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Pharmaceutical Sales Resume - Excel

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					                                       National Coalition of Pharmaceutical Distributors
                                                Application for Membership 2006
Membership Type                                                                                            Date

                     Directive Membership             Initial Fee $25,000              Annual Dues    $5,000.00
                     Founders Membership              Initial Fee $10,000              Annual Dues    $3,000.00                                 NEW
                     Full Membership                  Initial Fee                       Annual Dues    $5,000.00                                RENEWAL
                     Associate Membership            Initial Fee                        Annual Dues    $2,500.00


Company Details

Company Name:                                                                   Contact Name:
DBA (If any)                                                                    Title:
Address:                                                                        Phone Number:
City                                                                            Fax Number:
State:                                                                          Email Address:
Zip Code:                                                                       Web Site URL


Facility Details

Facility 1                                                                      Facility 2
Street/Floor                                                                    Street/Floor
City                                                                            City
State                                             Zip Code                      State                                                   Zip Code
State License #                                   Expiration                    State License #                                         Expiration
*DEA #                                            Expiration                    *DEA #                                                  Expiration
Facility Manager                                                                Facility Manager
Telephone Number                                                                Telephone Number
Facility 3                                                                      Facility 4
Street/Floor                                                                    Street/Floor
City                                                                            City
State                                             Zip Code                      State                                                   Zip Code
State License #                                   Expiration                    State License #                                         Expiration
*DEA #                                            Expiration                    *DEA #                                                  Expiration
Facility Manager                                                                Facility Manager
Telephone Number                                                                Telephone Number


If your company has more than four facilities please attach an additional sheet using the format listed above.
* DEA number only if applicable to this facility.




 State Licensing Information for Pharmaceutical Sales and Distribution
Check all jurisdictions for which your company is currently licensed and compliant. Attach a valid license for each location.
       Alabama                  Georgia               Maine                      Nevada                   Oregon                Virginia
       Alaska                   Hawaii                Maryland                   New Hampshire            Pennsylvania          Washington
       Arizona                  Idaho                 Massachusetts              New Jersey               Rhode Island          West Virginia
       Arkansas                 Illinois              Michigan                   New Mexico               South Carolina        Wisconsin
       California               Indiana               Minnesota                  New York                 South Dakota          Wyoming
       Colorado                 Iowa                  Mississippi                North Carolina           Tennessee             Puerto Rico
       Connecticut              Kansas                Missouri                   North Dakota             Texas                 Guam
       Delaware                 Kentucky              Montana                    Ohio                     Utah                  DEA
       Florida                  Louisiana             Nebraska                   Oklahoma                 Vermont               Check All


                                            National Coalition of Pharmaceutical Distributors
       Mailing Address: 601 Pennslvania Avenue, NW, South Building Suite 900 Washington, District of Columbia 20004
                                 United States Telephone 202-220-3115 Fax 202-639-8238

                 Call: 202-220-3115                                                     1      www.ncpdusa.org
                                 National Coalition of Pharmaceutical Distributors
                                          Application for Membership 2006
Company Compliance History

   Yes      1) Has your company been enjoined, disciplined, fined, or punished by a court, administrative tribunal, or regulatory agency for violation
   No       of federal or state law relating to drug or device sale or distribution?

            If yes, provide details, including outcome, on a separate sheet of paper, and sign and date it.

   Yes      2) Has your company held or does your company currently hold a license, registration, or permit that has been suspended, revoked, or
   No       otherwise disciplined by a federal, state, or local regulatory agency relating to violations of state or federal laws regarding drugs or
            devices?

            If yes, provide details, including outcome, on a separate sheet of paper, and sign and date it.

   Yes      3) Has your company been denied a permit or license for violations of federal or state laws regarding drugs or devices?
   No

            If yes, provide details, including outcome, on a separate sheet of paper, and sign and date it.

   Yes      4) Has your company been found guilty of any criminal offense under federal, state, or local laws, regardless of whether adjudication of
   No       guilt was withheld or whether your company pled guilty or nolo contendere?

