Good Manufacturing Practices (cGMP) Compliance
The NESA herbal dispensary is required to abide by Good Manufacturing Practices (GMP) as defined by the FDA. By July of 2010, all dispensaries and private dispensaries of herbs will be required to comply with FDA Good Manufacturing Practices.
Complying with the many requirements is time-consuming for any dispensary, and NESA is proud to be leading the way. Prescriptions must be appropriately labeled with the common names of herbs and the amounts in each prescription. Each prescription must also be labeled with the practitioner's name, the patient's name and the instructions for use and dose. Also required to be included are the best-use-by date, date of compounding and internal identifiable lot number of the compound.
At NESA, the lot numbers of all ingredients in a prescription are documented and traceable back to the manufacturer. Additionally, samples of all ingredients in all compounds are retained if further testing is requested. Attention is paid to the quality of the ingredients used in prescriptions and whether or not they were generated in GMP- or TGA- certified plants and whether the ingredients have been tested for the presence of pesticides, heavy metals, fungus and biological contaminants as well as active ingredients. Procedures for receiving and approving ingredients, adverse incidents, dispenser training and dispensary cleanliness and environmental controls are adhered to.
Newton, MA 02458