Examples of Bulk Drug in a sentence
USP also notes that it plays no role in enforcement and that regulators continue to have the authority to make their own determinations regarding enforceability of Chapter <800>.FDA Issues Statement on Compounded Bulk Drug Substances RulingA US district court judge in Washington, DC, recently upheld Food and Drug Administration’s (FDA’s) interpre- tation of clinical need regarding bulk substances that may be used by outsourcing facilities in drug compounding.
The Evaluation Framework, similar to the Planning Framework, depends on data that accurately measures Rural Generalists and their scope of practice, alongside other rural workforce, and links this with other data from rural health services and rural communities.
For proposed policies pertaining to compounding drug products from bulk drug substances for use in animals, see FDA’s draft guidance, Compounding Animal Drugs from Bulk Drug Substances.All FDA guidances are available on the FDA guidance web page.
In the Commercial Supply Agreement, the Parties shall determine the percentage of the Net Sales Price(s) for Drug Product(s) that shall be attributed to the price for Bulk Drug Substance supplied by VERTEX for the manufacture of such Drug Product(s) sold in the Territory.
VERTEX, its Affiliates or VERTEX Licensees will be the principal contact for and will otherwise take the lead role in all interactions with Regulatory Authorities concerning Bulk Drug Substance or a Drug Product in the VERTEX Territory.