[Federal Register Volume 60, Number 94 (Tuesday, May 16, 1995)]
[Notices]
[Pages 26050-26054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11934]



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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 93-18]


Johnson Matthey, Inc.; Approval of Registration

    On September 14, 1992, Johnson Matthey, Inc. of West Deptford, New 
Jersey (Johnson Matthey) applied for registration under 21 U.S.C. 
823(a) with the Drug Enforcement Administration (DEA) as a bulk 
manufacturer of methylphenidate, a Schedule II controlled substance. 
Notice of Johnson Matthey's application was published in the Federal 
Register on November 13, 1992 (57 FR 53935). On December 11, 1992, MD 
Pharmaceutical, Inc. of Santa Ana, California (MD), a registered bulk 
manufacturer of methylphenidate, objected to the proposed registration 
and filed a request for a hearing on Johnson Matthey's application 
pursuant to 21 CFR 1301.43(a).
    The matter was docketed before Administrative Law Judge Mary Ellen 
Bittner. On July 27, 1993, Judge Bittner issued a memorandum, ruling 
and protective order designating as ``confidential and protected'' 
certain exhibits, as well as the identification of certain witnesses. 
Following extensive prehearing proceedings, a hearing was held in 
Arlington, Virginia on August 10, 11, 12, and 20 and September 28, 
1993. Johnson Matthey, MD, the Government and a third party research 
partner of Johnson Matthey introduced testimony and documentary 
evidence. During opening statements, the Government stated the DEA, at 
that time, had no information upon which to base a decision that the 
application of Johnson Matthey for registration as a bulk manufacturer 
of methylphnidate should not be approved.
    On September 29, 1994 the administrative law judge issued her 
opinion and recommended ruling, findings of fact, conclusions of law 
and decision, as well as an order allowing all parties to submit 
motions to redact confidential and protected information from the 
opinion pursuant to the terms of the July 27, 1993 protective order. A 
redacted opinion was issued on November 1, 1994. Exceptions to the 
opinion were filed by MD, Johnson Matthey and the Government.
    The administrative law judge transmitted the record of the 
proceedings to the Deputy Administrator on November 30, 1994. Portions 
of the transcript and certain exhibits were designated confidential and 
protected pursuant to the protective order. Additionally, the Deputy 
Administrator received redacted versions of the opinion and such 
motions, briefs, exceptions and other pleadings subject to the 
protective order. On January 10, 1995, MD filled with the Deputy 
Administrator a response to the Government's exceptions to the opinion 
of the administrative law judge.
    The Deputy Administrator has carefully considered the record in 
this matter in its entirety, as well as all exceptions thereto. 
Pursuant to 21 CFR 1301.57, the Deputy Administrator hereby issues his 
final order in this matter based upon findings of fact and conclusions 
of law as set forth herein.
    The administrative law judge made the following findings of fact as 
background for her opinion. Methylphenidate, a central nervous system 
stimulant, is a Schedule II controlled substance. There currently are 
two DEA registered bulk manufacturers of methylphenidate: CIBA 
Pharmaceutical Company (CIBA), which manufactures methylphenidate under 
its brand name ``Ritalin''; and MD, which manufactures a generic form 
of methylphenidate. Johnson Matthey produces some bulk pharmaceuticals 
and is a major manufacturer of platinum-based anti-cancer drugs. The 
principal controlled substance manufactured by Johnson Matthey is 
fentanyl, a Schedule II controlled substance.
    The administrative law judge found that Johnson Matthey applied for 
registration as a researcher and bulk manufacturer of methylphenidate 
in 1989. The researcher registration was issued by DEA on January 26, 
1990. Johnson Matthey withdrew its application for registration as a 
bulk manufacturer of methylphenidate following the filing of an 
objection by CIBA.
    The administrative law judge referred to testimony that, in the 
fall of 1990, Johnson Matthey began initial studies on methylphenidate. 
In November of 1990, Johnson Matthey applied for a researcher 
registration for methylphenidate, but did not apply for a registration 
to manufacture it. Judge Bitter noted testimony by Johnson Matthey's 
compliance and regulatory manager that he was advised by DEA that 
Johnson Matthey's application for registration as a researcher had been 
processed and that drug codes did not have to be reported on the 
application unless Johnson Matthey intended to import or manufacture 
Schedule II controlled substances as a coincident activity of its 
researcher registration. The administrative law judge noted evidence 
that Johnson Matthey responded, by letter dated January 30, 1991, 
advising DEA that Johnson Matthey does manufacture on a research basis 
and therefore must be registered. She further noted that the letter did 
not indicate how much methylphenidate Johnson Matthey had manufactured 
or intended to manufacture in the future.
