In the landscape of pharmaceutical and medical device regulation, AB128 emerges as a pivotal document to ensure that manufacturers and wholesalers adhere to a stringent code of conduct, especially in the state of Nevada. Established under Nevada Chapter 409 and effective as of October 1, 2007, this certification underscores the annual audit's completion and the continual monitoring of compliance with the established code of conduct for entities dealing in drugs, medicines, chemicals, devices, or appliances. The thorough nature of this form serves as a testament to Nevada's commitment to uphold ethical marketing practices within the pharmaceutical and medical device industries. It mandates a comprehensive submission process by June 1st each year, detailing adherence to marketing standards and practices that prioritize patient benefit and the integrity of healthcare professional judgments. This requirement extends to the adoption of either PhRMA or AdvaMed Codes of Conduct, with allowances for companies to implement these codes with or without modifications, provided that any changes are clearly documented and submitted annually. Moreover, AB128 emphasizes the importance of training programs for sales and marketing personnel, investigation policies for non-compliance instances, and the role of a designated compliance officer, establishing a proactive approach towards maintaining high ethical standards in marketing and sales practices within the healthcare sector.
| Question | Answer |
|---|---|
| Form Name | Ab128 Form |
| Form Length | 11 pages |
| Fillable? | No |
| Fillable fields | 0 |
| Avg. time to fill out | 2 min 45 sec |
| Other names | nevada certification monitoring, ab128, nevada ab128, nv certification annual |
AB128 CERTIFICATION OF COMPLETION OF ANNUAL AUDIT MONITORING COMPLIANCE
WITH CODE OF CONDUCT FOR MANUFACTURERS AND WHOLESALERS OF DRUGS,
MEDICINES, CHEMICALS, DEVICES, OR APPLIANCES
This form is to be used for a company’s initial filing and the annual certification of audit.
AB 128, Statutes of Nevada Chapter 409 (effective October 1, 2007) requires that all wholesalers or manufacturers who employ a person to sell or market a drug, medicine, chemical, device, or appliance in Nevada must comply with certain requirements regarding their marketing practices. On January 30, 2008, regulations promulgated by the Nevada State Board of Pharmacy to implement AB 128 became effective.
∙To be deemed compliant, the form must be received by the Board’s office by 5:00 p.m. P.S.T. on June 1st of every year. Mail postmarked by June 1st each year will be deemed to be compliant even if it is received later than June 1st. Forms dated prior to May 1 will be deemed
∙The annual certification period is from 5/1 through 4/30 each year.
∙You should indicate on each document attached to the form the number of the item for which the document is being submitted.
∙Please clearly indicate on any document submitted with the form any claim that the document is confidential or proprietary business information subject to the disclosure protections of Section 1, subsection 4(d) of AB 128.
Because the definition of “drug” and “medicine” under Nevada law (NRS 639.007) includes both prescription drugs and OTC medicines, manufacturers and wholesalers of both prescription drugs and OTC medicines are required to comply with AB 128. You do not need to complete a Compliance Form or otherwise comply with AB 128 if any of the following apply to your company:
∙Your company does not sell or market a drug, medicine, chemical, device or appliance in Nevada.
∙The only product or products you market or sell in Nevada are food, aspirin, or effervescent saline analgesics. See NRS 639.007(3).
The Board of Pharmacy will also be providing a compilation of the information received to the Governor’s Office and the Director of the Legislative Counsel Bureau.
Please only submit the required compliance pages and not the pages of the text of assembly bill 128 or regulations as adopted by the Board of Pharmacy.
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AB128 CERTIFICATION OF COMPLETION OF ANNUAL AUDIT MONITORING COMPLIANCE
WITH CODE OF CONDUCT FOR MANUFACTURERS AND WHOLESALERS OF DRUGS,
MEDICINES, CHEMICALS, DEVICES, OR APPLIANCES
Name of Company: |
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Manufacturer |
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Please indicate your business type (check all that
Manufacturer or Wholesaler of Drug, Medicine, or Chemical Manufacturer or Wholesaler of Device or Appliance
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Does your company use one of the two model codes of conduct [Code of Interactions with Healthcare Professionals by PhRMA (for manufacturers or wholesalers of drugs, medicines, or chemicals) or Code of Ethics on Interactions with Health Care Professionals by AdvaMed (for manufacturers or wholesalers of devices or appliances)] without modification? The Board accepts the current or the prior model Code of Conduct for PhRMA or ADvaMed.
