Compounders sometimes produce drugs using bulk drug substances or active pharmaceutical ingredients. Because compounding from these substances presents risks to patients, sections 503A and 503B of the FD&C Act place limits on the bulk drug substances that can be used in compounding.
Similar Posts
Purity Products Announces Recall on the Dietary Supplement, My Bladder Because of Possible Health Risk
Plainview, NY. October 27, 2025— Purity Products is announcing a recall of one lot of of its dietary supplement MyBladder because it has the potential to be contaminated with Escherichia coli O7:K1 and 1303. The presence of these E. coli strains may pose a risk for gastrointestinal or other infectioPotential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication
FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devicesGeneric Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – 04/10/2024
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug AccesseCTD Submission Standards for eCTD v4.0 and Regional M1
A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0BlendHouse LLC. Reading, PA. 483 issued 02/17/2023
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/17/2023
Short Title (70 char) BlendHouse LLC. Reading, PA. 483 issued 02/17/2023
FEI Number 3015728839
Firm Name BlendHouse LLC
Record Type 483
State PA
Establishment Type ManufacturerResources for Biomarker Requestors
Information and resources for requestors about FDA’s Biomarker Qualification Program
