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Partnering with
Compounders to
Address the Pediatric

December 13, 2022 | 7 min read

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Drug Shortages in Canada

We all hear and talk about ‘drug shortages’ and medication ‘back-orders’ – but what do they really mean? A shortage occurs when a drug manufacturer is unable to produce adequate supply in order to meet the demands of consumers; meaning the product is on back-order or completely out-of-stock1. This can be caused by manufacturing delays, difficulty obtaining raw ingredients, discontinuation of the drug, or – as we have seen recently with the COVID-19 pandemic – a sudden increase in the demand for a medication.

Drug shortages in Canada – which are reported on Drug Shortages Canada – impact more than 1 in 4 drugs sold annually2. Drug shortages can have drastic clinical outcomes by contributing to treatment delays and disease proliferation3. The use of wrong therapeutic alternatives becomes a concern and the risk of medication errors and adverse drug reactions can increase3. While commercial substitutions are sometimes available during drug shortages, what happens when there are none and the shortage is ongoing? That is what we are all now experiencing with the pediatric acetaminophen shortage in Canada – a shortage impacting one of the most vulnerable patient populations at a time when pain and fever medication is needed the most.

Shortage of Pediatric Acetaminophen

Occurring just as the season of flu, respiratory syncytial virus (RSV), COVID-19, and other respiratory illnesses is beginning, the nationwide shortage of pediatric acetaminophen – an essential pain and antipyretic medication – has left parents, children, and healthcare providers feeling helpless. Health Canada cites increased demand as the reason for the acetaminophen shortage – mostly due to COVID-19 and an early spike in viral illnesses over the spring and summer of 20224.

In response to the shortage, Health Canada is working to secure alternate supplies of children’s medication5 – but this may not be enough. When and if supply comes in, there may still be an insufficient amount to meet consumer demand. Further adding to commercial unavailability is medication stockpiling, fueled by media coverage of the shortage and the fear of not having enough medication on hand in case of need.

Parents and caregivers are left scrambling for options, and some have resorted to using adult acetaminophen products for pediatric patients, which presents many challenges. While pediatric acetaminophen typically comes in liquid format for ease of weight-based dosing and administration, adult acetaminophen typically comes in fixed-dose increments and hard-to-swallow tablets. This places the burden on parents and caregivers to figure out how to dose and administer essential medication to their children, leaving room for error. A better solution must be out there – and for our compounding pharmacies, you know firsthand what is possible.

Compounded Acetaminophen – Addressing the Shortage

Defined as the practice of preparing customized medications in accordance with a licensed practitioner’s prescription, pharmaceutical compounding allows providers the opportunity to explore patient-tailored therapeutic plans that are otherwise not commercially available6. This includes personalizing dosage strengths so it is more suitable to the patient, considering alternative dosage forms such as a liquid over a tablet, eliminating unwanted ingredients that a patient may be allergic to, combining therapeutics, or – perhaps the most critical of all – filling demands during product unavailability, like we are experiencing with the pediatric acetaminophen shortage.

Medisca – Partnering to Support Compounders and Health Authorities with the Pediatric Acetaminophen Shortage

As a supplier of pharmaceutical compounding products and services, Medisca is witnessing first-hand the impact of the Canadian pediatric acetaminophen shortage through drastic increases in demand. To put some numbers to this impact – the demand for Medisca acetaminophen raw ingredient has increased by 600%, Medisca oral bases has risen by 300%, and requests for Medisca Formulas to support the on-going shortage has increased by 1,000%. This recent volume of demand is estimated to support 3 -12 million doses of acetaminophen for children across Canada. This is an unprecedented demand for compounded medication and an illustration of how critical the practice of pharmaceutical compounding is, particularly during times of drug shortages.

All things considered, it is not hard to imagine that compounding pharmacies across the country are working around the clock to ensure parents, children, and providers have access to this important medication. To support compounding pharmacies and hospitals, Medisca Supply Chain has been actively leveraging our vast manufacturer and supplier network to meet the demand for product. Medisca has also been collaborating closely with Healthcare authorities, keeping them regularly informed of inventory levels and incoming supply, as well as supporting their efforts with formula development and technical support services. Medisca Compounding Services – led by a team of highly skilled formulation chemists, pharmacists, and technical support service representatives – have been fielding an increasingly high volume of calls to support compounders with formula searches, preparatory questions, pharmaceutical calculations, ingredient selection, formula customization, and more. The demand for compounding formulation support is often at its highest during a drug shortage, and Medisca has the resources and processes in place to assist.

Acetaminophen Formulas – A Complimentary Resource to Support Current Shortages

The bread and butter of compounding and the most sought after support during a drug shortage, second to the ingredients themselves, are compounding formulas. Akin to a recipe, compounding formulas provide all the pertinent details and instructions needed for pharmacists and pharmacy technicians to prepare a compounded medication. With over 10,000 compounding formulas in our library, Medisca is well-recognized in the industry as the go-to resource for formulation support. Packed with all the essential information a compounder needs to prepare a compounded medication, Medisca formulas include the step-by-step breakdown on the preparatory process with details on ingredient sensitivities, calculation templates that support batch variations and ingredient adjustments, auxiliary labels, beyond-use dating instructions, references, and more. The formulations themselves are further supported by the Medisca Compounding Services team who assist with day-to-day calls and email inquiries. Compounding pharmacies can learn more about Medisca Compounding Services here.

For drug shortages – given the critical nature of them – we provide all Medisca formulas that are on potential shortage to the Healthcare community free of charge. Shortage formulas are consolidated on the Medisca Shortage Support section of our website, packaged in an easy-to-filter through table format. Shortages are continuously monitored across the globe and the Medisca Compounding Services team proactively develops formulas to support the need. As mentioned earlier, the team has increased their output for shortage formulas by 1,000% in the last month alone, a reflection of the acetaminophen shortage crisis. Currently, there are over 170 formulas on the Canadian Shortage Support page, created to address current or former shortages, 7 of which are intended to support the current pediatric acetaminophen shortage.

Listed below are the acetaminophen formulas organized by the base used.

Formulas using Medisca Oral Suspend / Medisca Oral Syrup:

Formulas using ORA Blend®:

Formulas using Methylcellulose Gel (1%):

In addition to the formulas themselves, we are currently offering free compounding services related to the pediatric acetaminophen drug shortage – including support with formula searches, preparatory questions, pharmaceutical calculations, and more – to compounding pharmacies and hospitals across the country. Inquiries can be sent to or to call directly dial 1-800-665-6334 ext. 1203.

If you are a provider, caregiver, or patient in need of this care, we encourage you to reach out to your local compounding pharmacy or physician.


  1. Health Canada. (2022). Drug shortages in Canada. Government of Canada.
  2. Health Canada. (2022). Drug shortages in Canada and their implications on public drug plans, 2017/18 to 2019/20. Government of Canada.
  3. Atif, M., Sehar, A., Malik, I. et al. (2021). What impact does medicines shortages have on patients? A qualitative study exploring patients’ experience and views of healthcare professionals. BMC Health Serv Res 21, 827 (2021).
  4. Caring for Kids. (2022). Shortage of infant and children’s liquid pain and fever medication. Canadian Pediatric Society.
  5. Health Canada. (2022). Health Canada secures additional supply of children’s acetaminophen products. Government of Canada.
  6. NAPRA. (2018). Guidance document for pharmacy compounding of non-sterile preparations. Companion to the model standard for pharmacy compounding od non-sterile preparations.

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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