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

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]

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