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From commercial
to compounded:
What you need to
know for your
thyroid patients

September 6, 2022 | 7 min read

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Not all thyroid conditions are the same. Not all patients are the same. As a healthcare provider you know this all too well. When it comes to thyroid balance, too much or too little, and everything is thrown off – changes in mood, weight, and energy level are just some of the many symptoms. The complexity and crossover effect of thyroid function, as well as individual set points, lead to differences in clinical expression – and the challenging part – differences in response to therapeutics.

While commercial medications for the treatment of thyroid imbalance exist, fixed dosing increments and forms, unwanted ingredients, and commercial unavailability may impose limitations for healthcare providers that may result in unmet needs for their patients. With these challenges, providers are tasked to think outside the box – something we know compounders do on the daily. In this blog we will explore compounding options for managing thyroid insufficiency when commercially available products are unavailable or unsuitable to meet patient needs. Let’s break it down.


When commercially available products are unavailable or unsuitable to meet patient needs, alternative measures, such as compounding may be required. Defined as the practice of preparing customized compounded medications in accordance with a licensed practitioner’s prescription to address a patient’s unique set of conditions, tolerances, and preferences, pharmaceutical compounding allows providers to consider the following for thyroid treatment plans:
  1. Personalize Dosing
  2. Dosing is based on an individual’s age, height, weight, cardiovascular status, concomitant medications, and severity of thyroid imbalance. With so many factors at play, pharmaceutical compounding provides the flexibility to prescribe various dosage strengths and dosage forms that are suitable in meeting the patient’s specific needs.

  3. Eliminate Unwanted Ingredients
  4. It is known that lactose, an excipient found in many thyroid preparations, may affect absorption of thyroid drugs and may contribute to patient intolerance2. Gluten, aluminum, and colorants may have similar effects and are also of concern. Compounded thyroid preparations can be made free of unsuitable fillers that may impede drug absorption or impact patient tolerance.

  5. Tailor Dosage Form
  6. Part of the pharmaceutical compounding process includes considering alternative dosage forms. At present, thyroid medications are generally commercially available in oral tablet and capsule form3. Other options may include oral liquids for patients unable to swallow tablets/capsules and sublingual forms for patients with refractory hypothyroidism that may be caused by gastric absorption4,5.

  7. Consider Combination L-T4/L-T3 Therapy
  8. Levothyroxine (L-T4) is the gold standard for hypothyroid treatment and one of the most commonly prescribed drugs in America6. However, approximately 5-10% of the population continue to have symptoms despite normal TSH and T4 levels7. A hypothesis for this symptom prevalence includes individual differences in the ability to convert L-T4 to its active form, liothyronine (T3), leaving these individuals limited in their ability to achieve therapeutically effective levels. Indeed, genetic differences and age are known to impact this conversion8,9. Taken together, for certain individuals, L-T4 alone may not be able to achieve the desired outcome, creating a rationale for L-T3 supplementation8.

    Further contributing to the discussion around combination therapy is the growing evidence supporting patient preference for combination L-T4 + L-T3 therapy. In a 2018 survey of more than 12,000 people with hypothyroidism, desiccated thyroid extract – a naturally derived source of L-T4/L-T3 – was preferred over LT-4 alone10. Although not currently considered by the American Thyroid Association as a first-line treatment option, certain patients may benefit from this therapeutic alternative1. Interestingly, in a 2017 survey of American Thyroid Association members, it was discovered that combination therapy is becoming more commonly prescribed by North American physicians11.
When considering combination L-T4 and L-T3 therapy, providers have the following options available to them:
  • Commercially available L-T4 alone + commercially available L-T3 alone. At present, L-T4 and L-T3 are only commercially available as separate medications that would need to be taken independently. While this can be a suitable option for some patients, it can be challenging for others to maintain leading to poor compliance.

  • Compounded L-T4 and L-T3 combination. Simplifying the treatment regimen, L-T4 and L-T3 can be combined into a single dosage form at the desired strength and ratio. Excipient ingredient and dosage form selection can also be tailored when preparing the compounded medication.

  • Commercially available desiccated thyroid extract. Desiccated thyroid extract or DTE is a natural source of combination T4 and T3 that is available in a variety of strengths. The challenge with this medication is the frequent recalls due to inconsistent potency12. Furthermore, certain commercial forms of DTE contain excipients that may interfere with absorption and impact patient tolerance.

