FDA Issues Draft Interim Guidance Documents on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FD&C Act
Food and Drug Administration (FDA) has issued two draft interim guidance documents that address the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under Section 503A of the FD&C Act, compounders can only use bulk substances that are included in the […]
Read More ›FDA Issues Final Guidance Document on Developing Monoclonal Antibodies for Treating COVID-19
Food and Drug Administration (FDA) has released a final guidance document offering recommendations to sponsors on developing monoclonal antibody products targeting SARS-CoV-2 intended to prevent or treat COVID-19. Additionally, the guidance document lists the criteria needed for FDA to issue emergency use authorizations. The Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization […]
Read More ›USP Fact Sheet Available to Help Pharmacists Advise Consumers on Dietary Supplements
The Dietary Supplements Sector of United States Pharmacopeia (USP) has designed a fact sheet to guide and inform pharmacists about quality considerations for dietary supplements. The guidelines recommend helping consumers understand how quality is defined and why it matters, as well as advising them to look for certain trusted third-party quality verification indicators, such as […]
Read More ›Draft Guidance on Prohibition of Compounded Drug Wholesaling Released by FDA
Food and Drug Administration (FDA) has released draft guidance that describes how the agency intends to apply the provisions of Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning the prohibition of wholesaling for certain compounded drugs. The guidance, titled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, […]
Read More ›DEA Addresses Suspicious Orders of CS With Guidance Document
Drug Enforcement Administration (DEA) published a guidance document regarding “suspicious orders” of controlled substances (CS). The document clarifies that neither DEA nor the Controlled Substances Act have regulations that dictate quantitative thresholds or place limits on the volume of CS that DEA-registered manufacturers or distributors can order and dispense. Instead, to comply with statutory and […]
Read More ›DEA Outlines New Guidelines After Elimination of the DATA-Waiver Program
DEA sent a letter to all DEA registrants informing them that the DATA-Waiver Program was eliminated after the Consolidated Appropriations Act of 2023 was signed on December 29, 2022. Since then, the “DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.” Furthermore, “all prescriptions for buprenorphine will only require […]
Read More ›FDA Issues Guidance Regarding Distribution of Approved Naloxone Products
Food and Drug Administration (FDA) has released new guidance to address the accessibility and availability challenges of naloxone products in underserved communities. The document, “Exemption and Exclusion from Certain Requirements of the DSCSA for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency,” does not include information about the current prescription-only status […]
Read More ›CDC Releases the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain
Centers for Disease Control and Prevention (CDC) has published the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain (2022 Clinical Practice Guideline) as part of the Morbidity and Mortality Weekly Report. This clinical tool includes new recommendations to help clinicians and patients weigh the benefits and risks of tapering or continuing opioids, additional […]
Read More ›FDA Issues Draft Guidance on Dietary Supplements
Food and Drug Administration (FDA) announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications. The agency intends to exercise enforcement discretion, for a limited time and in […]
Read More ›FDA Issues Final Guidance/Q&A on Importation of Prescription Drugs
This Food and Drug Administration (FDA) guidance is intended to help small entities better understand the final rule “Importation of Prescription Drugs,” published October 1, 2020 (85 FR 62094). The secretary of the United States Department of Health and Human Services issued the final rule to implement Section 804(b) through (h) of the Federal Food, […]
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