Yes £ Adopted without modification. Fill out the form on the page noted above based on your business type and submit with this page. You do not need to submit a copy of your Code of Conduct.
Yes £ Adopted PhRMA or ADvaMed Code with more stringent elements. Fill out the form on the page noted above based on your business type and submit with this page. You do not need to submit a copy of your Code of Conduct.
No £ Attach a copy of your Code of Conduct. Your initial submission of your Code of Conduct must address the subjects noted on page 3 or 4 depending on your business type. On subsequent annual submissions fill out the form on the page noted above based on your business type and submit with this page. If changes were made, describe the changes in a separate document.
Your company needs to provide a complete overview of investigation of instances of noncompliance and training program. These two submissions must be submitted annually even if no changes were made. If changes were made, describe the changes.
Section 1, subsection 1 (d) AB128 Adopt policies and procedures for investigating instances of noncompliance with the marketing code of conduct, including, without limitation, the maintenance of effective lines of communication for employees to report noncompliance, the investigation of reports of noncompliance, the taking of corrective action in response to noncompliance and the reporting of instances of noncompliance to law enforcement authorities in appropriate circumstances.
Adopt a training program to provide regular training to appropriate employees, including, without limitation, all sales and marketing staff, on the marketing code of conduct.
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AB128 CERTIFICATION OF COMPLETION OF ANNUAL AUDIT MONITORING
COMPLIANCE WITH CODE OF CONDUCT FOR MANUFACTURER OR
WHOLESALER OF DRUG, MEDICINE, OR CHEMICAL
USING A MODIFIED CODE OF CONDUCT
Has your company made any changes in your training to appropriate employees, including all sales and marketing staff, regarding your marketing code of conduct? Yes £ No £ Please attach a description of your current training program as a separate document. [Identify any changes from prior year]
Has your company made any changes to your investigation policies for investigating instances of noncompliance with your marketing code of conduct, including addressing the items contained in Section 1, subsection 1(d) of AB 128? (see page 2) Yes £ No £ Please attach a description your current investigative policies as a separate document.
If your company did not adopt PhRMA or ADvaMed Code without modification or with more stringent criteria, has your company made any changes to the following subjects required in your code of
conduct? [Please address changes in your code in a separate document.]
a. |
The basis of interactions |
Yes £ |
No £ |
b. |
Information presentations by or on behalf of a manufacturer |
Yes £ |
No £ |
c. |
Yes £ |
No £ |
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d. |
The use of consultants |
Yes £ |
No £ |
e. |
Speaker training meetings |
Yes £ |
No £ |
f. |
Scholarships and educational funds |
Yes £ |
No £ |
g. |
Educational and |
Yes £ |
No £ |
h. |
Independence of decision making |
Yes £ |
No £ |
i. |
Adhere to market code of conduct |
Yes £ |
No £ |
Are there any other companies, affiliated companies, or subsidiaries for which this form will also apply? Yes £ No £
Please provide the following information regarding your company’s compliance officer responsible for developing, operating, and monitoring your marketing code of conduct.
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Street Address |
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I certify that the annual audit to monitor compliance with the code of conduct for the named company and all other companies, affiliated companies, or subsidiaries listed has been completed and the named company and all other companies, affiliated companies, or subsidiaries are in compliance with the code of conduct.
Signed this |
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Signature: |
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AB128 CERTIFICATION OF COMPLETION OF ANNUAL AUDIT MONITORING
COMPLIANCE WITH CODE OF CONDUCT FOR MEDICAL PRODUCTS MANUFACTURER OR WHOLESALER OF DEVICE OR APPLIANCE USING A MODIFIED CODE OF CONDUCT
Has your company made any changes in your training to appropriate employees, including all sales and marketing staff, regarding your marketing code of conduct? Yes £ No £ Please attach a description of your current training program as a separate document.
