United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued March 25, 2013 Decided July 23, 2013

No. 12-5176

DANIEL WAYNE COOK, ET AL.,

APPELLEES

v.

FOOD & DRUG ADMINISTRATION, ET AL.,

APPELLANTS

Consolidated with 12-5266

Appeals from the United States District Court

for the District of Columbia

(No. 1:11-cv-00289)

Daniel Tenny, Attorney, U.S. Department of Justice, 

argued the cause for appellants. With him on the briefs were 

Stuart F. Delery, Principal Deputy Assistant Attorney 

General, Ronald C. Machen Jr., U.S. Attorney, Scott R. 

McIntosh, Attorney, William B. Schultz, Acting General 

Counsel, U.S. Health and Human Services, and Eric M. 

Blumberg, Deputy Chief Counsel.

Kent S. Scheidegger was on the brief for amicus curiae 

Criminal Justice Legal Foundation in support of appellant. 
2

Eric A. Shumsky argued the cause for appellees. With 

him on the brief were Coleen Klasmeier and Dale A. Baich, 

Assistant Federal Public Defender, Office of the Federal 

Public Defender for the District of Arizona. 

Before: ROGERS, Circuit Judge, and GINSBURG and 

SENTELLE, Senior Circuit Judges.

Opinion for the Court filed by Senior Circuit Judge

GINSBURG.

GINSBURG, Senior Circuit Judge: A group of prisoners 

on death row in Arizona, California, and Tennessee sued the 

Food and Drug Administration, the Department of Health and 

Human Services, and the official in charge of each agency

(collectively, the FDA) for allowing state correctional 

departments to import sodium thiopental (thiopental), a 

misbranded and unapproved new drug used in lethal injection 

protocols, in violation of the Food, Drug, and Cosmetic Act 

(FDCA), 21 U.S.C. § 381(a), and the Administrative 

Procedure Act (APA), 5 U.S.C. § 706(2)(A). The district 

court entered summary judgment for the plaintiffs, 

permanently enjoined the FDA from allowing the importation 

of apparently misbranded or unapproved thiopental, and 

ordered the FDA to notify state correctional departments that 

the use of imported thiopental is unlawful and that existing 

stocks must be sent to the FDA. For the reasons that follow, 

we affirm the judgment of the district court but vacate the 

portion of its remedial order pertaining to thiopental already 

in the possession of the states. 
3

I. Background

The Food, Drug, and Cosmetic Act (FDCA), makes it 

unlawful to introduce into interstate commerce a misbranded 

drug, 21 U.S.C. § 331(a), or an unapproved new drug, § 

355(a).* A drug is misbranded if, among other things, it was 

“manufactured, prepared, propagated, compounded, or 

processed in an establishment not duly registered” with the 

FDA. § 352(o). An unapproved new drug is one that is 

neither “generally recognized, among experts ... as safe and 

effective” for its labeled use, § 321(p)(1), nor approved by the 

FDA as safe and effective for its proposed use, § 355(d). 

The FDCA also regulates the importation of drugs. 21 

U.S.C. § 381(a) provides:

The Secretary of the Treasury shall deliver to the 

Secretary of Health and Human Services [HHS], upon his 

request, samples of ... drugs ... being imported or offered 

for import into the United States .... The Secretary of 

[HHS] shall furnish to the Secretary of the Treasury a list 

of establishments registered [with the FDA] ... and shall 

request that if any drugs ... manufactured, prepared, 

propagated, compounded, or processed in an 

establishment not so registered are imported or offered 

for import into the United States, samples of such drugs

... be delivered to the Secretary of [HHS] .... If it appears 

from the examination of such samples or otherwise that 

... such article is adulterated, misbranded, or [an 

unapproved new drug] ..., then such article shall be 

refused admission. 

