SHSSR Diabetes Oral and Non-Insulin Injectable Medication Overview Revision 5.17.2013 References OnlineTM, Pediatric Lexi-Drugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc.; Facts & Comparisons. Facts & Comparisons Web site. http://online.factsandcomparisons.com.ezproxy.samford.edu/. Clinical Pharmacology Web site. http://cpip.gsm.com.ezproxy.samford.edu/. Pharmacist’s Letter. Drugs
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Worldwide Facilities, Inc. – 725 Figueroa Street, Suite 1900 – Los Angeles, CA 90017
1. Full name and description of operations for all entities to be named insureds:
_____________________________________________________________________________ _____________________________________________________________________________ 2. Business Location & Mailing Address: Street:________________________________________________________________________ City:______________________ County: ___________ State:_______ Zip:________________ Contact Person: ______________________________ Title:____________________________ Phone No.: __________________________________ Fax No.:_________________________ Website Address: _____________________________ E-mail: __________________________ 3. Length of time in business: _____________________ 4. a) Proposed effective date of insurance ____/____/____ 5. Indicate percentage of Gross Sales in each of the following areas: ____ Manufacturing ____ Wholesale ____ Retail ____ Manufacturers Representative
SPECIFIC PRODUCT INFORMATION:
1. Do you promote any of your dietary supplements for use in children?
2. Do you provide any products for use in prenatal or post-natal care? 4. Do any past, present or planned products contain any of the following: ___ Any Derivatives of Any of the Above Ingredients ___ Any Pharmaceuticals (Prescription or Over-The-Counter) ___ Dehydroepiandrosterone (DHEA) ___ Magnolia (Magnolia Bark) ___ Hoodia (Hoodia Gordonii) Product Categories
% of Total Sales
Vitamin & Multi-Vitamin Products
(Only Contain Vitamin Ingredients, i.e. C, B6, B12, etc)
Herbal & Botanical Products
(Contain Herbal and Botanical Ingredients i.e. Ginkoba,
Chromium, Green Tea, Melatonin, Milk Thistle, etc.)
Weight Gain, Weight Loss, or Sexual Enhancement Products
(Products that Promote W.G./W.L./S.E. without any of the below
Products that Contain Any of the Following Ingredients **
(5-HTP, Bitter Orange, DHEA, Hoodia, Kava, L-Tryptophan,
Lobelia, Magnolia, Synephrine, Yohimbe)
Other Products (Please Describe)
** Please list all product names that contain any of the listed ingredients: ___________________ ______________________________________________________________________ ______________________________________________________________________ PRODUCT IDENTIFICATION:
1. Please attach your catalog of products or copies of your product labels. (All products must be
included. Coverage consideration will only be given to those products presented.) 2. Do you export products or have foreign operations: If Yes, please explain including percentage (%) of goods and gross sales:
_____________________________________________________________________________ 3. Have you discontinued or are you considering discontinuing any product? If Yes, please describe the product (s), when it was discontinued and why it was discontinued:
1. Are written quality control and testing procedures followed? If so, please attach . ___ Y ___ N
2. How long are quality control and testing records kept?
3. Can you identify your product from those of competitors? 4. Do your records indicate when each product was manufactured? 5. Do your records show to whom and the date each product was sold? 6. Do your records show who supplied the ingredients going into your products? 7. Do you have a formal product recall plan? (Please attach a copy) 8. Do you obtain certificates evidencing Products Liability insurance from suppliers? ___ Y ___ N Please explain any “NO” answers: _________________________________________________
PROCESSING AND QUALITY CONTROL:
1. Do others manufacture or package products under your name or label?
a) Who formulates these products? ________________________________________ ____________________________________________________________________ b) Do you obtain certificates of insurance named as an additional insured? ___ Y ___ N c) What percentage (%) are manufactured or packaged by others? 2. Do you manufacture or package products for others under their name or label? ___ Y ___ N a) What percentage (%) of your gross sales does this reflect? _________% 3. Do you provide any professional services? If Yes, please provide details: ____________________________________________
______________________________________________________________________ LOSS PREVENTION, LOSS CONTROL, CLAIM DEFENSE:
1. Do you formulate your own products?,(If not, please provide name and address of formulator.)
___ Y ___ N, Details:_____________________________________________________ 2. Do you maintain records of all changes in formulas? 3. Are all labels, advertisements and warranties reviewed by legal counsel to avoid misunderstandings relative to product safety or intended use? 4. Do you obtain certificates of insurance from all manufacturers making products ___ Y ___ N 5. Are you named as an additional insured/vendor on the manufacturer’s or 6. Are any of your products subject to FDA approval? If Yes: a) What products? _______________________________________________________
b) Attach a copy of most recent FDA inspection. c) Has any inspection required any change to your operations? 7. Do you have a specific program in place to withdraw known or suspected 8. Have you ever recalled or are you considering recalling any known or suspected 9. Do you comply with Good Manufacturing Practices (GMP)? 10. Are imported products and ingredients tested for contamination and to verify 11. How many adverse events have been reported to you and/or have you reported to the FDA concerning your products in the past 3 years? ______ a) Have any adverse events resulted in remedial actions?
