One should realize that Big Pharma does make bioidentical hormones, ex: estradiol tablet, transdermal estradiol patches and gels, progesterone capsules are all bioidentical. The chemical make-up is the same as the estradiol and progesterone made by the ovary. These products have multiple doses, allowing for tailored dosing for each individual woman. Big Pharma bioidentical products are FDA approved. There dosing is always consistent if it is created by the same manufacturer meaning that Brand names will always be the dosing that is stated but generics can be 25% higher or lower than brand products. But, if one uses the same generic product made by the same manufacturer, then the dosing will be consistent.
Compounded hormones can also be tailored specially for the patient and many times women like to put there hormones all together into one cream which is more convenient and sometimes less expensive. Compounded hormones can also be placed in creams or oral capsules that are anti-allergenic and don’t have harmful preservatives or compounds in them: cleaner drugs, without fillers in them. The only issue is that compounded hormones are not FDA approved because they do not contain the FDA package warnings and not all compounded pharmacies meet the new FDA sterilization guidelines leading to sterility issues. Minimal government regulation and monitoring exists, so each pharmacy could potential create a different dosing and depending on the pharmacy overdosing/underdosing could potentially occur. Patients must realize that the FDA package warnings that are placed in Big Pharma bioidentical hormones also relate to compounded bioidenticals. Thus, American College of Obstetrics and Gynecology does not approve of compounded hormones unless there is a documented medical issue with prescribing Big Pharma medication, ex: the patch doesn’t stick or the gels are too expensive.
The GOOD NEWS is that there is regulation of these pharmacies. The practice of compounding is regulated by state boards of pharmacy. … FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations. Thus, the drug that is used in the cream is FDA regulated. The state board of pharmacy has created further oversight of compounding pharmacies. Compounding pharmacies must meet compliance with PCAB Pharmacy Compounding Accreditation Standards. PCAB is a service of Accreditation Commission for Health Care (ACHC) and is a third-party accreditation organization that has developed the highest national standards that providers are measured against in order to illustrate their ability to effectively deliver quality compounded medications to consumers. PCAB performs on-site visits with industry-expert surveyors who audit specific areas of performance. PCAB Accreditation also requires annual validation to ensure continued compliance with all applicable standards, similar to FDA regulation. Furthermore, in Jan 2020 there will be new FDA sterilization guidelines for all compounding pharmacies too meet.
Bottom Line: compounded bioidentical hormones are similar to Big Pharma Bioidentical Hormones
Definition:
1. The word “bioidentical hormones” means that the hormones in the medication are the same chemical make-up as the hormones made by the ovary.
2. Big Pharma Hormones: estradiol tablet, Estrogel, Divigel, estradiol patches, femring, estring, estrace/estradiol