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Credit unions everywhere are faced with the challenges of passing their Bank Secrecy Act examination. This exam also incorporates OFAC

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

and the USA Patriot Act (Customer Identification Program – CIP). This article will assist your credit union in addressing those challen

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

es by laying out the important components associated with this task.

Policies and procedures:

Policies need to address the credit uni

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

n’s commitment to insuring overall compliance by Management, the Board of Directors, Supervisory Committee, and the credit union’s enti

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e staff.

BSA also includes the Currency Transaction Report (CTR), the Suspicious Activity Report (SAR), the Report of Foreign Bank and

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

Financial Accounts (FBAR) and the Report of International Transportation of Currency or Monetary Instruments (CMIR).

The CIP must addr

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ss: receipt of certain identifying data on anyone who opens an account; verification of the identity of any customer who opens an accou

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nt; maintenance of records; determination of whether the person appears on any government list; and, notice to the person that the cred

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

t union will be requesting information to verify identity.

The USA Patriot Act further requires the credit union to check their databa

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

e against the Section 314(a) requests.

Credit union's BSA policy also needs to include: a system of internal controls, the designation

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

of a BSA officer who coordinates/monitors BSA compliance (for OFAC, there must be a designated person in each physical location), indep

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ndent testing (annual audit) and training of appropriate personnel (this would be everyone).

The credit union’s policy must also inclu

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e the credit union’s commitment to a set of procedures that are familiar to each and every staff member.

Training:

Training for BSA p

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ocedures must be a monthly activity at any credit union. One or more procedures can be incorporated into a staff meeting or other regul

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ar training session, but at the very least on a quarterly basis.

In addition to staff training, it is imperative that any board or sup

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

rvisory committee complete updated training on an annual basis to reinforce their knowledge of the process, as well as become familiar

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ith any new procedures during the year. It is not acceptable for any volunteer or staff member to not have a working knowledge of the c

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

edit union’s BSA program!

Auditing:

Every financial institution is required to receive an annual audit of their BSA/OFAC/USA Patriot

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ct program.

Each credit union needs to maintain logs showing that they are flagging the appropriate cash transactions, and these logs

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ust be signed by the auditing person (in some cases, the BSA Officer will sign off if someone else is maintaining logs for wires, etc.)

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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