Opinion for the Court filed by Circuit Judge BROWN.
John Doe, Inc. 1 sеeks review of the DEA’s denial of a permit to import for bioequivalency testing a generic version of an FDA-approved drug. Doe challenges the permit denial as contrary to law, arbitrary and capricious, and viola-tive of the Fifth Amendment to the United States Constitution. Doe further argues the district court erred in dismissing its complaint for lack of jurisdiction. We conclude the district court correctly determined exclusive jurisdiction over Doe’s claims lies in the courts of appeals pursuant to 21 U.S.C. § 877. We further conclude the DEA acted within its discretion in denying Doe’s permit application. We accordingly affirm the district court and deny Doe’s petition.
I
Doe, a drug manufacturer, hopes to market a generic version of the drug Mari-nol — an FDA-approved drug containing the same active ingredient as marijuana and used to treat nausea and loss of appetite in cancer and AIDS patients. To get approval to market its generic alternative, Doe must successfully complete “bioequi-valency” studies, demonstrating to the FDA that its drug is in all relevant aspects equivalent to Marinol. In order to conduct the necessary bioequivalency testing, Doe seeks to immediately import over half a million capsules of its drug from its overseas manufacturing partner.
Doe’s plans, however, have been stymied by the DEA. Pursuant to the Controlled Substances Act (“CSA”), the DEA regulates importation of “controlled substances.” 21 U.S.C. § 952.
2
Under the CSA, controlled substances are categorized into five schedules based on their potential for abuse or dependence, their accepted medical use, and their accepted safety for use under medical supervision. Schedule I is the most stringently controlled, and schedule V the least.
Id.
§ 812. Only schedules I and III are at issue here. Schedule I substances are subject to very strict controls because they have “no currently accepted mеdical use in treatment in the United States,” have “a lack of accepted safety for use ... under medical supervision,” and have “a high potential for abuse.”
Id.
§ 812(b)(1). Schedule III substances, in contrast, have “a currently accepted medical use in treatment in the United States,” and less potential for abuse.
Id.
§ 812(b)(3). Controlled substances were initially allocated to the various schedules by Congress when it first enacted the CSA.
Gettman v. DEA,
Dronabinol, the active ingredient in both Marinol and Dоe’s generic alternative, has been assigned to schedule I since Congress first enacted the CSA in 1970.
See
CSA, Pub. L. No. 91-513, § 202, schedule I
*564
¶ (c)(17), 84 Stat. 1236, 1249 (1970). Dro-nabinol remains in schedule I today, with one notable exception. The FDA, after extensive testing and research, approved the drug Marinol — described as “[drona-binol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule” — for treatment of nausea associated with cancer patients and anorexia associated with weight loss in AIDS patients. 51 Fed. Reg. 17,476, 17,478 (1986). As a result of this FDA approval, the DEA eventually assigned “Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule
in a U.S. Food and Drug Administration approved product
” to schedule III. 21 C.F.R. § 1308.13(g)(1) (emphasis added); 64 Fed. Reg. 35,928 (1999). DEA was careful to stress, however, that it was rescheduling dronabinol only “in a FDA approved drug product.”
When Doe applied for a permit to import its drug containing dronabinol, it was registered with the DEA to import schedule III, but not schedule I, substances. On February 28, 2006, Doe applied for a permit to import 1,200 capsules of its drug to begin equivalency testing. On its permit application, instead of using the general DEA code number for dronabinol, Doe listed the DEA code number for “Dronabi-nol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product.” The DEA issued the permit, and Doe imported the 1,200 capsules.
Shortly thereafter, Doe sought another permit to import 525,000 capsules of its drug, again using the DEA code number for “Dronabinol ... in a U.S. Food and Drug Administration approved product.” This time, however, the large quantity prompted further investigation by the DEA. When the DEA learned that the substance Doe sought to import was not in fact Marinol, the DEA denied Doe’s permit application. Because Doe’s drug containing dronabinol has not been approved for marketing by the FDA, the DEA classifies the drug as falling within the general category of “dronabinol” in schedule I, not schedule Ill’s narrow description of “[dro-nabinol ... in a U.S. Food and Drug Administration approved product.” 21 C.F.R. § 1308.13(g)(1) (emphasis added). Thus, Doe found itself in a catch-22 of sorts: while it sought to import its drug under schedule III so it could conduct testing necessary to obtain FDA approval, the DEA’s interpretation of its regulatory provision effectively prohibits importation of a drug containing dronabinol under schedule III until the drug is FDA approved.
