OTC Drug Consultants Archives - Focal Point

Health Canada updates guidance on nitrosamine impurities in medications

Srishti Chaudhari — Thu, 04 Jun 2026 13:49:46 +0000

Health Canada has released an updated version of its Guidance on Nitrosamine Impurities in Medications, incorporating several important changes. The summary below applies to Non-Prescription Drugs, chemically synthesized excipients and raw materials used in the manufacturing of drug products.

Key updates include:

Reporting Requirements: Following confirmatory testing, Market Authorization Holders (MAHs) must assess whether nitrosamine impurities exceed the established Acceptable Intake (AI) limit and determine whether market action is required. MAHs are no longer required to notify Health Canada each time an elevated nitrosamine impurity level is detected. Notification is only required when a recall decision has been made, in accordance with the Drug, Natural Health Product and Biocide Recall guide (GUI-0039).

Risk Mitigation Expectations: While the guidance maintains a 3-year CAPA implementation timeline, Health Canada expects MAHs to implement risk mitigation measures and reduce nitrosamine levels below AI limits as soon as possible.

Safety: New contact information has been added for enquiries regarding applicable Acceptable Intake (AI) limits, including proposal for new AI limits.

Appendix 2: The decision tree has been updated to reflect the revised expectations for filing nitrosamine risk mitigation-related changes.

If you wish to understand how these changes might affect your business, please reach out to us.

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FDA Announces Fiscal Year 2026 OMOR Fee Rates: Costs to Increase

Srishti Chaudhari — Fri, 13 Feb 2026 22:12:06 +0000

The U.S. Food and Drug Administration (FDA) has officially released the fee rates for Over-the-Counter (OTC) Monograph Order Requests (OMOR) for the upcoming Fiscal Year (FY) 2026. As the OTC landscape continues to evolve under the CARES Act reforms, manufacturers and sponsors planning to submit monograph order requests must prepare for an increase in regulatory fees across both tiers.

The Numbers at a Glance

For FY 2026, the FDA has adjusted fees upward, reflecting an approximate 4.9% increase compared to the previous fiscal year.

Tier 1:

FY2026 – $587,529

(FY2025 was $559,777)

Tier 2:

FY2026 – $117,505 (FY2025 was $111,955)

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Final FDA Guidance for Drugs & Biologics Containing Nanomaterials

Delsie Braganza — Mon, 13 Jun 2022 16:45:21 +0000

If your company has nanomaterials in any drug (including OTC drugs) or biologic products sold in the US, this Guidance is important to you. The US Food and Drug Administration (FDA) has recently released its final industry guidance on human drug and biological products containing nanomaterials. This guidance is for applicants and sponsors of investigational, premarket and post market submissions of products. While there is no regulatory definition of nanomaterial, the FDA considers it products or materials with at least one external dimension or internal or surface structure in the nanoscale range, approximately 1 nm to 100 nm.

This guidance is comparable to one which was published in 2014 concerning cosmetic products. For the sale of cosmetic products containing nanomaterial ingredients, the FDA published recommendations for safety assessments for cosmetics to address certain important factors including characterizations of the nanomaterial ingredient, the safety assessment of nanomaterials and considerations for its toxicology when developing cosmetic products containing nanomaterials.

This guidance, which was initially drafted in 2017 will be concerning the development of OTC drug products in which a nanomaterial is present in the finished dosage form. It should be noted that this guidance should be viewed as recommendations for monograph drug manufacturers unless specific regulatory requirements are cited.

The guidance highlights the need to obtain further understanding of the interactions of nanomaterials within the body, including both intrinsic and extrinsic factors, as well as how these attributes will impact the overall product quality, safety and efficacy. These considerations presented in this guidance include drug development, safety evaluation and quality considerations

The FDA proposes a risk-based approach when developing nanomaterial-containing drugs, with a focus on the following risk factors:

Adequacy of characterization and function of the nanomaterial
Complexity of the nanomaterial structure
Understanding of the mechanism by which the physiochemical properties of the nanomaterial impact its biological effects
Predictability of in vivo release based on in vitro methods
Physical and chemical stability
Route of administration

The information of the structure of a specific nanomaterial can be referenced within the appropriate letter of authorization as part of the drug application or to a drug master file. This is to ensure adequate characterization of the nanomaterial and understanding of the nanomaterial’s intended use and application. It should be noted that this list is not comprehensive and other risk factors may need to be evaluated during product development.

