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March 15, 2023

Explain Compounding pharmacies need stricter federal oversight through https://www.statnews.com/2019/07/15/compounding-pharmacies-stricter-federal-oversight/ Explain ?503 EXEMPTIONS AND CONS

Kindly summarize THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL. V. WESTERN STATES MEDICAL CENTER ET AL.
Explain Compounding pharmacies need stricter federal oversight through https://www.statnews.com/2019/07/15/compounding-pharmacies-stricter-federal-oversight/
Explain ?503 EXEMPTIONS AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES, AND BIOLOGICAL PRODUCTS and ? 503A Pharmacy Compounding and ?504 VETERINARY FEED DIRECTIVE DRUGS
What is your opinion of the FDA and/or Congress allowing unconstitutional language to remain in the Act for over 10 years?
Relate the regulatory process a new drug must take before it is released into the
American marketplace.
Understand how the FDA fast tracks a lifesaving drug to a patient.
Relate how manufacturing changes affect the regulations of a drug.
7. Read and summarize in :
Skim through NEW DRUGS, Section 505 (FDCA pdf found in Pages section,
Sec. 505, Pgs. 185-240)
Read RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL
PRODUCTS, Section 505B (FDCA pdf found in Pages section, Sec. 505B, Pgs.
264-277)
Read EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-
THREATENING DISEASES OR CONDITIONS, Section 506 (FDCA pdf found
in Pages section, Sec. 506, Pgs. 300-307)
Read MANUFACTURING CHANGES, Section 506A (FDCA pdf found in
Pages section, Sec. 506A, Pgs. 307-309)
UNITED STATES v. RUTHERFORD, 442 U.S. 544 (1979).
8. Explain –
?505 NEW DRUGS
?506A MANUFACTURING CHANGES

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