    The administrative law judge noted testimony that, in 1991, Johnson 
Matthey discussed with a third party research partner the possibility 
of Johnson Matthey manufacturing bulk methylphenidate for the third 
party to market and, if Johnson Matthey [[Page 26051]] obtained the 
requisite approvals to manufacture methylphenidate, the third party 
would purchase Johnson Matthey's output. She further noted that, in 
August 1991, DEA, in response to Johnson Matthey's request to 
manufacture methylphenidate coincidental to its researcher 
registration, authorized Johnson Matthey to produce 0.1 kg of 
methylphenidate for use by the third party in its product development. 
At this time, DEA also authorized the third party to procure 
methylphenidate from Johnson Matthey, although DEA did not know at the 
time if Johnson Matthey had, in fact, produced and methylphenidate yet.
    Judge Bittner found that, in November 1991, Johnson Matthey applied 
for both re-registration as a researcher and additionally applied for 
registration as a bulk manufacturer of methylphenidate. She further 
noted testimony by Johnson Matthey that DEA, again, notified Johnson 
Matthey that there was no need to report drug codes unless 
manufacturing would be a coincident activity to its research 
activities.
    The administrative law judge found that, in April 1992, Johnson 
Matthey made its first scale-up lot of methylphenidate. Judge Bittner 
also noted that Johnson Matthey shipped methylphenidate to the third 
party pursuant to DEA order forms. In May 1992, when Johnson Matthey 
received the first order form from the third party, Johnson Matthey 
realized that the third party had put Johnson Matthey's fentanyl 
manufacturer registration number on the form. Judge Bittner found that 
it was uncontroverted that the third party listing of that number was 
improper both because the supplier, rather than the purchaser, is 
required to fill in the supplier's registration number and because, in 
any event, the form should have shown Johnson Matthey's researcher 
registration number instead of its fentanyl manufacturer number.
    Johnson Matthey's compliance and regulatory affairs manager 
testified that Johnson Matthey assumed that its 1992 application for 
registration as a manufacturer for methylphenidate had been approved 
because they had not heard anything to the contrary. Consequently, the 
compliance and regulatory affairs manager wrote to DEA requesting 1993 
manufacturing quotas for Johnson Matthey's production of fentanyl and 
methylphenidate. In August 1992, Johnson Matthey received a 1993 quota 
for fentanyl, but did not receive any DEA quota for methylphenidate. 
Following inquiries by Johnson Matthey, DEA advised Johnson Matthey 
that there was no record of Johnson Matthey being registered to 
manufacture methylphenidate.
    Judge Bittner noted testimony by DEA maintaining that it had not 
been advised, either orally or in writing, that Johnson Matthey had 
manufactured 3.5 kg of methylphenidate under its researcher 
registration in April 1992, nor was it aware that Johnson Matthey had 
been producing the quantity of methylphenidate that it had actually 
manufactured.
    The administrative law judge also noted that, on December 12, 1992, 
the third party ordered another 500 grams of methylphenidate from 
Johnson Matthey who subsequently shipped 325 grams on December 16, 
1992. On December 30, 1992, Johnson Matthey shipped approximately 7.8 
kilograms to the third party pursuant to its December 23, 1992 order 
for 8.0 kilograms. The administrative law judge found that there was no 
dispute that the third party compensated Johnson Matthey for costs 
incurred in the manufacturing of these amounts of methylphenidate.
    The administrative law judge referred to 21 CFR 1301.22(b)(5) which 
allows a researcher to manufacture controlled substances for which it 
is registered to conduct research ``if and to the extent that such 
manufacture is set forth in a statement filed with the application for 
registration . . .'' Judge Bittner held that it is undisputed that 
Johnson Matthey did not file such a statement with DEA for any of the 
applications for registration as a researcher for methylphenidate 
discussed throughout the course of this proceeding.
    As a threshold matter, the administrative law judge first addressed 
the complicated issue of allocation of the burden of proof. Title 21 
U.S.C. 823(a) provides that the Deputy Administrator shall register an 
applicant to manufacture controlled substances in Schedules I and II 
upon a determination that such registration is consistent with the 
public interest. Before taking action to deny any such application for 
registration, the Deputy Administrator, in accordance with 21 U.S.C. 