 

* The FDCA is codified at 21 U.S.C. § 301 et seq. For 

convenience, we refer to sections of 21 U.S.C. as though they were 

sections of the Act.
4

The duties of the Secretary of the Treasury under § 381(a) are 

administered by Customs and Border Protection, a unit of the 

Department of Homeland Security, see Del Monte Fresh 

Produce N.A., Inc. v. United States, 706 F. Supp. 2d 116, 117 

n.1 (D.D.C. 2010); those of the Secretary of HHS are 

administered by the FDA, see FDA, 2 STAFF MANUAL 

GUIDES 1410.10, at 1 (2012), http://www.fda.gov/downloads/

AboutFDA/ReportsManualsForms/StaffManualGuides/UCM

273771.pdf. In addition to physically examining samples, as 

required by § 381(a), the FDA “receives notification from 

[Customs] of all formal and informal entries of articles under 

FDA jurisdiction at ports of entry” and “electronically 

screen[s]” those entry data “against criteria developed by 

FDA.” FDA, REGULATORY PROCEDURES MANUAL 9-2 to 9–3

(2013), http://www.fda.gov/downloads/ICECI/Compliance

Manuals/RegulatoryProceduresManual/UCM074300.pdf. 

Each of the plaintiffs in this action has been sentenced to 

death under the laws of Arizona, California, or Tennessee. At 

the time of the complaint those states and many others 

executed prisoners by injecting them with a sequence of three 

drugs: (1) sodium thiopental, which induces anesthesia; (2) 

pancuronium bromide, which causes paralysis; and (3) 

potassium chloride, which stops the heart. Baze v. Rees, 553 

U.S. 35, 44 (2008) (plurality opinion). The administration of 

thiopental is critical because absent “a proper dose ... 

render[ing] the prisoner unconscious, there is a substantial, 

constitutionally unacceptable risk of suffocation from the 

administration of pancuronium bromide and pain from the 

injection of potassium chloride.” Id. at 53. Although 

thiopental has been used as an anesthetic since the 1930s, it is 

presently an unapproved new drug. 
5

In 2009 the last domestic manufacturer of thiopental 

stopped making it. Several state departments of correction 

then began ordering thiopental from Dream Pharma Ltd., a 

wholesaler located in the United Kingdom. The thiopental 

sold by Dream was prepared and marketed by Archimedes 

Pharma UK, Ltd., which obtained unfinished thiopental from 

a facility in Austria; neither Dream nor Archimedes was 

registered with the FDA. The FDA therefore detained the 

first two shipments from Dream because, per § 381(a), the 

thiopental appeared to be a misbranded and unapproved new 

drug. After state officials explained the purpose of the 

imported thiopental, however, the FDA released the 

shipments. Several states, including Arizona, California, and 

Tennessee, thereafter imported thiopental from Dream 

without interference from the FDA. 

In 2011 the FDA issued a policy statement concerning

the importation of thiopental for the execution of state 

prisoners. The FDA stated that it “neither approves nor 

reviews [thiopental] for use in lethal injections.” Rather, in 

“defer[ence] to law enforcement” agencies, henceforth it 

would exercise its “enforcement discretion not to review these 

shipments and allow processing through [Customs’] 

automated system for importation.” 

The plaintiffs then brought this suit alleging the FDA’s 

policy statement and its failure to “refuse[] admission,” § 

381(a), to certain specific shipments of thiopental coming 

from Dream violated the APA. The FDA argued first that its 

“decision not to take enforcement action with respect to 

thiopental is not subject to judicial review because ‘agency 

refusals to institute investigative or enforcement proceedings’

are ‘committed to agency discretion.’” Beaty v. FDA, 853 F. 

Supp. 2d 30, 39 (D.D.C. 2012) (quoting Defendants’ 

Memorandum in Support of Motion to Dismiss and/or for 
6

Summary Judgment and in Opposition to Plaintiffs’ Motion

for Summary Judgment at 1, 14–15). The district court, 

however, reasoned the FDA’s conduct was reviewable 

because it “did not involve a decision whether to initiate 

enforcement proceedings ... [but rather its] duty to obey the 

law and deny admission to a drug according to unambiguous 

statutory provisions.” Id. at 40. On the merits of the dispute, 

the district court held the FDA acted contrary to law because 

§ 381(a) “impose[s] a mandatory obligation on [the FDA] to 

refuse to admit the misbranded and unapproved drug, 

thiopental, into the United States.” Id. at 39. The district 

court also held the FDA had been arbitrary and capricious, in 

violation of the APA, because it had “acted inconsistently 

with FDA regulations, acted inconsistently with its 

longstanding practices, and acted in a manner contrary to the 

purpose of the FDCA, thereby threatening the public health.” 

Id. at 41. The district court therefore granted summary 

judgment for the plaintiffs. 