The DEA provided Doe written notice of its permit denial on June 12, 2006. The letter advised that Doe could request an agency hearing within thirty days. Doe оpted not to pursue further agency consideration, but instead sought immediate redress from the courts.
3
Because the law governing such appeals is unsettled, Doe filed two actions — one in district court,
see John Doe, Inc. v. Gonzalez,
No. 06-966,
*565 On June 29, 2006, the district court dismissed Doe’s case for lack of subject matter jurisdiction. In a lengthy and well-reasoned opinion, the court considered whether the DEA’s denial of Doe’s permit was sufficiently “final” to permit judicial review under the Administrative Procedure Act (“APA”), see 5 U.S.C. § 704, and, even if sufficiently final, whether 21 U.S.C. § 877 nonetheless divests the district court of original jurisdiction over Doe’s claims, see id. (locating original jurisdiction in the courts of appeals over “[a]ll final determinations, findings, and conclusions” of the DEA under the CSA). Ultimately, the district court concluded it lacked jurisdiction. The court reasoned that, at least insofar as Doe’s claims are concerned, § 877’s reference to “final determinations, findings, and conclusions” encompasses the APA’s requirement of final agency action. Thus, either the permit denial wasn’t sufficiently final to confer jurisdiction under the APA, or, in the event it was sufficiently final, proper recourse lay in the court of appeals pursuant to § 877. Either way, the district court concluded it did not have jurisdiction, and dismissed Doe’s complaint.
Doe appealed the dismissal. That case has been consolidated with Doe’s petition seeking direct review in this court under 21 U.S.C. § 877, and we address both here. While the district court found it possible to resolve Doe’s case without reaching a definitive conclusion on the issues of finality and the scope of our exclusive direct-review jurisdiction under 21 U.S.C. § 877, we must decide both issues.
II
Doe continues to press the argument that the DEA’s denial of Doe’s permit was not a “final determination[ ], finding[ ], [or] conclusion! ]” sufficient to trigger this court’s original jurisdiction under 21 U.S.C. § 877. But if the permit denial wasn’t a “final determination[ ]” under § 877, it may also fail to constitute “final agency action” sufficient to comprise a claim under the APA, 5 U.S.C. § 704, effectively denying Doe any judicial review of its permit denial. Indeed, the district court expressed serious reservations about this possible lack of finality.
Doe’s briefing addresses the finality question in a single sentence in a footnote, declaring the district court’s concerns about finality “now moot” because the DEA concedes its permit denial constituted final agency action. Pet’r’s Br. 22 n. 9. Finality is not synonymous with jurisdiction. When judicial review is sought under the APA, for example, the requirement of “final agency action” is not jurisdictional.
See Trudeau v. Fed. Trade Comm’n,
*566 To evaluate finality, this court applies a two-part test:
First, the action under review must mark the consummation of the agency’s decisionmaking process — it must not be of a merely tentative or interlocutory nature. Second, the action must be one by which rights or obligations have been determined, or from which legal consequences will flow.
Nat’l Ass’n of Home Builders v. Norton,
In
Cibr-Geigy Corp. v. United States EPA
Noting the Supreme Court’s instruction to “apply the finality requirement in a ‘flexible’ and ‘pragmatic’ way,” this court reversed on appeal.
Id.
at 435 (quoting
Abbott Labs. v. Gardner,
Both
Bennett
and
Cibcu-Geigy
firmly support a finding of finality here. The DEA’s action in this case was not mеrely tentative, but rather definitive: the DEA affirmatively denied Doe’s permit application. Moreover, the DEA candidly acknowledged before the district court that its position would not change in further administrative proceedings.
See
Defs.’ Opp’n at 18 (June 2, 2006) (noting that “[tjhrough [the administrative] process, Plaintiff would be informed
again
that [its] April 18, 2006 application was denied because the product Plaintiff sought to import is a schedule I controlled substance that Plaintiff is not registered to handle”) (footnote omitted) (citing Decl. of Matthew Strait, Chief of the DEA’s Quota and United Nations Reporting Unit, attached as Ex. B to Defs.’ Opp’n (hereinafter Strait Decl.)). And the permit denial, which be
*567
came final thirty days after its issuance, clearly “determined” Doe’s rights,
Bennett,
Moreover, this court has recognized that “[a]n agency’s past characterization of its own action, while not decisive, is entitled to respect in a finality analysis.”