Please explain any “Yes” answers:
CLAIM & LOSS HISTORY:
1. Please attach 5-year currently valued hard copy company loss runs. Including injuries sustained
and status of each claim. (Please attach descriptions of any losses over $10,000.) If this business is loss free and less than 1 year old, please attach a letter stating that you are aware of no losses, claims or incidents that may give rise to a claim. 3. Are you aware of any incidents, conditions, circumstances, defects, or suspected defects which may result in claims against you? (If yes, please attach explanation) ___ Y ___ N 4. Has any insurance company ever cancelled, restricted or refused to renew your If Yes, please explain: ___________________________________________________________
IF HIRED & NON-OWNED AUTOMOBILE LIABILITY COVERAGE IS TO BE PROVIDED,
PLEASE COMPLETE THE FOLLOWING:
(This information MUST be provided or no coverage wil be afforded.)
1. Number of employees: ____________
2. Number of employees of applicant who use own autos annually during course of conducting
business on behalf of applicant: ____________ a) Description/type of autos driven by employees: __________________ b) Estimated annual mileage for use of all the non-owned autos: ____________ 3. Does the applicant currently purchase or have an in-force Commercial Auto Policy? ___ Y ___ N 4. Has any claim arising out of the operation of a hired and/or non-owned automobile been made against the applicant within the past five (5) years for which this proposed insurance would apply,
or is the applicant aware of any situation, incident, fact or circumstance that may give rise to a
hired and/or non-owned auto liability claim within the past five (5) years? ___ Y ___ N
If Yes, please explain: ___________________________________________________________
IF EMPLOYEE BENEFITS IS TO BE COVERED, PLEASE COMPLETE THE
FOLLOWING: (This information MUST be provided or no coverage wil be afforded.)
1. __________ Number of Employees
2. ___/___/___ Retroactive Date of Current EBL Coverage if Claims-Made
3. Loss History (please attach if current or prior EBL coverage existed)
PLEASE ATTACH THE FOLLOWING INFORMATION TO THIS APPLICATION:
1. Product Labels or Provide Website Links Where Labels are Available (showing all ingredients)
4. Product Advertising Materials (if available)
5. Quality Control Documents (if available)
6. Any Other Supporting Documentation
ACKNOWLEDGEMENTS, AUTHORIZATION AND SIGNATURE:
By signing this Application, you represent and agree to each of the following four (4) items: 1. You have made a comprehensive internal inquiry or investigation to determine whether anyone in your firm is aware of any actual or alleged fact, circumstance, situation, act, error or omission which may reasonably be expected to result in a claim, and have fully and completely divulged any and all such situations in this Application. 2. Each of the statements and answers given in this Application, are: a) Accurate, true and complete to the best of your knowledge; b) No material facts have been suppressed or misstated; c) Representations you are making on behalf of all persons and entities proposed to be insured; d) A material inducement to the insurance company to provide insurance, and any policy issued by the insurance company issued in specific reliance upon these representations. 3. This Application, along with any other Application or Supplemental Applications are hereby deemed to be attached to the policy contract, and incorporated into the policy contract, whether or not any of the other Supplemental Applications are physically attached to a particular copy of the policy contract, and regardless of whether any of the other Supplemental Applications are signed or dated. 4. You agree to promptly report to the Company, in writing, any material change in your operations, conditions, or answers provided in this Application, or any other Application or Supplemental Application, that may occur or be discovered after the completion date of said Application(s), but before the inception date of the policy. Upon receipt of any such written notice, the Company has the right, at its sole discretion, to modify or withdraw any proposal for insurance.
Any person who knowingly, and with the intent to defraud any insurance company or other
person, files an application for insurance or statement of claim containing any material false
information or conceals for the purposes of misleading, information concerning any fact
material thereto commits a fraudulent insurance act, which is a crime and subjects the person
to criminal and civil penalties and denial of insurance benefits.
IMPORTANT NOTICE: Failure to report any claim made against you during your current policy term, or
facts, circumstances or events which may give rise to a claim against you to your current insurance
company BEFORE expiration of your current policy term may create a lack of coverage.
Completion of this form does not bind coverage. Applicant’s acceptance of Company’s quotation is
required prior to binding coverage and policy issuance. It is agreed that this form shall be the basis of
the contract should a policy be issued. And it will be attached to the policy.
An authorized representative who is an active owner, officer, or partner of your firm must sign this
Application within thirty (30) days prior to the policy inception date.
Application must be signed and dated by principal, partner, officer or director of the firm.
Applicant’s Signature: ____________________________________ Date: _________________ Title: _________________________________________________ Agent or Broker: _______________________________________________________________
PLEASE NOTE: COMPLETION AND SUBMISSION OF THIS APPLICATION IS FOR THE
PURPOSE OF SECURING A PREMIUM QUOTATION ONLY.
Review by Jacqueline CONARD, Paris, France *Abstract presented at the 64th Meeting of the French Society of Angiology, Paris, France, 27-28 January, 2012 Although the contraceptive pill is taken by millions of women daily, cases of venous thrombosis or venous thromboembolism are rare. Yet, such cases are severe and may result in the patient’s death. Therefore, it is important to detect pa