21 U.S.C. § 360b — New animal drugs

(a) Unsafe new animal drugs and animal feed containing such drugs; exemptions; import tolerances (1) A new animal drug counts as "unsafe" for a particular use unless one of four things is true: (A) an application approved under (b) covers that use, and the drug, its label, and the use match that approved application; (B) a conditional approval under section 360ccc covers that use, with everything matching; (C) an index listing under section 360ccc–1 covers that use in a minor species, with everything matching; or (D) an emergency authorization under section 360bbb–3 covers that use, with everything matching its conditions. A drug is also "unsafe" if it leaves a manufacturer's, packer's, or distributor's site for use in making animal feed anywhere in a state, unless at that moment the seller holds an unrevoked written statement (or a notice from the Secretary) that the buyer either holds a feed-mill license under (m) and has current approved labeling for feed use, or — if the buyer doesn't use the drug itself — will only resell it to a license holder. (2) Animal feed containing a new drug is "unsafe" for a given use unless: (A) an approved application, conditional approval, or index listing covers the drug's use in that feed, with the feed, its labeling, distribution, holding, and use all matching; and (B) the feed is made at a site holding a license under (m)(1). (3) A drug or drug-containing feed isn't "unsafe" if it's for investigational use and follows an exemption in effect under (j). (4)(A) Once an application under (b) is approved for one use, the drug isn't "unsafe" for a different use (other than a feed use) — and is excused from the labeling rule in section 352(f) — if a licensed veterinarian prescribes that different use within a vet-client-patient relationship, following regulations the Secretary sets for such different uses. Those regulations can ban specific different uses, and can't allow a different use if another approved drug with the same active ingredient, dosage form, and concentration already covers it. (B) If the Secretary finds a reasonable chance that such a different use poses a public health risk, the Secretary can set a safe residue level and require a practical test for detecting residues above it; a use that produces residues over that level counts as "unsafe" under paragraph (1). (C) The Secretary may, by regulation, get access to veterinarians' records to check on a different use the Secretary thinks may be risky. (D) After giving the public a chance to comment, the Secretary may order a different use stopped if it's found to pose a health risk, or if a required detection method was never developed and submitted. (5) If a human drug is approved under section 355, using it in animals isn't "unsafe" — and is excused from the section 352(f) labeling rule — if a licensed veterinarian prescribes it within a vet-client-patient relationship, following regulations the Secretary sets for that use. (6) For imported food under section 342(a)(2)(D), a new animal drug use isn't "unsafe" if the Secretary sets a tolerance and the imported animal's edible parts don't exceed it. The Secretary must base that tolerance on data proving safety by the same food-safety standards used for domestic drug approvals, and may rely on data the manufacturer submits — including data given to foreign regulators or available from a "relevant international organization" (the Codex Alimentarius Commission, or another body the Secretary approves) — as long as it's consistent with the domestic standards. The Secretary may later revoke a tolerance if evidence shows real-world use produces imports exceeding it, or if science shows the tolerance itself is unsafe. (b) Filing an application (1) Anyone may file an application for any intended use of a new animal drug. The application must include: (A) full reports of studies on whether the drug is safe and effective; (B) a full list of the drug's components; (C) a full statement of its composition; (D) a full description of how it's manufactured, processed, and packed, including facilities and controls; (E) samples the Secretary requires of the drug, its components, any feed it's meant for, and edible animal parts or products; (F) proposed labeling for the drug (or, for feed use, appropriate feed labeling), plus the labeling the applicant will actually use; (G) a description of practical methods for measuring the drug — or anything it forms — in food; and (H) any proposed tolerance, withdrawal period, or other use restriction needed to keep the use safe. The applicant must also file the number and expiration date of any patent claiming the drug, or a method of using it, that could reasonably support an infringement claim; if such a patent issues after filing but before approval, the applicant must amend the application to add it. Once the application is approved, the Secretary publishes this patent information. (2) Anyone may file an "abbreviated application" — essentially a generic-drug application — containing the information (n) requires. (3) Anyone planning to file an application under paragraph (1), under section 360ccc, or a request for an investigational exemption under (j), can get one or more conferences beforehand to reach an agreement with the Secretary on what must be submitted or investigated, possibly including a field study. That agreement binds both the Secretary and the applicant unless they mutually agree to change it, or the Secretary later finds in a written order that an essential new scientific requirement