Has your company made any changes to your investigation policies for investigating instances of noncompliance with your marketing code of conduct, including addressing the items contained in Section 1, subsection 1(d) of AB 128? (see page 2) Yes £ No £ Please attach a description your current investigative policies as a separate document.
If your company did not adopt PhRMA or ADvaMed Code without modification or with more stringent criteria, has your company made any changes to the following subjects required in your code of conduct?
a. |
Providing or sponsoring product training and education |
Yes £ |
No £ |
b. |
Supporting |
Yes £ |
No £ |
c. |
Sales and promotional meetings |
Yes £ |
No £ |
d. |
Arrangements with consultants |
Yes £ |
No £ |
e. |
Gifts |
Yes £ |
No £ |
f. |
Providing reimbursement and other economic information |
Yes £ |
No £ |
g. |
Grants and other charitable donations |
Yes £ |
No £ |
Are there any other companies, affiliated companies, or subsidiaries for which this form will also apply? Yes £ No £
Please provide the following information regarding your company’s compliance officer responsible for developing, operating, and monitoring your marketing code of conduct.
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I certify that the annual audit to monitor compliance with the code of conduct for the named company and all other companies, affiliated companies, or subsidiaries listed has been completed and the named company and all other companies, affiliated companies, or subsidiaries are in compliance with the code of conduct.
Signed this |
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Signature: |
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TEXT OF ASSEMBLY BILL 128
2007 SESSION OF THE NEVADA LEGISLATURE
EFFECTIVE OCTOBER 1, 2007
1.A wholesaler or manufacturer who employs a person to sell or market a drug, medicine, chemical, device or appliance in this State shall:
(a) Adopt a written marketing code of conduct which establishes the practices and standards that govern the marketing and sale of its products. The marketing code of conduct must be based on applicable legal standards and incorporate principles of health care, including, without limitation, requirements that the activities of the wholesaler or manufacturer be intended to benefit patients, enhance the practice of medicine and not interfere with the independent judgment of health care professionals. Adoption of the most recent version of the Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America satisfies the requirements of this paragraph.
(b)Adopt a training program to provide regular training to appropriate employees, including, without limitation, all sales and marketing staff, on the marketing code of conduct.
(c)Conduct annual audits to monitor compliance with the marketing code of conduct.
(d)Adopt policies and procedures for investigating instances of noncompliance with the marketing code of conduct, including, without limitation, the maintenance of effective lines of communication for employees to report noncompliance, the investigation of reports of noncompliance, the taking of corrective action in response to noncompliance and the reporting of instances of noncompliance to law enforcement authorities in appropriate circumstances.
(e)Identify a compliance officer responsible for developing, operating and monitoring the marketing code of conduct.
2.A wholesaler or manufacturer who employs a person to sell or market a drug, medicine, chemical, device or appliance in this State shall submit to the Board annually:
(a)A copy of its marketing code of conduct;
(b)A description of its training program;
(c)A description of its investigation policies;
(d)The name, title, address, telephone number and electronic mail address of its compliance officer;
and
(e)Certification that it has conducted its annual audit and is in compliance with its marketing code of conduct.
3.On or before January 15 of each
4.The Board:
(a)Shall adopt regulations providing for the time of the submission and the form of the information required pursuant to this section and defining “compliance” for the purposes of this section.
(b)May not require the disclosure of the results of an audit conducted pursuant to this section.
(c)Shall post on its Internet website information concerning the compliance of all wholesalers and manufacturers with the requirements of this section.
(d)Shall not disclose any proprietary or confidential business information that it receives pursuant to this section.
ADOPTED REGULATION OF THE
STATE BOARD OF PHARMACY
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LCB File No.
Effective January 30, 2008
Section 1. Chapter 639 of NAC is hereby amended by adding thereto the provisions set forth as sections 2 to 14, inclusive, of this regulation.
Sec. 2. As used in NAC 639.610 and 639.615 and sections 11, 12, 13 and 14 of this regulation, unless
the context otherwise requires, the term “manufacturer” has the meaning ascribed to it in NRS 639.009.
