Drug Shortages Reveal GMP Concerns

Drug shortages have been in the limelight in recent months, turning attention toward pharmaceutical manufacturing regulations and standards. FDA’s Web site, www.fda.gov, lists several therapies that are in short supply as a result of production problems and manufacturing difficulties. Limited access to routine vaccines for infants and children has public health authorities concerned. Pharmacists have stepped up tracking efforts because they cannot obtain important therapies in hospitals and clinics. The drug shortage situation has prompted FDA and other health authorities to examine the underlying factors of this troubling development. o­ne potential cause being discussed is whether stricter FDA enforcement of good manufacturing practices (GMPs) standards and new production rules is forcing companies to close or upgrade plants or discontinue production of low-profit medicines. Manufacturers have launched limited-distribution programs to reserve available critical therapies, but such actions offer o­nly temporary relief.For full article Click Here