Moreover, as a guidance document, the information issued are considerations for the industry for drug manufacturers when submitting applications, including Investigational New Drug Applications, New Drug Applications, Biological License Applications, Abbreviated New Drug Applications and Drug Master Files. The FDA suggests that as the drug product development progresses, more information will be obtained about the nanomaterial and understanding will continue to be revised based on findings.

If you need any assistance or have any questions about whether this applies to your company or have any concerns, do not hesitate to contact us.

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New French Language Requirements per Québec – Bill 96

Sagarika Sharma — Mon, 13 Jun 2022 16:36:37 +0000

On June 1, 2022, Québec’s Bill 96 became law. While most of the amendments will come into force at a later date, some significant changes came into force immediately on June 1, 2022. As a result, most businesses operating in Québec will have to adjust their practices to ensure compliance with the new requirements.

How may this affect your business?

Notable changes brought by Bill 96 include narrowing the recognized trademark exception (that applies to registered and unregistered marks) to only apply to registered trademarks on product packaging. Even if your non-French mark is registered, any generic or descriptive portions included in your registration will have to appear in French elsewhere on the product permanently affixed to it. Other changes include a prohibition on making available commercial publications, invoices, receipts, and other documents in another language unless the French translation is unavailable.

Businesses will have three years to comply, and these requirements come into force on June 1, 2025. Fines will be imposed for non-compliance ranging from $700 to $7000 (for individuals) and $3000 to $30,000 (for companies).

For additional information on this or if you have any questions, please do not hesitate to contact us.

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Health Canada’s Pilot Project to assess the compliance of lower risk MAHs

Sagarika Sharma — Mon, 13 Jun 2022 16:31:56 +0000

Health Canada is initiating a Pilot Program to assess the compliance of sites defined as lower risk (drugs that are not likely to generate many serious adverse drug reactions) Market Authorization Holders (MAHs). The scheduling of Good Pharmacovigilance Practices (GVP) inspections would utilize a risk-based approach and take into consideration multiple factors such as the product portfolio of the MAH and compliance history.

What to expect?

Health Canada will inform selected MAHs in July 2022 of their inclusion in the pilot program. Selected MAHs will be asked to respond to a questionnaire and provide requested documents by the end of August 2022, which GVP inspectors will review. The questionnaire will be used to assess whether the MAH has adequate procedures and systems. If a MAHs response is deemed unsatisfactory, an inspection will be scheduled between September 2022 and March 2023. Additionally, Health Canada may decide to inspect a certain number of MAHs who provided a satisfactory response.

The results of the questionnaire assessment stage will not be made public. Only the results of regular GVP inspections will be posted.

Please contact us if you have any questions regarding this notice or would like assistance with complying with Health Canada’s GVP requirements.

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Reminders

Jenn Porter — Mon, 13 Jun 2022 16:26:37 +0000

Reminder for DIN Renewals

As a DIN Owner, you should have received your Annual DIN Renewal package from Health Canada. These are due to be submitted by July 29, 2022. Should you require assistance with this, please reach out.

FDA User Fees For OTC Monograph Drug Facility

On June 1^st 2022, OTC Monograph Drug Facility User Fees for the fiscal year of 2022 were due to the US FDA. The fee for 2022 is $24,178 for facilities that manufacture or process a finished dosage form and $16,119 for contract manufacturing facilities. The annual facility fees for covered OTC drug facilities were introduced in 2021 to help fund FDA regulatory activities.

Facilities that are exempt from these fees include sanitizer manufacturers that distributed hand sanitizer products under the COVID-19 public health emergency as well as facilities that only manufacture active pharmaceutical ingredients, produce clinical research supplies, or conduct testing.

If you are unsure about whether your US-based drug facility has any fees due to the FDA, we can help determine which applicable fee applies to your establishment. Feel free to contact us.

Reminder for Drug Listings

Should you have any Drug Listing updates, now is a good time to file. If you require assistance, we are happy to help.

