[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR73a.735-401]



[Page 201-202]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 73a_STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION 

SUPPLEMENT--Table of Contents

 

                      Subpart D_Outside Employment

 

Sec.  73a.735-401  General provisions.





    (a) Employees of the Food and Drug Administration shall obtain 

advance approval for all outside employment, whether paid or unpaid. 

Employment, as used in this section, does not include:

    (1) Memberships in charitable, religious, social, fraternal, 

recreational, public service, civic, or similar nonbusiness 

organizations.

    (2) Memberships in professional organizations. (Officeholding, 

however, requires advance approval.)

    (3) Performance of duties in the Armed Forces Reserve or National 

Guard.

    (b) Control activity employees (defined in Sec.  73a.735-502) will 

not generally be granted approval to:

    (1) Manage or direct an organization whose activities are subject to 

FDA regulation, or

    (2) Be employed in an organization whose business activities are 

subject to FDA regulation unless:

    (i) The regulated activities of the organization are an 

insignificant part of its total operations, i.e., the regulated products 

of the organization constitute no more than 10 percent of its annual 

gross sales, and

    (ii) The outside employment is in nonregulated activities of the 

organization.

    (c) All other employees will generally be granted approval to engage 

in outside employment which is compatible with the full performance of 

their FDA duties and responsibilities and which will not give rise to a 

real or apparent conflict of interest. Permissible employment includes 

but is not limited to:

    (1) Employment where the sale of FDA-regulated products is 

incidential to the purpose of the establishment, e.g., hotels, theaters, 

bowling alleys, and sports arenas.

    (2) Sales and clerical occupations relating to regulated products, 

e.g., supermarkets, drugstores, department stores, liquor stores.

    (3) Trade, industrial, and service occupations relating to regulated 

products, e.g., gasoline service station attendant, line production or 

assembly work, cook, waiter, waitress, hospital attendant, snack bar 

vendor, warehouseman.

    (d) All employees will generally be granted approval to engage in 

paid or unpaid outside employment which contributes to their technical 

or professional development, e.g.,

    (1) Medical, dental, and veterinary practices.

    (2) Pharmacy practice after meeting the following conditions which 

will serve to protect against possible conflicts or apparent conflicts 

of interest and to avoid other problems resulting



[[Page 202]]



in embarrassment to the employee or FDA:

    (i) The primary purpose of the part-time employment is to contribute 

to the overall professional development of the employee and generally 

enhance his capability to better perform his current FDA duties.

    (ii) The part-time duties will be confined generally to dispensing 

Rx drugs and related professional pharmacy duties.

    (iii) The employee will avoid unrelated nonprofessional duties such 

as supervision or management of store operations, contractual or 

purchasing responsibilities (except normal ``out-of-stock'' 

requisitioning) and repacking and relabeling of bulk items.

    (iv) The employee will demonstrate a high degree of discretion and 

judgment in his contacts with customers and representatives of regulated 

industry and competitor firms so as to avoid giving the impression that:

    (a) His part-time actions, recommendations, opinions, or remarks are 

official points of view;

    (b) He is using his FDA position for private gain by oral 

misrepresentations and false claims of the company's products;

    (c) He is making a Government decision outside official channels, 

e.g., to customers, prescribing physicians, buyers, distributors;

    (d) He or other FDA representatives will give preferential treatment 

to any regulated organization or representatives of such organizations, 

or that FDA employees have not exercised complete independence or 

impartiality in carrying out their regulatory and consumer protection 

responsibilities; or

    (e) His part-time work is creating an adverse effect on the image of 

FDA or discrediting the integrity of official FDA regulatory decisions.