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.
Our patients, many of whom contact us with questions, often wonder: can I still find HCG near me? Here we break down the latest FDA rules for HCG as of 2021.
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 Near Me.
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.
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.”
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.
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.
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.
To sum up, the FDA rules for HCG have changed, but we are happy to report that we can still provide our excellent service at a very fair price.
Contact HCG Near Me to learn more about safely sourcing HCG to shred fat and achieve a healthy weight.