In a separate order, the district court granted the plaintiffs

declaratory and injunctive relief. It declared the thiopental 

that had been imported already was a misbranded and 

unapproved new drug that “cannot lawfully be ... imported 

into the United States.” The district court permanently 

enjoined the FDA from “permitting the entry of, or releasing 

any future shipments of, foreign manufactured thiopental that 

appears to be misbranded or [an unapproved new drug].” 

Finally, the district court ordered the FDA to “immediately 

notify any and all state correctional departments which it has 

reason to believe are still in possession of any foreign 

manufactured thiopental that the use of such drug is 

prohibited by law and that, that thiopental must be returned 

[sic] immediately to the FDA.” 
7

II. Analysis

The FDA’s principal contention on appeal is that its 

“determination whether to invoke [§ 381(a)] and refuse 

admission to any particular drug offered for import is ... not 

subject to judicial review.” On the merits, the FDA briefly 

argues its actions were neither arbitrary and capricious nor 

otherwise contrary to law. Underlying both arguments is the 

claim that § 381(a) gives the FDA unreviewable enforcement 

discretion and that, pursuant to Chevron U.S.A. Inc. v. Natural 

Resources Defense Council, Inc., 467 U.S. 837 (1984), the 

court should defer to the FDA’s interpretation of the statute.

Whether Chevron applies to an agency’s interpretation 

that a statute commits a matter to its discretion and thereby 

precludes judicial review is not entirely clear. Our recent 

opinions on agency claims to unreviewable discretion make 

no reference to Chevron. See, e.g., Sierra Club v. Jackson, 

648 F.3d 848, 855–57 (D.C. Cir. 2011); Ass’n of Irritated 

Residents v. EPA, 494 F.3d 1027, 1031–33 (D.C. Cir. 2007); 

Drake v. FAA, 291 F.3d 59, 70–72 (D.C. Cir. 2002); but see 

Nat’l Wildlife Fed’n v. EPA, 980 F.2d 765, 770–71 (D.C. Cir. 

1992) (citing Chevron but refusing to defer to agency’s 

“attempt to carve out ... discretion” because it could not “be 

squared with the language of the statute”); see also CornejoBarreto v. Seifert, 218 F.3d 1004, 1014 (9th Cir. 2000) (citing 

Chevron but refusing to defer to agency’s claim of statutory 

discretion because it was “contrary to Congressional intent”),

overruled by Trinidad y Garcia v. Thomas, 683 F.3d 952 

(2012); Dubois v. Thomas, 820 F.2d 943, 951 (8th Cir. 1987) 

(deferring to agency’s interpretation “impos[ing] only 

discretionary duties” upon the agency). Whether Chevron

applies in this case, however, is of no moment because

Chevron itself instructs that if the agency has “violated 

Congress’s precise instructions ... ‘that is the end of the 
8

matter.’” Village of Barrington, Ill. v. Surface Transp. Bd., 

636 F.3d 650, 660 (D.C. Cir. 2011) (quoting Chevron, 467 

U.S. at 842). Here, we proceed “without showing the agency 

any special deference,” id., because, as we explain below, § 

381(a) unambiguously imposes mandatory duties upon the 

FDA. 

In addition to the arguments raised by the FDA, we 

consider the argument of the amicus curiae that the case must 

be dismissed because the states affected by the litigation were

required parties under Federal Rule of Civil Procedure 19. 

Although ordinarily “we would not entertain an amicus’ 

argument if not presented by a party,” Michel v. Anderson, 14 

F.3d 623, 625 (D.C. Cir. 1994) (emphasis deleted), in this 

case the argument of the amicus is in aid of our “independent 

duty to raise [a Rule 19(a) issue] sua sponte,” Wichita & 

Affiliated Tribes v. Hodel, 788 F.2d 765, 772 n.6 (D.C. Cir. 

1986); see also Republic of Philippines v. Pimentel, 553 U.S. 

851, 861 (2008) (“A court with proper jurisdiction may ... 

consider sua sponte the absence of a required person”). 

Accordingly, we welcome the presentation of the amicus with 

our thanks for its contribution to this case. 

A. Justiciability

Judicial review under the APA is unavailable insofar as 

“agency action is committed to agency discretion by law.” 5 

U.S.C. § 701(a)(2). This “very narrow exception” to the 

general rule applies only “in those rare instances where 

‘statutes are drawn in such broad terms that in a given case 

there is no law to apply.’” Citizens to Preserve Overton Park, 

Inc. v. Volpe, 401 U.S. 402, 410 (1971) (quoting S. REP. NO.

