[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Rules and Regulations]
[Pages 32925-32926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16299]



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DEPARTMENT OF THE TREASURY
Drug Enforcement Administration

21 CFR Parts 1309 and 1310

[DEA-133F]
RIN 1117-AA29


Waiver of Requirements for the Distribution of Prescription Drug 
Products Drug Products That Contain List I Chemicals

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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SUMMARY: DEA is amending its regulations to waive the registration 
requirement for persons who distribute prescription drug products that 
are subject to regulation on List I chemicals and to allow that the 
records required to be maintained pursuant to the Federal Food and Drug 
Administration (FDA) regulations for prescription drug products shall 
be deemed adequate for satisfying DEA's recordkeeping requirements with 
respect to distribution. In response from industry, DEA has conducted a 
review and determined that such prescription drug products are already 
subject to extensive regulatory controls regarding their distribution 
and there is no evidence that the products are being diverted at this 
time. This action will relieve distributors and manufacturers of 
regulated prescription drug products containing List I chemicals from 
the chemical control requirements in circumstances where compliance 
would be unnecessary for enforcement of the law.

EFFECTIVE DATE: July 26, 1996.

FOR FURTHER INFORMATION CONTACT:
G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of 
Diversion Control, Drug Enforcement Administration, Washington, DC 
20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: On September 26, 1995, DEA published a 
notice in the Federal Register (60 FR 49527) proposing to amend Title 
21, Code of Federal Regulations (CFR), parts 1309 and 1310, to waive 
the requirement of registration for persons distributing prescription 
drug products that are regulated as List I chemicals and to allow that 
the records required to be maintained pursuant to the FDA regulations 
for prescription drug products shall be deemed adequate for satisfying 
DEA's recordkeeping requirements with respect to distribution. This 
rule responds industry's requests for relief based on existing 
regulatory controls and the lack of evidence of diversion of the 
products.
    One comments was submitted in response to the proposed rulemaking. 
That comment, while supporting the proposed amendments, requested that 
DEA include in the regulations a provision that the FDA record 
retention requirement of two years, rather that the four year retention 
period required under the Controlled Substances Act (CSA), would apply 
to records of distributions of regulated prescription drug products. 
DEA is aware of the discrepancy between the record retention 
requirements between the FDA and DEA for these products; however, DEA 
does not have flexibility regarding the recordkeeping retention period 
for List I chemicals since 21 U.S.C. 830(a)(1)(A) of the CSA mandates 
that records of transactions involving List I chemicals shall be 
maintained for four years. There is no provision in the CSA allowing 
DEA the discretion to waive or modify that requirement. Only the 
Congress could amend the statute as proposed by the commentor. Until 
that requirement of the law is amended, records of regulated 
transactions involving List I chemicals must be maintained for the 
required four year period.
    The Deputy Administrator of the Drug Enforcement Administration 
hereby certifies that this rulemaking will not have a significant 
impact on a large number of entities whose interests must be considered 
under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This 
rulemaking grants those persons who distribute regulated prescription 
drug products relief from DEA's chemical registration requirement and 
allows for the use of records already maintained pursuant to FDA 
regulations in lieu of requiring that separate records be maintained. 
These amendments could potentially ease the regulatory burden for 1,200 
or more distributors and manufacturers of regulated prescription drug 
products.
    This rule has been drafted and reviewed in accordance with 
Executive Order 12866. DEA has determined that this is not a 
significant regulatory action under the provisions of Executive Order 
12866, section 3(f) and accordingly this rule has not been reviewed by 
the Office of Management and Budget. This rule will eliminate 
unnecessary regulatory requirements for distributors of regulated 
prescription drug products.
    This action has been analyzed in accordance with the principles an 
criteria in Executive Order 12612, and it has been determined that the 
rule does not have sufficient federalism

[[Page 32926]]

implications to warrant the preparation of a Federalism Assessment.