  • Compounded desiccated thyroid extract. Compounded DTE can be considered when commercial products are unavailable, when dosage strength or form need to be tailored, or when certain ingredients need to be avoided.

Here to Support Your Thyroid Compounding

Having the right tools to compound thyroid is an important part of the overall planning process when establishing personalized medications for patient-specific needs. From quality premade bases to reliable compounding equipment, and formulation support – all are vital pieces to the puzzle.


For capsules, Medisca CapsuBlend®-S is an ideal option. A premixed excipient blend, this base is recommended for highly soluble active ingredients, such as Thyroid, USP, and features improved drug dissolution13. This base is free of lactose, corn, and gluten.

For rapid dissolve tablets, Medisca Medi-RDT™ Base is a finely granulated powder that is compatible with a wide range of active ingredients. It has a significantly faster wetting time (5 seconds) and disintegrating time (93 seconds) compared to similar products on the market, and is free of preservatives, dyes, sugar, lactose, and gluten.

For liquid compounding, Medisca Oral Mix is an alcohol and dye-free vehicle that brings together the suspending properties of Medisca Oral Suspend and the cherry flavoring properties of Medisca Oral Syrup. A one-step vehicle that helps deliver elegant, flavourful, and physically stable suspensions.


After selecting the appropriate base for your patient’s needs, equipment such as the Profiller Capsule Filling System and Medi-RDT Kit, and mixing technology such as the Inversina and Medisca MAZ can change the way you compound by making the process quicker, easier, reproducible, and more efficient.


Don’t do it alone. Day-to-day Compounding Service Support is available – everything from access to an online formula databank, to daily compounding support with our team of Compounding Service experts, and clinical consultation support with our subject matter experts.


The education opportunity is also plentiful – From LP3 Network’s renowned Hormone Seminar to their free webinar on Alternative Approaches to Hypothyroid Therapy.


References below are for information only and not for the purpose of representing or suggesting any ingredients or formulations for any indications.
  1. Jonklaas, J., et al. (2014). Guidelines for the Treatment of Hypothyroidism: Prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement. Thyroid 24(12): 1670-1751.
  2. Virili, C., Antonelli, A., Santaguida, M. G., Benvenga, S., & Centanni, M. (2019). Gastrointestinal Malabsorption of Thyroxine. Endocrine Reviews, 40(1), 118–136.
  3. Lexi-drugs online [database on the Internet]. Hudson (OH): Lexicomp, Inc.; 2022. Available from: Subscription required to view.
  4. Tortora A, La Sala D, Vitale M. (2019) Switch from tablet levothyroxine to oral solution resolved reduced absorption by intestinal parasitosis. Endocrinol Diabetes Metab Case Rep. 2019 Mar 21;2019:19-0026. doi: 10.1530/EDM-19-0026
  5. Peirce, C. Ippolito S., et al. (2018) Treatment of refractory and severe hypothyroidism with sublingual levothyroxine in liquid formulation. Endocrine 60, 193–196
  6. Fuentes, A.V., et al. (2018). Comprehension of top 200 prescribed drugs in the US as a resource for pharmacy teaching, training and practice. Pharmacy (Basel), 6(2): 43.
  7. Tariq, A., et al. (2018). Effects of long-term combination LT4 and LT3 therapy for improving hypothyroidism and overall quality of life. South Med J, 111(6): 363-369.
  8. Biondi, B., & Wartofsky, L. (2012). Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism? The Journal of Clinical Endocrinology & Metabolism, 97(7), 2256-2271.
  9. Bégin ME, Langlois MF, Lorrain D, Cunnane SC. (2008) Thyroid Function and Cognition during Aging. Current Gerontology in Geriatrics Research. 2008:474868. doi: 10.1155/2008/474868. Epub 2008 Sep 1.
  10. Peterson S.J., et al. (2018). An online survey of hypothyroid patients captured predominantly dissatisfied individuals. Thyroid. 28:707–721.
  11. Jonklaas, J., Tefera, E., & Shara, N. (2019). Short-term time trends in prescribing therapy for hypothyroidism: Results of a survey of American Thyroid Association members. Frontiers Endocrinology, 30.
  12. Mangieri, C.N. & Lund, M.H. (1970). Potency of United Stated pharmacopeia dessicated thyroid tablets as determined by the antigoitrogenic assay in rats. Journal of Clinical Endocrinology & Metabolism, 30, 102-104
  13. Pinheiro, V.A., Danopoulos, P., Demirdjian, L., Nogueira, R.J.L., & Dubois, F. (2013). In vitro evaluation of extemporaneously compounded immediate-release capsules with premixed excipients, based on the biopharmaceutics classification system (BCS) of the drugs. IJPC, 17(5): 423-431.

