Compounding Pharmacies: What Every Woman Should Know About Personalized Hormone Therapy
Compounding is the creation of a pharmaceutical preparation by a licensed pharmacist to meet the unique needs of an individual patient when a commercially available drug does not meet those needs. There are many reasons a person may opt for a compounded medication — they may not be able to tolerate the commercially available drug, the exact preparation needed may not be commercially available, or they may need a drug that is currently in shortage or discontinued.
The U.S. Pharmacopeia Convention (USP) formally defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.” [1] Compounding typically cannot be done in a commercial pharmacy. It must be done in a specialty pharmacy that has the equipment and training to do so safely and efficiently. Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services.[2]
Why do so many clinicians “dis” compounded HRT?
You’ll hear a lot of conventionally trained clinicians and professional medical organizations tout FDA-approved HRT as the gold standard, while condemning compounded bioidentical HRT as “unsafe, unregulated and ineffective.” But that’s not true. Medical schools and the healthcare industry are heavily influenced by pharmaceutical interests, so many doctors are trained to view FDA-approved hormone formulations as superior and compounded hormones as subpar.[3], [4], [5]
I want to make sure you hear both sides of the story so you can make the best decision for yourself.
An important backstory...
Before commercially manufactured medications were available, prescriptions were often prepared by compounding pharmacies. In the 1930s and 40s, approximately 60% of all medications in the U.S. were compounded. Compounding declined during the 1950s and 60s with the advent of manufacturing and the mass production of medications. The pharmacist's role as a "preparer" of medications quickly changed to that of a "dispenser" of mass-produced manufactured medications. Today, fewer than 10% of prescriptions are filled at compounding pharmacies.
There’s no question that the FDA, Big Pharma, and many conventionally trained medical providers have an “anti-compounding” attitude toward HRT. It certainly isn’t because compounded hormones are unsafe or ineffective. It comes down to the fact that medicine is a profit-driven industry.
Like many in healthcare, I was conventionally trained (as a nurse) in a school and practiced in an industry with financial ties and influence from the pharmaceutical industry. Most of us were “trained” to believe FDA-approved medication (including HRT) is superior, and anything else is second-rate. This isn’t new. Pharmaceutical manufacturers have a long history of putting profits over patients. In the early 1900s, drug companies pushed opiates as miracle cures for everything from indigestion to toothaches.
It was a bit of a free-for-all until The Food, Drug, and Cosmetic Act of 1938 was passed. This act gave taxpayer money to fund the FDA, which was supposed to protect consumers from unsafe and ineffective pharmaceuticals. This was a win for consumers because we had a regulatory agency (the FDA) whose primary job was to protect public health by ensuring the safety and efficacy of human and veterinary drugs, biological products, and medical devices, as well as the safety of our nation's food supply, cosmetics, and products that emit radiation.
As time passed, more and more drug manufacturers sought FDA approval for medications, which meant longer and longer drug approval wait times. So, in 1992, in response to intense pressure to speed up the rate at which medications were being approved, congress enacted (and President George W. Bush signed into law) the Prescription Drug User Fee Act (PDUFA). This law essentially requires that drug and medical device manufacturers submit “fees” to the FDA when applying for new drug or medical device approval.
In 2022, the FDA charged over $3 million in user fees for a new drug application requiring clinical data — up from around $2 million in 2017. What began as a way for pharmaceutical companies to help fund the FDA’s costs associated with staffing, infrastructure, and improved and more expedited approval processes, has turned into something else entirely.
In 2022, user fees paid by Big Pharma accounted for around 46% ($2.9 billion) of the FDA's total budget of $6.2 billion. For the human drugs program, user fees paid by Big Pharma made up about 66% ($1.4 billion) of that program's budget. For the biologics program, Big Pharma fees covered around 43% ($197 million) of the budget. In other words, the FDA profits from Big Pharma, and Big Pharma profits when their medications (including HRT) are FDA-approved and prescribed. It’s important to note again that the law prohibits the patenting of any molecule present in the human body. Hence, bioidentical hormones cannot be patented; their delivery system can be patented, but the hormones themselves cannot. If you know anything about the pharmaceutical industry, you know that some big bucks are involved in selling patented drugs. Without the exclusivity of patents, huge profits are not possible.
Knowing this backstory, hopefully, you can start to understand why there’s been such a massive marketing campaign to smear compounded medications — they’re not profitable for Big Pharma or the FDA.
Compounded Medications
Compounded medications are only made with FDA-approved active pharmaceutical ingredients (API’s) procured from FDA-registered and GMP-regulated facilities. All the API’s have a USP-NF monograph. USP monographs for bulk drug substances and other ingredients provide standards for identity, quality, purity, strength, packaging, and labeling for bulk substances and other ingredients that may be used in compounded preparations.[6] Compounded medications prepared in a professional and compliant compounding pharmacy are as safe as the FDA-approved API’s they contain.
Federal and state laws regulate all pharmacies, including compounding pharmacies. Pharmaceutical compounding is regulated by the State Boards of Pharmacy, although the FDA supersedes it if necessary. The new pharmaceutical compounding model, 503B (also called “outsourcing facility”), is regulated by the FDA and follows Certified Good Manufacturing Practice (CGMP) guidelines. States and the FDA perform regular on-site inspections and safety checks on compounding pharmacies, so I’m not sure why so many clinicians refer to compounding pharmacies as unregulated. To the contrary!
