I never considered this…
Is a compounding pharmacy giving you exactly the same prescription as a regular FDA regulated pharmacy?
Of course, if a compounding pharmacy isn’t controlled by the FDA, then there could be variation.
However, if I use a compounding pharmacy that my vet trusts, shouldn’t I trust it, too?
As it turns out, some drugs are known to be NOT AS EFFECTIVE when compounded… I had no idea.
WHAT IS A COMPOUNDING PHARMACY AND WHAT ARE THE RISKS?
I have lifted these questions off of this site.
What is “compounding”? In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.
Is combining two or more drugs considered compounding? Yes, compounding includes the combining of two or more drugs.
Why do some patients need compounded drugs? Sometimes, the health needs of a patient cannot be met by an FDA-approved medication. For example:
- if a patient has an allergy and needs a medication to be made without a certain dye; or
- if an elderly patient or a child can’t swallow a pill and needs a medicine in a liquid form that is not otherwise available.
Are compounded drugs approved by the FDA? Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective and made in accordance with Federal quality standards. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.
Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA, although FDA retains some authority over their operations. However, outsourcing facilities that register under section 503B are regulated by FDA and must comply with CGMP requirements and will be inspected by FDA according to a risk-based schedule.
What are the risks associated with compounded drugs? There can be health risks associated with compounded drugs that do not meet federal quality standards. Compounded drugs made using poor quality practices may be sub- or super?potent, contaminated, or otherwise adulterated. Additional health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.
Who regulates and inspects facilities that compound drugs? Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA, although FDA retains some authority over their operations. For example, the adulteration or misbranding of drugs compounded under section 503A, or false or misleading statements in the labeling or advertising of such drugs, may result in violations of Federal law. Firms that register with FDA as “outsourcing facilities” under section 503B will be regulated by FDA and inspected by FDA according to a risk-based schedule.
BUT I’VE LEARNED THAT THERE ARE MORE QUESTIONS YOU NEED TO ASK… THEY DON’T ALL WORK AS WELL AS FDA CONTROLLED PRESCRIPTIONS
While Tess was at Loomis Basin Equine Hospital for boarding, I remarked to Dr. Fielding that she looked shaggy. I was beginning to think that her compounded Prascend (Pergolide) was not strong enough.
He turned to me and told me that there were reports stating exactly that.
That compounded Prescend is reported to not work consistently.
Why didn’t anyone tel me that? I think I would have still tried the compounded Prascend, but at least I would have known to watch for signs of it not working…
So, she is back on FDA regulated Pharmaceutical Prascend.
WHAT ABOUT COMPOUNDED DOXYCYCLINE, THEN?
We are again giving Tess Doxycycline for varied reasons. But, the Doxycycline that I have is compounded – most is nowadays.
So, I asked if the compounded Doxycycline had reports of not being as good as a Doxycycline pharmaceutical substitute.
I was told that there are no reports that state compounded Doxycycline is less effective than the pharmaceutical substitutes.
ASK OR GET ON THE INTERNET WHEN YOU CONSIDER COMPOUNDED PRESCRIPTIONS!
I always assumed that compounded prescriptions were just as good as the regulated prescriptions because they use the same ingredients. As long as there is quality control, what could be the issue?
And, if the compounded pharmacy has been in business for years and has high ratings, why not?
Now I know… do the homework. Not all compounded prescriptions are the same as FDA regulated drugs.
Compounded Doxycycline is reported to be fine.
I WILL LET YOU KNOW IF THE NEW PRASCEND HELPS TESS DE-SHAG!
So, Tess was started back on the FDA regulated Prascend. I will let you know if she becomes less shaggy in the few last days of summer!
I received a shipment from the UK artist that supports Tess as well as the Polish artist! I love getting these packages from Europe! Opening them is such a thrill!
1) DANDELION PENDANT, COPPER AND TIN from the artist in Poland. Isn’t this special?! I love this one a lot! Also, the shape is unusual. The pendant is approximately 1.5 inches across and 2″ tall.
2) CRYSTAL DROP EARRINGS made with copper and tin from the UK artist! I looooooove these! I want to keep them for myself! The drops are about 1.5″ long and just GORGEOUS! Very unique! The photo doesn’t do them justice – TRUST ME.