article thumbnail

Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

The FDA Law Blog

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. By Karla L. the ability to associate the saleable return product with the transaction information/statement with the particular product).

FDA 52
article thumbnail

Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” Ahmed et al. One case of drug contamination from 2021 was highlighted in the paper.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

FDA 72
article thumbnail

DSCSA Compliance for Independent Pharmacies

DiversifyRx

Exploring the Drug Supply Chain Security Act (DSCSA) The DSCSA, signed into law in 2013, aims to heighten the security of the pharmaceutical supply chain by creating a framework for traceability and accountability. It also enables precise tracking and tracing of each drug package. Its main goals are: 1.

article thumbnail

Case Study 6 – Regulatory Operations Department Developed and Flourishing

Impact Pharmaceutical Services

In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. During the last year, IMPACT has submitted several FDA meeting packages for this consultant as well.

FDA 40
article thumbnail

Plan B One-Step side effects

The Checkup by Singlecare

Plan B prescribing information shared by the Food and Drug Administration (FDA) lists heavier menstrual bleeding (31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), dizziness (10%), and headache (10%) as the most commonly reported side effects in original clinical trials of Plan B. Plan B can be taken with or without food.

FDA 90
article thumbnail

Contamination Trends & Proposed Solutions

ISPE

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.