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Tag: compounding pharmacy

UH OH–Naturethroid and WP Thyroid Shortages and what to do

NOTE: this post starts with what was going on in September 2017, and there are updates to it at the bottom of the article. If you didn’t know about this, you need to sign up for blog post notifications at the bottom right of the STTM website.

UPDATE: since the new Naturethroid has come out in 2018, there have been an awful lot of patients reports in seeing their hypothyroidism return, with labs to prove it. It has not been pretty.

Feeling panicked or frustrated by the shortages of two particular brands of Natural Desiccated Thyroid? Let’s take a look at all of this and what you can do.

Brands of NDT

Nature-Throid® and WP Thyroid® are two brands of NDT produced by the U.S. pharmaceutical RLC Labs. (There’s even an older third brand occasionally still foundable: Westhroid, which is said to be exactly the same as Naturethroid, though in less strengths than Naturethroid provides.)

As mentioned in the most sought-after patient-to-patient hypothyroid book on the market, RLC (formerly Western Research) has been around a long time–since the early 1930’s. And it appears they aren’t about to end that long tradition of their existence.

Why the shortage

RLC explains that the shortages are due to “significant upgrades to our facility and equipment”. And though that has created great inconveniences to and frustrations by users of their products, it’s clearly stated by RLC to be a temporary issue, though the resolution may take awhile.

Steps to consider in the meantime

  1. Writing the prescription differently First, make sure you doctor writes your prescription in a way that you are able to get any other brand of NDT your favorite pharmacy provides. One way is for him to write simply “desiccated thyroid”, then the amount you use, instead of mentioning a brand.
  2. Call around to different pharmacies. Patients are reporting that some still have their supplies of Naturethroid or WP, and especially WP. See if that makes you lucky.
  3. Consider other NDT brands. For example, NP Thyroid by Acella has been proven by patients to be a solid and well-made Natural Desiccated Thyroid, similar to the old version of Armour. And there are no shortages of NP.
  4. Compounding pharmacies Though more expensive, these versions of pharmacies are a way to have your NDT made according to you or your doctor’s specifications, especially fillers used.
  5. Using synthetic T3 with synthetic T4 If the two synthetics are used, patients have learned that their goals end up being the same as Natural Desiccated Thyroid as far as lab results with the free T3 and free T4, plus removal of symptoms, as well as not going by the TSH lab test. To see different brands of synthetic T3 like Cytomel and others, go here and see them in pink.

Why a pharmaceutical might be doing an upgrade

The U.S. Food and Drug Administration (FDA) states they inspect pharmaceutical manufacturing facilities worldwide, based on standards outlined by the Current Good Manufacturing Practice (CGMPs) regulations. This is especially true for those facilities which manufacture active ingredients like “thyroid tissue”, as well as the finished pill or liquid product from the contained ingredients. They state “inspections follow a standard approach and are conducted by highly trained FDA staff.” 1

Says the FDA:

CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.2

If you really want to get detailed information on CGMPs, here you go: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064971.htm

Stop the Thyroid Madness has not seen anything stated from RLC that this is the reason for the upgrades causing the shortages. But it will be interesting to see what the Naturethroid and WP Thyroid tablets look like, and act like, after this upgrade and catchup.

UPDATE as of OCTOBER 10th, 2017:

Heard the following from a gal who called RLC Labs: They have been working on the one grain tablets, and stated they should be finished in about two weeks. Then they will be mass shipping to pharmacies after that time around the first of November.

UPDATE as of November 2nd, 2017

From RLC Labs:

We are happy to announce that Nature-Throid 1 grain (65 mg) is shipping! Shipping for this strength began a few weeks ago and it should be hitting pharmacy shelves soon, but that can be variable; some locations may even already have it stocked and available. If your usual pharmacy is unable to fill your prescription, we recommend contacting other local pharmacies to see what they have in stock. You can also try any of the mail-order pharmacies listed on our website for a potentially faster turnaround. Strengths are being prioritized based on highest demand, starting with Nature-Throid 1 grain, and we are releasing in all counts. The next strength to be released will be Nature-Throid ½ grain (32.5 mg), and we will post here when it starts shipping. We are unable to provide any updates around WP Thyroid at this time, but will share them and any other new details on this page as soon as they are available. Every effort is being made to have all strengths stocked and available as quickly as possible while still maintaining our strict quality standards—the industry allows for a monograph discrepancy of +/-10% between T4 and T3, but WP Thyroid and Nature-Throid are not released outside of +/-2%. Patients are and always have been the top priority at RLC Labs, and we are literally working day and night to get back to our usual pace as quickly as possible. Your understanding and continued support are greatly appreciated as we do our best to get back to our usual pace. *Please discuss all health-related questions or concerns, including those about symptoms, with your physician.

UPDATE as of January 15, 2018

https://getrealthyroid.com/product-availability.html

In the meantime, NP Thyroid by Acella is a good one to switch to. You may have to adjust it for your own needs.

MORE INFORMATION:

  • Can Hashimoto’s patients do well on Natural Desiccated Thyroid? Find out here.
  • Is it true that thyroid cancer patients should avoid NDT? See this.
  • How do I use Natural Desiccated Thyroid? See what patients have learned here.
  • What if I want to use synthetic T3 instead? See this.
  • Where do I get the Stop the Thyroid Madness books I hear so much about? Right here.