Amoxicillin Shortage
Non-Sterile Compounding:
A Guide to Primary
Engineering Controls

August 29, 2023 | 5 min read

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Revised USP <795> and Primary Engineering Controls

In November 2022, the long-awaited update to the United States Pharmacopoeia (USP) General Chapter <795> on Non-Sterile Compounding was released. The revisions have many non-sterile compounding pharmacies across the United States buzzing with questions about what necessary changes must be implemented, sparking renewed interest in primary engineering controls (PECs).

PECs are devices employed directly at the point of use1 that control airborne contamination from the working environment2. The USP <795> Chapter calls out specific requirements for PECs used in non-hazardous and hazardous compounding in order to ensure compounder safety and minimize environmental exposure. PECs can be broken down into three main categories2:
  • Containment ventilated enclosure (CVE, i.e., powder hoods).
  • Biological safety cabinet (BSC, i.e., laminar flow hoods).
  • Compounding aseptic containment isolator (CACI).

During the compounding of hazardous drugs, PECs are designed to ensure the containment of hazardous material, hence the name containment PECs (C-PECs)2. But the challenge remains: which PECs to use and how to be compliant with USP Chapters <795> and <800>?.
The regulations surrounding PECs used in non-sterile compounding leave room for interpretation, illumining the importance of implementing best practices. Being compliant is one thing. Applying best practices is another. It is the collective responsibility of all compounders to uphold the integrity of the compounding practice. As you adopt these standards and apply best practices, you'll not only stand out from the competition but, more importantly, position yourself as a preferred partner for physicians seeking collaboration and patients needing your services. After all, physicians look for trusted partners who prioritize quality and patient safety. Patients, in turn, seek reliable pharmacies they can entrust with their health.

Non-Hazardous Compounding

Although the USP <795> does not lay forth specifics on hood selection for non-sterile non-hazardous compounding, it does require that compounding pharmacies perform an evaluation to determine what compounding activities result in powder generation. To better understand where such activities must be conducted in a hood, see the excerpt from the new USP <795> chapter below3:

"Weighing, measuring, or otherwise manipulating components that could generate airborne chemical particles (e.g., active pharmaceutical ingredients [APIs], added substances, and conventionally manufactured products) must be evaluated to determine if these activities must be performed in a closed-system processing device to reduce the potential exposure to personnel or contamination of the facility or CNSPs. Examples of closed-system processing devices include containment ventilated enclosures (CVEs), biological safety cabinets (BSCs), and single-use containment glove bags. The process evaluation must be carried out in accordance with the facility’s SOPs, and the assessment must be documented.”

Interestingly, the USP stops short of clearly defining how to assess powder generation, making it vague. However, if you've ever weighed out stevia and tasted its sweet flavor in the air or seen wisps of ketoprofen dust floating around while compounding, you know for certain that powders can indeed become airborne. By these lines, although the chapter takes a roundabout way of outlining when hoods are required, it is hard to imagine an instance where they should not be required. There is also value in consistency. All powders can generate airborne particles, so rather than evaluate each product (through an undefined, objective method), performing non-sterile, non-hazardous weighing, measuring, and manipulative activities in that same closed-system space would be more straightforward.
It’s important that we do not underscore the importance of taking the precautions to protect the compounder, safeguard the integrity of the preparation, and reduce cross-contamination exposure. Compounding pharmacist and owner with over 25 years of experience, Mark Filosi, said it well:

“We used to think coal dust and sawdust was inconsequential. I don’t want to learn 20 years from now that I should have been using a hood. Also, regardless of the hazard level, a hood does help prevent cross-contamination from one prep to the next. It cuts down on the residue of the previous preparation.”