has appeared since the conference. If the agreement calls for more than one field investigation, the Secretary must, within 25 days of the conference, issue a written order scientifically justifying that. Nothing here forces the Secretary to require any field investigation at all. (4) Starting October 1, 2018, every application or submission under this subsection must be filed electronically, in whatever format the Secretary requires. (c) Timing for review and approval; withdrawal periods; effective dates; bioequivalence; extra patent filings (1) Within 180 days of a (b) filing (or a longer period both sides agree to), the Secretary must either (A) approve the application if none of the (d) grounds for refusal applies, or (B) notify the applicant of a chance for a hearing on whether it's approvable. If the applicant asks for a hearing within 30 days, it must start within 90 days after that (unless both sides agree otherwise), run on an expedited schedule, and the Secretary's decision must issue within 90 days after final briefs are due. (2)(A) Except as (C) allows, the Secretary must approve an abbreviated (generic) application unless the Secretary finds any of the following: (i) the manufacturing methods, facilities, or controls are inadequate to preserve the drug's identity, strength, quality, and purity; (ii) the proposed label's conditions of use aren't reasonably likely to be followed in practice, or — unless (B) applies — the submission doesn't show that every proposed condition of use was already approved for the reference drug; (iii) the submission doesn't sufficiently show the active ingredients match the reference drug's; (iv) where the ingredients, route, dosage form, strength, or feed-combination use are claimed to be the same as the reference drug, the submission doesn't sufficiently prove that — or, where they're claimed to differ, no petition for that different version was approved under (n)(3); (v) where the application follows an approved (n)(3) petition, it lacks the information the Secretary required about what's different; (vi) the submission doesn't sufficiently show bioequivalence to the reference drug — or, if filed under an (n)(3) petition, doesn't sufficiently show the new drug shares the reference drug's pharmacological or therapeutic class and would work the same way when used as labeled; (vii) the submission doesn't sufficiently show the label matches the reference drug's label, apart from approved differences, a different withdrawal period, or a different manufacturer; (viii) available information shows the inactive ingredients or overall composition are unsafe under the proposed label conditions, or — for a food-animal drug — may be unsafe for human food safety; (ix) the reference drug's approval was withdrawn or suspended for the safety grounds in (e)(1), or the Secretary has published a hearing notice to do that, or this generic's own approval was earlier withdrawn or suspended under (2)(G) for such grounds, or the Secretary has determined the reference drug was pulled from sale for safety or effectiveness reasons; (x) the application fails any other requirement of (n); or (xi) the application contains an untrue statement of material fact. (B) If the Secretary finds the new drug bioequivalent to the reference drug and its residues consistent with the reference drug's tolerances, but at a different withdrawal period, the Secretary may set that different withdrawal period for the new drug based on the submitted information. (C) The Secretary must approve or disapprove an abbreviated application within 180 days of its filing, or a longer period both sides agree to. (D) An abbreviated application's approval takes effect on whichever date applies: (i) if the applicant only certified that no patent info was filed or that the patent expired, approval can be immediate; (ii) if the applicant certified a future patent-expiration date, approval takes effect on that date; (iii) if the applicant certified the patent is invalid or won't be infringed, approval takes effect immediately unless a patent-infringement suit is filed within 45 days after the required notice — if it is, approval takes effect after a 30-month period from the notice (shortened or lengthened by court order if a party didn't cooperate in speeding the case), except that approval takes effect right away if the court rules the patent invalid or not infringed, on the court-ordered date under 35 U.S.C. 271(e)(4)(A) if the court rules infringement, or right away if the court had issued a preliminary injunction but then rules the patent invalid or not infringed. Both sides must reasonably cooperate to speed such a suit. No declaratory-judgment suit under 28 U.S.C. 2201 may be filed until 45 days after the notice, and any such suit must be filed where the defendant has its main or a regular place of business. (iv) If this is a patent-invalid/non-infringement certification and an earlier applicant already filed one for the same drug, this approval can't take effect earlier than 180 days after the earlier applicant's first commercial sale, or a qualifying court ruling — whichever comes first. (E) If the Secretary decides to disapprove, the same hearing-request and expedited-hearing timeline from (1) applies. (F) Marketing exclusivity: (i) For a genuinely new drug (none of its active ingredients approved before) approved after November 16, 1988, no application under (b)(2) referring to it may be filed for 5 years — or, if it includes a patent-invalid/non-infringement certification, not before 4 years. The effective-date