Compounded HCG now banned in California?

[xqfq]

According to this post on reddit, Defy just told their California patients that compounded HCG is no longer allowed to be shipped to or produced in California. This is nuts!

https://www.reddit.com/r/Testosterone/comments/nxsw1f

https://imgur.com/BN0Hdap

Does anyone have any details? What are the relevant laws / codes here? I will write to some of my elected representatives, but I need to know why this is happening.

 

[Anonymon]

According to this post on reddit, Defy just told their California patients that compounded HCG is no longer allowed to be shipped to or produced in California. This is nuts!

https://www.reddit.com/r/Testosterone/comments/nxsw1f

https://imgur.com/BN0Hdap

Does anyone have any details? What are the relevant laws / codes here? I will write to some of my elected representatives, but I need to know why this is happening.

Considering Biden back in the day was one of the guys behind restricting test so much to my knowledge, I imagine it’s a continuation of that asshattery.

 

[Nelson Vergel]

@Jason Sypolt

 

[Nelson Vergel]

This is how it all started and now CA is running with it.

The FDA Ended Your Access to More Economical hCG and FSH

UPDATE ON DECEMBER 1, 2021: The FDA has just made it a lot more difficult for couples seeking fertility to start a family. They have shut down the only affordable access to fertility hormones made by compounding pharmacies for over 40 years . All compounders were ordered to stop making...

www.excelmale.com

The FDA and hCG: Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020

On March 23, 2020, an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (see section 7002(e)(4)(A) of the...

www.excelmale.com

 

[Jason Sypolt]

I wasn’t able to get more information before the weekend. We just found out Friday afternoon and this goes into effect on Tuesday, June 15.

No compounded HCG will be permitted to ship to an address in CA and no compounded HCG will be permitted to be made within CA. So that leaves name brand HCG (Pregnyl, Novarel) which is already very difficult to find because those are only indicated for fertility and the pharmaceutical companies have no interest in mass-manufacturing additional supply of a drug for off-label use.

 

[xqfq]

I wasn’t able to get more information before the weekend. We just found out Friday afternoon and this goes into effect on Tuesday, June 15.

No compounded HCG will be permitted to ship to an address in CA and no compounded HCG will be permitted to be made within CA. So that leaves name brand HCG (Pregnyl, Novarel) which is already very difficult to find because those are only indicated for fertility and the pharmaceutical companies have no interest in mass-manufacturing additional supply of a drug for off-label use.

Do we know what ruling, law, etc made this happen? When I contact my representatives I’d like to have a concrete change to point to.

I even went through and watched hours of the CA State Board of Pharmacy meeting videos, read their minutes, etc. I can’t find any change that would have led to this.

 

[Nelson Vergel]

Getting background info today so that we draft a letter people can send to CA Board of Pharmacy and legislators in that state. Other states usually follow CA, so this is important for everyone.

 

[goolapsh]

The next thing is going to be compounded hormones. Watch

 

[Anonymon]

The next thing is going to be compounded hormones. Watch

If it affects trans people CA won’t touch it. They’re now our front line.

 

[Nelson Vergel]

If your doctor prescribes pharma brand hCG, please let me know if you run into issues trying to get the prescription filled at a regular pharmacy.

Here is the GoodRx info on brand name hCG

https://www.goodrx.com/hcg

 

[Nelson Vergel]

If it affects trans people CA won’t touch it. They’re now our front line.

hCG affects any person (women, men, transgender) that needs fertility help.

 

[Nelson Vergel]

The next thing is going to be compounded hormones. Watch

Yes. It is happening eventually. Read this:

Group Tells the FDA to Restrict the Use of Compounded Hormones

That is the message this group is using to convince the FDA to make prescribing compounded products a very restricted field. The use of compounded bioidentical hormone therapies (cBHTs) — an increasingly popular approach to relieve symptoms of menopause and male hypogonadism — should be limited...

www.excelmale.com

CALL TO ACTION: Stop the FDA from restricting compounded hormone therapy!

