FYI: FDA research chemicals guidelines

[big_boy_1]

[Code of Federal Regulations]
[Title 21, Volume 8, Parts 800 to 1299]
[Revised as of April 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR809.30]

[Page 96-97]

TITLE 21--FOOD AND DRUGS

SERVICES--(Continued)

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents

Subpart C--Requirements for Manufacturers and Producers

Sec. 809.30 Restrictions on the sale, distribution and use of analyte specific reagents.

(a) Analyte specific reagents (ASR's) (Sec. 864.4020 of this
chapter) are restricted devices under section 520(e) of the Federal
Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set
forth in this section.
(b) ASR's may only be sold to:
(1) In vitro diagnostic manufacturers;
(2) Clinical laboratories regulated under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), as qualified to perform high
complexity testing under 42 CFR part 493 or clinical laboratories
regulated under VHA Directive 1106 (available from Department of
Veterans Affairs, Veterans Health Administration, Washington, DC 20420);
and
(3) Organizations that use the reagents to make tests for purposes
other than providing diagnostic information to patients and
practitioners, e.g., forensic, academic, research, and other nonclinical
laboratories.
(c) ASR's must be labeled in accordance with Sec. 809.10(e).
(d) Advertising and promotional materials for ASR's:
(1) Shall include the identity and purity (including source and
method of acquisition) of the analyte specific reagent and the identity
of the analyte;
(2) Shall include the statement for class I exempt ASR's: ``Analyte
Specific Reagent. Analytical and performance characteristics are not
established'';
(3) Shall include the statement for class II or III ASR's: ``Analyte
Specific Reagent. Except as a component of the approved/cleared test
(name of approved/cleared test), analytical and performance
characteristics are not established''; and
(4) Shall not make any statement regarding analytical or clinical
performance.

[[Page 97]]

(e) The laboratory that develops an in-house test using the ASR
shall inform the ordering person of the test result by appending to the
test report the statement: ``This test was developed and its performance
characteristics determined by (Laboratory Name). It has not been cleared
or approved by the U.S. Food and Drug Administration.'' This statement
would not be applicable or required when test results are generated
using the test that was cleared or approved in conjunction with review
of the class II or III ASR.
(f) Ordering in-house tests that are developed using analyte
specific reagents is limited under section 520(e) of the act to
physicians and other persons authorized by applicable State law to order
such tests.
(g) The restrictions in paragraphs (c) through (f) of this section
do not apply when reagents that otherwise meet the analyte specific
reagent definition are sold to:
(1) In vitro diagnostic manufacturers; or
(2) Organizations that use the reagents to make tests for purposes
other than providing diagnostic information to patients and
practitioners, e.g., forensic, academic, research, and other nonclinical
laboratories.

[62 FR 62259, Nov. 21, 1997]

 

[bittersuit_98]

Good info bro.

Like i said in different threads, in my opinion there is no such thing as "safe" or "legal" posession of research substances. Unfortunately, the law is not as white or black as we want, in fact, most of the time is pretty "gray" and here is where Law enforcement agencies love to twist the facts to make a case against you. Rick Collins said it just right in his analogy, "they (law enforcement) define apples as oranges, and everything else that looks or smells alike are thrown into the mix as well. So the same principle applies to research substances...whether these substances have anabolic properties or not, that is not the issue, the issue is that why would you need research substances such as ancillary products if you are not using or selling steroids or doing both?

Play safe fellas!!