rules in (D) apply, except that if an infringement suit is filed in the one-year window starting 48 months after approval, the 30-month period is extended so that a full 7.5 years passes from the original approval. (ii) If a drug shares an active ingredient with an already-approved drug, but its post-1988 approval contains substantial new evidence of effectiveness, new animal-safety studies, or (for food animals) new human-food-safety studies the applicant sponsored (not counting bioequivalence or most residue studies), a referencing (b)(2) approval can't take effect before 3 years from this approval. (iii) The same 3-year rule applies to a post-1988 supplement containing this kind of new evidence. (iv) An applicant that would get the 5-year period in (i) only because of a non-food-animal use may, within 10 days of approval, elect to waive it and take the 3-year rule in (ii) instead. (v) If that same applicant later wins approval — with similar new evidence — extending the same active ingredient to a food-producing-animal use, the rule becomes 5 years instead of 3, but only for that applicant's first such food-animal approval after the waiver. (G) If an approved (b)(2) drug refers to a reference drug whose approval was withdrawn or suspended for safety grounds, or under this subparagraph, or that the Secretary found pulled from sale for safety or effectiveness reasons, the generic's own approval is withdrawn or suspended for the same period — or, if the reference drug was pulled from sale, for as long as that lasts (or less, once the Secretary decides the sale-withdrawal wasn't about safety or effectiveness). (H) "Bioequivalence" means the rate and extent to which an active or therapeutic ingredient is absorbed and becomes available where the drug acts. A new drug counts as bioequivalent to the reference drug if: (I) its absorption rate and extent aren't significantly different from the reference drug's under similar conditions at the same dose; or (II) its absorption extent isn't significantly different, and any difference in absorption rate is intentional, disclosed in labeling, not needed for effective drug levels, and scientifically insignificant for the drug's purpose and for human food safety; or (III) where directly measuring absorption or excretion is impractical, an appropriate pharmacological or other test shows no significant difference from the reference drug. If the reference drug is approved for more than one species, bioequivalence data is needed for at least one species, or more if the Secretary decides that's scientifically necessary; the Secretary may set the dose used for testing. To keep the new drug's residues consistent with the reference drug's tolerances once its withdrawal period ends, the Secretary may require bioequivalence data, residue-depletion studies, or other appropriate scientific data; if residue studies are required, the testing method can't be made more rigorous than the one used for the reference drug, and studies are done in one species (or more, if scientifically appropriate). (3) If a patent couldn't be listed with a (b)(1) application because the filing predated the patent-disclosure requirement, or because the patent issued after approval, the approved-application holder must still file the patent's number and expiration date. The deadline is 30 days after November 16, 1988, if the requirement simply didn't exist yet, or 30 days after the patent issues if none existed at filing or approval. The Secretary publishes this information once it's filed. (4) A drug made in a small, pilot-scale facility may be used to prove safety and effectiveness and win approval before the drug is made at a larger facility — unless the Secretary decides a full-scale facility is actually necessary to ensure safety or effectiveness. (d) Grounds for refusing an application (1) After notice and a hearing opportunity, the Secretary must refuse an application if the Secretary finds: (A) the safety studies aren't thorough enough, using every reasonably applicable method; (B) the test results show the drug is unsafe, or fail to show it's safe, under the proposed label's conditions; (C) the manufacturing methods, facilities, or controls are inadequate to preserve the drug's identity, strength, quality, and purity; (D) there isn't enough information — from the application or elsewhere — to judge safety; (E) taken together, the submitted and other information don't add up to "substantial evidence" the drug works as claimed under its proposed label; (F) any use suggested on the proposed label would leave a residue above a tolerance the Secretary finds safe; (G) the application is missing the patent information (b)(1) requires; (H) fairly evaluated, the label is false or misleading in any respect; or (I) the drug causes cancer in people or animals when eaten, or in appropriate safety tests — except this cancer ground doesn't apply if the Secretary finds that, under label conditions reasonably certain to be followed, the drug won't harm the animals it's meant for, and Secretary-approved testing finds no residue in edible animal parts after slaughter or in food from living animals. If none of (A) through (I) applies after notice and a hearing, the Secretary must approve the application. Any refusal order must state the findings behind it. (2) In deciding whether a drug is safe under its proposed label conditions, the Secretary must weigh, among other things: (A) how much of the drug — and anything it forms in or on food — people are likely to eat; (B) its cumulative effect on people or animals, counting