Nat’l Ass’n of Home Builders,
What arguably cuts against finality in this case is the lack of a comprehensive administrative record to assist judiсial review. Because Doe opted to forgo further administrative review of its permit denial, the administrative record is — as the district court correctly observed — “largely devoid of an explicit analysis by the DEA laying out its reasoning” for the permit denial.
To allow the meager administrative record in this case to undercut finality, however, would confuse jurisdictional finality with prudential concerns over the fitness of issues for judicial review. Finality, ripeness, and exhaustion of administrative remedies are related, overlapping doctrines that are analytically but not categorically distinct. Exhaustion focuses on the process a litigant must follow; ripeness describes the fitness of issues for judicial review; finality focuses on the conclusiveness of agency action. “Ripeness and exhaustion are complementary doctrines ... designed to prevent unnecessary or untimely judicial interference in the administrative process.”
Ticor Title Ins. Co. v. FTC,
Thus, even if exhaustion, ripeness, and finality may be difficult to distinguish in some contexts, they must be carefully delineated when, as here, finality is a statutory jurisdictional prerequisite rather than merely a precaution related to concreteness and institutional capacity. An administrative order is final for jurisdictional purposes when it “imposes an obligation, denies a right or fixes some legal relationship as a consummation of the administrative process.”
Am. Train Dispatchers Ass’n v. ICC,
*568 III
Having concludеd the DEA’s permit denial was sufficiently final to permit judicial review, we must still decide where jurisdiction properly lies — in the district court pursuant to the APA, 5 U.S.C. § 704, or in this court pursuant to 21 U.S.C. § 877.
21 U.S.C. § 877 vests exclusive jurisdiction in the courts of appeals over “[a]ll final determinations, findings, and conclusions” of the DEA applying the CSA. Doe argues the district court erred in dismissing its complaint for lack of subject matter jurisdiction, because § 877 does not apply to the DEA’s permit denial in this case. Instead, Doe argues, this case is renewable under the APA as “final agency action for which there is no other adequate remedy in a court.” 5 U.S.C. § 704.
If Doe is correct, the permit denial must be “final agency action” under § 704, but not a “final determination[ ], finding! ], [or] conclusion!]” under § 877. On the plain terms of the two provisions, however, that assertion seems implausible. Perhaps “agency action” encompasses more than “determinations, findings, and conclusions,” but the permit denial at issue here falls squarely within the plain meaning of “determination.”
See
BlacK’s Law Diotio-naey 480 (8th ed. 2004) (defining “determination” as “[a] final decision by a court or administrative agency”). Nonetheless, Doe correctly points out that, in a few cases, district courts have exercised jurisdiction over some DEA decisions implementing the CSA, concluding there is a spherе of DEA activity that falls within the APA’s “final agency action,” but outside § 877’s “final determinations, findings, and conclusions.”
See, e.g., PDK Labs Inc. v. Reno,
Before addressing Doe’s argument, it is worth noting, as did the district court below, that as a matter of practice almost all cases challenging DEA decisions under the CSA have been filed directly in the courts of appeals pursuant to 21 U.S.C. § 877.
See, e.g., Noramco of Del., Inc. v. DEA,
And yet a few district courts discern some play in the joints between “agency action” under the APA and DEA “determinations, findings, and conclusions” under 21 U.S.C. § 877. Those cases rely heavily on the Supreme Court’s decision in
McNary,
which held that a narrow grant of individualized review, vested exclusively in the courts of appeals, did not preclude district court jurisdiction over a class action claiming a pattern or practice of constitutional violations by the Immigration and Naturalization Service.
We do not find the other reasons district courts have given for exercising jurisdiction any more persuasive. First, the opinions presume the applicability of 21 U.S.C. § 877 turns on whether the DEA complied with the procedural requirements for final agency “determinations, findings, and conclusions.”
See, e.g., PDK Labs,
Similarly, concern over the lack of a comprehensive administrative record is not sufficient cause to narrow the scope of 21 U.S.C. § 877, as some district courts have attempted.
