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Introduced to prevent counterfeit, stolen, or contaminated prescription drugs from entering the supply chain, the DSCSA is enforced by the Food and Drug Administration FDA and provides regulations for manufacturers, wholesale distributors, dispensers, repackagers, and third-party logistics providers 3PLs.
In addition to product labeling and traceability standards, the DSCSA created a framework for credentialing and identifying authorized trading partners ATPs.
This allows supply chain actors to ensure that they are working only with verified and compliant companies.
Every member of the supply chain has a responsibility to maintain drug traceability records, thereby promoting public health interests under the DSCSA. Broadly, interoperability means that manufacturers, wholesale distributors, dispensers, repackagers, 3PLs, and other supply chain members can exchange mandated Transaction Information TI and Transaction Statements TS every time a drug changes hands.
And they must do so in a secure, electronic, and interoperable manner. Required product data includes Product Identifiers PIs serial numbers, expiration dates, and lot and batch codes. Pharmaceutical supply chain members are considered to be trading partners if they are involved in the exchange, purchase, or sale of drug products and biologics.