Information for
Nutrient - Natural Product Purveyors
& Alternative Practitioners
OUTLINES OF FORMATS FOR BUSINESSES
"Are your papers in order?"
Index:
(0) Introduction
(a) Update - 05/2007
(b) GMPs Issued Update
-
06/2007
(1) Standard SUS
(2) Standard SOP - updated 08/08
(3) Small Entity SOP
(4) Professional Practice SOP
(5)
Employee Manual
(6) Compliance Notebooks
(7) Specialized Documents
Introduction
This page reproduces sample Tables of
Contents of Site Use Statements (SUS), current Good Marketing Practices (cGMPs) Standard Operating
Procedures (SOPs) for dietary supplement purveyors and alternative practices,
available from the Consultancy.
Everyone in the nutritional - natural products and alternative practitioner
fields
need to have their paperwork in order as we enter a period of more sophisticated
government oversight of their activities. While we may agree, "That government
is best which governs least..." you need to prepare to meet the highest modern
standards, for your customers' satisfaction and your most efficient operations.
Please email me at ralph.fucetola@usa.net
with "Operating Documents" in the subject line if you would like to discuss
documentation for your business or practice.
Index
Update: 05/18/07 - New GMP Standards
Cleared by OMB
Sen.
Hatch: Dietary Supplement cGMPs Finalized.
OMB Completes Effort to Implement Key
Aspect of DSHEA
>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of
Management and Budget (OMB) has given final clearance for good manufacturing practices
(GMP) regulations for dietary supplements.
>
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been
pushing the FDA to publish these for more than a decade.”
>
>Hatch is one of the principal authors of the Dietary Supplement Health and
Education Act of 1994, which gave the FDA the authority to write GMP guidelines
specific to supplements. GMPs are the standards inspectors will use to assure
purity, potency, and all the other requirements of clean, legal manufacturing.
The GMPs are expected to be published within the next five weeks.
>
>“GMPs are crucial because they assure the public that the products they are
buying live up to their labels,” Hatch said. “Since it took an unusually long
time to issue these final guidelines, I want to review the final version very
carefully to make certain they are good regulations. Every indication leads me
to believe the Administration was very sensitive to the impact the GMPs might
have on the industry, especially on small businesses.”
Update: June 22, 2007:
GMPs issued.
The FDA's new Dietary Supplement Current Good Manufacturing
Practices (cGMPs) are at:
http://www.cfsan.fda.gov/~dms/dscgmps6.html (467 pages when downloaded to MS
Word; the actual rule doesn’t start until page 426, after 359 comments…).
Here are some comments by FDA, from the commentary preceding the new rule, that
tell us a lot about where the present administration of FDA wants to take us:
“…we disagree with the comments asserting dietary supplements have a track
record of safety such that dietary supplement CGMP requirements are unnecessary.
Section 402(g) of the act does not require us to establish a ‘bad’ track record
of safety in the manufacture of dietary supplements before we may issue a
dietary supplement CGMP rule. Furthermore, we disagree with the comments
comparing dietary supplement safety to drug safety; there are different
statutory requirements, different regulatory requirements, and different safety
evaluations for dietary supplements and drugs.”
And this, from the economic impact section:
“We find that this final rule will have a significant economic impact on a
substantial number of small entities.... Establishments with above average
costs, and even establishments with average costs, could be hard pressed to
continue to operate. Some of these may decide it is too costly and either change
product lines or go out of business.... very small ...
and ... small dietary supplement manufacturers ... will be
at risk of going out of business.... costs per establishment are proportionally
higher for very small than for large establishments....The regulatory costs of
this final rule will also discourage new small businesses from entering the
industry.”
The Rules become effective 08/24/07 and are being phased in
over a two year period for small companies.
The Consultancy's standard formats are being updated to
take into account these new rules. It is expected that by the end of summer new
rules will also be posted for the Adverse Event Reporting Act of 2006, due to be
implemented by 12/22/07. More about AER see:
www.aer-consultants.com
.
For further GMP and regulatory developments see:
http://vitaminlawyerhealthfreedom.blogspot.com
Index
(1) Standard SUS - Site Use
Statement (4 pages) includes:
1. Scope of Statement
2. Terms and Conditions
Disclosures
Territory & Access
No Warranties
Non-private Communications
Trademarks
Testimonials
Third Party Statements
Accuracy
Disclaimers
3. Privacy Statement
4. Security & Choices
More on SUS:
www.siteusestatement.com
Index
(2)
Standard SOP
(16 pages) includes:
A. Refund,
Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy
Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management
K.
Payment Card Industry Data Security
System
(added 08/08)
Index
(3) Small Entity “Record Keeping” SOP (5
pages) includes:
I General Provisions
II Record Maintenance and Production
Tax Records
Employment Records/Personnel
Records
Management Materials
Press Releases/Public Filings
Legal Files
Marketing and Sales Documents
Invoices, Contracts, Leases,
Licenses, etc
Development/Intellectual
Property and Trade Secrets
Final Contracts
Electronic Mail
Notes, Draft Copies
III Adverse Event Records
IV General Compliance Provisions
Index
(4) The Professional Practice
Record Keeping SOP (4 pages) describes record keeping standards
for the Advanced healthcare (CAM) practitioner who provides nutrients and
natural remedies to his or her clients.
