Declaring some pharmacies are mass-producing non-FDA-approved nebulizer drugs for substitution without the patient's approval, asthma and allergy specialists proposed a resolution urging AMA to ask the FDA to take enforcement action against such pharmacies and to ask CMS to reconsider paying for such drugs. The resolution also urges AMA to educate physicians about the potential liability of approving such drug substitutions.
AMA resolution opposes some compounding
Declaring some pharmacies are mass-producing non-FDA-approved nebulizer drugs for substitution without the patient's approval, asthma and allergy specialists proposed a resolution urging AMA to ask the FDA to take enforcement action against such pharmacies and to ask CMS to reconsider paying for such drugs. The resolution also urges AMA to educate physicians about the potential liability of approving such drug substitutions.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.