824(c), shall provide the applicant the opportunity to be heard 
pursuant to an order to show cause. Pursuant to 21 CFR 1301.43(a), a 
hearing on a proposed application for registration as a manufacturer 
also may be requested by bulk manufacturers who are registered, or have 
applied for registration, to manufacture Schedule I or II controlled 
substances. Title 21 CFR 1301.55(a) specifically provides:

    At any hearing on an application to manufacture any controlled 
substance listed in Schedule I or II, the applicant shall have the 
burden of proving that the requirements for such registration 
pursuant to * * * [21 U.S.C. 823(a)] are satisfied. Any other person 
participating in the hearing pursuant to 1301.43 shall have the 
burden of proving any propositions of fact or law asserted by him in 
the hearing.

    In keeping with the plain language of 21 CFR 1301.55(a), the 
administrative law judge assigned the initial burden of proof to 
Johnson Matthey, as the applicant, to demonstrate by a preponderance of 
credible evidence, that its application for registration as a bulk 
manufacturer of methylphenidate met the statutory criteria. She also 
found that MD and the Government had the burden to show that the 
registration of Johnson Matthey as a bulk manufacturer nonetheless is 
not in the public interest.
    The administrative law judge further asked the Deputy Administrator 
to overrule the standard for allocating burdens of proof elicited by 
Administrative Law Judge Young in a series of decisions starting with 
McNeilab, Inc., 46 FR 22089 (1981). Although not explicitly decided by 
the then-Administrator, Judge Young's opinion in McNeilab was adopted 
by the then-Administrator. In McNeilab and its progeny, Judge Young 
construed 21 CFR 1301.55(a) as assigning the burden of proof to the 
applicant seeking registration as a Schedule II bulk manufacturer only 
if an order to show cause had been issued. In all other situations, the 
applicant had the initial burden to make a preliminary showing to the 
agency that registration met the public interest criteria, but had no 
obligation at the hearing except to rebut adverse evidence presented by 
third parties.
    In the present case, Judge Bittner's opinion noted that Judge 
Young's interpretation did not comport with the plain language of 21 
CFR 1301.55(a) which specifically assigns the burden of proof to the 
applicant at any hearing concerning registration of a manufacturer of 
Schedule I and Schedule II controlled substances. Judge Bittner also 
expressed concern that McNeilab did not address the potential problem 
where the Government does not initially oppose the application but 
nonetheless participates in the hearing. In such a situation, if the 
Government later concludes that the application should be denied, a 
literal reading of 21 U.S.C. 824(c) would require the subsequent 
issuance of a show cause order and a second hearing pursuant to that 
order. Beyond the hardship this would impose on the applicant, an 
issuance is raised as to whether the [[Page 26052]] Government should 
be estopped from introducing evidence at the second hearing that it 
knew or should have known existed at the time of the first hearing.
    In assigning the burden of proof in this matter, Judge Bittner 
noted that such assignment would promote judicial economy by avoiding 
multiple hearings. She stated that, although the regulations provide 
that a hearing may be requested either by an applicant in response to 
an order to show cause, or by a third party pursuant to 21 CFR 
1301.43(a), the issue of the applicant's compliance with the statutory 
criteria for registration as a manufacturer, as well as any third party 
objections, should be raised in a single hearing with the applicant 
bearing the burden of proof as to his or her compliance with the 
statutory requirements. She concluded that the language contained in 21 
U.S.C. 824(c) should be interpreted as a notice provision rather than a 
condition precedent to the denial or revocation of a registration.
    Judge Bittner concluded that the burden is on Johnson Matthey to 
prove, by a preponderance of the credible evidence, that its 
application for registration as a bulk manufacturer of methylphenidate 
meets the public interest criteria of 21 U.S.C. 823(a), and, if so, 
whether any other party has demonstrated, by a preponderance of the 
credible evidence, that Johnson Matthey's registration, nonetheless, 
would not be in the public interest.