79-752, at 26 (1945)). “In such circumstances, the courts 

have no legal norms pursuant to which to evaluate the 

challenged action, and thus no concrete limitations to impose 
9

on the agency’s exercise of discretion.” Drake, 291 F.3d at 

70. 

1. The relevance of Heckler v. Chaney

The leading Supreme Court case applying § 701(a)(2), 

Heckler v. Chaney, is factually quite similar to the present 

case. 470 U.S. 821 (1985). There, too, a group of death row 

inmates claimed the drugs used for lethal injection were 

misbranded and unapproved new drugs. They had asked the 

FDA 

to affix warnings to the labels of all the drugs stating that 

they were unapproved and unsafe for human execution, 

to send statements to the drug manufacturers and prison 

administrators stating that the drugs should not be so 

used, and to adopt procedures for seizing the drugs from 

state prisons and to recommend the prosecution of all 

those in the chain of distribution. 

Id. at 824. When the FDA refused to take the requested 

actions the inmates sought judicial review under the APA. 

The Supreme Court held “an agency’s decision not to take 

enforcement action should be presumed immune from judicial 

review under § 701(a)(2).” Id. at 832. Although “the 

presumption may be rebutted where the substantive statute 

has provided guidelines for the agency to follow in exercising 

its enforcement powers,” id. at 832–33, the Court found no 

such guidance in the relevant provisions of the FDCA; for 

example, “the Act’s general provision for enforcement, [21 

U.S.C.] § 372, provides only that ‘[t]he Secretary is 

authorized to conduct examinations and investigations,’” id. 
10

at 835.* Similarly, the Court refused to read the section 

“stat[ing] baldly that any person who violates the Act’s 

substantive prohibitions ‘shall be imprisoned ... or fined,’” as 

requiring “criminal prosecution of every violator of the Act.” 

Id. (quoting 21 U.S.C. § 333). 

Here the FDA argues Chaney applies straightforwardly to 

§ 381(a), which provides that “[i]f it appears” an article 

offered for import violates a substantive prohibition of the 

FDCA, then “such article shall be refused admission.” 

According to the agency, it has unreviewable discretion under 

both the antecedent and the consequent phrases: The 

antecedent “if it appears” implies the FDA may choose 

whether to “make a formal determination that a statutory 

obligation has been violated,” and the consequent “shall be 

refused admission” provides a permissive sanction, as did the 

criminal provision in Chaney itself. 

The plaintiffs respond that Chaney is inapposite because 

the discrete actions here under challenge, viz., adoption of a 

“general policy of automatically releasing all thiopental 

shipments destined for correctional facilities” and “a series of 

FDA determinations that [particular shipments of] foreign 

thiopental ‘may proceed’ into domestic commerce,” are 

affirmative acts of approval rather than refusals to take 

enforcement action. We do not consider this jejune dispute 

for, even assuming the presumption against judicial review 

announced in Chaney does apply to the FDA’s refusal to 

enforce § 381(a), that presumption is rebutted by the specific 

“legislative direction in the statutory scheme.” Chaney, 470 

U.S. at 833. Contrary to the FDA’s interpretation, § 381(a)

 

* Chaney concerned the FDCA’s enforcement provisions governing 

“the use of drugs in interstate commerce,” 470 U.S. at 828, not the 

provision governing importation, § 381(a), at issue here. 
11

sets forth precisely when the agency must determine whether 

a drug offered for import appears to violate the FDCA, and 

what the agency must do with such a drug. 

2. Textual analysis

Section 381(a) provides the FDA “shall furnish” to 

Customs a list of registered establishments and “shall request” 

from Customs samples of drugs offered for import that are 

“manufactured, [etc.,] in an establishment not so registered.” 

Customs, in turn, “shall deliver” to the FDA the requested 

samples. Id. “If it appears from the examination of such 

samples or otherwise” that a drug violates a substantive 

prohibition of the FDCA, then the drug “shall be refused 

admission.” Id. The plaintiffs argue each of these directives 

is unambiguously binding: The FDA must request samples of 

all drugs offered for import that have been made in an 

unregistered establishment, must examine those samples for a 

violation of the FDCA, and must refuse admission to any drug 

that appears, through the sampling process or otherwise, to 

violate the FDCA. We agree. 