See Oregon,
Moreover, while in some cases an underdeveloped administrative record might prevent effective consideration of
any
legal issue, this is not one of those cases. The limited administrative record in this case establishes sufficient facts to squarely present the critical legal issue. And, in future cases where an insufficient administrative record is crippling, a court of appeals always has the option of either remanding to the agency for further factual development or invoking the prudential doctrine of ripeness.
See Fla. Power & Light Co. v. Lorion,
As the district court here rightly cautioned, adopting Doe’s narrow interpretation of § 877 encourages forum shopping and encourages dissatisfied claimants to “jump the gun” by going directly to the district court to develop their case instead of exhausting their administrative rеmedies before the agency. Moreover, it encourages “duplicative and potentially conflicting review, and the delay and expense incidental thereto.”
Telecomms. Research & Action Ctr. v. FCC,
The DEA’s denial of Doe’s permit is properly reviewable in this court pursuant to 21 U.S.C. § 877.
IV
This court reviews the DEA’s interpretation of the CSA’s provisions governing the scheduling of controlled substances under
Chevron’s
familiar two-step analysis.
See Gonzales v. Oregon,
The DEA interprets its schedule III regulatory language — “Dronabinol (syn
*571
thetic) in sesamе oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product,” 21 C.F.R. § 1308.13(g)(1) — as not encompassing Doe’s dronabinol drug, because Doe’s drug is not FDA “approved” for marketing. Doe argues this interpretation is contrary to law, arbitrary and capricious, and violates the due process clause of the Fifth Amendment. Doe’s argument rests on two supposed parallels: (1) that Doe’s drug is essentially the same as schedule III Marinol, and (2) that what the DEA did in this case is essentially the same as what it attempted in
Grinspoon v. DEA
In
Grinspoon,
the DEA took the position that two of the three findings necessary to place a drug on schedule I — i.e., that the drug has “no currently accepted medical use in treatment in the United States” and “a lack of accepted safety for use ... under medical supervision,” 21 U.S.C. § 812(b)(1) — were conclusively established by the drug’s lack of FDA marketing approval.
Grinspoon,
Doe contends the DEA has done effectively the same thing here; that is, defined schedule III dronabinol so as “to exclude any product that does not yet have specific FDA marketing approval.” Pet’r’s Br. 15. But that is not what the DEA has done. Quite the opposite, the regulation simply includes a certain form of FDA “approved” dronabinol under schedule III; it does not affirmatively “exclude” any drug from schedule III. There is nothing in 21 C.F.R. § 1308.13(g)(1) thаt would pose an obstacle to Doe petitioning to have its dronabinol drug placed on schedule III.
Doe’s comparison to
Grinspoon,
therefore, is inapt. In
Grinspoon,
the DEA equated the absence of FDA marketing approval with a lack of currently accepted medical use for purposes of placing a substance on schedule I and refusing to schedule it less restrictively.
Grinspoon,
The DEA’s interpretation of FDA “approval” in 21 C.F.R. § 1308.13(g)(1) therefore bars consideration of Doe’s drug under that specific provision, but it does not bar Doe’s drug from schedule III altogether. If Doe wishes to have schedule III revised to include its drug, it can petition the DEA and offer evidence that its drug meets the requirements for being placed in that schedule. See 21 U.S.C. § 811(a); 21 C.F.R. § 1308.43(a). Instead, Doe invites this court to eliminate a limitation on an already existing schedule III category, effectively rescheduling Doe’s drug without it making the statutorily required showing. We decline. See 21 U.S.C. § 812(b) (“[A] drug or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance.”).
Doe’s failed analogy to Grinspoon is not its only argument, however. Doe also argues the DEA’s differential treatment of its drug and Marinol under 21 C.F.R. § 1308.13(g)(1) is arbitrary and capricious because its drug is “indisputably an identical formulation to Marinol.” Pet’r’s Br. 17. Not surprisingly, however, the DEA disputes the indisputable, calling Doe’s claim “wishful thinking at best.” Resp’t’s Br. 18. More important, we have scoured the record in vain, searching for evidence Doe’s drug is in fact functionally equivalent to Marinol. While the record is replete with Doe’s repeated and forceful assertions that its drug is the same thing as Marinol, Doe has not provided any evidence its drug is in all relevant respects identical. Doe therefore hasn’t established — -indeed, hasn’t even attempted to establish — the factual predicate necessary for this court to resolve the legal question Doe asks us to resolve.