Have you benefited from compounded hormone therapy? If so, you won't be happy with what the FDA is planning. The FDA has never been a fan of pharmacy compounding, but now it looks to be making a move that could keep millions of people from using a critical therapy. Here's the deal: Last...

www.excelmale.com

FDA-funded report on compounded hormones is tainted, analysis shows

FDA-funded report on compounded hormones is tainted, analysis shows Published April 23, 2021 A 2020 FDA-funded report published by the National Academies of Science, Engineering, and Medicine on the safety and utility of compounded hormones is compromised by potential bias, conflicts of interest...

www.excelmale.com

 

[xqfq]

Yes. It is happening eventually. Read this:

Group Tells the FDA to Restrict the Use of Compounded Hormones

That is the message this group is using to convince the FDA to make prescribing compounded products a very restricted field. The use of compounded bioidentical hormone therapies (cBHTs) — an increasingly popular approach to relieve symptoms of menopause and male hypogonadism — should be limited...

www.excelmale.com

CALL TO ACTION: Stop the FDA from restricting compounded hormone therapy!

Have you benefited from compounded hormone therapy? If so, you won't be happy with what the FDA is planning. The FDA has never been a fan of pharmacy compounding, but now it looks to be making a move that could keep millions of people from using a critical therapy. Here's the deal: Last...

www.excelmale.com

FDA-funded report on compounded hormones is tainted, analysis shows

FDA-funded report on compounded hormones is tainted, analysis shows Published April 23, 2021 A 2020 FDA-funded report published by the National Academies of Science, Engineering, and Medicine on the safety and utility of compounded hormones is compromised by potential bias, conflicts of interest...

www.excelmale.com

I was told by my clinic they can’t even send me compounded testosterone in California anymore. I hope they were just misinterpreting the HCG decision, because that would be pretty crazy.

 

[Anonymon]

I was told by my clinic they can’t even send me compounded testosterone in California anymore. I hope they were just misinterpreting the HCG decision, because that would be pretty crazy.

I’d rather still go through my Doctor and get pharma grade test and HCG, but it is funny that CA may be pushing me to buy things underground and save some money while putting myself further at risk. Test-e or c’s usually $25-30 for 250mg in a 10ml bottle. That’s almost a year’s worth of TRT for $25.

 

[Nelson Vergel]

If any of you live in California, this meeting is happening soon. They accept public comments.

California State Board of Pharmacy
2720 Gateway Oaks Drive, Suite 100
Sacramento, CA 95833
Phone: (916) 518-3100 Fax: (916) 574-8618
www.pharmacy.ca.gov

​

AGENDA AND FUTURE MEETINGS: Full Board Meetings - California State Board of Pharmacy​

Notice of Meeting and Agenda Teleconference Public Board Meeting​

DATE & TIME: Thursday, June 17, 2021, 9:00 a.m. Pacific

NOTE: Pursuant to the provisions of Governor Gavin Newsom’s Executive Order N-29-20, dated March 17, 2020, neither a public location nor teleconference locations are provided.

INSTRUCTIONS FOR OBSERVATION:
WEBCAST: https://thedcapage.blog/webcasts Webcast will be available earliest at 9:00 a.m. on June 17, 2021. While the Board intends to webcast this meeting, it may not be possible to webcast the entire meeting due to technical difficulties or limitations on resources. If you wish to participate or to have a guaranteed opportunity to observe, please plan to participate via the WebEx option listed below.

FOR OBSERVATION AND PUBLIC COMMENT, PLEASE LOG ON TO THIS WEBSITE: https://dca-meetings.webex.com/dca- meetings/onstage/g.php?MTID=ef123e6ebacd7127d0184d0b8ac384c27

The preferred audio connection is via phone bridge. The phone number and access code will be provided as part of your connection to the meeting. General instructions for using WebEx can be found at the end of the agenda.

Members of the public may but are not obligated to provide their names or personal information as a condition of observing or participating in the meeting. When signing into the WebEx platform, participants may be asked for their name and email address. Participants who choose not to provide their names will need to provide a unique identifier such as their initials or another alternative, so that the meeting moderator can identify individuals who wish to make public comment; participants who choose not to provide their email address may utilize a fictitious email address in the following sample format: [email protected].




Important Notices to the Public: The Board of Pharmacy will hold a meeting via WebEx – access information is provided above. General instructions for using WebEx are attached to the agenda. The meeting is open to the public and is accessible to the physically disabled. A person who needs a disability-related accommodation or modification in order to participate in the meeting may make a request by contacting Debbie Damoth at (916) 518-3090, by emailing [email protected] or sending a written request to the Board of Pharmacy, 2720 Gateway Oaks Drive, Suite 100, Sacramento CA 95833. Providing your request at least five business days before the meeting will help to ensure availability of the requested accommodation.
The time and order of agenda items are subject to change at the discretion of the Board President. In the event a quorum of the Board is unable to attend the meeting, or the Board is unable to maintain a quorum once the meeting is called to order, the members present may, at the president’s discretion, continue pursuant to Business and Professions Code section 4309(c), as well as continue to discuss items from the agenda and make recommendations to the full Board at a future meeting.
Government Code section 11125.7 provides the opportunity for the public to address each agenda item during discussion or consideration by the Board or prior to the Board taking any action on said item. Members of the public will be provided appropriate opportunities to comment on any issues before the Board, but the