Hospitals rely on compounding pharmacies to prepare medications that are not commercially available in the required form or dosage.[7], [8] Some of the commonly compounded medications include:
Total Parenteral Nutrition (TPN): Customized nutritional solutions for patients who cannot eat or absorb nutrients through the gastrointestinal tract.
Chemotherapy drugs: Tailored doses for cancer treatment.
Antibiotics: Specific formulations for patients with allergies or special needs.
Pain management medications: Customized pain relief solutions, including epidurals and patient-controlled analgesia.
Sterile irrigations: Solutions used during surgical procedures.
Pediatric formulations: Special doses and forms for infants and children.
Geriatric formulations: Adjusted doses for elderly patients.
These compounded medications are essential for providing personalized care and meeting the unique needs of patients in hospital settings. So, the next time you hear a provider “dis” compounded medications as being unsafe, remind them that their hospitalized patients are routinely given compounded medications.
These compounded medications are essential for providing personalized care and meeting the unique needs of patients in hospital settings. So, the next time you hear a provider “dis” compounded medications as being unsafe, remind them that their hospitalized patients are routinely given compounded medications.
Every industry has issues, and the medical industry is no different. Are some compounding pharmacies better than others? Sure, just like some pharmaceutical companies are better than others. Some doctors and nurses are better than others, and some of the pharmacists at commercial pharmacies are better than others. Human beings make mistakes, and there’s no doubt that compounding pharmacists — just like your commercial pharmacists — have made mistakes. I’ve been a nurse for 30 years, and I can tell you that mistakes happen. It’s a part of medicine that will never go away.
Compounding pharmacies are highly regulated in their state and must meet rigorous safety standards. Big Pharma and its allies in Congress and the media dislike the competition from compounding pharmacies, so they've continued to push the messaging that "compounded medications are unsafe," often citing this isolated incident that occurred over a decade ago (which had nothing to do with HRT).
The FDA has been working for years to remove and limit access to hormones and other critical compounded ingredients and make it next to impossible to provide alternate solutions for patients who cannot tolerate mass-manufactured medications. The FDA tried to ban estriol in 2008 but was unsuccessful because of public pushback.
To categorically claim that FDA-approved medications (including HRT) are “safe” and that anything else is not safe is simply untrue. Need I remind you of the largest civil and criminal (yes, criminal!) lawsuits in pharmaceutical history that have paid out BILLIONS of dollars for misrepresenting their products?[9] Or the recent approval of Alzheimer’s medications that have massively detrimental side effects, yet were still approved? The truth matters. And it’s important to understand that the anti-compounding attitudes have nothing to do with the safety of the products but rather are an attempt to discredit an entire industry to eliminate the competition. You can learn more about this in Gerald Posner’s book, “Pharma: Greed, Lies, and the Poisoning of America” — it’s eye opening!
The FDA is signaling that it may consider new restrictions on compounded hormones based on a flawed and biased report it commissioned. It’s interesting that the FDA hasn’t commissioned a similar report on FDA-approved medications, even though drug recalls and medication dispensing errors — totaling about 1.5 million per year in the U.S. — are some of the top threats to patient safety.
Attacking compounded hormones is just one way the FDA and the federal government bolster drug monopolies and undermine natural health options. If they manage to get their way, millions and millions of pausal women and other patients who rely on compounding pharmacies for specialty medicines will severely suffer.
Compounding pharmacists are the cream of the crop in terms of pharmacists. They are chemistry specialists with advanced training in precision customization of HRT and other solutions for patients. Most physicians work with just a handful of compounding pharmacists who are well-trained and trusted to maintain the utmost quality and safety. Clinicians and compounding pharmacists will often work together to tailor a woman’s prescription or troubleshoot issues.
I encourage you to fight back against the FDA and Big Pharma to preserve your access to BHRT by writing to your representatives, donating to the campaign to protect BHRT, and sharing your BHRT story. To learn more, visit: The Alliance for Pharmacy Compounding.
References
[1] https://www.pharmacist.com/Practice/Patient-Care-Services/Compounding/Compounding-FAQs. Accessed June 2023.
[2] https://www.pharmacist.com/Practice/Patient-Care-Services/Compounding/Compounding-FAQs. Accessed June 2024.
[3] Hensley, Laura. “Big pharma pours millions into medical schools — here’s how it can impact education.” Global News, 12 August. 2019. https://globalnews.ca/news/5738386/canadian-medical-school-funding/.
[4] DeJong C, Aguilar T, Tseng C, Lin GA, Boscardin WJ, Dudley RA. “Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries.” JAMA Intern Med. 2016;176(8):1114–1122. doi:10.1001/jamainternmed.2016.2765
[5] American Medical Student Association. “Evidence and Recommendations for a Model PharmFree Curriculum.” Available from: https://www.amsa.org/wp-content/uploads/2015/03/ModelPharmFreeCurriculum.pdf (Accessed November 2021)
[6] https://hcompound.com/myths-and-facts-about-compounding/. Accessed June 2023.
[7] https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/sterile-compounding/sterile-compounding-hospital-admin-guide.ashx (Last accessed February 2025).
[8] https://www.fda.gov/media/162166/download
[9] https://www.enjuris.com/blog/resources/largest-pharmaceutical-settlements-lawsuits/. Accessed June 2023.
[10] U.S. Food and Drug Administration, “Pathway to Global Product Safety and Quality External Link Disclaimer,” A Special Report, p. 20. Accessed May 16, 2023.
[11] https://news.mit.edu/2019/inactive-ingredients-reactions-study-0313. Accessed July 2023.
[12]https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019. Accessed June 2023.