1. Maintaining copies of all
paid invoices
2. Maintaining regular back-up copies of client database
3. Maintaining copies product ordered for resale records
4. Records of products
ordered
A. Records showing that the products are manufactured in accordance with the
marketer’s standards for the product
B. Records showing any available analysis to prevent improper manufacturing,
packaging, and mislabeling
C. Reasonably necessary records of claimed “serious adverse events.”
5. Lawful written request
for records; client objection
6. Record Types
(a) Research and other development records
(b) Records required by law to maintain for a certain period of time
(c) Comply with any published records retention or destruction policies and
schedules
(d) Records relevant to litigation, or potential litigation
(e) Practitioner
establishes retention or destruction policies
(f1) Tax Records
(f2) Employment Records/Personnel Records
(f3) Board and Committee Materials
(f4) Press Releases/Public Filings
(f5) Legal Files
(f6) Marketing and Sales Documents
(f7) Sales invoices, contracts, leases, licenses and other legal documentation
(f8) Development/Intellectual Property and Trade Secrets
(f9) Trade secret information
(f10) Contracts: final, execution copies of all contracts
(f11) Electronic Mail
(g) Notes, drafts and
documents - no longer provide relevant
(7) Compliance
(a) EU Directive on Privacy and Electronic Communications (Directive 2002/58/EC)
compliance
(b) Health Insurance Portability and Accountability Act (HIPPA) compliance
7. Practitioner Product
Sales Record Keeping (in detail):
1. The Practitioner shall maintain order invoice copies
2. The Practitioner shall maintain back-up copies
3. The Practitioner shall maintain copies of records
4. Records of products
5. Record Availability
6. Report on FDA Form
7. Not construed by FDA as an admission
Index
(5) Employee Manual
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Table of Contents
Notice
Title Page
Welcome to the Company
Disclaimer
Introduction
The Company Mission Statement
Career Opportunities
Open Door Policy
Code of Conduct
Employment
Equal Opportunity Employment
Eligibility For Employment
Familial Employment
Criminal Convictions
Violence
Weapons
Alcohol, Drugs & Illegal Substance Abuse
Sexual and Other Unlawful Harassment
Domestic Violence Statement
Employment Evaluation
Personnel File
Policies & Procedures
Attendance
Parking
Work Schedule Requirements & Designated Areas
Staff Meetings
Bulletin Boards
Suggestion Box
Time Cards
Lunch Break
Breaks
Workplace Dress Code
Medical Attention
Compensation
Overtime
Commissioned Sales
Wage and Salary Disclosure
Payroll Schedules
Your Paycheck
Payroll Deductions for Federal Tax, State Tax, FICA and Medicare
IRA’s - Individual Retirement Accounts
Working Away From the Office
|
Performance & Evaluation Reviews
Reimbursement of Expenses
Reporting Personal Information Changes
Gifts, Entertainment & Meals
Visitors
Personal Property
Personal Safety
Food & Beverage
Smoking
Company Property
Confidential Information Security
Facilities Security
Office Supplies, Postage & Company Accounts
Company Vehicles
Company Equipment
Phone Systems, Voice Mail and Personal Calls
Conservation and Recycling
Computer Related
Computers and Related Equipment
Internet
eMail & Electronic Communication
Policies for Leave of Absence
Eligibility
Personal Leave of Absence
Sick Leave
Short-Term Disability Leave
Unpaid Family & Medical Leave
Funeral Leave
Jury Duty
Military Duty
Severe Weather Closings
Benefits
Overview
Eligibility
Group Medical Insurance
401K Plan
Retirement
Worker's Compensation
Holidays
Vacations
Vacations Schedule:
COBRA
Education - Tuition Reimbursement
Employee Discounts
Discipline Policies
Problem Resolutions
Violation of Company Policy
Termination of Employment
Termination
Acknowledgement
Notice |
Index
(6) Compliance
Notebooks
(A) "Standard Operating
Procedures Notebook" (or “SOP Notebook”)
(1) Operations Manual/SOPs and
Employee Manual
(2) Formula sheets
(3) Label copies (with dates as to when they were in use)
(4) Literature copies (likewise dated)
(5) Copies of your Structure and Function Notices
(6) Insurance Policy binder page
(7) Certificate of Incorporation (or LLC Certificate of Formation)
(8) EIN and Bank Account number information
(B) “Substantiation Notebook.”
(1) Abstract pages of scientific
journal articles regarding the ingredients
(2) Clinical study reports about the
ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters
Index
(7)Specialized Documents
The Vitamin Lawyer Consultancy has many specialized
document formats for nutritional - natural products and alternative
practitioners. Some of these include: Physician's Standing Orders (to
staff of complementary clinic, providing oversight and instructions in case of
emergency), Alternative Practice Informed Consent - Private License Forms, Rules
and Regulations for Online Affiliate Programs, and numerous contracts, licenses,
joint ventures and similar formats.
As an example of a specialized document, here is an outline
of an alternative clinic's Physician's Standing Order:
1. Introduction
2. New Clients
3. Emergency Conditions
4. Client Records and Tests
5. Reports
Additional Information:
cGMP Report.htm
Traditional Uses.htm
FDA_& FTC Requirements.htm
Health Freedom
SOPs, cGMPs
Index
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