president may, at his or her discretion, apportion available time among those who wish to speak. If public comment is not specifically requested, members of the public should feel free to request an opportunity to comment. Individuals may appear before the Board to discuss items not on the agenda; however, the Board can neither discuss nor take official action on these items at the time of the same meeting (Government Code sections 11125, 11125.7(a)). The Board plans to webcast this meeting on its website at www.pharmacy.ca.gov. Webcast availability cannot, however, be guaranteed due to limited resources or technical difficulties. The meeting will not be cancelled if webcast is not available. Using the WebEx link will allow for participation and observation. Using the Webcast link will allow for observation with closed captioning. Adjournment will not be broadcasted in any way.

Agenda

DISCUSSION AND ACTION MAY BE TAKEN ON ANY ITEM LISTED ON THE AGENDA​

Thursday, June 17, 2021

Call to Order 9:00 a.m.

Call to Order, Establishment of Quorum, and General Announcements and Recognitions

Public Comments on Items Not on the Agenda/Agenda Items for Future Meetings
Note: The board may not discuss or take action on any matter raised during this public comment section that is not included on this agenda, except to decide whether to place the matter on the agenda of a future meeting. [Government Code sections 11125, 11125.7(a)]

Discussion and Consideration of Adoption of Board Approved Regulation, 16 California Code of Regulations Section 1717.5 Related to Automatic Refill Programs, and Discussion and Consideration of Public Comments Received during the 15-day comment period on the proposed new modifications to the Regulation

Petitions for Reinstatement of Licensure, Early Termination or Other Modification of Penalty
Olugbenga Oduyale, RPH 42719
Mohamadali Abolahrar, RPH 47336
Keith Chung, RPH 50486
Maher Kaldas, RPH 39184

Closed Session Matters
Pursuant to Government Code Section 11126(c)(3), the Board Will Convene in Closed Session to Deliberate on Disciplinary Matters, Including the above Petitions, Proposed Decisions, Stipulated Decisions, Defaults, Petitions for Reconsideration, Decisions After Remand or Rejection, and Any Other Disciplinary Matters.
Pursuant to Government Code Section 11126(e), the Board Will Convene in Closed Session to Discuss Pending Litigation
Pursuant to Government Code Section 11126(c)(1), the Board Will Convene in Closed Session to Consider the Preparation, Approval, Grading or Administration of One or More Licensing

Examination(s)



Reconvene Open Session


Adjournment Upon conclusion of business



Due to technological limitations, adjournment will not be broadcast. Adjournment will immediately follow closed session, and there will be no other items of business discussed.

 

[Nelson Vergel]

Here is their Twitter. Please post in it with a #HCGaccess

https://twitter.com/CAPharmBoard

 

[Trip McNeely]

Six months gives you enough time to move out of California and into a free state. Ron DeSantis (total T of 1000+ easily) would never pull something like that in Florida. Fair warning: If you move here from Cali, leave your Cali politics behind.

 

[Nelson Vergel]

The CA State Board of Pharmacy posts their meetings on youtube

If you are adding a public comment, they will give you two minutes.

These are the points to convey:

1- You have found out that no compounding pharmacies in or outside CA are allowed to sell hCG.

2- How this decision affects your access for treatment (fertility is the best indication to bring up)

3- They do not care about pricing issues, so concentrate on the word "access".

4- Do not mention any compounding pharmacies in particular. This decision affects all compounding pharmacies. Mentioning specific ones increases the risk of retaliation.

5- Mention that hCG is an old compound that has been compounded for over 30 years all over the country and that eliminating potential suppliers is not in the best interest of male, female and transgender patients (hCG is used by both genders and in transgender people who need reproductive assistance).

6- hCG is not known to cause any psychological or behavioral effects that require greater regulations.

 

[DorianGray]

I see Nelson already posted the notification of the meeting. Great, Thanks Nelson. I just received email from Defy with the meeting info. Yes, these bureaucracies do fulfill their public obligation then blow people off anyway but they can be swayed if enough people express their disagreement and dissatisfaction. Let your voices be heard.

 

[ivkonst2017]

Just for a reference how much the branded HCGs cost in the USA?