            If yes, provide details, including outcome, on a separate sheet of paper, and sign and date it.

            5) If a criminal conviction is under appeal, submit a copy of the notice of appeal of the criminal offense and, within 15 days after the
            disposition of the appeal, submit a copy of the final written order of disposition.

Designated Representative
The following section involves information regarding the person or people who are responsible for the standard operating procedures for your facility. Certain
states require the designated representatives of companies engaged in the sale or distribution of drugs to pass a graded examination certifying proficiency in the
care and handling of pharmaceuticals. Please include all state/federal certifications your employees have completed (e.g., designated representative license,
pharmacist license, pharmacy technician license).

Contact Name                                                                   Email Address:
Title:                                                                         Telephone:
Date of Birth                                                                  Fax:
Address                                                                        State License 1
City                                                                           State License 2
State / Zip Code                                                               State License 3


   Yes
            1) Has your company's designated representative, during the last seven years, been enjoined, disciplined, fined, or punished by a court,
   No
            administrative tribunal, or regulatory agency for violation of federal or state law regarding drugs or devices?

            If yes, provide details on a separate sheet of paper, and sign and date it.


   Yes      2) Has your company's designated representative held or does your company's designated representative currently hold a license,
   No       registration, or permit that has been suspended, revoked, or otherwise disciplined by a federal, state or local regulatory agency relating
            to violations of state or federal laws regarding drugs or devices?

            If yes, provide details on a separate sheet of paper, and sign and date it.


   Yes      3) Has your company's designated representative been denied a permit or license for violations of federal or state laws regarding drugs
   No       or devices?

            If yes, provide details on a separate sheet of paper, and sign and date it.


   Yes      4) Has your company's designated representative, as an adult, been found guilty of any criminal offense (not including minor traffic
            violations), regardless of whether adjudication of guilt was withheld or whether your company's designated representative pled guilty or
   No
            nolo contendere?

            If yes, provide details on a separate sheet of paper, and sign and date it.


            5) If your company is not required to have a licensed designated representative, please include a resume detailing your experience in
            pharmaceutical sales and/or distribution.




            Call: 202-220-3115                                                            www.ncpdusa.org
                                                                                      2
                                  National Coalition of Pharmaceutical Distributors
                                           Application for Membership 2006
Ownership Information Corporate Structure

Please check which applies
    Sole Proprietorship               Company Name                                                   Phone
    Partnership                       Address                                                        Fax
    Limited Liability Company         City                                                           Tax ID (FEIN)
    Publicly Held Corporation         State                                                          State of Inc.
    Closely Held Corporation          Zip Code                                                       Year Incorporated




Executive Officers

Please list the names and addresses of all officers, directors, and other persons who are in charge of the operations of your company's facility.


Full Name                                         Telephone                     Title                Address




Major Investors
List the name and address of any person, partnership, or corporation who directly or indirectly owns a greater than 10% equity position or controlling interest in
your company and/or a greater than 10% voting interest in your company.


Full Name                                         Telephone                     Pct % Ownership      Address




Background Checks
The following persons affiliated with your company are required to undergo criminal and financial background checks:



1) Designated representative, or the most senior person responsible for facility operations, purchasing, and inventory control.


2) The supervisor of the designated representive or most senior person referenced above.


3) Principals and owners who directly or indirectly own a greater than 10% interest in company, if company is not publicly held.


4) The aforementioned persons must complete authorization and release forms so that NCPD and/or its contractor may perform the background
checks and evaluate the information and data that is collected.


Please contact NCPD for more information about the fees and forms, info@ncpdusa.com or 202-220-3115.



              Call: 202-220-3115                                                            www.ncpdusa.org

                                                                                        3
                                  National Coalition of Pharmaceutical Distributors
                                           Application for Membership 2006
Documentation / Checklist
The following documents must be included with this application:

            Proof of surety bond in an amount of at least $100,000 (examples of acceptable proof include evidence of insurance, a statement showing that
            funds have been deposited in a trust account or financial institution, or an irrevocable letter of credit).