In one sense this is unsurprising. The whole reason Doe seeks to import its drug is to perform bio
equivalency
testing comparing its drug and Marinol. If equivalency was as “undisputed]” as Doe asserts, it is unclear why this testing would be necessary. Our best guess from the record, therefore, is that functional equivalency is a factual issue that remains to be determined. What that means for this case is that Doe has asked this court to decide an abstract legal question, unrelated to the actual established facts in this ease. That we cannot do. Doe simply has not “present[ed] the court with the concrete facts that are necessary to an informed decision” on its equivalency claim, and therefore that claim is not “ripe for adjudication.”
Buckley v. Valeo,
At oral argument, Doe’s counsel protested that it was never asked to demonstrate its drug’s equivalency to Marinol. But when the DEA first notified Doe of the permit denial, the DEA specifically invited Doe to “submit a letter explaining the Company’s plans in exact and precise detail ....” Strait Decl. ¶ 18. Doe opted not to respond. Id. ¶ 22. Shortly thereafter, the DEA also advised Doe of its right to request a hearing challenging the permit denial. See June 12, 2006 Letter. Doe opted not to exhaust its administrative remedies, seeking instead immediate redress in the courts. Doe was given ample opportunity tо demonstrate to the DEA that its drug was effectively the same *573 thing as Marinol, and thereby build a record that would present this court with a ripe controversy.
In sum, we see nothing in 21 C.F.R. § 1308.13(g)(1) that is contrary to the Controlled Substances Act. Nor is the DEA’s interpretation limiting that specific provision to drugs with FDA marketing approval plainly erroneous. 6 It is inappropriately restrictive for the DEA to say, as it did in Grinspoon, that FDA approval is the only way to demonstrate a drug is safe and has currently accepted medical use. But it is completely different (and eminently reasonable) for the DEA to require an importer, relying on functional equivalency as the basis for a drug’s safety and current acceрtance for medical use, to demonstrate that its drug is actually equivalent.
* * *
Contrary to Doe’s assertion that the DEA’s interpretation of 21 C.F.R. § 1308.13(g)(1) leaves Doe with “requirements [that] are impossible to satisfy,” Pet’r’s Reply Br. 7, Doe does have options: (1) petitioning to have its dronabinol drug rescheduled, or (2) obtaining schedule I registration. We are not, however, unsympathetic to Doe’s predicament. The DEA’s interpretation obviously does make it harder (and costlier) for Doe to obtain final FDA approval to market its generic drug. As Doe has pointed out, this result runs counter to Congress’s purpose manifested in the so-called Hatch-Waxmаn Amendments, Pub. L. No. 98-417, 98 Stat. 1585 (1984), “to make available more low cost generic drugs.”
Serono Labs., Inc. v. Shalala,
Y
The petition for review is denied, and the judgment of the district court is affirmed.
So ordered.
Notes
. This case was filed under seal pursuant to Petitioner/Appellant’s request. Accordingly, the Petitioner/Appellant is referred to as “John Doe, Inc.” or "Doe” throughout this opinion.
. The CSA grants regulatory authority to the Attorney General, 21 U.S.C. §§ 821, 871(b), who has in turn delegated that authority to the Administrator of the DEA, 28 C.F.R. § 0.100(b).
. Because Doe chose to forgo its administrative remedies, the agency’s decision became final thirty days after Doe's receipt of the DEA’s June 12, 2006 letter. See Letter from Joseph T. Rannazzisi, Deputy Assistant Administrator, DEA Office of Diversion Control, to John Doe, Inc. (June 12, 2006) (Administrative Record at 117) (hereinafter June 12, 2006 Letter); 21 C.F.R. § 1312.44.
. Both
Norton
and
Bennett
construe the APA's requirement of
"final
agency action.” 5 U.S.C. § 704 (emphasis added). Here we are evaluating finality under 21 U.S.C. § 877’s limitation of review to a
“final
decision” (emphasis added). We see no reason, however, that the word "final” in § 877 should be interpreted differently than the word "final” in the APA.
Cf. Indep. Equip. Dealers Ass’n,
. This court did review a later phase of the
PDK Labs
litigation,
see
. Doe’s Fifth Amendment claim likewise fails. Doe has not shown that the permit denial has changed its “formal legal status,” or had the "broad effect of largely precluding” it from pursuing a business.
Kartseva v. Dep’t of State,