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The Puerto Rico State Agency that oversees the collection and reporting of State income taxes deducted from payroll checks is:

Department of the Treasury Bureau of

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

Income Tax Intendente Alejandro Ramirez Bldg. Paseo Covadonga, Stop 1 P.O. Box S-4515 San Juan, PR 00905 (787) 721-2020 http://www.hacienda.gobierno.pr/

Puerto Rico h

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

Examples of combination products may in

as no State Income Tax. Therefore, there are no State W2's to file, no supplement wage withholding rates and no State W2's to file.

The Puerto Rico State Unemployment In

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

surance Agency is:

Department of Labor and Human Resources Bureau of Employment Security Prudencio Rivera Martinez Bldg. 505 Munoz Rivera Ave. Hato Rey, PR 00918 (

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

787) 754-5262

The State of Puerto Rico taxable wage base for unemployment purposes is wages up to $7,000.00.

Puerto Rico has no provision of quarterly wages on magnetic me

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

Combination pro

dia.

Unemployment records must be retained in Puerto Rico for a minimum period of five years. This information generally includes: name; social security number; dates of h

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

ire, rehire and termination; wages by period; payroll pay periods and pay dates; date and circumstances of termination.

The Puerto Rico State Agency charged with enforci

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

ng the state wage and hour laws is:

Department of Labor and Human Resources 505 Munoz Rivera Ave. Hato Rey, PR 00918 (787) 754-2119 http://www.dtrh.gobierno.pr/

Th

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

ere is no provision for minimum wage in Puerto Rico.

The general provision in Puerto Rico concerning paying overtime in a non-FLSA covered employer is one and one half time

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

s regular rate after 40-hour week except under contract, custom, nature of work.

There is no provision of new hire requirements in the Puerto Rico law.

There is no provisi

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

on of rules for direct deposit for Puerto Rico.

Puerto Rico has no Wage and Hour Law provisions concerning pay stub information except that employees paid by direct deposit

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

Following aspects would a

must get a voucher showing all deductions.

Puerto Rico requires that employee be paid every 15 days.

In Puerto Rico there are no statutory requirements concerning the lag

dd to the challenges in developing combination products:

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

time between when the services are performed and when the employee must be paid.

Puerto Rico payroll law requires that involuntarily terminated employees must be paid thei

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

r final pay by next regular payday.

Puerto Rico has no general provision on when voluntarily terminated employees must be paid their final wages.

There is no provision in

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

Puerto Rico law concerning paying deceased employees.

There is no provision of when unclaimed wages should be paid in Puerto Rico.

There is no provision in Puerto Rico law

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

concerning record retention of abandoned wage records.

There is no provision in Puerto Rico law concerning tip credits against State minimum wage.

In Puerto Rico the payr

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

Professional from academic institutions, pharmaceutical industries, health care indust

oll laws covering mandatory rest or meal breaks are only that all employees must have 1-hour meal period after 3rd and before 6th hour of shift unless agreed otherwise.

The

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

re is no provision in Puerto Rico law concerning record retention of wage and hour records therefore it is probably wise to follow FLSA guidelines.

The Puerto Rico agenc

.

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

y charged with enforcing Child Support Orders and laws is:

Child Support Enforcement Program Department of Social Services P.O. Box 3349 San Juan, PR 00902-3349 (78

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

Companies that provide selfless information through particip

7) 767-1500

Puerto Rico has no provisions for child support deductions.

Please note that this article is not updated for changes that can and will happen from time to time

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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