviously, compounders cannot afford to do these studies, so when assigning a beyond-use date, compounders consult and apply drug-specific and general stability documentation and literature, and consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy to come to a conservative BUD.</p><p></p><p>There are many factors to consider in a compounded product including the preservative, base, concentration, excipient, source of active ingredient, vial, stopper, seal, sterilization method, etc. If any of these factors in a compounded product deviates greatly from a manufacturer's then we can't use the same stability results the manufacturer came up with. Since most compounds are made differently from manufactured products we assign very conservative BUDs.</p><p></p><p>Even though some compounders feel safe to assume stability information on certain compounds, like testosterone cypionate, and have years of data from patients receiving good results from the medication even after the 6 month BUD has past, technically we are still required to put a BUD of 6 months or less unless we have the proper stability study to reference and our product doesn't vary greatly from the manufacture's.</p><p></p><p>I've personally done 2 year long potency over time studies on our Testosterone Cypionate and it's shown a degradation of less than 7%, but this isn't considered a full blown stability study that the FDA considers valid. Other compounders put what they feel comfortable with at the risk of getting in trouble with the FDA, but that all depends on the compounder.</p></blockquote><p></p>
[QUOTE="EmpowerPharmacy, post: 1741, member: 109"] This is a great question as there is a lot on confusion on how Beyond Use Dates (BUD) are established with compounded products. All compounders are required to use the United States Pharmacopeia (USP) standards when compounding preparations. USP states that for Oil-Based Products a BUD of 6 months or less shall be used if a stability study isn't available for that specific compound. For Water Based Products a BUD of 14 days or less shall be used if a stability study isn't available for that specific compound. The reason manufacturers can assign 2-3 year Expiration Dates is because they have performed stability studies that take $100,000+ and years to perform. Obviously, compounders cannot afford to do these studies, so when assigning a beyond-use date, compounders consult and apply drug-specific and general stability documentation and literature, and consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy to come to a conservative BUD. There are many factors to consider in a compounded product including the preservative, base, concentration, excipient, source of active ingredient, vial, stopper, seal, sterilization method, etc. If any of these factors in a compounded product deviates greatly from a manufacturer's then we can't use the same stability results the manufacturer came up with. Since most compounds are made differently from manufactured products we assign very conservative BUDs. Even though some compounders feel safe to assume stability information on certain compounds, like testosterone cypionate, and have years of data from patients receiving good results from the medication even after the 6 month BUD has past, technically we are still required to put a BUD of 6 months or less unless we have the proper stability study to reference and our product doesn't vary greatly from the manufacture's. I've personally done 2 year long potency over time studies on our Testosterone Cypionate and it's shown a degradation of less than 7%, but this isn't considered a full blown stability study that the FDA considers valid. Other compounders put what they feel comfortable with at the risk of getting in trouble with the FDA, but that all depends on the compounder. [/QUOTE]
Insert quotes…
Verification
Post reply
Share this page
Facebook
Twitter
Reddit
Pinterest
Tumblr
WhatsApp
Email
Share
Link
Sponsors
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Easy breezy question about expiration date on T
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to our use of cookies.
Accept
Learn more…
Top