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While adding an ingredient might theoretically satisfy the FDAs clinical difference requirement for 503A pharmacies (if prescribed for a valid medical need), it does not negate patent infringement of the underlying active ingredient

CV = cardiovascular

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Injection-Related Risks With Injectable GHK-Cu FDA identifies compounded injectable drugs containing GHK-Cu as a potential immunogenicity risk because of aggregation and peptide-related impurities, and FDA notes limited human data to inform safety considerations [8]

For example, these medications can minimize angry outbursts, self-injurious behaviors, or severe irritability