 |
What is IMPAC? |
| |
IMPAC, Inc. is dedicated to the promotion of consumer safety and quality improvement in the pharmaceutical wholesale industry.
IMPAC, Inc is an accreditation company located in the United States. As an accreditation company, we develop quality
standards for specific industries and offer accreditation based on those standards. The IMPAC quality standards are the ‘gold
standard’ for the industry and are reviewed by members of the Advisory Panel.
|
|
|
|
Why should a pharmaceutical wholesaler seek IMPAC accreditation? |
| |
Accreditation provides purchasers, state and federal agencies, and ultimately the consumer an assurance that a pharmaceutical wholesaler has met essential quality standards. This transition to voluntary accreditation occurs at a time when there is concern about the safety of the U.S. drug supply. This concern is highlighted in The Giuliani Partners’ Report, Examination and Assessment of Prescription Drug Importation from Foreign Sources to the United States in May 11, 2004, where it was noted “On its face it appears that the distribution chain for prescription drugs in the United States is fairly straightforward-manufacturers sell their products to wholesalers, who in turn sell the products to retail pharmacies or stores, who in turn dispense medicines to patients with prescriptions. It is not until the system is studied in greater detail that one begins to appreciate both the complexities and the vulnerability of the distribution chain and the potential for exploitation and abuse.” The pharmaceutical wholesale industry needs to develop methodologies to protect the U.S. drug supply. Accreditation is one of the methodologies that will support a safe drug supply.
|
|
|
|
How will a purchaser know that a pharmaceutical wholesaler is IMPAC accredited? |
| |
IMPAC accredited pharmaceutical wholesalers receive an IMPAC seal when they are accredited. The pharmaceutical wholesaler can display the IMPAC seal on their website and on any marketing materials.
Purchasers can also go to the IMPAC website, www.impacsurvey.org, and click on Consumer Information to get a complete list of IMPAC accredited pharmaceutical wholesalers. Purchasers can also call 1-800-677-7019 during normal business hours for a complete list of accredited mailorder pharmacies.
|
|
|
|
Who is eligible for an IMPAC Accreditation Survey? |
| |
Any pharmaceutical wholesaler in the United States, is eligible to apply for IMPAC Accreditation. A pharmaceutical wholesaler is defined as follows: Anyone or any organization that buys or offers to buy pharmaceuticals for resale and distribution to corporations, individuals or entities other than the consumer.
|
|
|
|
What is the cost for an IMPAC Accreditation Survey? |
| |
The cost for an IMPAC Accreditation Survey depends on the number of distribution sites that the pharmaceutical wholesaler has. For wholesalers with one to three distribution sites, the cost is $30,000. For wholesalers with four to six distribution sites, the cost is $40,000. For wholesalers with seven to ten distribution sites, the cost is $50,000. There is an $1000 application fee submitted with the application. Half of the survey fee is due thirty days prior to the survey. The remaining half of the survey fee plus reimbursement of the surveyors’ travel expenses is due prior to the final accreditation report.
|
|
|
|
What is the IMPAC Accreditation Survey process? |
| |
The IMPAC Accreditation Survey is conducted by a pharmacist surveyor and an administrative surveyor at the corporate headquarters and all distribution sites. The number of days for the on-site survey is dependent on the number of distribution sites and locations. The survey includes a review of documents and records; interviews with the staff and leadership; inspection of the facilities; observation of work processes; and review of human resource files. At the end of the survey, there is a verbal preliminary report. Within two weeks of the survey, the pharmaceutical wholesaler will receive a Written Summary of Findings and any recommendations.
|
|
|
|
What is the scope of the IMPAC Accreditation Survey? |
| |
The IMPAC Accreditation Survey is based on the IMPAC Pharmaceutical Wholesaler Standards and includes the full scope of the pharmaceutical wholesale industry as follows:
Quality Assurance: There are mechanisms in place to assure the quality of pharmaceutical distribution.
Product Management: The facility is organized and functions to assure drug integrity.
Product Security: The facility and processes are organized and functions to assure drug safety.
Information Management: Information systems are secure.
|
|
|
|
How is IMPAC Accreditation earned? |
| |
The pharmaceutical wholesaler must be in 100% compliance with the IMPAC Pharmaceutical Wholesaler Standards and the compliance must be fully verified during the survey. When the wholesaler is in full compliance, it earns the IMPAC Accreditation.
If the wholesaler is found in 75% compliance with the IMPAC Pharmaceutical Wholesaler Standards during the survey and there are no consumer safety issues, the wholesaler will be given recommendations for the standards not met. The wholesaler has 90 days to submit evidence that meets the standards. If they are in full compliance within the 90 days, the pharmaceutical wholesaler will earn IMPAC accreditation.
If the wholesaler is found with less than 75% compliance with IMPAC Pharmaceutical Wholesaler Standards or if there are consumer safety issues, the wholesaler will not earn IMPAC accreditation. The pharmaceutical wholesaler can re-apply for an IMPAC Accreditation Survey after a six month waiting period.
|
|
|
|
How long is the IMPAC Accreditation term for pharmaceutical wholesalers? |
| |
The IMPAC Accreditation term is two years.
|
Close Window