The plaintiffs begin by arguing simply that “the ordinary 

meaning of ‘shall’ is ‘must.’” The case law provides ample 

support. See, e.g., Lexecon Inc. v. Milberg Weiss Bershad 

Hynes & Lerach, 523 U.S. 26, 35 (1998) (“[T]he mandatory 

‘shall’ ... normally creates an obligation impervious to judicial 

discretion”); Ass’n of Civilian Technicians, Montana Air 

Chapter No. 29 v. Fed. Labor Relations Auth., 22 F.3d 1150, 

1153 (D.C. Cir. 1994) (“The word ‘shall’ generally indicates a 

command that admits of no discretion on the part of the 

person instructed to carry out the directive”). Citing Chaney, 

the FDA objects that “in the enforcement context ... [the word 

‘shall’] may not be properly read to curtail the agency’s 

discretion.” In Chaney, however, the word “shall” appeared 
12

in the consequent of a section providing for criminal 

sanctions: A violator “shall be imprisoned ... or fined.” 470 

U.S. at 835 (quoting 21 U.S.C. § 333). The criminal statute in 

Chaney did not use “shall” in connection with the antecedent

condition of prosecution; in fact, the Court emphasized that 

“[t]he Act’s general provision for enforcement, [21 U.S.C.] § 

372, provides only that ‘[t]he Secretary is authorized to 

conduct examinations and investigations;’” thus, “the Act 

charges the Secretary only with recommending prosecution; 

any criminal prosecutions must be instituted by the Attorney 

General.” Id. The “enforcement” discretion held 

unreviewable in Chaney, therefore, was whether to 

recommend prosecution. Cf. Her Majesty the Queen in Right 

of Ontario v. EPA, 912 F.2d 1525, 1533 (D.C. Cir. 1990)

(analyzing statute with a similar dichotomy between a 

discretionary antecedent and a mandatory consequent). Here, 

by contrast, the word “shall” appears in both an antecedent 

(“shall request ... samples”) and the consequent (“shall be 

refused admission”). 

The plaintiffs further argue, and again we agree, that 

reading “shall be refused admission” as mandatory gives 

meaning to the exception to that command, “except as 

provided in subsection (b).” That subsection provides “[i]f it 

appears to the [FDA] that ... an article ... can, by relabeling or 

other action, be brought into compliance,” then “final 

determination as to admission of such article may be 

deferred” while the owner posts a bond and takes remedial 

action. A permissive construction of “shall be refused 

admission” would render “the express exception ... 

insignificant, if not wholly superfluous.” TRW Inc. v. 

Andrews, 534 U.S. 19, 31 (2001) (internal quotation marks 

omitted). The FDA objects that the Senate Report 

recommending that the exception in § 381(b) be added to the 

Act said it merely codified “a continuing administrative 
13

practice of the [FDA],” S. REP. NO. 81-890, at 1 (1949); 

therefore, the FDA argues, “the authority to take steps short of 

outright refusing admission ... was inherent in the statutory 

scheme from the very beginning.” On the contrary: The 

Senate Report states § 381(b) was needed to “provide specific 

authority” for the FDA’s procedure because “[u]nder ... the 

act as it now stands, imports which are found to be 

inadmissible into the United States by reason of mislabeling

... must be either reexported or destroyed.” Id. In other 

words, § 381(b) was added precisely because “shall be 

refused admission” left the agency with no discretion to make 

an exception, no matter how sensible making a particular

exception might be. 

The FDA next objects that even if the agency lacks

discretion under the consequent “shall be refused admission,” 

it at least has discretion under the antecedent condition “if it 

appears.” “[B]y authorizing refusal of admission when ‘it 

appears’ that the statutory requirements have not been met, [§ 

381(a)] contemplates a role for FDA in making a formal 

judgment about the relevant facts. ... The provision does not 

speak to, much less eliminate, FDA’s discretion whether to 

make such a determination.” The FDA, however, omits the 

second half of the relevant clause: “If it appears from the

examination of such samples or otherwise.” § 381(a). The 

clear implication is the FDA must examine the samples that it 

must request and determine whether they appear to violate the 

FDCA. Indeed, it would make no sense for the Congress to 

mandate the collection, but not the examination, of samples of 

drugs made in an unregistered facility. 