    In accordance with the provisions of 21 U.S.C. 823)a) the Deputy 
Administrator shall register an applicant to manufacture controlled 
substances in Schedules I and II upon a determination that such 
registration is consistent with the public interest. The following 
factors are to be considered in determining whether registration is 
consistent with the public interest:
    (1) Maintenance of effective controls against diversion of 
particular controlled substances and any controlled substance in 
schedule I or II compounded therefrom into other than legitimate 
medical, scientific, research, or industrial channels, by limiting the 
importation and bulk manufacture of such controlled substances to a 
number of establishments which can produce an adequate and 
uninterrupted supply to these substances under adequately competitive 
conditions for legitimate medical, scientific, research and industrial 
purpose;
    (2) Compliance with applicable State and local law;
    (3) Promotion of technical advances in the art of manufacturing 
these substances and the development of new substances;
    (4) Prior conviction record of applicant under Federal and State 
laws relating to the manufacture, distribution, or dispensing of such 
substances;
    (5) Past experience in the manufacture of controlled substances, 
and the existence in the establishment of effective control against 
diversion; and
    (6) Such other factors as may be relevant to and consistent with 
the public health and safety. 21 U.S.C. 823(a).
    It is well established that the Deputy Administrator is not 
required to make findings with respect to each of the above-listed 
factors, but has discretion to give each factor the weight he deems 
appropriate, depending upon the facts and circumstances in each case. 
See Michael J. Schnitzer, M.D., 56 FR 67331 (1991).
    The administrative law judge stated in her opinion that Johnson 
Matthey and MD had agreed that competition in the methylphenidate 
market is not an issue in this proceeding. Further, Judge Bittner found 
that there is no dispute concerning Johnson Matthey's physical 
security, nor whether Johnson Matthey has complied with applicable 
state and local law, that registration of Johnson Matthey as a bulk 
manufacturer of methylphenidate would promote technical advances in 
manufacturing controlled substances, nor whether Johnson Matthey has 
any prior convictions relating to the manufacture, distribution or 
dispensing of controlled substances. Therefore, the only public 
interest factors which remain to be considered in this matter are 21 
U.S.C. 823(a) (1) and (5).
    The administrative law judge found that there is insufficient 
evidence in the record to make any findings as to 21 U.S.C. 823(a)(1). 
Judge Bittner, referring to the legislative history of the Controlled 
Substances Act, concluded that 21 U.S.C. 823(a)(1) contemplates that 
the concern for diversion of controlled substances would determine the 
maximum number of manufacturers to be registered and, similarly, that 
concern for insuring an adequate and uninterrupted supply of the same 
substances would determine the minimum number. However, in the instant 
case, the administrative law judge found that there is no evidence that 
registering an additional bulk manufacturer would increase the risk of 
diversion, nor is there evidence that the two bulk manufacturers 
currently registered to manufacture methylphenidate are incapable of 
assuring an adequate supply of the drug.
    With respect to 21 U.S.C. 823(a)(5), the administrative law judge 
found that there is no evidence of diversion of any of the controlled 
substances, such as fentanyl, that Johnson Matthey has manufactured 
pursuant to its existing manufacturer registration. Judge Bittner 
specifically found that Johnson Matthey's successful past experience in 
manufacturing fentanyl weighed in favor of granting its application to 
manufacture methylphenidate.
    With respect to Johnson Matthey's experience producing 
methylphenidate, the administrative law judge found that Johnson 
Matthey's history with regard to compliance with DEA regulations is 
much less satisfactory. On a number of occasions, Johnson Matthey 
failed to file a statement with DEA specifying how much methylphenidate 
the company intended to manufacture coincident to its researcher 
registration, as required by 21 CFR 1301.32(e). Additionally, order 
forms used to transfer methylphenidate from Johnson Matthey to the 
third party were altered to reflect Johnson Matthey's researcher 
registration number instead of a manufacturer registration number.
    Judge Bittner further found that Johnson Matthey's principal 
witness with respect to the company's handling of methylphenidate, its 
compliance and regulatory affairs manager, was unfamiliar with DEA 
regulations and procedures and concluded that he was not a particularly 
credible witness. She additionally found that the record does not 
establish that Johnson Matthey advised any DEA official how much 
methylphenidate it had manufactured or that it intended to manufacture 
coincidental to its researcher registration.
    The administrative law judge found that the record did not provide 
support for Johnson Matthey's argument that these incidents were merely 
technical violations of DEA regulations and, therefore, do not indicate 
that Johnson Matthey's registration as a bulk manufacturer would be 
inconsistent with the public interest. Johnson Matthey further argued 
that DEA officials were aware of its handling of methylphenidate at all 
times and approved of it.
