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Mail Order Pharmacy

Mail Service Pharmacy Compliance with Good Manufacturing Practices (GMPs)

Industry	Mail Order Pharmacy
Problem	A mail service pharmacy needed to prove compliance with Good Manufacturing Practice (GMP) regulations for finished pharmaceutical products to successfully obtain a Patient Assistance Program (PAP) contract from a pharmaceutical manufacturer. The pharmacy also needed to update their policies and procedures to comply with the manufacturer’s specifications for drug storage, safety, and distribution.
PHSL Solution	PHSI performed a GAP analysis and evaluated the pharmacy’s current policies and procedures with GMP and the manufacturer requirements. PHSI identified all issues that needed to be addressed and assisted with updating the policies and procedures. During an onsite visit, PHSI toured the facility and noted any areas that could prove problematic in passing a GMP audit. PHSI then designed and administered a mock-audit for the pharmacy staff in advance of the actual audit. Issues identified were in advance of the manufacturer’s audit. Finally, PHSI conducted GMP training sessions for all pharmacy staff.
Results	With PHSI’s help, the mail service pharmacy responded to all issues in the audit report, which were minor in nature. The mail service pharmacy confidently and successfully passed the audit and obtained the Patient Assistance Program (PAP) contract from the pharmaceutical manufacturer.

May 2023 Question of the Month

Which type of project(s) could you or your organization most benefit from in 2023?

Future forecast: 0%

Competitor comparison: 20%

Contract variance analysis: 20%

Historical trend analysis: 20%

Legislative/regulatory impact: 0%

Procurement cost/savings: 20%

Stakeholder program impact: 20%

April 2023 Question of the Month

In July 2022, the FDA proposed expanding the NDC to a uniform 12 numeric digit format to accommodate future needs when all options using the current formats have been exhausted. Alternative options shared by the industry have asked the FDA to consider retaining the current NDC formats and allow the use of alpha characters when all numeric options have been exhausted.

Which of the following transition types is your organization prepared for in the next 5 years?

Make the transition to alphanumeric using the current NDC formats: 70%

Make the transition to the 12-digit numeric format: 20%

Make the transition to neither option: 10%

Make the transition to either option: 0%

March 2023 Question of the Month

What information would you most like to gain from an Online Listening Assessment for a particular drug therapy or device? (Multiple selections allowed)

Prescribing & Dispensing Concerns: 25%

Competitor Comparisons: 25%

Prescribing Information Alignment: 17%

Coverage & Reimbursement: 17%

Patient Affordability: 8%

Misinformation: 8%

Disease State Concerns: 0%