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Amendment to the Quebec Charter of the French Language

Sagarika Sharma — Thu, 14 Apr 2022 19:18:22 +0000

When it comes to trademarks, there is currently an exemption for French-language requirements for owners of “recognized trademarks” who may display a trademark in a language other than French as long as the trademark is legally recognized as a trademark and there is no French version registered in Canada. This has applied to both public signage, commercial advertising and product packaging and labelling. Bill 96, which was introduced into the Quebec National Assembly in May of 2021, will impact your company if your company labels products specifically for the Quebec (or Canadian Market) or utilizes an international (North American) label to manage a single inventory. Bill 96 will necessitate the translation of any generic word or phrase or a description of a product included within a trademark. In addition, only those trademarks that are ‘registered’ may be used in a language other than French.

As this bill is now in the final stages of the legislative process and is expected to become law this spring, in advance of the upcoming provincial election, it will be important for companies to be prepared for changes needed to comply with the proposed changes.

For additional information on this or if you have any questions, please do not hesitate to contact us.

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FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2022

Sagarika Sharma — Thu, 17 Mar 2022 17:54:19 +0000

On March 14, 2022, the U.S Food and Drug Administration (FDA) has announced the rates for over the counter (OTC) monograph drug user fees for fiscal year (FY) 2022 in a Federal Register Notice (FRN) titled ‘Over-The-Counter Monograph Drug User Fee Rates for FY 2022”. The FRN includes information about facility fee calculations, OMOR fee calculations, fee due dates, and payment options.

Spoiler alert: The FY 2022 facility fees rates are an increase of approx. 19% in comparison to the FY 2021 facility fee rates.

Application fees are as follows:

Monograph Drug Facility (MDF) Facility Fee – USD 24,127
Contract Manufacturing Organization (CMO) Facility Fee – USD 16,119

The fees also apply to the submitter of OTC Monograph Order Request (OMOR) and is as follows:

Tier 1 Monograph Fee – USD 507,021
Tier 2 Monograph Fee – USD 101,404

The OTC monograph drug facility fees are due on June 1, 2022.

If you need any assistance or have any questions related to whether this fee program applies to your company or have any concerns about payment options, do not hesitate to contact us.

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NOTICE WITH RESPECT TO CERTAIN SUBSTANCES ON THE REVISED IN COMMERCE LIST (R-ICL)

Sagarika Sharma — Thu, 17 Mar 2022 17:50:55 +0000

The Department of the Environment published a notice on March 12, 2022 to collect information on the commercial status and use of approximately 700 substances including biopolymers, plant extracts, mineral extracts, proteins, fats, animal extracts, waxes and carbohydrates. The purpose of this notice is to gather the information on the commercial status and downstream use of the substances.

Substances that are imported or manufactured with respect to use patterns beyond the scope of the Food and Drugs Act are subject to notification requirements.

If your company manufactured or imported any applicable substance, in 2019 or 2020, in a total quantity greater than 100 kg, and that is in, or is intended to be in, an applicable product. The list of applicable substances can be found at: https://canadagazette.gc.ca/rp-pr/p1/2022/2022-03-12/html/notice-avis-eng.html#na2.

Every person to whom this notice applies shall comply with this notice within the timeframe specified. Responses to this notice shall be submitted to the Minister of the Environment, no later than September 14, 2022, using the online reporting system available through Environment and Climate Change Canada’s Single Window.

Should you not meet the requirements of the notice and have no interest in the substances, you may submit a Declaration of Non-Engagement (DNE).

If you require any assistance in determining whether or not this notice applies to your company or if you need assistance with gathering information and responding to the notice, please do not hesitate to contact us.

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Full Producer Responsibility for Post Consumer Waste in Ontario

Nathan John — Tue, 26 Oct 2021 17:11:19 +0000

Ontario is moving its existing waste diversion programs to a producer responsibility model. Producers are the companies that design, create and market products and packaging. Producers will be responsible for managing and paying for the full life-cycle of their products to make recycling easier and more accessible across the province. If you are a Producer, you will need to:

Register your 2020 tonnage with RPRA (Deadline to Register – October 1st)
Pay your 2021 registry Fee when submitting your 2020 supply data
Join a Producer Responsibility Organization (PROs)

If you would like further information on this, please do not hesitate to contact us

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