[1] The bill was written in response to the New England Compounding Center meningitis outbreak that took place in 2012, which killed 64 people.

These requirements included a ten-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

In the case of office use, a prescriber may utilize compounded products from a 503B outsourcing facility registered with the FDA according to the act.

FDA spends fee revenues to hire, support, and maintain personnel for the oversight of these outsourcing facilities.

CQA lists the conditions under which drugs compounded by outsourcing facilities can qualify for the exemptions in section 503B and is available on FDA's website.

CQA requires FDA to submit an annual report to Congress no later than 120 days after each fiscal year (section 744K(h) of the FD&C Act).

The act preempts state and local requirements related to tracing drugs through the distribution system, and licensure of wholesale distributors and third party logistics providers.

Section 203 of the act prescribes additional requirements related to the tracing of products at the package level (enhanced drug distribution security) to enter into effect by November 27, 2023.

Under this section, the Secretary is required to: (1) establish one or more pilot projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain, (2) issue a final guidance document that outlines and makes recommendations with respect to the system attributes necessary to enable secure tracing at the package level, and (3) identify and make recommendations with respect to the standards necessary for adoption in order to support the secure interoperable electronic data exchange among the pharmaceutical distribution supply chain that comply with a form and format developed by a widely recognized international standards development organization.

The act also requires the Secretary to establish standards for the licensing of wholesale distributors and third party logistics providers.

In November 2019, the regulatory milestone requiring wholesalers to verify the authenticity of product returns was delayed by the FDA for one year.

[14] These included standards organizations and industry associations, manufacturers, wholesale distributors, logistics providers, and dispensers.

[16][17] The Drug Quality and Security Act was introduced in the United States House of Representatives on September 27, 2013, by Rep. Fred Upton (R, MI-6).

[1] That bill would require Senators and Representatives to "disclose which of their staff they have exempted from enrolling in insurance through the ObamaCare health exchange.

"[1] Majority Leader Harry Reid criticized this move, insisting that the Drug Quality and Security Act was more important to finish.