QUALITY CONTROL

The acceptable range for potency is the same for compounded medications as it is for commercially available drugs. The potency must be +/-10% of the labeled strength.  Beyond use dating is determined by existing pharmaceutical literature and independent testing.  We hold back samples of compounded medications and send the samples out over time.

Our internal Quality Control Team verifies that we are always following USP 795 Guidelines and our internal Policy & Procedures.  Testing for potency of our compounds is performed both randomly and continuously by an independent lab.  

All of our active pharmaceutical ingredients (API’s) come with a Certificate of Analysis (C of A) stating the powder’s identification and purity.  Additionally, Belmar Pharmacy requires that our wholesalers test API’s of our hormones for the most common contaminants: heavy metals like arsenic, lead & mercury, as well as e-coli, salmonella and others.  To date, we have had only one lot fail to meet our standards and was rejected.  We believe we are the only compounding pharmacy in the U.S. that has these standards.

We procure our hormone preparation ingredients from manufacturers and distributors that comply 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 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  None of the drugs imported have been withdrawn or removed from the market for safety reasons.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 in the U.S.
 
  
 
 
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Belmar Pharmacy  800.525.9473  I  303.763.5533  I  12860 W. Cedar Drive, Suite 210  I  Lakewood, Colorado 80228