            Copy of the lease agreement, property deed, or other document evidencing rightful ownership or possession of the property.



            Copies of general and product liability insurance policies.



            An organizational chart.



            Resume detailing operational experience in the sale and/or distribution of pharmaceuticals.



            Copies of state and DEA inspection reports and notices for the last three years.



            Copies of policies and procedures evidencing compliance with the NCPD eligibility criteria*, as set forth herein below. Please label each policy and
            procedure with the category number and criterion number (for example, “Recordkeeping 1a”)


            List of state pharmaceutical distribution, sales and controlled substance licenses, and DEA licenses and registrations.



Privacy Notice
The information in the application and that NCPD and its agents obtain concerning the applicant may be used and disclosed in accordance with NCPD's privacy
policy and to NCPD board members, member boards of pharmacy and/or appropriate regulatory or law enforcement authorities: (a) for the purpose of
evaluating the applicant’s eligibility for membership in the NCPD, (b) when NCPD or any of its employees or agents are requested to disclose the information
through any governmental, administrative, or judicial process, (c) when NCPD or any of its employees or agents believe in good faith that the company, the
corporation, the owners, the corporate staff, designated representative, and/or the company staff are engaging in conduct that violates state or federal law, (d)
concerning any denial of application or continuing status as a member of the NCPD, including, without limitation, any denial of any any NCPD accredidation and
(e) as otherwise allowed by applicable law.




Testament

I swear that to the best of my knowledge the information contained in this application is true and accurate and that I have the authority to act and to bind the
organization as an agent or representative for purposes of participation as a member of the NCPD. I further affirm that the company, the corporation, the
owners, the corporate staff, and the company staff currently are operating and will operate in compliance with all state and federal laws. For the organization, I
authorize release of any and all information from applicable regulatory agencies to NCPD and its contractors for the purpose of verifying licensure status and
investigating any disciplinary actions of record involving any person or entity associated with the organization in the practice of the sale and/or distribution of
pharmaceuticals.




x__________________________________                x______________               x__________________________________________________
Print Name                                         Title                         Signature

*Only eligible applicants will be considered for NCPD membership. Eligibility does not guarantee NCPD membership. Membership is granted or
denied in NCPD's sole and absolute discretion.


                 Call: 202-220-3115                                                      www.ncpdusa.org


                                                                                     4
                                  National Coalition of Pharmaceutical Distributors
                                           Application for Membership 2006
NCPD Eligibility Criteria*

Licensure

Eligible company shall provide information to verify that:

The company that provides services within a state, whether the company is located within the state or outside of the state, is licensed or registered in good
standing, or eligible to become licensed or registered, to engage in the sale or distribution of drugs in all applicable jurisdictions.



The company complies with all applicable statutes and regulations governing the sale or distribution of drugs where licensed or registered, and complies with
the more stringent law or regulation as determined by conflicts of law rules.



If the company is involved in the distribution of controlled substances, including any product that has been identified as a precursor to the manufacture or
compounding of methamphetamines, it is duly registered with United States Drug Enforcement Administration (DEA) and the appropriate state controlled
substance agency and in compliance with all applicable laws and rules for the storage, handling, reporting, transport, shipment, and distribution of controlled
substances and such precursor products.


The company maintains sufficient liability insurance coverage and secured monetary funds to ensure payment in the event damages, fines, costs, and the like
are assessed against company.



The company has a person to serve as the designated representative for the company facility who is actively involved in and aware of the actual daily operation
of the company that engages in the distribution of drugs and devices and, if required, shall be licensed or registered with the Board of Pharmacy or appropriate
state regulatory agency.


