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Main Subject - Loan Officers & Minimum Wage
I. INTRODUCTION
The FLSA requires that most employees in the United States be paid at least the federal minimum wage for all hour worked and overtime pay at time and one-half the regular rate of pay for
The FLSA requires that most employees in the United States be paid at least the federal minimum wage for all hour worked and overtime pay at time and one-half the regular rate of pay for
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
all hours worked over 40 in a workweek.
However, Section 13(a)(1) of the FLSA provides an exemption from both minimum wage and overtime pay for employees employed as bona fide executive, administrative, p
However, Section 13(a)(1) of the FLSA provides an exemption from both minimum wage and overtime pay for employees employed as bona fide executive, administrative, p
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ofessional and outside sales employees.
Section 13(a)(1) and Section 13(a)(17) also exempts certain computer employees.
To qualify for exemption, employees must meet certain tests regarding their job dut
Section 13(a)(1) and Section 13(a)(17) also exempts certain computer employees.
To qualify for exemption, employees must meet certain tests regarding their job dut
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ies and be paid on a salary basis at not less than $455 per week.
II. FINANCIAL SERVICES EMPLOYEES
To qualify for the administrative employee exemption, all of the following tests must be met:
1. The e
II. FINANCIAL SERVICES EMPLOYEES
To qualify for the administrative employee exemption, all of the following tests must be met:
1. The e
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ployee must be compensated on a salary or fee basis (as defined in the regulations) at a rate not less than $455 per week;
2. The employee’s primary duty must be the performance of office or non-manual wo
2. The employee’s primary duty must be the performance of office or non-manual wo
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
k directly related to the management or general business operations of the employer or the employer’s customers; and
3. The employee’s primary duty includes the exercise of discretion and independent judg
3. The employee’s primary duty includes the exercise of discretion and independent judg
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
ment with respect to matters of significance.
Employees in the financial services industry generally meet the duties requirements for the administrative exemption and are not entitled to overtime pay IF t
Employees in the financial services industry generally meet the duties requirements for the administrative exemption and are not entitled to overtime pay IF t
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
eir duties include work such as collecting and analyzing information regarding the customer’s income, assets, investments or debts; determining which financial products best meet the customer’s needs and f
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
inancial circumstances; advising the customer regarding the advantages and disadvantages of different financial products; AND marketing, servicing or promoting the employer’s financial products.
However,
However,
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
n employee whose primary duty is selling financial products does not qualify for the administrative exemption. In applying the exemption, it does not matter whether the employee’s activities are aimed at
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
n end user or an intermediary. The status of financial services employees is based on the duties they perform, not on the identity of the customer they serve.
III. OUTSIDE SALES
To qualify for the outs
III. OUTSIDE SALES
To qualify for the outs
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ide sales employee exemption, all of the following tests must be met:
1. The employee’s primary duty must be making sales (as defined in the FLSA), or obtaining orders or contracts for services or for th
1. The employee’s primary duty must be making sales (as defined in the FLSA), or obtaining orders or contracts for services or for th
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
use of facilities for which a consideration will be paid by the client or customer; and
2. The employee must be customarily and regularly engaged away from the employer’s place or places of business.
3
2. The employee must be customarily and regularly engaged away from the employer’s place or places of business.
3
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
. The salary requirements of the regulation do not apply to the outside sales exemption. An employee who does not satisfy the requirements of the outside sales exemption may still qualify as an exempt em
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
loyee under one of the other exemptions allowed by Section 13(a)(1) of the FLSA and the Part 541 regulations if all the criteria for the exemption is met.
A. Primary Duty
“Primary duty” means the princi
A. Primary Duty
“Primary duty” means the princi
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
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
al, main, major or most important duty that the employee performs. Determination of an employee’s primary duty must be based on all the facts in a particular case, with the major emphasis on the character
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
of the employee’s job as a whole.
B. Making Sales
“Sales” includes any sale, exchange, contract to sell, consignment for sales, shipment for sale, or other disposition. It includes the transfer of tit
B. Making Sales
“Sales” includes any sale, exchange, contract to sell, consignment for sales, shipment for sale, or other disposition. It includes the transfer of tit
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e to tangible property, and in certain cases, of tangible and valuable evidences of intangible property.
C. Obtaining Orders or Contracts for Services or for the Use of Facilities
Obtaining orders for “
C. Obtaining Orders or Contracts for Services or for the Use of Facilities
Obtaining orders for “
.
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
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
the use of facilities” includes the selling of time on radio or television, the solicitation of advertising for newspapers and other periodicals, and the solicitation of freight for railroads and other tra
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
sportation agencies. The word “services” extends the exemption to employees who sell or take orders for a service, which may be performed for the customer by someone other than the person taking the order
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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