    Judge Bittner found that Johnson Matthey's refusal to acknowledge 
that it had engaged in substantial misconduct indicates that the 
responsible officials of the company lacked not only understanding of 
DEA's regulatory scheme, but respect for it. Further, by not filing the 
requisite statement with DEA and not otherwise advising DEA of its 
intentions, Johnson Matthey was able to manufacture significant 
quantities of [[Page 26053]] methylphenidate while avoiding, not only 
the regulatory restrictions on bulk manufacturers, but also the 
scrutiny of potential competitors. The administrative law judge 
concluded that sufficient grounds exist to deny Johnson Matthey's 
application.
    Notwithstanding this finding, Judge Bittner recommended that the 
Deputy Administrator grant Johnson Matthey's application, subject to 
certain requirements, because Johnson Matthey has demonstrated that it 
had no relevant prior convictions or history of noncompliance with 
state and local law, that its security systems are adequate to handle 
methylphenidate, and that it has a satisfactory history of handling 
other controlled substances. Judge Bittner additionally relied on her 
finding that DEA's own actions served to complicate the issue by 
granting Johnson Matthey's application for a researcher registration 
even though Johnson Matthey's yearly applications for researcher 
registration clearly expressed the company's intent to manufacture 
methylphenidate but were not accompanied by statements of the quantity 
of methylphenidate the company intended to manufacture. Further, DEA 
had not published any clarification of the permissible scope of 
manufacturing under a researcher registration, and that Johnson 
Matthey's conduct may already have resulted in adverse consequences to 
that company in view of the lengthy hearing and consequent delay in 
achieving the registration. Finally, Johnson Matthey's most recent 
application for renewal of registration as a researcher, lists the 
quantity of methylphenidate that the company intends to manufacture, 
indicating that Johnson Matthey may have learned from the experience.
    The administrative law judge recommended that Johnson Matthey's 
application be granted subject to the requirements that: (1) within 120 
days following issuance of its registration to manufacture bulk 
methylphenidate, Johnson Matthey provide, at its own expense, training 
for its regulatory and compliance affairs staff about DEA regulations 
(the curriculum and number of hours of such training to be approved by 
the Deputy Assistant Administrator of the Office of Diversion Control 
or his designee); (2) until such time as Johnson Matthey receives an 
individual manufacturing quota to manufacture methylphenidate pursuant 
to 21 CFR 1303.21, Johnson Matthey receive permission from DEA's office 
of Drug and Chemical Evaluation in advance of undertaking any 
manufacture of methylphenidate; and (3) Johnson Matthey limit such 
manufacture to a quantity authorized in writing by the Office of Drug 
and Chemical Evaluation of DEA.
    Johnson Matthey took exception to the administrative law judge's 
conclusion that there is no evidence that the two currently registered 
bulk manufacturers of methylphenidate were incapable of assuring an 
adequate supply of methylphenidate. Johnson Matthey argued that these 
two producers cannot produce an adequate and uninterrupted supply of 
methylphenidate and, therefore, that the market situation is not 
competitive. Johnson Matthey also took exception to Judge Bittner's 
statements that the record does not support Johnson Matthey's 
contention that DEA knew that it was manufacturing methylphenidate, 
arguing that the record provides ample evidence of DEA's knowledge. 
Additionally, Johnson Matthey took exception to the administrative law 
judge's conclusions that Johnson Matthey's record with regard to 
methylphenidate presented a ``history of evasion and/or outright 
violations of DEA regulations,'' arguing that Johnson Matthey never 
deliberately misled DEA and DEA has no written public policy defining 
research and quantities permitted to be manufactured under a researcher 
registration. Johnson Matthey also noted that it had hired a new DEA 
coordinator who had already attended training, that Johnson Matthey's 
training plan is broader in scope than that recommended by the 
administrative law judge, and that Johnson Matthey already had 
presented its curriculum to DEA for approval.
    MD, while concurring with the majority of the administrative law 
judge's findings of fact and conclusions of law, took exception to 
Judge Bittner's recommendation to grant Johnson Matthey's registration 
subject to certain restrictions. MD argued that Johnson Matthey's 
conduct and its part experience in manufacturing controlled substances, 
particularly methylphenidate, are bases to deny Johnson Matthey's 
application. MD argued that the administrative law judge's proposed 
restrictions are inadequate and improperly reward Johnson Matthey's 
illegal activities. Additionally, MD argued that the instant proceeding 
is similar in many respects to that of Alra Laboratories, Inc., 59 FR 
50620 (1994) wherein the application for registration as a manufacturer 
was denied by the Deputy Administrator after the administrative law 
judge recommended approval. MD submitted that DEA registration of 
Johnson Matthey would not be in the public interest.
