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  "documentTitle": "Hims & Hers Health, Inc. (HIMS)",
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  "authorName": "Spruce Point Capital Management",
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  "presentationDate": "2023-07-13 00:00:00",
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  "notes": "Uses regulatory citations (Section 503A/503B) to cast doubt on the company's operational compliance and scalability.",
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      "kind": "callout",
      "text": "Section 503B Contains An Exemption For Outsourcing Facilities: HIMS is Not One",
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      "text": "Section 503A Restricts Compounding to Individual Patient Orders, and Anticipatory Compounding Increases Risks",
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      "text": "The FDA Highlights the Risks to Customers of Anticipatory Compounding",
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      "text": "None of HIMS' affiliated pharmacies or pharmacy partners are FDA-registered outsourcing facilities",
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      "text": "None of HIMS’ affiliated pharmacies or pharmacy partners are FDA-registered outsourcing facilities (List Here)",
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      "text": "Section 503A describes two situations under which a drug product can be compounded: (1) Based on the receipt of a valid prescription order for an identified individual patient, or (2) In limited quantities before the receipt of a valid prescription order",
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      "text": "Section 503A places serious restrictions on the ability of compounding operators to build inventory in order to facilitate scalability. We question whether HIMS is properly adhering to these regulations.",
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      "text": "Section 503B states that an outsourcing facility may or may not obtain prescriptions for identified individual patients... HIMS is not one.",
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      "text": "However, anticipatory compounding also has risks... there is an inherently greater chance of a production mistake or contamination.",
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      "kind": "quote",
      "text": "Because drug products compounded in accordance with section 503A are exempt from CGMP requirements, there is an inherently greater chance of a production mistake or contamination. — FDA Guidance for Industry",
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      "text": "Source: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry, Spruce Point Research",
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      "text": "We Also Question The Scalability And Profitability of HIMS' Bespoke Compounded Products",
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