Ameridose

Ameridose

File:Ameridose logo.svg

The logo of Ameridose

Ameridose was a pharmaceutical company based in the United States, known for providing sterile admixing and repackaging services to hospitals and healthcare providers. The company was founded in 2006 and was headquartered in Westborough, Massachusetts.

History

Ameridose was established with the aim of improving the efficiency and safety of medication delivery in healthcare settings. The company quickly grew to become a significant player in the pharmaceutical compounding industry, offering a wide range of products and services designed to meet the needs of hospitals and clinics.

Products and Services

Ameridose specialized in the preparation of sterile injectable medications. The company provided customized solutions for hospitals, including the repackaging of medications into ready-to-use formats, which helped healthcare providers manage their inventory more effectively and reduce medication errors.

Sterile Compounding

Sterile compounding involves the preparation of medications in a sterile environment to prevent contamination. Ameridose adhered to strict United States Pharmacopeia (USP) standards to ensure the safety and efficacy of its compounded products. The company’s facilities were designed to meet rigorous Good Manufacturing Practice (GMP) guidelines.

Repackaging Services

Ameridose offered repackaging services that allowed healthcare providers to receive medications in unit-dose formats. This service was particularly beneficial for hospitals, as it facilitated the administration of medications and improved patient safety by minimizing the risk of dosing errors.

Regulatory Challenges

In 2012, Ameridose faced significant regulatory challenges following a nationwide outbreak of fungal meningitis linked to contaminated steroid injections produced by the New England Compounding Center (NECC), a sister company. Although Ameridose was not directly implicated in the outbreak, the incident led to increased scrutiny of compounding pharmacies and their practices.

FDA and State Inspections

Following the outbreak, the Food and Drug Administration (FDA) and state health officials conducted inspections of Ameridose’s facilities. These inspections revealed several deficiencies in the company’s manufacturing processes, leading to a temporary suspension of operations to address the identified issues.

Closure

In 2013, Ameridose announced its permanent closure. The decision was influenced by the regulatory challenges and the financial impact of the suspension of operations. The closure of Ameridose marked a significant moment in the pharmaceutical compounding industry, highlighting the importance of stringent regulatory oversight and quality control in the production of compounded medications.

Legacy

The closure of Ameridose and the associated regulatory actions led to increased awareness and reforms in the compounding pharmacy sector. The incident underscored the need for enhanced regulatory frameworks to ensure the safety and quality of compounded medications, ultimately leading to the enactment of the Drug Quality and Security Act in 2013.

Related Pages

• New England Compounding Center
• Pharmaceutical compounding
• Drug Quality and Security Act
• Food and Drug Administration