Sec. 3. The Board hereby adopts by reference:
1.The Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America. A copy of this publication may be obtained, free of charge, from the Pharmaceutical Research and Manufacturers of America at the Internet address http://www.phrma.org/code_on_interactions_with_healthcare_professionals.
2 . The Code of Ethics on Interactions with Health Care Professionals adopted by the Advanced Medical Technology Association. A copy of this publication may be obtained, free of charge, from the Advanced Medical Technology Association at the Internet address http://www.advamed.org/MemberPortal/About/code.
Sec. 4. The Board will periodically review:
1.The Code on Interactions with Healthcare Professionals, as adopted by reference in subsection 1 of section 3 of this regulation; and
2.The Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in subsection 2 of section 3 of this regulation, and determine, within 30 days after the review, whether any change made to a publication listed in subsection 1 or 2 is appropriate for application in this State. If the Board does not disapprove a change to an adopted publication within 30 days after the review, the change is deemed to be approved by the Board.
Sec. 5. 1. Except as otherwise provided in subsections 2 and 6, on or before June 1 of each year, a wholesaler who employs a person to sell or market a drug, medicine or chemical in this State shall submit to the Board the information required pursuant to subsection 2 of NRS 639.570.
2.If a wholesaler described in subsection 1 uses, without modification, the Code on Interactions with Healthcare Professionals, as adopted by reference in section 3 of this regulation, as its marketing code of conduct, the wholesaler may indicate this on its submittal in lieu of submitting a copy of its marketing code of conduct.
3.If a wholesaler described in subsection 1:
(a)Develops its own marketing code of conduct; or
(b)Uses a modified version of the Code on Interactions with Healthcare Professionals, as adopted by reference in section 3 of this regulation, as its marketing code of conduct,
the staff of the Board shall review the marketing code of conduct to ensure that it addresses the subjects listed in subsection 4.
4.A marketing code of conduct submitted pursuant to this section and subsection 2 of NRS 639.570 must address the following subjects:
(a)The basis of interactions;
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(b)Informational presentations by or on behalf of a wholesaler;
(c)
(d)The use of consultants;
(e)Speaker training meetings;
(f)Scholarships and educational funds;
(g)Educational and
(h)Independence of decision making; and
(i)Adherence to the marketing code of conduct.
5.If the staff of the Board determines that a marketing code of conduct submitted by a wholesaler described in subsection 1 does not address each of the subjects set forth in subsection 4, the marketing code of conduct shall be deemed incomplete and noncompliant with the provisions of this section and subsection 2 of NRS 639.570.
6.The provisions of this section do not apply to a wholesaler whose sole function is to distribute prescription drugs to pharmacies if the wholesaler and the pharmacy to which the prescription drugs are distributed are wholly owned by a common owner.
Sec. 6. 1. If a wholesaler has submitted to the Board the information required pursuant to section 5 of this regulation at least once, the wholesaler may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to section 5 of this regulation.
2.The submission of information to the Board pursuant to this section and section 5 of this regulation may be made by:
(a)Mail or personal delivery of a printed copy of the information required;
(b)Electronic mail to the Board at the electronic mail address pharmacy@pharmacy.nv.gov; or
(c)Such other technological means as the Board may develop, including, without limitation, through the use of the Internet website of the Board.
Sec. 7. 1. The Board will refuse a submittal of information from a wholesaler pursuant to section 5 or 6 of this regulation if the submittal is incomplete. The Board will treat such an incomplete submittal as noncompliant for the purposes of NRS 639.570.
2.If the staff of the Board determines that a submittal of information pursuant to section 5 or 6 of this regulation is incomplete, improperly completed or noncompliant, the staff shall, as soon as practicable, notify the wholesaler who submitted the information that the submittal is incomplete, improperly completed or noncompliant and provide the wholesaler with instructions for correcting the deficiencies in the submittal. The Board may retain an incomplete, improperly completed or noncompliant submittal or return the submittal to the wholesaler.