Facility

Eligible company shall provide information to verify that:

The facility at which drugs and devices are received, stored, warehoused, handled, held, offered, marketed, displayed, or transported from shall:


a. Be of suitable construction to ensure that all drugs and devices in the facility are maintained in accordance with labeling of such drugs and devices, or in
compliance with official compendium standards such as the United States Pharmacopeia – National Formulary (USP-NF);


b. Be of suitable size and construction to facilitate cleaning, maintenance, and proper sales and/or distribution operations;


c. Have adequate storage areas to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions:



            i. All drugs and devices shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the
            labeling of such drugs and devices, or in accordance with requirements in the current edition of an official compendium such as the USP-NF;


            ii. If no storage requirements are established for a drug, the drug may be held at “controlled” room temperature, as defined in an official
            compendium such as USP-NF, to help ensure that its identity, strength, quality, and purity are not adversely affected; and


            iii. Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment and/or logs shall be utilized to document
            proper storage of drugs and devices;


d. Have a quarantine area for storage of drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated, counterfeit, or suspected of
being counterfeit, otherwise unfit for distribution, or that are in immediate or sealed secondary containers that have been opened;


*Only eligible applicants will be considered for NCPD membership. Eligibility does not guarantee NCPD membership. Membership is granted or
denied in NCPD's sole and absolute discretion.

                 Call: 202-220-3115                                                       www.ncpdusa.org

                                                                                     5
                                     National Coalition of Pharmaceutical Distributors
                                              Application for Membership 2006
NCPD Eligibility Criteria*

Facility                  Continued

e. Be maintained in a clean and orderly condition;


f. Be free from infestation of any kind; and


g. Not be a personal residence.


Appropriate inventory controls are maintained in order to detect and document any theft, counterfeiting, or diversion of drugs or devices.


Controlled substance drugs are isolated from non-controlled substance drugs and stored in a secure area in accordance with DEA security requirements and
standards.


Adequate security for the facility has been provided for:


a. All facilities used for distribution shall be secure from unauthorized entry;


b. Access from outside the premises shall be kept to a minimum and be well controlled;


c. The outside perimeter of the premises shall be well lighted;


d. Entry into areas where drugs or devices are held shall be limited to authorized personnel;


e. All facilities shall be equipped with an alarm system to detect entry after hours; and


f. All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system
shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.


Personnel

Eligible company shall provide information to verify that:

The company’s designated representative has not been enjoined, disciplined, fined, punished, or the like for violating any federal or state laws regulating
prescription drugs or devices.


The company’s designated representative has not been found guilty, pled guilty, or pled nolo contendere to any criminal offense.


The company’s designated representative has a sound financial history.


The company's designated representative:


a. Has a minimum of two years of verifiable full-time managerial or supervisory experience in a pharmacy or distributor where the designated representative’s
responsibilities included, but were not limited to, record keeping, storage, and shipment of drugs or devices;


b. Serves as the designated representative for only one company at any one time;


c. Is actively involved in and aware of the actual daily operations of the company;


d. Is employed full-time in a managerial position by the company;


e. Is physically present at the company during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled
vacation, or other authorized absence; and


*Only eligible applicants will be considered for NCPD membership. Eligibility does not guarantee NCPD membership. Membership is granted or
denied in NCPD's sole and absolute discretion.


            Call: 202-220-3115                                                              www.ncpdusa.org
                                                                                      6
                                 National Coalition of Pharmaceutical Distributors
                                          Application for Registration 2006
NCPD Eligibility Criteria*

Personnel                 Continued

f. Is aware of, and knowledgeable about, all policies and procedures pertaining to the operations of the company.


Additional key personnel (shipping manager, inventory control, compliance, COO, etc.) engaged in the operation and handling of drugs or devices who are
employed by the company have met the following qualifications:


a. Appropriate criminal and financial background checks; and


b. Appropriate education and experience necessary to safely and lawfully engage in the sale or distribution of drugs.


The company maintains and enforces policies and procedures requiring documentation of responsible persons and persons in charge, including such persons’
titles, duties, and qualifications.


The company maintains and enforces policies and procedures that ensure suitable background checks are conducted and documented on the owner(s) and/or
chief executive officer and key personnel, management, and officers who actively engage in or supervise the operation and handling of drugs or devices, prior
to their association, employment, or contracting and regularly thereafter.