 

 

1. https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm
2. https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm
663 replies

Are we running out of desiccated thyroid powder???

And now that I have your attention, here’s the answer straight from the mouth of Kenny Soejoto, Chief Operating Officer of the only North American maker of desiccated porcine natural thyroid powder (American Laboratories): a firm NO!

“We have amply supply and so do the distributors for compounding pharmacists”, underscores Soejoto when I chatted with him today.

He also added in response to the recent shortages:  “We didn’t spare an expense to push it along”.  i.e  “American Laboratories have caught up with all backorders, with the exception of one major company which has tight specifications, but they should be caught up by the first quarter in 2010”, explained Soejoto.

So what about specific rumors we keep hearing??

  1. My compounding pharmacy said they weren’t able to get it. Kenny explained that a small compounding pharmacy often can’t afford the minimum order that American Laboratories requires, nor does the smaller pharmacy want that much, which is an 110 lb drum of powder.  So, says Soejoto, they need to contact their distributor, who is the middle man between a compounding pharmacy and American Laboratories. “The distributor for compounding pharmacies, “ explained Kenny, “will buy the larger amounts, make smaller packets, and then sell those to the compounding pharmacies”.
  2. American Laboratories can’t be the only North American makers of powdered thyroid because my compounder told me a different name. The different name you heard is the middle man mentioned above–a distributor for the thyroid powder to the compounding pharmacy. But that distributor got their supply from American Laboratories.
  3. My regular pharmacy said there is a supply issue for the brand I wanted. Again, Kenny explains there is no supply issue–they have plenty. Any pharmaceutical company that makes desiccated thyroid has to have ongoing credit worthiness and documentation before AI can sell to them. Also, we are simply experiencing continued demand being greater than supply, and it can take time to catch up.  i.e. there may be more to the story than you hear under any comment about a supply issue problem.

In conclusion, Kenny Soejoto said they simply got into trouble from the growth of interest in desiccated thyroid the past few years, and they are much better prepared. Even Europe is inquiring more about it, he said. And my response to him?? Get ready, because you are doing millions of potential thyroid patients a HUGE favor by making it,  and we’re going to continue to spread the world about natural desiccated thyroid.  🙂

Check out posts below about other important issues, including more from Erfa, plus the problem of cellulose in compounded and regular desiccated thyroid.

*HO HO HO! Have a STTM book sent to someone  you care about as a CHRISTMAS or HOLIDAY present. A card will be included, and the book will be in an envelope with a red bow!! Save money the more you buy!

12 replies

Interesting information about Compounded Natural Desiccated Thyroid

We had a great Thyroid Patient Community Call Friday night on TalkShoe with John Voliva, RPh, the President of Hooks Apothecary in Evansville, Indiana. Hooks Apothecary is a compounding-only pharmacy that has been in existence for ten years and is a small and high quality family-owned business.

And with our current shortage of desiccated thyroid via the tablets we were used to, compounding pharmacies are a good alternative in the meantime. Here’s what we learned from Mr. Voliva:

1) Different compounding pharmacies will use different fillers. Hooks Apothecary, for example, uses powdered acidophiles, the “active culture” which helps replace the good flora in your gut and improves digestion.

2) Compounded desiccated thyroid can be more expensive for two reasons: they acquire smaller amounts of the powder as compared to the huge amounts obtained by a pharmaceutical like Forest, and it takes time to compound it.

3) A good compounding pharmacy will give you the Certificate of Analysis right when you ask for it, and you should ask for it. This Certificate will tell you how much T4 and T3 is in one grain..and it’s not always simply 38/9 mcg.  It could be 35/8.6 or 39/8.5 per grain…for example.   Find out because there are allowed deviations of 10 mcg +-.  A really good pharmacy will shoot for an even better deviation and will also produce that Certificate right when you ask for it, not a day later. To not receive that documentation right when you ask implies they really weren’t paying much attention to the deviation.

4) A compounding pharmacy will get better deviations when they create a 65 mg grain of compounded desiccated thyroid than when they create a 60 mg grain.

5) Top notch Compounding Pharmacies will be accredited by, or be close to completing the steps towards, the Pharmacy Compounding Accreditation Board.

6) Compounding pharmacies can’t make a desiccated thyroid trouche because of the problems with heat in the processing of the trouche.

7) Mr. Voliva feels it would be too easy to overdose with transdermal (on the skin) desiccated thyroid.

8 ) Compounding pharmacies, via their 5-6 distributors, get the powder from American Laboratories.  But not all compounding pharmacies will be as diligent as others to make sure the deviation is closer to 5%.

9) If the compounding pharmacy is getting their powder via the distributor PCCA (Professional Compounding Centers of America), you can be assured you are getting a good product.  Ask the pharmacist where they are getting it.

10) Compounding pharmacies generally have plenty of desiccated thyroid powder.

My apologies to a group of callers whose chat questions I wasn’t able to see. I have sent a question about that to Talk Shoe’s Customer Support to find an answer before the next Community Call. But on the good side,  the audio worked on everyone’s computer.

9 replies