3.If the staff of the Board provides notice of an incomplete, improperly completed or noncompliant submittal to a wholesaler pursuant to this section, the wholesaler must comply with the instructions for correcting the deficiencies in the submittal within 120 days after the receipt of the instructions. Within the
Posted 4/4/2008
Sec. 8. 1. Except as otherwise provided in subsection 2, on or before June 1 of each year, a medical products wholesaler who employs a person to sell or market a device or appliance in this State shall submit to the Board the information required pursuant to subsection 2 of NRS 639.570.
2.If a medical products wholesaler who employs a person to sell or market a device or appliance in this State uses, without modification, the Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in section 3 of this regulation, as its marketing code of conduct, the medical products wholesaler may indicate this on its submittal in lieu of submitting a copy of its marketing code of conduct.
3.If a medical products wholesaler:
(a)Develops its own marketing code of conduct; or
(b)Uses a modified version of the Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in section 3 of this regulation, as its marketing code of conduct,
the staff of the Board shall review the marketing code of conduct to ensure that it addresses the subjects listed in subsection 4.
4.A marketing code of conduct submitted by a medical products wholesaler pursuant to this section and subsection 2 of NRS 63 9.570 must address the following subjects:
(a)Providing or sponsoring product training and education;
(b)Supporting
(c)Sales and promotional meetings;
(d)Arrangements with consultants;
(e)Gifts;
(f)Providing reimbursement and other economic information; and
(g)Grants and other charitable donations.
5.If the staff of the Board determines that a marketing code of conduct submitted by a medical products wholesaler does not address each of the subjects set forth in subsection 4, the marketing code of conduct shall be deemed incomplete and noncompliant with the provisions of this section and subsection 2 of NRS 639.570.
Sec. 9. 1. If a medical products wholesaler has submitted to the Board the information required pursuant to section 8 of this regulation at least once, the medical products wholesaler may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to section 8 of this regulation.
2.The submission of information to the Board pursuant to this section and section 8 of this regulation may be made by:
(a)Mail or personal delivery of a printed copy of the information required;
(b)Electronic mail to the Board at the electronic mail address pharmacy@pharmacy.nv.gov; or
(c)Such other technological means as the Board may develop, including, without limitation, through the use of the Internet website of the Board.
Sec. 10. 1. The Board will refuse a submittal of information from a medical products wholesaler pursuant to section 8 or 9 of this regulation if the submittal is incomplete. The Board will treat such an incomplete submittal as noncompliant for the purposes of NRS 639.570.
2.If the staff of the Board determines that a submittal of information pursuant to section 8 or 9 of this regulation is incomplete, improperly completed or noncompliant, the staff shall, as soon as practicable, notify the medical products wholesaler who submitted the information that the submittal is incomplete,
Posted 4/4/2008
improperly completed or noncompliant and provide the medical products wholesaler with instructions for correcting the deficiencies in the submittal. The Board may retain an incomplete, improperly completed or noncompliant submittal or return the submittal to the medical products wholesaler.
3.If the staff of the Board provides notice of an incomplete, improperly completed or noncompliant submittal to a medical products wholesaler pursuant to this section, the medical products wholesaler must comply with the instructions for correcting the deficiencies in the submittal within 120 days after the receipt of the instructions. Within the
Sec. 11. 1. Except as otherwise provided in subsection 2, on or before June 1 of each year, a manufacturer who employs a person to sell or market a drug, medicine or chemical in this State shall submit to the Board the information required pursuant to subsection 2 of NRS 639.570.
2.If a manufacturer described in subsection 1 uses, without modification, the Code on Interactions with Healthcare Professionals, as adopted by reference in section 3 of this regulation, as its marketing code of conduct, the manufacturer may indicate this on its submittal in lieu of submitting a copy of its marketing code of conduct.
3.If a manufacturer described in subsection 1:
(a)Develops its own marketing code of conduct; or
(b)Uses a modified version of the Code on Interactions with Healthcare Professionals, as adopted by reference in section 3 of this regulation, as its marketing code of conduct,
the staff of the Board shall review the marketing code of conduct to ensure that it addresses the subjects listed in subsection 4.
4.A marketing code of conduct submitted pursuant to this section and subsection 2 of NRS 639.570 must address the following subjects:
(a)The basis of interactions;
(b)Informational presentations by or on behalf of a manufacturer;
(c)
(d)The use of consultants;
(e)Speaker training meetings;
(f)Scholarships and educational funds;
(g)Educational and
(h)Independence of decision making; and
(i)Adherence to the marketing code of conduct.
