Source: PDSA
Initially convened to address threat of CA pedigree system, PDSA worked closely with Congress, FDA and other stakeholders to propose and pass the DSCSA. After the DSCSA law was signed… Read More →
Source: PDSA
The DSCSA establishes national standards for the licensure of wholesale distributors and third-party logistics providers (3PLs). As part of that licensure scheme, wholesale distributors and 3PLs are required to annually report to… Read More →
Source: PDSA
PDSA formally submitted comments on the Food and Drug Administration’s proposed rule on the importation of pharmaceutical products. In short, PDSA has significant concerns that the proposed rule would undermine… Read More →
Source: PDSA
The DSCSA establishes a national system for the traceability of certain prescription pharmaceutical products through the distribution chain. A cornerstone of that system is the identification and disposition of “illegitimate… Read More →
Source: PDSA
The national uniformity of the DSCSA is achieved through preemption of certain state requirements, as set out in Section 585 of the Food, Drug, and Cosmetic Act (FDCA). PDSA appreciates the FDA’s efforts… Read More →
Source: PDSA DSCSA Resource Document
PDSA DSCSA Resource Document – General PDSA DSCSA Resource Document – Manufacturers & Repackagers PDSA DSCSA Resource Document – Wholesale Distributors & Third-party Logistic Providers PDSA DSCSA Resource Document –… Read More →
Source: PDSA
National uniformity is established through the DSCSA by preempting certain state requirements related to product tracing, licensure of wholesale distributors, and licensure of 3PLs. The DSCSA requires a common understanding and approach from… Read More →
Source: PDSA
PDSA respectfully asks that the FDA expressly acknowledge the acceptability and appropriateness of using an abbreviated transaction statement and specifically asks that the FDA acknowledge the acceptability and appropriateness of… Read More →
Source: PDSA
PDSA respectfully asks that the FDA provide further direction and clarity with regard to, and consistent with, the following additional question and answer: If an entity constitutes a “manufacturer” under… Read More →
Source: PDSA
Consistent State adherence to the uniform national requirements of the DSCSA is critical to the successful implementation of the statute. PDSA is concerned that the lack of uniformity among State approaches will… Read More →
We are a coalition of more than 30 stakeholders spanning the supply chain spectrum – including biologic and pharmaceutical manufacturers, distributors, pharmacies, and logistics providers.
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