Useful Advices - Business

Is it OK to use a box that was already used in the shipping process? The answer is: sometimes!

Man

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

y times, when we receive something that we want to send back, we think nothing of using the origina

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

Examples of combination products may in

box for the return shipment. This is usually acceptable, but there are things you want to look out

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

for when reusing a corrugated box.

First, make sure it is a shipping box. A box that is rated for

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

hipping contains a round seal called the certification. The seal indicates the testing that the box

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

Combination pro

went through to become certified for shipping.

Second, make sure that the box has no holes in it.

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

Cover any holes with carton sealing tape. Never use masking tape, duct tape, or cellophane (e.g., S

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

otch) tape for shipping. These tapes do not hold during the shipping process.

Third, make sure the

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

e are no "hazardous" markings. These are usually triangular symbols that indicate the presence of h

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

azardous contents that must be specially handled. In the case of Avon products, most of the boxes t

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

at are shipped to distributors contain the ORM-D label on the top flap of the box. According to DOT

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

Following aspects would a

regulations, the ORM-D label MUST be removed before shipping back your Avon returns, or the common

dd to the challenges in developing combination products:

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

arrier will not be able to accept the package. The only carriers permitted to handle hazardous mate

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

rials containers are those trained in handling them, such as the UPS or FedEx customer counters (i.

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

., the local "hub" facilities). If you take an ORM-D labeled box to a The UPS Store location, you w

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

ll have to cut out the ORM-D label yourself and assure the store personnel that there is nothing ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

ardous being shipped in the container.

Lastly, cover up any old labels that are on the box. Barcod

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

es are used by common carriers' sorting systems, so extraneous barcodes must be covered up. Note th

.

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

t they should NOT be removed. Tearing off old labels ruins the integrity of the corrugate. NEVER pe

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

Companies that provide selfless information through particip

l off old labels; simply cover them with new blank labels or use a marker to black out old barcodes

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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