Changing Rules For HCG Compounding: An FDA 2021 Update

The FDA’s Changing Rules For HCG Compounding: HCG Diet Miami Still Has HCG!

In March of 2020, the Food and Drug Administration (FDA) announced sweeping changes to how, where, and which drugs can be compounded for sale in the United States. These new rules may affect your ability to obtain prescription-grade human chorionic gonadotropin (HCG), a popular and effective tool to safely burn fat and lose weight.  Lets explain these changing rules for HCG.

FDA Changing Rules For HCG

Our patients, many of whom contact us with questions, often wonder: can I still find HCG near me? What’s the latest information regarding the FDA’s changing rules for HCG compounding? Lets break it down.

Is HCG Illegal Now?

It’s important to note: HCG is not banned or illegal based on the recent regulatory changes governing its production and sale.

So, what do these regulatory changes mean for adherents to the HCG Diet? Miami residents – and weight-loss patients across the country — can still access high-quality HCG compounded right here in the US through HCG Diet Miami.

Let’s discuss how the recent updates to the FDA’s HCG compounding rules may impact patients who rely on the supplement for weight loss therapy.

Drugs vs Biologics: What’s the Legal Difference?

To understand the shift in FDA regulations regarding HCG, let’s first explain the legal difference between a “drug” and a “biologic” via the Professional Compounding Centers of America:

“‘Drugs’ are generally approved under Section 505 of the Food, Drug, & Cosmetic Act (FD&C Act) while ‘biologics’ generally receive a biologics license… While [current law] provides pharmacies some exemptions, it does not provide an exemption from requiring approval for a biologics license under Section 351 of the PHS Act — meaning that pharmacies cannot compound with biologic products.”

How Did the FDA Rule Change Affect HCG Compounding?

In early March 2020, the FDA posted a notice that read:

“A change to the law will impact compounding of certain products beginning on March 23, 2020. On that date, biological products that were approved under the Federal Food, Drug, and Cosmetic (FD&C) Act will transition to being licensed under the Public Health Service (PHS) Act… beginning on March 23, these transitioning biological products will not be eligible for the exemptions for compounded drugs.”

In practice, this meant – as industry analysts warned it would — that scores of HCG providers stopped producing HCG supplements out of fear of legal consequences, HCG cost skyrocketed, and supply lines dried up.

HCG Diet Miami, fortunately, rode the regulatory wave to stay in business thanks to our high-volume business model and low overhead expenses.

As of August 2021, only Houston-based Empower Pharmacy can legally compound HCG in the US based on an FDA carve-out.

What Are the Most Important Considerations For Finding Prescription HCG Near Me?

In light of the recent FDA changes we’ve discussed here, always follow these basic guidelines when seeking high-quality HCG to meet your weight-loss goals.

  • Check the manufacture date. Real, pharmaceutical-grade, prescription HCG has a maximum shelf-life of 30 days, so pay careful attention to the label. The fresher the product, the more effective the hormone will be for turbo-charging weight loss – another reason to avoid imported HCG that may have spent months spoiling in shipping containers.
  • Never buy HCG in pre-filled syringes. In addition to being an illegal form of HCG for sale, you (the patient) do not know where the “HCG'” inside came from, when it was produced, or whether it is real HCG.
  • Get a prescription from a licensed medical doctor for HCG prior to purchase. The only legal and safe way to access high-quality HCG compounded in a regulated US pharmacy is through a doctor. HCG Diet Miami offers telemedicine conferences for maximum convenience to patients who cannot physically travel to their appointments. With a virtual consultation and the option for legally buying HCG on the web, you can complete the entire process 100%-online. While HCG is only officially recognized as a fertility treatment by the FDA, healthcare providers may prescribe it off-label as a weight-loss supplement.

Avoid ‘Homeopathic HCG’ at All Costs

These non-prescription products come in several forms, most often as “homeopathic HCG drops.” The reasons to avoid these products are multiple, but most importantly, if you inspect the label carefully, what you will discover is that they do not actually contain any HCG hormone – meaning they will not work to help you achieve a healthy weight. In addition, these products are manufactured without any regulatory oversight by the FDA, often in unsanitary and ill-equipped labs, and often in Third World sites outside of the country for import into the United States. When patients use “homeopathic HCG,” they are not only wasting their money but are also gambling with their health and potentially with their lives.

The FDA’s Changing Rules For HCG Compounding has caused some changes, but luckily for you, it has not affected the ability for HCG Diet Miami to provide it’s excellent service.

Contact HCG Diet Miami to learn more about safely sourcing HCG to shred fat and achieve a healthy weight.