At QueerDoc, we do work with different compounding pharmacies especially for transdermal and topical preparations. However, as with everything we do at QueerDoc, we want you to have all of the information, so you can make the choice that fits best for you (informed consent).
Compounding pharmacies and retail pharmacies are regulated differently. FDA oversight of retail pharmacies is much stricter which means the products available from retail pharmacies are held to higher standards of safety and consistency.
Prescriptions you get from pharmacies like Walgreens, CVS, the supermarket, Amazon, or Honeybee have been found to vary in concentration less than 2% of the time.1 So whatever it says is in the medication is actually in it.
Compounding pharmacies have less strict oversight. When their products have been tested by outside facilities, the concentration has varied anywhere from 30% to 300% of what was labeled on the medication.2 Additionally, compounding pharmacies have a higher rate of product contamination leading to health complications like infections. Between January 1, 2001 and December 31, 2013, 19 outbreaks linked to compounding pharmacies were reported, resulting in at least 1000 cases, including deaths. Almost half of these outbreaks included death of patients.3
Compounding pharmacies are sounding a little scary, but they are essential for accessing some life-saving medications. Some strategies for finding safer compounding pharmacies include:
- Verify that the license is in good standing at the state board of pharmacy’s website and check for any disciplinary actions taken against the pharmacy
- Check the FDA website: the FDA inspects compounding pharmacies when there’ve been reports of problems
- Verify the pharmacy is accredited. Several accrediting bodies exist. The more the better. Also look for accreditation from the Pharmacy Compounding Accreditation Board (PCAB).
- Verify the pharmacies implementation of best practices as a survey of insiders found some compliance to be desired.
The FDA has an educational FAQ about compounding pharmacies, and this article from the American Society of Healthsystem Pharmacists is informative if you want to know more about compounding.
At QueerDoc, we frequently use topical medications and transdermal hormones. We often use CareFirst pharmacy in New Jersey- they are accredited. You can see their NJ license here. They had a violation in 2019 which generally seems less concerning and resolved. You can review the violation here. The FDA has a concern from 2022 and you can see the response here. As we use CareFirst for non-injectables and the violations in question seem less concerning overall as well as actively being address, we feel comfortable prescribing there. They ship to 49 states, DC, and the Virgin Islands. They also make the products we look for, in the concentrations we want at a very competitive price. We frequently prescribe these products there:
- BLT topical numbing cream
- Hair support with minoxidil, latanoprost, and/or finasteride
- Transdermal progesterone and testosterone
What’s the deal with Empower?
If you know Dr. Power’s work, you know Empower. He uses them regularly for this compounded medication. At QueerDoc we appreciate Dr. Powers’ work- he has strived to push the field of trans healthcare to be better both with his endocrine and physiological clinical reasoning and his transparency in sharing information online. We do have some concerns about some of his recommendations being in direct opposition to the evidence, his lack of willingness to engage with other clinicians, and his seeming suggestion that there is one “right” or “best” medical approach to gender care.
We have worked with Empower at QueerDoc as they are one of the few compounding pharmacies that compounds injectable medications. They will also compound hormones in grapeseed oil which is more hypoallergenic then the castor or cottonseed oil in commercial (retail pharmacy) products. Working with them was challenging. Patients might have to wait 3-8 weeks for prescriptions. There were always multiple delays and calls back and forth. It was such an administrative burden, we had to start charging patients additional fees to cover the cost of the additional time and work for our team.
Then we learned Empower has been under investigation by the FDA. As such, we no longer prescribe there. Lloyd Central Compounding Pharmacy in Portland and Kelly-Ross in Seattle both offer sterile compounding; however, we do not specifically recommend or endorse either.
If you are considering accessing prescriptions through a compounding pharmacy, we recommend you speak with your hormone prescribers to better understand the risks and benefits as individualized to you. There are many times the benefits might outweigh the risk when it comes to compounded medications- you and your prescriber should decide together.
References
- United States Food and Drug Administration. Limited FDA Survey of Compounded Drug Products. 2001. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155725.htm.
- Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013;13(1):1-8. doi:10.1007/s40268-013-0005-9
- Shehab N, Brown MN, Kallen AJ, Perz JF. U.S. Compounding Pharmacy-Related Outbreaks, 2001-2013: Public Health and Patient Safety Lessons Learned. J Patient Saf. 2018;14(3):164-173. doi:10.1097/PTS.0000000000000188
