A letter to the FDA said, "CLMA is concerned that imposition of additional regulatory requirements as outlined in the proposed compliance policy guide
would drastically affect patient access to a wide range of laboratory services that are currently available, the list of which includes tests and methods far in excess of those listed on the FDA temporary exempt list."
FDA has issued a special Compliance Policy Guide
(CPG) related to products that are purported to contain live (viable) microorganisms (bacteria and/or yeast).
AAHP president Mark Land said, "We are confident that the majority of homeopathic drug products in the market are manufactured and labeled in substantial compliance with the Compliance Policy Guide
(CPG) and the Food, Drug and Cosmetic Act, ensuring consumers have access to safe and clearly identified homeopathic products to choose from for their health care needs."
Nonetheless, the CPG [the FDA's Compliance Policy Guide
for marketed unapproved drugs] provided the industry with specific notice that any illegally marketed unapproved drug is subject to FDA enforcement at any time," Deborah M.
A new compliance policy guide
, for example, should facilitate pilot projects involving RFID tagging.