Of course, the clause “[i]f it appears from the

examination of such samples or otherwise” may leave the 

FDA enforcement discretion in other respects. For example, 

the open-ended phrase “or otherwise” implies the FDA may
14

examine drugs it is not obligated to sample, such as those 

made in a registered establishment. Indeed, the FDA 

interprets § 381(a) as giving it general authority to examine 

“drugs ... offered for entry into the United States.” FDA, 

INVESTIGATIONS OPERATIONS MANUAL ch. 6.1.1 (2012),

http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM

123512.pdf. The same phrase also implies the FDA may 

detect a violation through a method other than “examination,”

such as electronic screening of entry data that importers 

submit to Customs. Moreover, the phrase “if it appears” 

implies discretion in making the substantive determination 

whether a drug appears to violate the FDCA; a drug may 

appear to violate the FDCA to one examining officer but not 

to another. 

We identify these oases of possible agency discretion not 

to suggest they are beyond judicial review, a question not 

before us, but rather to delineate the bounds of our 

interpretation. We do not say the FDA must sample and 

examine every article under its jurisdiction that is offered for 

import but only that it must sample and examine drugs 

“manufactured, [etc.,]” in an unregistered establishment. Id. 

Nor do we say the FDA must find any type of drug “appears” 

to violate a substantive prohibition of the FDCA but only that,

having found a drug apparently violates the Act, the FDA 

must “refuse[] [it] admission.” Id. 

3. Policy considerations

Ordinarily, if a statute is “plain and unambiguous,” as is 

the FDCA in relevant respects here, “our analysis ends with 

the text.” Chao v. Day, 436 F.3d 234, 235 (D.C. Cir. 2006).

We may, however, in rare instances depart from the plain text 

when “adherence to the plain text leads to an ‘absurd’ result.” 

United States ex rel. Totten v. Bombardier Corp., 380 F.3d 
15

488, 494 (D.C. Cir. 2004). Although the FDA does not use

the word “absurd,” perhaps because the doctrine of avoiding 

absurd results is so rarely applied, see Barnhart v. Sigmon 

Coal Co., Inc., 534 U.S. 438, 459 (2002) (“the Court rarely 

invokes [the absurdity] test to override unambiguous 

legislation”); Territory of Hawaii v. Mankichi, 190 U.S. 197, 

223 (1903) (only in “rare cases” does “adherence to the letter 

lead[] to manifest absurdity”), the FDA does argue the 

practical consequences of reading § 381(a) as we do should 

give us pause. 

The FDA argues the court should not read § 381(a) to 

require enforcement because the agency is better able to 

determine “how to most effectively allocate scarce resources.” 

According to the FDA, § 381(a) “applies, by its terms, to the 

21 million discrete ‘lines’ of FDA-regulated imports each 

year ... [and] the agency understandably declines to take 

enforcement action in every case in which it suspects that a 

single importation may violate the statute.” Our reading of § 

381(a), however, does not require the FDA to inspect 21 

million articles offered for import; rather, it requires only the 

FDA examine the samples of articles that it is obligated to 

collect because they were “manufactured, [etc.,]” in an

unregistered facility. Of course the FDA is free to go further, 

as it has chosen to do by electronically screening “formal and 

informal entries of articles under FDA jurisdiction at ports of 

entry.” FDA, REGULATORY PROCEDURES MANUAL 9-2. 

The FDA next argues it must have discretion not to 

enforce § 381(a) in order to combat domestic shortages of 

medically necessary drugs. According to a report cited by 

both parties, the FDA has allowed “controlled importation of 

similar products approved abroad but not approved in the 

United States in 5% of” the drug shortages it studied. FDA, A

REVIEW OF FDA’S APPROACH TO MEDICAL PRODUCT 
16

SHORTAGES 4 (2011), www.fda.gov/DrugShortageReport. By 

its own account, however, the FDA has ways short of 

allowing importation of inadmissible drugs to counteract a 

drug shortage, including: “Asking other firms to increase 

production (31%),” “Working with manufacturers” to 

mitigate quality problems (28%), and “Expediting review of 

regulatory submissions (26%).” Id. The FDA may exercise 

enforcement discretion to allow the domestic distribution of a 

misbranded or unapproved new drug, as the Supreme Court 

recognized in Chaney, 470 U.S. at 837, and in some cases

may invoke its express statutory authority to permit the 

importation of an unapproved new drug. For example, the 

FDA may designate an unapproved foreign manufactured 

drug as an investigational new drug (IND), thereby allowing 

its lawful importation. 21 U.S.C. § 355(i); 21 C.F.R. § 

314.410(a)(1)(ii); see also 21 C.F.R. 312.315(a)(3)(ii) (FDA 

may expand access to an IND “contain[ing] the same active 

moiety as an approved drug product that is unavailable 

through ... a drug shortage”). In any event, even if reading § 

381(a) by its terms, as we do, deprives the FDA of one 

possible response to five percent of all drug shortages, that is 

hardly an absurd result. 

