Compounded Medications & Setting the Record Straight with Dr. Luis Delgado

In this episode, I sit down with my uncle, Dr. Luis Delgado, PharmD, owner of Village Pharmacy and Compounding in Miami.

We unpack what compounding pharmacies actually do, why personalized hormone therapy, especially testosterone for women, has become so essential, and how to identify a compounding pharmacy that leads with integrity.

Beyond the clinical content, Luis shares his entrepreneurial journey, from working in a federally qualified health center to opening Village Pharmacy with his wife, trading in his car to fund the business, and standing outside a restaurant in his early days introducing himself to potential patients.

If you have ever been told compounding pharmacies are unsafe, wondered whether your hormone therapy could be more precisely tailored, or simply needed permission to keep advocating for the care you deserve, this episode is for you.

FAQs

Are compounded medications safe?

Reputable compounding pharmacies operate within rigorous USP standards, are regulated through state boards of pharmacy (or the FDA, in the case of 503B outsourcing facilities), use FDA-approved active pharmaceutical ingredients with certificates of analysis, and follow detailed master formulas and batch records. As with any healthcare service, quality varies between providers, which is why asking the right questions matters.

Why is testosterone for women only available through compounding pharmacies?

There is no FDA-approved testosterone formulation designed for women. The financial incentive to invest in the trials required to gain a new indication for an already-generic molecule is limited, and as a result, there is no commercially designed product. Compounding pharmacies fill this gap by producing precisely dosed, female-appropriate testosterone preparations.

How do I know if a compounding pharmacy is reputable?

Key markers include FDA-approved active ingredients with certificates of analysis, written master formulas, computer-verified scales and batch records, conservative beyond-use dating, willingness to undergo third-party testing, transparent communication with prescribers, and openness to in-person visits. Asking about these directly is one of the most effective ways to assess quality.

Can my doctor prescribe compounded medications?

Yes. Any licensed prescriber can write a prescription for a compounded medication, just as they would for a commercial product. The prescription is sent to a compounding pharmacy, which prepares the medication to the specifications outlined in the order.

Does insurance cover compounded medications?

Coverage varies significantly by plan and medication. Many compounded preparations, especially in hormone therapy, are paid for out of pocket. Compounding pharmacies can typically provide cost estimates upfront.

Are compounded hormones safer or more natural than commercial hormones? Compounded hormones use the same active pharmaceutical ingredients found in commercial products. The advantage is not "naturalness", it is precision and customization. The clinical benefit comes from the ability to tailor dose, strength, and route of administration to the individual.

How long do compounded medications last?

Compounded medications carry beyond-use dates set conservatively within USP guidelines. For example, oral aqueous preparations with preservatives are typically dated around 30 days. These dates account for potency stability, sterility, and other safety considerations.

What should I do if my doctor refuses to prescribe a compounded medication I'm interested in?

Have an open, informed conversation about your interest, the clinical rationale, and the specific compounding pharmacy you are considering. If the relationship remains a poor fit for the level of personalization you are seeking, it is reasonable and appropriate to seek a provider whose approach aligns with your goals.

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