5.If the staff of the Board determines that a marketing code of conduct submitted by a manufacturer
does not address each of the subjects set forth in subsection 4, the marketing code of conduct shall be deemed incomplete and noncompliant with the provisions of this section and subsection 2 of NRS 639.570.
Sec. 12. 1. Except as otherwise provided in subsection 2, on or before June 1 of each year, a manufacturer who employs a person to sell or market a device or appliance in this State shall submit to the Board the information required pursuant to subsection 2 of NRS 639.570.
2.If a manufacturer described in subsection 1 uses, without modification, the Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in section 3 of this regulation, as its
Posted 4/4/2008
marketing code of conduct, the manufacturer may indicate this on its submittal in lieu of submitting a copy of its marketing code of conduct.
3.If a manufacturer described in subsection 1:
(a)Develops its own marketing code of conduct; or
(b)Uses a modified version of the Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in section 3 of this regulation, as its marketing code of conduct,
the staff of the Board shall review the marketing code of conduct to ensure that it addresses the subjects listed in subsection 4.
4.A marketing code of conduct submitted by a manufacturer pursuant to this section and subsection 2 of NRS 639.570 must address the following subjects:
(a)Providing or sponsoring product training and education;
(b)Supporting
(c)Sales and promotional meetings;
(d)Arrangements with consultants;
(e)Gifts;
(f)Providing reimbursement and other economic information; and
(g)Grants and other charitable donations.
5.If the staff of the Board determines that a marketing code of conduct submitted by a manufacturer does not address each of the subjects set forth in subsection 4, the marketing code of conduct shall be deemed incomplete and noncompliant with the provisions of this section and subsection 2 of NRS 639.570.
Sec. 13. 1. If a manufacturer has submitted to the Board the information required pursuant to section 11 or 12 of this regulation at least once, the manufacturer may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to section 11 or 12 of this regulation, as applicable.
2.The submission of information to the Board pursuant to this section and sections 11 and 12 of this regulation may be made by:
(a)Mail or personal delivery of a printed copy of the information required;
(b)Electronic mail to the Board at the electronic mail address pharmacy@pharmacy.nv.gov; or
(c)Such other technological means as the Board may develop, including, without limitation, through the use of the Internet website of the Board.
Sec. 14. 1. The Board will refuse a submittal of information from a manufacturer pursuant to section 11, 12 or 13 of this regulation if the submittal is incomplete. The Board will treat such an incomplete submittal as noncompliant for the purposes of NRS 639.570.
2.If the staff of the Board determines that a submittal of information pursuant to section 11, 12 or 13 of this regulation is incomplete, improperly completed or noncompliant, the staff shall, as soon as practicable, notify the manufacturer who submitted the information that the submittal is incomplete, improperly completed or noncompliant and provide the manufacturer with instructions for correcting the deficiencies in the submittal. The Board may retain an incomplete, improperly completed or noncompliant submittal or return the submittal to the manufacturer.
3.If the staff of the Board provides notice of an incomplete, improperly completed or noncompliant submittal to a manufacturer pursuant to this section, the manufacturer must comply with the instructions for correcting the deficiencies in the submittal within 120 days after the receipt of the instructions. Within
Posted 4/4/2008
NEVADA STATE BOARD OF PHARMACY
431 W. Plumb Lane• Reno, NV 89509
(775)
the
Sec. 15. NAC 639.585 is hereby amended to read as follows: 639.585 As used in NAC 639.585 to
63 9.607, inclusive, and sections 5, 6 and 7 of this regulation, unless the context otherwise requires, the words and terms defined in NAC 639.587 to 639.592, inclusive, have the meanings ascribed to them in those sections.
Sec. 16. NAC 639.693 is hereby amended to read as follows: 639.693 As used in NAC 639.693 to 639.6958, inclusive, and sections 8, 9 and 10 of this regulation, unless the context otherwise requires, the words and terms defined in NAC 639.6931 to 639.6938, inclusive, have the meanings ascribed to them in those sections.
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