In an effort to bolster its drug shortage argument, the 

FDA points to two provisions in a 2012 statute that it says 

reveal the Congress’s “understanding that FDA already has 

authority to exercise enforcement discretion.” 21 U.S.C. § 

356d(c) instructs the Secretary of HHS to “evaluate the risks 

associated with the impact” of a drug shortage before taking 

an enforcement action that “could reasonably cause or 

exacerbate a shortage,” and § 356c-1(a)(5) directs the 

Secretary to issue an annual report listing, among other 

things, “instances in which the [FDA] exercised regulatory 

flexibility and discretion to prevent or alleviate a drug 

shortage.” The Congress enacting these directives may have 
17

implicitly — and correctly — assumed the FDA already had 

some discretion in combating a drug shortage, but the agency 

gives us no reason to think the Congress was referring to the 

discretion to ignore § 381(a) and not to the discretion to allow 

the domestic distribution of a violative drug or to admit an 

unapproved foreign manufactured drug as an IND. 

Finally, the FDA argues it must have discretion to ignore 

§ 381(a) in order to allow the “importation of drugs that are 

clearly for personal use.” As evidence that the Congress is 

aware of and agrees with this view, the FDA points to a 2003 

statute, not yet in effect, directing the Secretary of HHS to 

“exercise discretion to permit individuals to make ...

importations” of prescription drugs for personal use. 21 

U.S.C. § 384(j)(1)(B). The FDA, however, conveniently 

overlooks the very next subsection, which effectuates the 

statute by authorizing the Secretary to grant individual 

waivers to import prescription drugs. § 384(j)(2). The 

Congress would have had no reason to grant the FDA explicit 

waiver authority if, as the FDA argues, the agency was 

already authorized not to enforce § 381(a). 

* * *

In sum, we hold 21 U.S.C. § 381(a) requires the FDA to 

(1) sample “any drugs” that have been “manufactured, 

prepared, propagated, compounded, or processed” in an 

unregistered establishment and (2) examine the samples and 

determine whether any “appears” to violate the prohibitions 

listed in § 381(a)(1)–(4). If, “from the examination of such 

samples or otherwise,” the FDA finds an apparent violation of 

the Act, then it must (3) “refuse[] admission” to the prohibited 

drug. Because these are clear statutory “guidelines for the 

agency to follow in exercising its enforcement powers,” 
18

Chaney, 470 U.S. at 833, the FDA’s compliance with § 381(a) 

is subject to judicial review under the standards of the APA. 

B. The APA on the Merits

From the foregoing analysis it follows apodictically that 

the FDA’s policy of admitting foreign manufactured 

thiopental destined for state correctional facilities, as well as 

the several individual admissions of such shipments

challenged by the plaintiffs, were “not in accordance with

law.” 5 U.S.C. § 706(2)(A). The FDA’s policy was not in 

accordance with law because § 381(a) requires the agency to 

sample and examine for violations any drug offered for 

import that has been prepared in an unregistered facility; as 

the FDA acknowledges, the preparer of the finished thiopental

identified in this case, Archimedes Pharma UK, Ltd., is not 

registered with the FDA. The FDA’s individual admissions 

of thiopental shipments were not in accordance with law 

because § 381(a) requires the FDA to refuse admission to any 

drug that appears to violate the substantive prohibitions of the 

FDCA, and the FDA conceded before the district court that 

the thiopental in these shipments “clearly ‘appears’ to be an 

unapproved new drug.” 

Because our holding the FDA acted contrary to law 

requires that we affirm the judgment of the district court, we 

need not decide whether the FDA’s actions were also 

arbitrary and capricious. See Duke Power Co. v. FERC, 864 

F.2d 823, 831 (D.C. Cir. 1989). 

