.webp)
.webp)
.webp)
.webp)
Facility inspection programs established across the country play an important role in regulatory oversight to help ensure the safety and compliance of the pharmaceutical supply chain.
A facility inspection is a common requirement to become registered and/or licensed in US states and jurisdictions to conduct pharmacy or distribution activities related to drugs and medical devices.
Organizations that can provide approved facility inspection programs are diverse and include: individual state boards of pharmacy, the National Boards of Pharmacy (NABP), and third-party organizations within dependent inspection programs approved by state regulatory agencies.
Each state and jurisdiction across the US has adopted its own regulations related to whether a facility inspection is required for licensure, and which facility inspections are accepted by the state for nonresident licensure or registration.
Individual state boards of pharmacy, or other relevant local regulatory agency, may conduct their own facility inspection within their state.
Typically, this occurs when a facility applies for licensure or has a change event. Many state inspections are also conducted after a complaint has been received by the state agency.
Factors that impact the scope of inspection may include the complexity of activities being performed, equipment utilized, and/or products the organization takes possession of or distributes.
Inspection requirements vary by state and reflect each state's individual licensing rules and regulations. However, not every state conducts inspections, and proof of inspection may be required to obtain licensure in other states.
If your home state agency does not license your business model or product, your home state agency most likely will not conduct an inspection of your facility.
This can be problematic if your facility is trying to get licensed in a nonresident state that does require a home state inspection. If that is the case, your facility would need to be inspected by a third-party organization.
There are a variety of non-regulatory bodies that have inspection programs that are accepted by jurisdictions across the U.S.
Organizations such as the National Boards of Pharmacy (NABP), the National Coalition for Drug Quality & Security (NCDQS), or Gates Health Care Associates conduct facility inspections for pharmacies and distributors.
Over time, NABP has demonstrated their ability to balance board priorities while keeping the protection of public health at the forefront.
NABP has worked closely with board members, inspectors, compliance staff, and executive officers to develop tools and services that facilitate information to state agencies, which support the development of strong, effective inspection programs and expand critical knowledge across states.
NABP, in collaboration with its member boards of pharmacy, using the United States Pharmacopeia standards, created the Pharmacy Inspection blueprint for Sterile Compounding.
This voluntary program helps states interested in a standardized inspection process for organizations that have committed to using the Pharmacy Inspection Blueprint Program.
According to NABP’s Multistate Inspection Blueprint Program website, there are at least 18 states currently approved to partner in the NABP’s Pharmacy Inspection Blueprint Program.
The individual state inspections created by these state boards of pharmacy meet the minimum criteria set by the program to ensure compliance and safety of pharmacy activities.
Those states include:
The NABP offers various inspection types that can be beneficial depending on your business model or the type of license you are trying to obtain.
The NABP Drug Distributor Accreditation (DDA) is an accreditation program for wholesale distributors and other business entities involved in the distribution of prescription drugs or devices, including manufacturers, third-party logistics providers (3PLs), outsourcing facilities, and others. The program was formerly known as Verified-Accredited Wholesale Distributors® (VAWD®).
Certain states require wholesale distributors and other applicable business entities to obtain this accreditation as a condition of licensure. States known to require DDA include North Dakota, Wyoming, Indiana, and Iowa, though requirements vary by state and business type, and distributors should confirm current requirements directly with each state board of pharmacy.
As described above, the NABP Supply Chain Inspection is one step in the DDA accreditation process.
The National Coalition for Drug Quality & Security (NCDQS) is an organization that offers an alternative option to the NABP’s inspection programs.
They offer the NCDQS QAS Accreditation for a number of business models within the US Pharmacy Supply Chain that conduct distribution activities, including: pharmaceutical and medical device manufacturers, distributors, third-party logistics providers, 503bs, and more.
The NCDQS is currently approved in 15 states, including:
More information can be found about the program here: https://www.ncdqs.org/qas-inspection-program
Regardless of the type of inspection or the regulatory body conducting it, there are common preparation practices that can help ensure a facility is ready. Being proactive and maintaining a consistent state of readiness is far more effective than scrambling to prepare once an inspection is scheduled.
Documentation and Records: Organized, up-to-date documentation is one of the most critical components of inspection readiness. Facilities should ensure that standard operating procedures (SOPs), records of licensure, storage and handling logs, and personnel certifications and training logs are accurate, current, and easily accessible to inspectors.
Facility and Equipment: The physical environment of a facility is closely evaluated during any inspection. Facilities should be clean, well-maintained, and meet applicable environmental control requirements. All equipment should be properly calibrated and in good working order prior to an inspection.
Self-Inspections and Mock Audits: Conducting regular internal audits is one of the most effective ways to identify compliance gaps before an official inspection takes place. Mock inspections can also help staff become familiar with the inspection process and reduce uncertainty on the day of the actual inspection.
Staff Training and Roles: Personnel should be trained on inspection procedures and understand their individual roles. Designating a point person or inspection team to coordinate with inspectors and manage document requests can help the process run more smoothly.
Review of Past Inspections: If a facility has undergone prior inspections, reviewing previous findings and ensuring that any identified issues have been resolved is an important preparatory step. Inspectors may reference past observations, so demonstrating that corrective actions were taken reflects positively on the organization.
State inspections play an important role in regulatory oversight; however, they are not sufficient as a standalone mechanism for ensuring comprehensive compliance in today’s complex pharmaceutical supply chain environment.
A private inspection program, self-audits, and frequent self-inspections are critical components of an effective compliance framework, providing continuous monitoring, risk mitigation, and operational consistency.
Maintaining such a program positions the organization to meet regulatory expectations, support business objectives, and uphold the integrity of the pharmaceutical supply chain.
Keep in mind that while a third-party inspector can help get your facility ready for an inspection, obtain state licensure, or review your compliance, they do not have any regulatory authority.
Jennifer Falkenrath is the Director, Regulatory &Legislative Tracking at LighthouseAI. Previous to this role, she was a BureauManager at Utah Division of Professional Licensing, which oversaw nineprofessional licensing Boards, including the drug supply chain and pharmacy.Additionally, she had also been a licensed pharmacy technician since 2005.
.svg){kind=small}
