Pharmacists Now Authorized to ‘Compound’ Hydroxychloroquine Sulfate
FDA adds hydroxychloroquine sulfate to category 1 under the Interim Policy on Compounding
The US Food and Drug Administration (FDA) added hydroxychloroquine sulfate to category 1 under the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.
Announced on March 25, 2020, the FDA stated when it categorized hydroxychloroquine sulfate, it did not change its approach.’
‘But we (have) prioritized this substance due to the COVID-19 pandemic.’
This is an important announcement since there are currently no FDA approved therapeutics or drugs to treat, cure or prevent COVID-19.
However, there are FDA-approved treatments that may help ease the symptoms of COVID-19.
‘We placed hydroxychloroquine sulfate on category 1 after it reviewed the nomination and determined there was sufficient information for the agency to evaluate the substance for outsourcing facilities to use in compounding,’ stated the FDA.
And, the FDA does not intend to object to registered outsourcing facilities using hydroxychloroquine (or chloroquine phosphate, which was already on category 1), to compound human drugs provided the drugs meet other conditions and requirements in the FD&C Act.
Additionally, state-licensed pharmacies and federal facilities that compound drugs under section 503A of the FD&C Act may compound drugs using hydroxychloroquine sulfate or chloroquine phosphate bulk drug substances because they are components of an FDA-approved drug, provide other requirements in the Act are met.
Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist.
The ‘Compounding’ process combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.
The US Centers for Disease Control and Prevention (CDC) states that ‘at present clinical management includes infection prevention and control measures and supportive care, including supplementary oxygen and mechanical ventilatory support when indicated.’
Moreover, ‘an array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe’ says the CDC, as of March 21, 2020.