FDA Proposes Ban on Cattle Tissue in Drugs - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Proposes Ban on Cattle Tissue in Drugs


ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

Rockville, MD (Jan. 12)—To prevent the spread of bovine spongiform encephalopathy (BSE) and related diseases, the US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) has proposed banning certain cattle tissues and tissue-products from the manufacture of drugs for human and ruminant use.

The proposal, “Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule” (published in the January 12 Federal Register, pp 1581-1619), estimates that cattle products of some kind are used in 75% of pharmaceutical manufacturing—and 90% of biotechnology processes. The proposal notes, however, that the agency has reviewed 10 years of data on cattle products used in drug-manufacturing and “we are aware of no approved drugs and no investigational drugs that are manufactured with cattle material that would be prohibited under this proposed rule....”

The rule will, however, impose new record-keeping requirements on some 1,200 manufacturing establishments (including an estimated 674 pharma plants and 253 biotech facilities), which must show that their processes do not employ the proscribed “Specified Risk Materials.” These SRMs are defined as the brain, skull, eyes, trigeminal ganglia, spinal cord, most of the vertebral column, and dorsal root ganglia of cattle 30 months and older, and the tonsils and distal ileum of the small intestine of all cattle.

Manufacturers would be required—under 21 CFR Sections 300.200(c)(1), 500.200(c)(1), 600.16(c)(1), 895.102(c)(1) and 1271.470(c)(1))—to maintain records that demonstrate that all cattle-derived materials conform to the prohibition. These could include signed and dated affirmations from slaughterhouses or renderer. The agency estimates the cost of compliance will be small, about $45 to $90 per year, depending on the size of the establishment.

The rule notes that cattle products may be used in manufacturing gelatin, heparin, surfactants, hormones, enzymes, glycosphingolipids, amino acids, glycerol, detergents, blood, collagen, fetal calf serum, bovine meat, and tallow and tallow derivatives.

BSE is a transmissible spongiform encephalopathy (TSE) thought to be caused by prions, for which no screening tests now exist. Human TSEs include Creutzfeld-Jakob Disease (CJD),variant Creutzfeld-Jakob Disease, Gerstmann-Strauussler-Scheinker syndrome, kuru, fatal familial insomnia, and sporadic fatal insomnia. Nonhuman TSEs include, in addition to BSE in cattle, scrapie in sheep and goats, transmissible mink encephalopathy, feline spongiform encephalopathy, and chronic wasting disease (CWD) in deer and elk.

 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here