Record Keeping

Eligible company shall provide information to verify that:

The company is establishing and maintaining inventories and records of all transactions regarding the receipt and distribution or other disposition of all drugs
and devices. These records shall include:



a. A statement identifying each prior sale, purchase or trade of a drug as required by federal law ("Statement") for each and every drug sold or distributed; and

b. Appropriate information and data to identify the source of the product and type of product being received or distributed, including, without limitation: (i) date of
purchase; (ii) lot number; (iii) sales invoice number; and (iv) contact information including name, address, telephone number, and e-mail address (if available)
for the company that sold the drug or device.


Inventories and records shall be made available for inspection and photocopying by any authorized official of any state, federal, or local government agency for
a period of three (3) years following their creation date, or as otherwise required by law.


A Statement is provided for the sale or distribution of drugs at the time of the transaction to another company, unless otherwise required by law.


Records described in this section are kept at the inspection site and readily available for inspection during the retention period. Records kept at a central
location must be available for inspection within two working days of a request.


An ongoing list of persons with whom the company conducts business is maintained.


The company is establishing and maintaining a system for the mandatory reporting of significant shortages or losses to the Board of Pharmacy or appropriate
state regulatory agency and Food and Drug Administration (FDA) of drugs and devices where it is known or suspected that diversion is occurring.


Drug and device records, data, and documents are securely stored and access is restricted, and that policies and procedures have been implemented to protect
the integrity of such records, data, and documents.




*Only eligible applicants will be considered for NCPD membership. Eligibility does not guarantee NCPD membership. Membership is granted or
denied in NCPD's sole and absolute discretion.

            Call: 202-220-3115                                                             www.ncpdusa.org

                                                                                       7
                                      National Coalition of Pharmaceutical Distributors
                                               Application for Membership 2006
NCPD Eligibility Criteria*

Authentification and Verification

Eligible company shall provide information to verify and assure:

The integrity, legitimacy, and authenticity of prescription drug and device purchase orders and/or requests.


The identity, legitimacy, and proper operation of entities seeking to sell or purchase prescription drug and device products.


That for cause authentications are conducted when an NCPD member that purchases drugs or devices from another company has reason to believe, based on
the totality of the facts and circumstances, that any drug or device purchased from the other company is counterfeit, suspected of being counterfeit, misbranded,
or adulterated.


That upon receipt, each shipping container shall be visually examined for identity and to determine if it may contain contaminated, contraband, counterfeit,
suspected of being counterfeit, or damaged drugs or devices, or drugs or devices that are otherwise unfit for distribution. This examination shall be adequate to
reveal container damage that would suggest possible contamination, adulteration, misbranding, counterfeiting, suspicion of being counterfeit, or other damage
to the contents.


That the drugs or devices found to be unacceptable under these criteria are quarantined from the rest of stock until it is determined that the drugs and devices
are not outdated, damaged, deteriorated, misbranded, counterfeited, or adulterated and they are further determined to be fit for human use.


That each outgoing shipment shall be carefully inspected for identity of the drugs or devices and to ensure that there is no delivery of drugs or devices that have
been damaged in storage or held under improper conditions.


Returned, Damaged, and Outdated Drugs

Eligible company shall maintain and enforce policies and procedures assuring that:

Any drug or device that is outdated, damaged, deteriorated, misbranded, counterfeited, suspected of being counterfeited, adulterated, or otherwise deemed
unfit for human use shall be quarantined and physically separated from other drugs and devices until it is returned to either the manufacturer or company from
which it was acquired.


When drugs and devices are adulterated, misbranded, counterfeited, or suspected of being counterfeit, notice of the adulteration, misbranding, counterfeiting, or
suspected counterfeiting shall be provided to the Board of Pharmacy or appropriate state regulatory agency, FDA, and the manufacturer or company from which
they were acquired within three (3) business days. Any drug or device returned to a manufacturer or company shall be kept under proper conditions during
storage, handling, transport, and shipment, and documentation showing that proper conditions were maintained shall be provided to the manufacturer or
company to which the drugs are returned.