List of Subjects

21 CFR Part 1309

    Administrative practice and procedure, Drug traffic control, List I 
and List II chemicals, Security measures.

21 CFR Part 1310

    Drug traffic control, List I and List II chemicals, Reporting and 
recordkeeping requirements.

    For reasons set out above, 21 CFR parts 1309, and 1310 are amended 
as follows:

PART 1309--[AMENDED]

    1. The authority citation for part 1309 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877, 
958

    2. Section 1309.21 is revised to read as follows:


Sec. 1309.21  Persons required to register.

    (a) Every person who distributes, imports, or exports any List I 
chemical, other than those List I chemicals contained in a product 
exempted under Section 1310.01(f)(1)(iv) of this chapter, or who 
proposes to engage in the distribution, importation, or exportation of 
any List I chemical, shall obtain annually a registration specific to 
the List I chemicals to be handled, unless exempted by law or pursuant 
to Secs. 1309.24 through 1309.28 of this part. Only persons actually 
engaged in such activities are required to obtain a registration; 
related or affiliated persons who are not engaged in such activities 
are not required to be registered. (For example, a stockholder or 
parent corporation of a corporation distributing List I chemicals is 
not required to obtain a registration.)
    (b) Every person who distributes or exports a List I chemical they 
have manufactured, other than a List I chemical contained in a product 
exempted under Sec. 1310.01(f)(1)(iv) of this chapter, or proposes to 
distribute or export a List I chemical they have manufactured, shall 
obtain annually a registration specific to the List I chemicals to be 
handled, unless exempted by law or pursuant to Secs. 1309.24 through 
1309.28 of this part.
    3. Section 1309.22 is amended by revising paragraph (b) to read as 
follows:


Sec. 1309.22  Separate registration for independent activities.

* * * * *
    (b) Every person who engages in more than one group of independent 
activities shall obtain a separate registration for each group of 
activities, unless otherwise exempted by the Act or Sections 1309.24 
through 1309.28 of this part, except that a person registered to import 
any List I chemical shall be authorized to distribute that List I 
chemical after importation, but no other chemical that the person is 
not registered to import.
    4. Section 1309.28 is added to read as follows:


Sec. 1309.28  Exemption of distributors of regulated prescription drug 
products.

    (a) The requirement of registration is waived for any person who 
distributes a prescription drug product containing a List I chemical 
that is regulated pursuant to Sec. 1310.01(f)(1)(iv) of this chapter.
    (b) If any person exempted by this section also engages in the 
distribution, importation or exportation of a List I chemical, other 
than as described in paragraph (a) of this section, the person shall 
obtain a registration for such activities, as required by Sec. 1309.21 
of this part.
    (c) The Administrator may, upon finding that continuation of the 
waiver granted in paragraph (a) of this section would not be in the 
public interest, suspend or revoke a person's waiver pursuant to the 
procedures set forth in Sec. Sec. 1309.43 through 1309.46 and 1309.51 
through 1309.57 of this part.

 PART 1310--[AMENDED]

    5. The authority citation for part 1310 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 830, 871(b)

    6. Section 1310.06 is amended by revising paragraph (b) to read as 
follows:


Sec. 1310.06  Content of records and reports.

* * * * *
    (b) For purposes of this section, normal business records shall be 
considered adequate if they contain the information listed in paragraph 
(a) of this section and are readily retrievable from other business 
records of the regulated person. For prescription drug products, 
prescription and hospital records kept in the normal course of medical 
treatment shall be considered adequate for satisfying the requirements 
of paragraph (a) of this section with respect to dispensing to 
patients, and records required to be maintained pursuant to the Federal 
Food and Drug Administration regulations relating to the distribution 
of prescription drugs, as set forth in 21 CFR part 205, shall be 
considered adequate for satisfying the requirements of paragraph (a) of 
this section with respect to distributions.
* * * * *
    Dated: May 28, 1996.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 96-16299 Filed 6-25-96; 8:45 am]
BILLING CODE 4410-09-M