Be careful of the interpretation because if you read the second subclause of that section if the company also manufactures cosmetic products that are not subject to Chapter V then the company is still expected to comply with all of the provisions of these sections (605-611) of MoCRA. As usual in this industry (and moreso with cosmetic products where the requirements are in such a major state of flux currently pending regulations being implemented) the answer is never really "simple" but more nuanced. If reading a section of the law seems to imply that you are not covered by the law I always strongly suggest reading all of the rest of the section because there are seemingly endless ways that that "exceptions" to the "exemptions" to the rules/laws find their way into the legislation.
Good general rule is that if the facility manufactures cosmetic products the facility and cosmetic products manufactured will be covered by MoCRA. This does not mean that it is a bad thing or that you are going to be required to have for example 2 different GMP programs because you could create a single program that supports your drug product GMPs and translate them into your cosmetics production program as well but this is a decision that you need to make as a business because I don't suspect that the regulations will be quite so well developed in the initial promulgation of the regulation for cosmetics as they already are for drug products.
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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 20-Jul-2023 13:41
From: Anjali Mukherji
Subject: Modernization of Cosmetics Regulation Act of 2022 ("MoCRA") Clause Sec. 613
Hello Everyone,
I am looking for some guidance regarding Sec. 613- EXEMPTION FOR CERTAIN PRODUCTS AND FACILITIES from MoCRA. This clause exempts a cosmetic product or facility that is also subject to the requirements of chapter V (drugs/devices) from the requirements of sections 605, 606, 607, 608, 609(a), 610, and 611 of MoCRA. Does this imply that a facility which also manufactures Drugs, Devices as well as Cosmetic products won't require to comply with SAE reporting, GMP, Facility registration & Product listing, safety substantiation, labelling (label including a domestic address, domestic phone number, or electronic contact information), records and mandatory recall authority? Please let me know your thoughts.
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Anjali Mukherji
Gurgaon
India
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