So, what’s the take-home message? Simple. A PEC should be required for all non-sterile compounding activities. When evaluating which hood, always look for certifications from reputable organizations to ensure that your chosen equipment aligns with USP standards. For instance, the XPert Filtered Balance System Powder Containment Hood by Labconco is a CVE that checks off all of the boxes. It uses a built-in blower and HEPA filter to contain powders during weighing to help ensure the safety of the compounder.

Hazardous Compounding

For hazardous drug compounding, the necessity of a hood is apparent. According to the USP General Chapter <800> on Hazardous Drug Compounding, all activities must be performed in a C-PEC offering personnel and environmental protection through external ventilation or HEPA filtration3. However, when choosing the right hood for your specific compounding activities and compounding space, several factors should be taken into consideration:

  • State Law Requirements: Before deciding on a hood, you must be aware of the specific requirements set forth by your state's laws. For instance, some states may stipulate the need for exterior hood ventilation, while others might leave it to the compounder's discretion. There might also be requirements for features like a waste chute.
  • Anticipated Volume: Reflect on the volume your lab is currently compounding and anticipating to compound to help determine whether you'll need multiple C-PECs for your HD compounding room. Remember, if you plan on having multiple C-PECs inside a containment secondary engineering control (C-SEC; i.e., the room in which the C-PEC is placed), you must respect hood placement and air change per hour (ACPH) requirements. For instance, the USP <800> Chapter mandates that all C-PECs be placed in a negative pressure room with a minimum of 12 ACPH4.
  • Type of Equipment: Keep in mind the equipment you plan to use within the hood, as it will directly affect the available workspace for compounders. It also influences the hood's height, especially if some equipment demands extra clearance.
  • Presence of Fumes: If your compounding activities involve fumes, it is essential to invest in a hood designed with filters to handle them safely and effectively.

With these points in mind, Class I BSCs are designed for personnel and environmental protection by pulling air from the room through the front, away from the operator. They may be externally vented with a single HEPA filter or have two redundant HEPA filters that exhaust back into the room, although USP indicates that the former is preferred3. The RXPert Single Filtered Balance System is an example of a high-quality C-PEC used for hazardous compounding. This Class I BSC is designed to meet the USP <800> standards and features a factory-installed canopy and HEPA filtration.

A Class II BSC used for sterile compounding may be used for occasional non-sterile hazardous compounding but must be decontaminated, cleaned, and disinfected before resuming sterile activities3. A Class II BSC is defined as a ventilated cabinet intended for personnel, product and environmental protection, designed with an open front and inward airflow (personnel protection), downward HEPA-filtered laminar airflow (product protection), and HEPA-filtered exhaust air (environmental protection).

The Medisca Advantage: Service, Selection and Peace of Mind

There are many factors to consider when selecting the proper engineering controls for your compounding pharmacy. Yes, you need to be compliant with USP <795> and USP <800>, but you also need to make sure that the devices you choose fit the needs and future direction of your pharmacy. It all boils down to a few questions:
  1. Are you compounding, and do you plan to continue compounding non-sterile preparations?
  2. What drugs are you handling (i.e., hazardous or non-hazardous)?
  3. What limitations exist regarding costs (i.e., budget) and facility (i.e., compounding space, lease restrictions, building permits, accessibility, outside ventilation, etc.)?

With a team of experts specializing in hood selection for pharmaceutical compounding needs and a portfolio of 40 hoods for non-sterile compounding, Medisca supports compounders in addressing these questions and finding the best-fitted solutions for their specific pharmacy and/or facility needs. Medisca equipment specialists – led by a team of highly trained individuals with years of in-field experience – are here to walk you through all the steps of implementing a USP-compliant hood in your compounding pharmacy.

Ready to embrace best practices and elevate your PECs? Contact an account representative to connect you with an Equipment Specialist today.

Looking for more information on the revised USP General Chapters <795> and <800>? Visit here.


  1. Wagner, JT. Considerations for choosing primary engineering control for compounding sterile products. IJPC 2005; 9(4): 284-290.
  2. Chapter 12: Types of Engineering Controls. The Chapter <800> Answer Book.
  3. <795> Pharmaceutical Compounding – Nonsterile Preparations. United States Pharmacopoeia WebSite. Retrieved from: USPNF/revisions/gc-795-postponement-rb-notice-20191122.pdf
  4. <800> Hazardous Drugs – Handling in Healthcare Settings. United States Pharmacopoeia WebSite. Retrieved from:


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