Is Compounding Pharmacy Unregulated? I quit my job BECAUSE of Regulations!
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- Опубликовано: 20 окт 2023
- Doctors, physician groups, and others are saying, "Compounding Pharmacy is unregulated!" As a 20-year veteran compounding pharmacist, I can address this widely believed claim and provide an insider's perspective.
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Thank you for enlightening us, Steve! The main argument/warning against compounded hormone or other medication preparations I’ve heard so far was that pharmacists don’t necessarily have a way of verifying the authenticity and exact potencies of the raw materials they purchase. I understood it to mean that there is a “market place” for substances (often) produced in foreign countries, like China or India, and that there is no official testing/verifying of those products by a U.S. agency. The implication was that pharmacists are “ innocent” but just can’t be sure of what they’re getting. And that this was different for pharmaceutical companies - that the input ingredients for drugs were “regulated”, i.e. tested for authenticity, purity, potency, etc.
You mentioned that compounding pharmacies are regulated by the individual states, not federally. What can you tell us about differences between states? Are there some that may have insufficient regulations to ensure quality of the preparations to protect patients’ safety? Or is this pretty much the same in all states?
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Thank you again, Steve. Your videos are great! 😊
@cm1906 I LOVE these questions, mainly because they are so EASY to answer!
There are several FDA licensed chemical manufacturers that produce active and inactive ingredients used by compounding pharmacists in creating compounded prescriptions. They are all required by the FDA to include a “Certificate of Analysis” with each and every batch sent to a pharmacy. That’s a legal document, certifying the purity and potency of the drug or hormone or inactive ingredient. It’s based on a complicated system of testing with HPLC (high performance liquid chromatography). As a compounding pharmacist, I read thousands of C of As. After a while, you start recognizing that every single one says “99.2% potency” or “99.8% potency” or (for some hormones) “92.5% potency” (in which case, I would adjust the compounding formula to account for that).
The pharmacy I worked for was licensed in all 50 states and Puerto Rico. There were significant differences between states (which is a nightmare to keep track of) but every state clearly knows what they’re doing and, in general, was very good at regulating compounding pharmacies. The differences between state laws are administrative.
Thanks for asking.
Also - a compounding pharmacy that’s buying and using garbage ingredients will be sanctioned and shut down. Every state has an inspection process that sometimes even invites the participation of the FDA. I’ve been through multiple state/FDA joint inspections and they SUCK! But they don’t let things slide . . . because compounding pharmacies ARE regulated!!!!!!!
@@SimpleHormones Dear Steve - thank you SO much for your detailed and comprehensive replies! I really appreciate it. From your video I also understand now how essential custom compounded medicines are for many patients. Therefore, how can it be possible that there are “forces” that want to “eliminate” (?) this important service?! What alternatives are they suggesting for patients who need and depend on compounded medications? Is this (solely) about “big pharma” not wanting to share a piece of the “pie”? I realize I still have many questions about this topic … I will check out the website you mentioned for those of us wanting to learn more.
Thank you again, Steve, for all that you do for us! You are a trusted source of information. 🥰
I find it strange that they would want to get rid of compounding pharmacies since that is the way medicine began and was delivered most accurately. We're seeing a lot of overreach with these three letter agencies lately
@seven471 It is a bit strange . . . but it definitely makes sense to them. The FDA gets a large portion of its funding from drug company fees. Is that a conflict of interest when it comes to getting rid of compounding pharmacy?
So glad your channel showed up in my feed. Such amazing and well explained info--thank you!
@rf9477 Thanks for watching and for the kind words. I need that encouragement. Comments on my videos are sometimes lacking in kindness.
What a wonderful video, well done!
@aprilluttrellaprnfnp-c7643 Thanks for watching and for the kind comment
Steve - Exceptional, absolutely EXCEPTIONAL...... Thank you!!! Greatly appreciate ALL you share here on your RUclips channel and emails!
You're so welcome @shaynebetts7243!
I didn’t know comp pharm need to be defended . I was a tech in comp and I really don’t see why ppl don’t trust comp pharm. It’s state of the art of drug dispensing. The scales are so sensitive , leave no room for error. I saw pharm throwing out batches of cream bc of minuscule “error” or wrong seal on a tube . Those ppl love this job, it’s not just pharmacy .
7:50 estradiol tablets have 0.5 tablets. She can split the 0.5mg tabs in half and take 1.5 tab of 1mg tab ≈1.75mg.
Absolutely correct !! You go Steve
Thanks for watching @svetlanaburtman7439!
I am SO overwhelmed with deciding what to do.
I’m in Canada. Post-cancer treatment now. Healing slowly. Hormones are zero due to the radiation/chemo. So now I’m in menopause in my early 40s. I don’t want my periods back, I just want to have a healthy amount of hormones.
I can’t decide between compounding or FDA approved BHRT. I know it all depends on the pharmacy making your prescriptions, but I’m scared to take the risk that the product might be contaminated or something.
@Blueskies7775 Thanks for watching. I’m so sorry you’ve had to go through cancer treatment. That must be a tough road to travel.
I’ll say 2 things in response to your comment:
1. There are advantages to compounded BHRT. There are trustworthy pharmacies that make high quality preparations.
2. Getting hormone replacement after cancer isn’t going to be easy but it IS possible.
Visit my website and request a referral if you haven’t already. I’ll check to see if there’s a provider near you.
simplehormones.com/referral
@@SimpleHormones Thank you so much. I don't have issues with my family doc or the oncologists wanting to write prescriptions for HRT, but the oncologists will only give equine HRT, no bio-identicals.
I just want to find someone who is more caring about me as a person and knowledgable in menopausal HRT....unfortunately both the gyno oncologists/radiation oncologists and my family are NOT either of those things. So I'm on the search.
Ok..but...compounded progesterone cream does or does not protect the uterus? And are compound pharmacies stating this?
In general, compounded progesterone cream is often less effective for protecting the uterus. Several providers I work with have told me about women with dangerously thickened uterine linings because they were on progesterone creams that did not prevent overgrowth. That may have to do with progesterone doses being too low in many cases. In general, oral progesterone is more effective.
Thanks for this video, Steve. Any ideas of where and how I could go about checking compounding pharmacies in South Africa? Many thanks advance!❤
@bomcabo To be honest, I don’t know anything about compounding in South Africa. Different countries are all over the place with it. Some are more restrictive and some less restrictive than the US.
@@SimpleHormones Thanks for your reply, Steve! 👍👍