Regulatory Open Forum

I have a client who is applying for a MA State Wholesale Drug Distributor license.  They have a main office in Massachusetts, but they have no warehouse or other operations in the state. All receiving, warehousing, shipping and distribution operations will be contracted out and are based in another state. The office in MA manages the commercial business, as well as quality, clinical and regulatory activities.  They expect to have an inspection by the MA State Board of Registration in Pharmacy.  Does anyone have any experience with this type of situation and what to expect for an office based inspection? Thanks for any advice on this.

------------------------------
Mary Keville, Independent Consultant
Plymouth MA
United States
------------------------------

I can't speak for MA, but I did have a similar inspection in MN at one point. They focused on procedures and records - do your records line up with the locations you warehouse/distribute, how do you ensure controls are in place, etc etc. They looked for evidence that you had processes, followed them, though the bigger focus was on records showing you met the various aspects of the regulations - which can vary depending on what you do and what substances you handle, so it pays to have an analysis of the specific regulations and what does/doesn't apply handy.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 25-Aug-2020 18:04
From: Mary Keville
Subject: Massachusetts - Wholesale Drug Distributor state license inspection

I have a client who is applying for a MA State Wholesale Drug Distributor license.  They have a main office in Massachusetts, but they have no warehouse or other operations in the state. All receiving, warehousing, shipping and distribution operations will be contracted out and are based in another state. The office in MA manages the commercial business, as well as quality, clinical and regulatory activities.  They expect to have an inspection by the MA State Board of Registration in Pharmacy.  Does anyone have any experience with this type of situation and what to expect for an office based inspection? Thanks for any advice on this.

------------------------------
Mary Keville, Independent Consultant
Plymouth MA
United States
------------------------------

Thank you Ginger.

------------------------------
Mary Keville
Plymouth MA
United States
------------------------------

Original Message:
Sent: 26-Aug-2020 09:27
From: Ginger Glaser
Subject: Massachusetts - Wholesale Drug Distributor state license inspection

I can't speak for MA, but I did have a similar inspection in MN at one point. They focused on procedures and records - do your records line up with the locations you warehouse/distribute, how do you ensure controls are in place, etc etc. They looked for evidence that you had processes, followed them, though the bigger focus was on records showing you met the various aspects of the regulations - which can vary depending on what you do and what substances you handle, so it pays to have an analysis of the specific regulations and what does/doesn't apply handy.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 25-Aug-2020 18:04
From: Mary Keville
Subject: Massachusetts - Wholesale Drug Distributor state license inspection

I have a client who is applying for a MA State Wholesale Drug Distributor license.  They have a main office in Massachusetts, but they have no warehouse or other operations in the state. All receiving, warehousing, shipping and distribution operations will be contracted out and are based in another state. The office in MA manages the commercial business, as well as quality, clinical and regulatory activities.  They expect to have an inspection by the MA State Board of Registration in Pharmacy.  Does anyone have any experience with this type of situation and what to expect for an office based inspection? Thanks for any advice on this.

------------------------------
Mary Keville, Independent Consultant
Plymouth MA
United States
------------------------------