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Compliance

VAWD Accredited

The Harvard Drug Group distribution facilities in Memphis, TN and Indianapolis, IN have been awarded VAWD accreditation for employing security and best practices for safely distributing prescription drugs.

vawd

Commitment to Ethics and Compliance

The Harvard Drug Group is committed to the highest standards of ethical conduct and corporate compliance. As a subsidiary of Cardinal Health™, we follow a comprehensive program that is designed to ensure we comply with all applicable legal requirements and conduct business responsibly and with integrity.

 

Q) What is required to order controlled substances from Harvard?

Title 21, CFR part 1300 to 1316 and Sections 823 (b) and (d) of the Controlled Substance Act call for the maintenance of effective controls against diversion of controlled substances. To adequately satisfy 21 CFR, Harvard has developed a “Know Your Customer” program. The program requires a complete due diligence package from every customer that intends to purchase controlled drugs and List 1 chemicals from Harvard. This package includes: 1) copies of the customer’s state board license and DEA registration; 2) a properly completed questionnaire; and 3) a properly completed affidavit. Some customers are also required to complete a successful onsite inspection prior to being quali­fied for controlled drug purchases.

Q) I sent in a copy of my online State Board License Verification and was told that Harvard needed a copy of my original license. Why can’t Harvard accept online state licenses?

The Harvard Regulatory group is required to follow specific Standard Operating Procedures (SOP). These procedures comply with Healthcare Distribution Management Association (HDMA) guidelines derived and interpreted from the Drug Enforcement Agency (DEA) requirements. The current SOP — detailing minimum requirements for doing business with Harvard — requires an actual copy of your state board license. Please send us a photocopy of the state board license that is on display at your facility.

Q) I filled out a customer questionnaire and received a follow-up call informing me that I needed to disclose all wholesalers I currently work with. Why does Harvard need this information?

Knowing a customer’s current wholesaler(s) and the percentage of purchases being made with each wholesaler allows Harvard to better understand your ordering quantities and patterns. This is a part of our “Know Your Customer” program.

Q) I just recently opened an account with Harvard to purchase controlled substances. Why do I need to update my due diligence paperwork after 6 months?

Harvard requires this information from new facilities that have been open for less than 6 months. Obtaining this information helps us to determine whether or not any major changes have taken place in that 6 month period. For example, a change of ownership, a new PIC or physician joining your facility, or a change in the quantity or type of controlled drug that you wish to purchase in this time period may require additional due diligence documents.

Q) I just received a call from your Customer Care department informing me that Harvard is sending a representative to conduct an onsite inspection of my pharmacy. Why is this necessary?

Our “Know Your Customer” program complies with the Healthcare Distribution Management Associ­ation (HDMA) guidelines. The guidelines recommend that we verify the information we have on file. An onsite inspection of the facility enables us to confirm the information we have received via other due diligence documents.

Q) I have an account with Harvard and am approved to order controlled substances but have not purchased any for a few months. I tried to place an order for a controlled substance and was told that my account was inactive. I purchase other products from Harvard on a regular basis. How can my account be inactive?

Accounts that have not ordered controlled substances for 90 days are considered “inactive.” Harvard requires refreshed paperwork to identify if any major changes have taken place during the inactive period. It is very easy to complete a reactivation form; once completed and reviewed, the account is normally able to order controlled substances.

Q) I completed all of my due diligence paperwork 2 years ago. Why is Harvard asking me to do it again?

All customer due diligence must be kept up to date. It is generally acceptable to allow up to a 2 year period prior to expiry. Updated due diligence is a way to ensure Harvard is staying current with the pertinent data related to your business.

Q) I received a call from Harvard requesting additional information regarding my controlled substance order. Why is Harvard asking me questions about my controlled substance purchases?

In accordance with CFR 1301.74 (b), when controlled substance orders deviate substantially from normal size, frequency, or pattern — and often for first time orders — Harvard requires additional information to update our files and better understand ordering changes. This will help us continue to keep your controlled substance orders on schedule.