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According to FDA guidance: The limitations in section 503A(b)(1)(D) apply to the compounding of drug products that are essentially copies of a commercially available drug productnot only to drugs that are exact copies or even to drugs that are nearly identical

Transfusion 46, 143152 10.1111/j.1537-2995.2006.00692.x [DOI] [PubMed] [Google Scholar] Guilbert B., Dighiero G., Avrameas S

Crucially, despite extensive matching and restriction strategies, confounding by indication remains a primary concern

Preclinical studies in rodents showed thyroid C-cell tumours, though the relevance to humans remains uncertain

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