Federal and state role in pharmacy compounding and reconstitution
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Federal and state role in pharmacy compounding and reconstitution exploring the right mix to protect patients : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Eighth Congress, first session, on examining state and federal oversight to ensure the safety and quality of drug compounding--the process of mixing, combining, or altering ingredients to create a customized medication for an individual patient--by pharmacies, October 23, 2003 by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions.

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Published by U.S. G.P.O., For sale by the Supt. of Docs., U.S. G.P.O. in Washington .
Written in English

Subjects:

  • Drugs -- Dosage forms -- United States -- Evaluation,
  • Pharmaceutical industry -- United States -- Quality control

Book details:

Edition Notes

SeriesS. hrg -- 108-378
The Physical Object
Paginationiii, 145 p. :
Number of Pages145
ID Numbers
Open LibraryOL15553289M
ISBN 100160715229
OCLC/WorldCa55059588

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BibTeX @MISC{For03federaland, author = {Medication For and An Individual and James M. Jeffords (i and Jeff Bingaman and New Mexico}, title = {FEDERAL AND STATE ROLE IN PHARMACY COMPOUNDING AND RECONSTITUTION: EX- PLORING THE RIGHT MIX TO PROTECT PA- TIENTS HEARING BEFORE THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS .   Federal And State Role in Pharmacy Compounding and Reconstitution Novem Mr. Chairman and Members of the Committee, thank you for the opportunity to speak with you today about the serious public health implications of pharmacy compounding—a topic which has been the focus of my professional practice and research for the past 8 years. Full Committee Hearing Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients. Senate Committee on Health Education Labor and Pensions Date: Thursday, Octo Time: AM Location: Dirksen application of federal law to practice of pharmacy compounding. (a) AmendmentChapter V is amended by inserting after section (21 U.S.C. ) the following: > ``SEC. A.

pliance with the pharmacy practice laws of the state. Compounding has long been recognized as a legal and vitally important core component of traditional pharmacy practice. In , the USP had already been providing compounding instructions for years. Compounding occupied such an important role in U.S. pharmacy. The British Society for the History of Pharmacy was formed in , having originated from a committee of the Royal Pharmaceutical Society. It seeks to act as a focus for the development of all areas of the history of pharmacy, from the works of the ancient apothe-cary to today’s ever changing role of the community, wholesale or industrial.   State-level oversight of compounding pharmacies isn't enough to prevent illness and death from contaminated medicines. Greater federal oversight is needed. 2 USP, Chapter: Pharmaceutical Compounding – Sterile Preparations, (It is important to note that while FDA states that compounding does not include products prepared according to package labeling, FDA-approved labeling (i.e., the product package insert) rarely describes environmental quality (e.g., ISO Class air designation, exposure durations to non-ISO classified air, personnel.

For additional information about compounding pharmacy, contact IACP, PCAB, USP, the National Association of Boards of Pharmacy (NABP) or the appropriate state board of pharmacy. If you are interested in information on new regulations, news stories, and practice standards in compounding pharmacy, these are available on APhA’s “Just the Facts. The DQSA, which was enacted on Novem , made important updates to the Federal Food, Drug and Cosmetic Act (FD&C Act) regarding human drug compounding.   Federal and state role in pharmacy compounding and reconstitution: exploring the right mix to protect patients. Hearing on Oversight Before the Senate Committee on Health, Education, Labor, and Pensions, th Cong. Oct 23 [online].   Federal and state role in pharmacy compounding and reconstitution: exploring the right mix to patients. Statement before the Senate Committee .