Title II: Drug Security

What is the Drug Quality and Security Act?

The Drug Quality and Security Act (Act) was signed into law in 2013.

It regulates drug compounding activities, and imposes regulatory requirements on the drug supply chain. Pharmacies are required to comply with certain provisions in the act, especially provisions related to product verification and tracing.

How can pharmacies become familiar with the requirements of the Act?

The Food and Drug Administration (FDA) has created a with information on best practices.

The Act has two titles that impact Pharmacies:

Title 1 - Drug Compounding, which amends the Federal Food Drug and Cosmetic Act (FDCA) relating to compounding.
Title 2 – Drug Supply Chain Security, which amends the FDCA relating to distribution and drug security. This includes requirements for the pharmacy industry.

Which major/historical changes to the Act should pharmacies be aware of?

In 1997, the FDCA was amended to allow pharmacists to compound for individual patients, however, it prohibited pharmacies from advertising their compounding services.
Quantity restrictions were also put into place:
- If a state had not entered into a Memorandum of Understanding (MOU) with the FDA, compounded prescriptions were limited to 5% of the total prescription orders in a pharmacy.
- Legal challenges ensued after this pronouncement from the FDA, and eventually states were provided with regulatory discretion in that area.
In 2012, an issue with the New England Compounding Center (NECC) led to contaminated epidural steroid injections, resulting in the death of at least 48 patients, and fungal infections in hundreds more. As a result, congress took action to re-evaluate and amend the law.

What changes did congress put into place after 2012?

Congress found that the language related to, “unsolicited prescriptions” was unconstitutional.
Pharmacies may now compound for individual patients as long as they:
- Meet the requirements of the law and the compounding is done under the proper licensing guidelines.
- Perform the activities in limited quantiles, informed by previous prescriber history.
- Compounding practices must comply with the U.S. Pharmacopeial Convention (USP) chapters on pharmacy compounding or the National Formulary Monograph (NFM).

What are outsourcing facilities?

Outsourcing facilities are engaged in the compounding of sterile drugs. They are not currently regulated by the FDA. These facilities are not required to be licensed pharmacies and therefore, they do not need to comply with rules regarding individual patient prescriptions. However, compounding practices must be under the direct supervision of a licensed pharmacist.

Outsourcing facilities can ship across state lines without concern for the “five percent” rule. They are also required to abide by the Good Manufacturing Practice requirements, which include batch sterility testing.

Is there additional guidance or resources provided to pharmacies?

The FDA is currently developing a list of substances that are approved for compounding, however pharmacies should consult the USP and NFM in the mean time.

The FDA provides information about the status and implementation of the Compounding Quality Act here.

You can also find information about their current regulatory policies here.