    The Government took exception to the administrative law judge's 
finding that ``once [a] hearing is requested [on an application to 
manufacture controlled substances under Schedule I or II], the issue of 
the applicant's compliance with the statutory requirements and any 
other issued raised by a third party should be litigated in a single 
hearing.'' The Government further objected to the administrative law 
judge's conclusion that 21 U.S.C. 824(c), requiring that a show cause 
proceeding be initiated prior to the denial of such application, is 
simply a ``notice provision'', stating that the Government was not ware 
of any situation in which the DEA did not require the issuance of a 
show cause order prior to denying an application for registration. The 
Government concurred with Judge Young's conclusion in McNeilab, that 
separate hearings could be required for a third party request under 21 
CFR 1301.43, or under a show cause order pursuant to 21 U.S.C. 824(c) 
and 21 CFR 1301.44.
    With regard to the allocation of burdens of proof, the Deputy 
Administrator concurs with, and hereby adopts, Judge Bittner's reliance 
on the plain language of 21 CFR 1301.55(a) which clearly assigns to the 
applicant the burden to the applicant to prove the statutory 
requirements for registration as a manufacturers
    The Deputy Administrator gave favorable consideration to the 
exceptions filed by Johnson Matthey, but concurs with the 
administrative law judge's recommended restrictions concerning the 
granting of Johnson Matthey's registration to manufacture bulk 
methylphenidate.
    The Deputy Administrator finds that the exceptions filed by MD were 
fully considered by the administrative law judge. The Deputy 
administrator rejects MD's argument that the decision rendered in Alra 
is applicable to the present case because the facts at issue in Alra 
are markedly different from those in the present case. In Alra, the 
denial of its application as a manufacturer of controlled substances 
followed findings of numerous recordkeeping violations, a failure to 
ensure proper security, failure to ensure proper DEA registration as a 
manufacturer, illegal possession and distribution of controlled 
substances and a lengthy history of Food, Drug & Cosmetic Act 
violations with respect to the manufacture and distribution of 
prescription drugs. Further, Alra twice had been the subject of seizure 
of its product, and its president consistently demonstrated that he had 
not taken his responsibilities concerning controlled substances 
seriously. Contrary to Alra, Johnson Matthey has an history of 
[[Page 26054]] responsible manufacture of controlled substances in 
accordance with its previous manufacturing registration. Additionally, 
Johnson Matthey has addressed and corrected prior regulatory 
discrepancies in a timely manner, demonstrating the commitment required 
of a DEA registrant.
    Finally, concerning the administrative law judge's recommendation 
with respect to duplicative mandated hearing provisions, the Deputy 
Administrator disagrees with Judge Bittner's conclusion in this 
proceeding that the requirement of an order to show cause, pursuant to 
21 U.S.C. 824(c), comprises simply a ``notice provision.'' Rather, the 
Deputy Administrator finds that, as currently written, the statute 
mandates that the Government issue an order to show cause whenever it 
seeks to deny or revoke a DEA Certificate of Registration. The Deputy 
Administrator acknowledges that, in some cases, this may subject an 
applicant to multiple hearings. however, whether the Government would 
be estopped from raising issues at a show cause hearing subsequent to a 
``third-party hearing'' would depend on whether the issues were 
actually litigated and determined. In any event, this decision could 
only be determined on a case-by-case basis. The Deputy Administrator 
also notes, as provided in the regulations, that hearings conducted 
pursuant to an order to show cause may be consolidated with a hearing 
requested by a third-party. 21 CFR 1301.43(a). The Deputy Administrator 
encourages that parties to these type of proceedings consolidate these 
hearings whenever possible.
    The Deputy Administrator hereby adopts the administrative law 
judge's findings of fact and conclusions of law, except as previously 
noted. Accordingly, the Deputy Administrator of the Drugs Enforcement 
Administration, pursuant to the authority vested in him by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that the 
application of Johnson Matthey, Inc. for registration as a bulk 
manufacturer of methylphenidate, be, and it hereby is, approved subject 
to the requirements enumerated by the administrative law judge.

    Dated: May 8, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-11934 Filed 5-15-95; 8:45 am]
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