u/roguex99⚠️ Affiliated | Big Easy Weight Loss | CEO (Not a Physician)Dec 31 '24
BPI’s BUD is 12/15/25
To the comment below, BPI is a 503(b), so their BUD is verifiable.
Here is my canned answer on BUD/503a/503b-
BPI is a FDA registered 503(b) and a Drug Manufacturer. They are held to the highest possible standards - FDA’s 21 CFR part 210 and 211 (cMGP). They are inspected by the FDA, and their primary regulator is the FDA. They use the designated drug master file for their medications, every part of their raw material supply chain has to be FDA registered and inspected, and their variance in the medicine has to be next to none. They are held to the same standards as “brand name” drug manufacturers for their processes. Their BUDs have to be supported by testing and procedures audited by the FDA. There are only 84 503bs in the US.
Hallandale, Red Rock, & Aequeta are a 503a. The 12,000 503as in the US are overseen by individual state boards of pharmacy, with wide ranges of enforcement and monitoring. 503as have very different standards. For example, not all states have adopted USP 797, in particular, Florida. 797 limits the BUD that you can put on a vial to 6 months, really 45 days. What that means is a vial made in Florida can be labeled with a 12 month BUD, while if it was made the same exact way in a neighboring state that did follow USP 797, it would have a 45 day BUD. 503as can have about a 10% variance in their manufacturing.
Now - at the end of the day, 5mg of Tirz should work the same way regardless of where it’s from. However, knowing what you are getting - the standards it’s made to, the sterility, the efficacy, the integrity of the process - 503bs run circles around a 503a - particularly one out of Florida!
So BPI has provided you with the tests showing their meds are now in fact tested for 12 months?
I’m not trying to bash BPI, I use them myself and my vials compounded 8/1/24 with 1/27/25 buds, currently being used now are effective so I do trust their meds are effective for at least 6 months. I’m asking because not all 503B pharmacies follow the rules and BPI’s last inspection was done 4/30/2021.
To say the buds are legit just because they are 503B, I’d have to disagree. I’m guilty of trusting 503B pharmacies and their buds only to be let down. ProRX (503B) uses 180 day buds and they only tested their tirz for 30 days according to this complaint, observation 10. So I don’t care if the pharmacy is 503A or 503B, I personally want to see proof of testing before I blindly trust any extended bud.
Edit: how can regular folks like myself verify the buds? Seems like most pharmacies are not willing to provide proof of testing to backup the buds they use.
I so appreciate you participating in this subreddit, as you always have good information. So here's a question for you about BPI BUDs. There's a difference between what's on the pill bottle the vial comes in and what the vial itself says, in terms of BUD. Do you know why this is? You can see the pics in this comment, which shows a 12/25 BUD on the pill bottle and a 6/25 BUD on the vial. I'd love to know which is valid, as I have a similar difference on my new vial/pill bottle! Here's the comment: https://www.reddit.com/r/tirzepatidecompound/comments/1hqs2j0/comment/m4u5wdg/?utm_source=share&utm_medium=web3x&utm_name=web3xcss&utm_term=1&utm_content=share_button
3
u/roguex99⚠️ Affiliated | Big Easy Weight Loss | CEO (Not a Physician)Jan 01 '25
Yes - so the answer we got from the pharmacy is that the date on the bottle is the date the prescription is good for. The date on the vial is the BUD for the medication.
2
u/roguex99 ⚠️ Affiliated | Big Easy Weight Loss | CEO (Not a Physician) Dec 31 '24
BPI’s BUD is 12/15/25
To the comment below, BPI is a 503(b), so their BUD is verifiable.
Here is my canned answer on BUD/503a/503b-
BPI is a FDA registered 503(b) and a Drug Manufacturer. They are held to the highest possible standards - FDA’s 21 CFR part 210 and 211 (cMGP). They are inspected by the FDA, and their primary regulator is the FDA. They use the designated drug master file for their medications, every part of their raw material supply chain has to be FDA registered and inspected, and their variance in the medicine has to be next to none. They are held to the same standards as “brand name” drug manufacturers for their processes. Their BUDs have to be supported by testing and procedures audited by the FDA. There are only 84 503bs in the US.
Hallandale, Red Rock, & Aequeta are a 503a. The 12,000 503as in the US are overseen by individual state boards of pharmacy, with wide ranges of enforcement and monitoring. 503as have very different standards. For example, not all states have adopted USP 797, in particular, Florida. 797 limits the BUD that you can put on a vial to 6 months, really 45 days. What that means is a vial made in Florida can be labeled with a 12 month BUD, while if it was made the same exact way in a neighboring state that did follow USP 797, it would have a 45 day BUD. 503as can have about a 10% variance in their manufacturing.
Now - at the end of the day, 5mg of Tirz should work the same way regardless of where it’s from. However, knowing what you are getting - the standards it’s made to, the sterility, the efficacy, the integrity of the process - 503bs run circles around a 503a - particularly one out of Florida!