When any drug or device whose immediate or sealed outer or secondary containers or labeling are adulterated, misbranded, counterfeited, or suspected of
being counterfeit, it shall be quarantined and physically separated from other drugs or devices until it is returned to either the manufacturer or company from
which it was acquired or destroyed. When the immediate or sealed outer or secondary containers or labeling of any drug or device are adulterated, misbranded,
counterfeited, or suspected of being counterfeit, notice of the adulteration, misbranding, counterfeiting, or suspected counterfeiting shall be provided to the
Board of Pharmacy or appropriate state regulatory agency, FDA, and the manufacturer or company from which it was acquired within three (3) business days.


 When any drug or device that has been opened or used, but is not adulterated, misbranded, counterfeited, or suspected of being counterfeit, it shall be
identified as such, and shall be quarantined and physically separated from other drugs or devices until it is returned to the manufacturer or company from which
acquired or it is destroyed.


If the conditions under which a drug or device has been returned cast doubt on the drug’s or device’s safety, identity, strength, quality, or purity, then the drug or
device shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the drug or device meets appropriate
standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug or device has been returned cast doubt on
the drug’s or device’s safety, identity, strength, quality, or purity, the company engaged in the distribution of the drug shall consider, among other things, the
conditions under which the drug or device has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or
labeling as a result of storage or shipping.


*Only eligible applicants will be considered for NCPD membership. Eligibility does not guarantee NCPD membership. Membership is granted or
denied in NCPD's sole and absolute discretion.


            Call: 202-220-3115                                                        8   www.ncpdusa.org
                                    National Coalition of Pharmaceutical Distributors
                                             Application for Membership 2006
NCPD Eligibility Criteria*

Policies and Procedures


Eligible company shall maintain, enforce, and adhere to written policies and procedures, which shall be followed for:

The receipt, security, storage, inventory, transport, and shipping and distribution of drugs, including policies and procedures for identifying, recording, and
reporting losses or thefts, for correcting all errors and inaccuracies in inventories, and for ensuring the oldest approved stock of a prescription drug product is
distributed first.

Qaulifying companies shall include in their written policies and procedures the following:


a. A procedure to be followed for handling recalls and written withdrawals of drugs and devices;


b. Any volunteer action by the manufacturer to remove defective or potentially defective drugs or devices from the market; or


c. Any action undertaken to promote public health and safety by the replacement of existing merchandise with an improved product or new package design.


To prepare for, protect against, and handle any crisis that affects the security or page 14 of 15 operation of any facility in the event of a strike, fire, flood, or
other natural disaster, or other situations of local, state, or national emergency.


To ensure that any outdated drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed in accordance with federal and
state laws including all necessary documentation and the appropriate witnessing. This procedure shall provide for written documentation of the disposition of
outdated drugs. This documentation shall be maintained for three (3) years after disposition of the outdated drugs.



A procedure for disposing of and destroying containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in
counterfeiting activities including all necessary documentation, maintained for a minimum of three (3) years, and the appropriate witnessing of the destruction of
any labels, packaging, immediate containers, or containers in accordance with all applicable federal and state requirements.


A procedure for investigating discrepancies involving counterfeit, suspected of being counterfeit, contraband, or suspected of being contraband product in the
inventory and reporting such discrepancies within three (3) business days to the Board of Pharmacy or appropriate state regulatory agency and appropriate
federal agency.

A procedure for reporting criminal or suspected criminal activities involving the inventory of drug(s) and device(s) to the Board of Pharmacy or appropriate state
regulatory agency and appropriate federal agency within three (3) business days.




*Only eligible applicants will be considered for NCPD membership. Eligibility does not guarantee NCPD membership. Membership is granted or
denied in NCPD's sole and absolute discretion.
                                                                                         9
            Call: 202-220-3115                                                               www.ncpdusa.org

				
DOCUMENT INFO
Description: Pharmaceutical Sales Resume document sample