Quality Assurance and Compliance
The Quality Assurance Department at ExpertMed™ is responsible for the company's compliance with cGMP guidelines, U.S. Pharmacopeia and the National Formulary (USP-NF) standards of quality, and current DEA regulations including List-1 chemicals. Our commitment to all of our customers is that ExpertMed™ complies with these standards and regulations for all our delivered products.
Commitment to Ethics & Compliance
ExpertMed™ provides a downloadable version of our Compliance Program in PDF format:
Certification of cGMP Compliance
The Quality Assurance Department at ExpertMed™ certifies that the Standard Operating Procedures, Laboratory Methods, Systems, and Facilities used in the manufacture of ExpertMed™'s products conform with Current Good Manufacturing Practice (cGMP) Regulations in accordance with the provisions set forth in the Code of Federal Regulations Title 21 Part 110, (21 CFR 110).
The Quality Assurance Department at ExpertMed™ also certifies that all personnel engaged in the manufacture, processing, packaging, and holding of drug products are adequate in number, education, training, and experience, or combination thereof, to assure that products have the safety, identity, strength, quality, and purity they are labeled to possess.
USP Standards
U.S. Pharmacopeia and the National Formulary (USP-NF) standards of identity, strength, quality, purity, packaging, labeling, and storage for medicines and other health care products are followed. Pharmaceuticals are tested to assure standard of quality as per USP. USP helps to ensure that consumers receive quality medicines by establishing state-of-the-art standards that pharmaceutical manufacturers must meet.
List-1 (pseudoephedrine/phenylpropanolamine) Containing OTC Drug Products
In order to comply with the current DEA regulations and to prevent diversion for use in the illicit manufacturing of methamphetamine, ExpertMed™ has instituted a companywide policy in which:
- No products are shipped to any retail or pharmacy customers without one of the following registrations:
- Controlled Substance Registration Certificate issued by the DEA
- Domestic Chemical Diversion Registration Certificate issued by the DEA
- We have restricted our order quantity to a maximum 2000 pills of List-I item per day to retail or pharmacy customers with above mentioned registrations.
- Wholesale customers are required to sign an agreement in which these items are not offered for sale to non-traditional outlets such as beauty parlors, liquor shops, record and video stores, auto part stores, etc.
- All inventory of DEA-Regulated List-I Chemicals are closely monitored, and any purchases above the threshold limits are reported to the DEA.
