Paul Davignon, chief of the PRB (and coauthor of the laetrile paper), wrote that this Mexican laetrile was "chemically subpotent
, mislabeled and of poor manufacturing quality." (2) Many samples were cloudy, teeming with bacterial life!
The PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and effective, and (2) to avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent
, or expired drugs.
Table R-1: Applications of molecular amplification methods for the diagnosis and management of malaria * Clinical situations: * Subpotent
Parasitemia associated with chemoprophylaxis or diagnosed during the convalescent period.
* Foreign outlets may distribute drugs that are expired, subpotent
, contaminated or counterfeit.
technologies to protect against counterfeit, diverted, subpotent
In the preamble to its proposed rule, FDA emphasized that its proposal "should not be interpreted to mean that there is not a problem with counterfeit and diverted drugs." The Agency-emphasized it will continue its efforts to implement the pharmaceutical security provisions set forth in section 913 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which created new section 505D of the FD&C Act and requires FDA to develop standards and identify and validate effective technologies for securing the drug supply chain against counterfeit, diverted, subpotent
, substandard, adulterated, misbranded, or expired drugs.
By selecting the wrong antibiotic and using a subpotent
dose, you are contributing to the development of resistant strains of bacteria."
(44) This Act prohibits counterfeit, misbranded, substandard, subpotent
, ineffective, or expired drugs, by regulating the distribution of drug samples.
In 2006, the FDA found supplements that were "significantly subpotent
" in some nutrients, including vitamin A, folic acid, and vitamin C.
Counterfeiting, by contrast, is likely to affect large numbers of people; delivering subpotent
product has become the subject of widespread criminal activity affecting many product types.
The immune responses elicited by subpotent
vaccines may exert selection pressure that favors antigenic drift and shift (Figure).
counterfeit drugs enable deadly mutations of the virus, which can reduce the drug's effectiveness," warns Marv Shepherd, director of the center for pharmacoeconomic studies at the University of Texas' College of Pharmacy.