Baer Law Firm Explains law in Colorado Regarding Compounding Pharmacies and NonResident Compounding Pharmacies Since December 2012

by admin of Baer Law Firm on July 11th, 2013 at 8:33 pm

In late 2012, an outbreak of fungal meningitis brought national attention to compounding pharmacies, the sterility and regulation of their compounded products, and the potential patient risks associated with compounded medications.

At the heart of the outbreak was a medication called methylprednisolone acetate, a preservative free injectable steroid that was produced at the New England Compounding Center (NECC). The medication was later found to be contaminated with mold and resulted in the worst pharmaceutical related public health care crisis in United States history. To date, over 50 people have died and another 700 others sickened as a result of the incident.

Over the past two decades, pharmacy compounding has dramatically changed. Traditionally, pharmacy compounding occurred when a pharmacist combined, mixed or altered various drug ingredients to create a medication for an individual patient in response to a practitioner’s prescription.

Today, however, internet pharmacies and large compounding pharmacies provide new avenues for patients wishing to receive compounded medications. Internet pharmacies send medications to patients all over the United States who may have never been examined or counseled, while some large compounding pharmacies produce enormous amounts of medications that are exact copies of the commercially available products. In both instances, laws are likely being broken, but while the Food and Drug Administration (FDA) has authority to regulate the development and manufacture of new drugs, the states remain the primary regulators of the traditional pharmacy practice.

In response to the horrible fungal meningitis incident, the National Association of Boards of Pharmacy (NABP) launched a nationwide program to identify and inspect compounding pharmacies as it was determined that many states:

1. did not know which pharmacies engaged in compounding;
2. did not know whether pharmacies shipped compounded medications across state lines, and
3. did not know which pharmacies manufactured large quantities of compounded medications.

In December 2012, the Colorado State Board of Pharmacy (Board) mailed affidavits to each of its 566 nonresident pharmacies. In the affidavit, each pharmacy was to attest that they would only dispense and deliver prescriptions into Colorado pursuant to a valid, patient specific prescription order. Each nonresident pharmacy that did not respond had a case initiated against them and the Board requested information detailing the dispensation and/or distribution of all prescription drugs and controlled substances from each nonresident pharmacy for the prior two years.
Ultimately, all nonresident pharmacies must be in compliance with the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act. The nonresident pharmacies that are in violation may face fines in excess of $1,000 per violation

quoted from here.    Pharmacist Attorney
25521 E. Smoky Hill Road
Suite #120, Aurora, CO 80016
720.222.1276