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The following are typical scenarios encountered by common carriers by customers who wish to ship a package. They are affectionately k

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

nown as the "Cardinal Sins of Shipping." Find out what you should and should not do when preparing your packages for shipping.

Q) Sh

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

Examples of combination products may in

uld I wrap my package in brown paper before bringing it to the store to ship?

A) NO, NO, NO! Brown paper is cardinal sin #1 in shipp

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

ng. The ONLY thing on the outside of a box should be the label that is printed with the "ship from" and "ship to" information on it.

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

f you wrap a package in brown paper, and the package goes along the conveyor belt during the sorting process in several sorting facil

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

Combination pro

ties, it has the potential to be bumping against packages that are much heavier next to it. All of this bumping tends to tear the bro

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

n paper. By the time your package arrives at the end of the assembly line, it has no paper on it and therefore no label. Now there is

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

a box at the end of the line and the carrier has no idea to where it should be shipped.

Q) Should I place string around the box to k

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

ep it sealed tightly?

A) NO, NO, NO! Tying packages with string is cardinal sin #2 in shipping. There should be a corrugated box on

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

he outside of the items being shipped and nothing else but the shipping label. Cross out the bar codes on any other labels on the out

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

ide of the box (no need to remove them - it hurts the integrity of the corrugate when you pull labels off the box).

Q) Can I use a s

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

Following aspects would a

hirt box or shoe box for shipping?

A) NO, NO, NO! Shirt boxes and shoes boxes, although they fit the shirt or shoes that are inside

dd to the challenges in developing combination products:

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

erfectly, are NOT for shipping. The ONLY type of box for shipping is a corrugated box with a certification seal on the bottom of the

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

ox (see one of my other articles about the corrugate seal).

Q) Can I send wrapped presents?

A) YES and NO. If you package the wrapp

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

d presents in a corrugated box, they are fine for shipping. If you bring a wrapped present for shipping and the shipper offers packag

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

ng service to have the item shipped, don't be offended... see answer #1 for an explanation.

Q) Can I ship the product back in the en

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

Professional from academic institutions, pharmaceutical industries, health care indust

elope in which it was shipped to me?

A) YES, if you seal the envelope tightly and there are no tears in the envelope, feel free to r

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

use it.

Q) Do carriers provide FREE supplies for shipping items?

A) YES, but generally only if you are sending the items via AIR se

.

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

vice (Next Day Air or Second Day Air). Free supplies include letter size envelopes, legal size envelopes, bubble mailers, and small,

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

Companies that provide selfless information through particip

edium, or large boxes.

Follow these guidelines and your package is likely going to arrive in good condition at its final destination

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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