Preparation Quality
Belmar Pharmacy procures its hormone preparation ingredients from manufacturers and distributors that comply with with all federal regulations outlined in the United States Food and Drug Administration's Code of Federal Regulations Title 21, parts 211 and 210 involving current Good Manufacturing Practice (GMP) in manufacturing, processing, packing, or holding of drugs.
Our sources for purchasing these ingredients uphold GMP methods that may pertain to a biological product and components / active ingredients for human use. In addition, our suppliers comply with part 12 of subchapter 210.3 in regards to packing and labeling operations, testing, and quality control of drug products.
Our suppliers also comply with FDA Compliance Policy Guide, Chapter 4, Sub Chapter 460, Section 460.200 titled "Pharmacy Compounding" dated May 2002. This Compliance Policy Guide replaces Section 127 (aka Section 503A) of the Food and Drug Modernization Act of 1997 as related to Pharmacy Compounding. None of the drugs imported have been withdrawn or removed from the market for safety reasons.
Our suppliers comply with all United States Department of Agriculture, United States Customs and Border Patrol, and all Drug Enforcement Administration's importing guidelines. Furthermore, our suppliers notify each of the previously stated agencies of all shipments as to when and where they will arrive within the U.S.
|