Comments of the Healthcare Supply Chain Association (HSCA) on Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments on the U.S. Drug Enforcement Administration’s (DEA or Agency) proposed aggregate production quotas for Schedule I and II controlled substances. HSCA supports DEA’s efforts to support interagency collaboration around controlling opioid diversion. We are concerned, however, that absent differentiation of injectable opioids from solid dosage form for purposes of the rule, these changes to aggregate production quotas could lead to injectable narcotic shortages that threaten patient care.
Click here for the full comments.
Group Comment Letter to FDA on Clinical Immunogenicity Considerations from Biosimilar and Interchangeable Insulin Products
Dear Commissioner Hahn, The undersigned groups share the Food and Drug...
Comments of the Healthcare Supply Chain Association (HSCA) on FDA Request for Comments on Ethylene Oxide Sterilization of Medical Devices
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the...