Update: 9/27/2022 - We have successfully been able to source Pregnyl/Novarel/Generics from most local pharmacies and mail order pharmacies. Prices have ranged from $120-220 per 10,000Iu Vial.
Many people have asked us what's going on with the supply of HCG (Human Chorionic Gonadotropin), patients have reported it very hard to find at local pharmacies, and the mail order pharmacies they were getting it from stopped carrying it seemingly overnight. If you were taking HCG you probably noticed the switch from Compounded varieties to brand name, and a stark price increase. This was very frustrating for a few industries, the first of which being fertility clinics which use this medication frequently to increase the chances of conception. The second industry being hormone replacement & anti-aging clinics which use this as a backstop to prevent the negative long term side effects caused by testosterone supplementation. The third industry is weight loss clinicians that utilize this medication in certain diet protocols.
FDA 3/23/22: 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.1 This transition affects compounding under sections 503A and 503B of the FD&C Act because, beginning on March 23, these transitioning biological products will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.
What happened to the supply?
Well, this medication has been around for a long time, but recently the FDA decided to change its classification under the FD&C Act, over to the PHS Act, dubbing HCG and 3 other commonly compounded drugs "biologic" which prevents compounding pharmacies from compounding it off label under the new guidelines. This matters because most people going through an anti aging clinic, weight loss center, or other private medical office were probably paying out of pocket for this compound. This was not a big deal when any compounding pharmacy with a 503B license could make this medication to order, which kept the supply high, and the price low. Once the FDA banned the compounding of this medication it changed the entire layout of the supply chain. All patients and providers were forced to purchase HCG from only a handful of commercially available companies. The most popular brand is Pregnyl, followed by Novarel. There are a few smaller companies who produce HCG under larger corporate pharmaceutical umbrellas but they are mainly sold to pharmacies who buy directly through a contract pricing setup. The average price for a vial of commercially available HCG 10,000IU is anywhere from $130-400 depending on availability, region, and pharmacy. Most pharmacies have a hard time keeping this medication in stock, and have for the past 6 months.
Why did this happen?
It's a good question. The FDA released a statement to compounders explaining that there is a separate license that will be needed for drugs that contain similar biological markers to their commercial or brand name counterparts. The original exemption from 2009 was part of the Biologics Price Competition & Innovation Act which basically was to help stimulate competition between manufactures, and lower the patients costs for these drugs since most of them aren't covered by insurance. If you are a brand name drug producer, this is exactly the thing you try to fight against.
The Biologics Price Competition and Innovation (BPCI) Act of 2009 created an abbreviated licensure pathway under the PHS Act for biological products that are demonstrated to be biosimilar to, or interchangeable with, an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.
What are the HCG options now...
Options have definitely become scarce, some clinics are switching to alternatives such as gonadarellin peptides, enclomiphene, LH/FSH modulators, etc..
The alternatives are sufficient and cheaper, for some cases, but are not applicable for many clinics that do weight loss, fertility, and hormones. Someone taking testosterone will get most of the protection HCG offered in micro doses from Enclomiphene, but the benefit to libido has a noticeable drop off. Our patients have been able to access commercially available Pregnyl vials from local pharmacies, but usually have to wait a day or two due to backorders. These medications are best filled at smaller local pharmacies instead of larger corporate ones.