C. Rule 19

Federal Rule of Civil Procedure 19(a)(1)(B)(i) provides: 
19

A person who is subject to service of process and whose 

joinder will not deprive the court of subject-matter 

jurisdiction must be joined as a party if ... that person 

claims an interest relating to the subject of the action and 

is so situated that disposing of the action in the person’s 

absence may ... as a practical matter impair or impede the 

person’s ability to protect the interest. 

The rule reflects the bedrock principle “that one is not bound 

by a judgment in personam in a litigation in which he is not ... 

a party,” Hansberry v. Lee, 311 U.S. 32, 40 (1940), or to put it 

more simply, that “everyone should have his own day in 

court.” 18A CHARLES ALAN WRIGHT, ARTHUR R. MILLER &

EDWARD H. COOPER, FEDERAL PRACTICE AND PROCEDURE § 

4449 (2d ed. 2002). For this reason, the parties before a 

district court, who “presumably know better than anyone else 

the nature and scope of relief sought in the action, and at 

whose expense such relief might be granted ..., [bear] a 

burden of bringing in additional parties where such a step is 

indicated.” Martin v. Wilks, 490 U.S. 755, 765 (1989). The 

district court, too, “has an independent responsibility” to seek 

the joinder of a required party, sua sponte if need be. 

Weisberg v. Dep’t of Justice, 631 F.2d 824, 830 & n.40 (D.C. 

Cir. 1980). 

The amicus argues, and we agree, the district court erred 

by failing, when the complaint was filed, to seek the joinder 

of the “state governments whose possession and use of 

[foreign manufactured] thiopental [the court] declared 

illegal.” In their complaint, the plaintiffs sought “[a]n order 

compelling FDA to immediately take reasonable steps to 

recover and remove from interstate commerce all shipments 

of foreign thiopental that have been released by FDA into 

interstate commerce during the preceding twelve months.”

The states that had received those shipments – Arizona, 
20

Arkansas, California, Georgia, South Carolina, and Tennessee

— had an obvious interest in keeping them and therefore had 

“an interest relating to the subject of the action” within the 

scope of Rule 19. Although the plaintiffs did not renew their 

request for injunctive relief in their motion for summary 

judgment, the district court nevertheless ordered the FDA to 

notify the states that “the use of [foreign manufactured 

thiopental] is prohibited by law and that, that thiopental must 

be returned [sic] immediately to the FDA.” That order, “as a 

practical matter” did “impair or impede” the named states’ 

“ability to protect the[ir] interest” in those shipments. FED. R.

CIV. P. 19(a)(1)(B)(i). 

Although we agree with the amicus that the affected 

states were required parties, we do not agree their absence 

means the case should have been dismissed. Under Rule 19 a 

district court is to join a required party if feasible; if joinder is 

not feasible, however, then the court is to consider, among 

other things, whether “any prejudice could be lessened or 

avoided by ... shaping the relief.” FED. R. CIV. P. 19(b)(2)(B). 

Here, the district court neither assessed the feasibility of 

joining the states as parties nor considered whether the 

prejudice to their interests might be reduced by shaping the 

relief. 

To remedy a departure from the strictures of Rule 19, “a 

court of appeals may ... require suitable modification [of the 

judgment] as a condition of affirmance.” Provident 

Tradesmens Bank & Trust Co. v. Patterson, 390 U.S. 102, 

112 (1968). Accordingly, we shall vacate the remedial order 

insofar as it directs the FDA to “notify any and all state 

correctional departments which it has reason to believe are 

still in possession of any foreign manufactured thiopental that 

the use of such drug is prohibited by law and that, that 

thiopental must be returned immediately to the FDA.” 
21

III. Conclusion

The FDCA imposes mandatory duties upon the agency 

charged with its enforcement. The FDA acted in derogation 

of those duties by permitting the importation of thiopental, a 

concededly misbranded and unapproved new drug, and by 

declaring that it would not in the future sample and examine 

foreign shipments of the drug despite knowing they may have 

been prepared in an unregistered establishment. The district 

court could not remedy the FDA’s unlawful actions, however, 

by imposing upon the interests of nonparties to this suit. The 

order of the district court pertaining to the thiopental already 

in the possession of the states, quoted in the paragraph above,

is therefore vacated, but the underlying judgment of the 

district court is 

Affirmed.