related substances; (C) safety margins that qualified experts consider appropriate when using animal-test data; and (D) whether the proposed label conditions are reasonably certain to actually be followed. (3) "Substantial evidence" means evidence from one or more adequate, well-controlled studies — such as a study in the target species, a lab-animal study, a required field investigation that follows the (b)(3) presubmission-conference process, a bioequivalence study, or an in-vitro study — done by qualified experts, sufficient for them to fairly conclude the drug works as claimed on its label. (4) Combination-drug rule: where a drug has more than one active ingredient, or its label recommends using it together with other animal drugs, and each ingredient or drug was already separately approved for the uses intended in the combination: (A) the Secretary can't refuse on human-food-safety grounds unless the application fails to show that no ingredient exceeds its tolerance at the combination's longest withdrawal time, and that no ingredient interferes with detecting another's residue; (B) the Secretary can't refuse on target-animal-safety grounds unless there's a substantiated scientific issue about one or more ingredients that the application's own data can't resolve, or a scientific issue raised by the application's own animal observations, and the Secretary's evaluation of that issue still supports refusal; (C) for combinations without a nontopical antibacterial ingredient, meant for uses other than feed or drinking water, the Secretary can't refuse on effectiveness grounds unless the application fails to show that any ingredient serving the same purpose as another actually contributes to the labeled effect, that each ingredient serving a distinct purpose properly serves its target patients, and — where the Secretary suspects incompatibility or mismatched dosing — that the ingredients are actually compatible and matched; (D) for feed or drinking-water combinations, similar rules apply, and where more than one nontopical antibacterial ingredient is combined (not counting ionophores or arsenicals), the application must also show each contributes to the labeled effect, and drinking-water combinations must show physical compatibility where that's in doubt. (5) When an application only adds a minor-use or minor-species use to an already-approved drug, the Secretary reevaluates just the relevant new information. Approving that addition doesn't reaffirm the drug's original approval. (e) Withdrawing approval (1) After notice and a hearing, the Secretary must withdraw an approved application's approval if the Secretary finds: (A) experience or data show the drug is unsafe under its approved conditions (or an (a)(4)(A) authorized different use); (B) new evidence, new test methods, or previously unusable methods — combined with the original evidence — now show the drug isn't proven safe, or that the (d)(1)(I) cancer finding applies; (C) new information combined with the original shows a lack of substantial evidence of effectiveness; (D) the (c)(3) patent information wasn't filed within 30 days of the Secretary's written notice about the omission; (E) the application contains an untrue statement of material fact; or (F) the applicant changed something that affects safety or effectiveness beyond what the application allows, without filing and getting approval of a supplemental application — supplements are handled the same way as original applications. If the Secretary (or the acting Secretary) finds an imminent hazard to human or animal health, approval can be suspended immediately, with prompt notice to the applicant and a chance for an expedited hearing — but this power to suspend immediately can't be delegated to anyone else. (2) The Secretary may also withdraw approval, after notice and a hearing, if: (A) the applicant never set up required recordkeeping, repeatedly or deliberately failed to keep records or file reports required under (l), or refused to let the Secretary access, copy, or verify those records; (B) new information combined with the original shows manufacturing methods, facilities, or controls are inadequate, and weren't fixed within a reasonable time after written notice; or (C) new information combined with the original shows the label is false or misleading, and wasn't corrected within a reasonable time after written notice. (3) Any withdrawal order must state the findings behind it. (f) Revoking a prior refusal, withdrawal, or suspension — Whenever the facts require it, the Secretary must revoke any earlier order under (d), (e), (m), or section 360ccc(c), (d), or (e) that refused, withdrew, or suspended approval, and must approve or reinstate the application as appropriate. (g) Service of orders — Orders under this section or section 360ccc (other than orders that make, change, or repeal regulations) are served either in person by an officer or employee the Secretary designates, or by registered or certified mail to the applicant's or respondent's last address on file with the Secretary. (h) Appeal — An applicant may appeal an order that refuses or withdraws approval under (b) or (m). The appeal follows the same rules that govern an appeal under section 355(h). (i) Publication in the Federal Register — When an application under (b) or section 360ccc is approved, the Secretary must publish — effective as a regulation — the applicant's name and address, the drug's approved conditions and uses (including any tolerance, withdrawal period, or other restriction), and, for feed use, the approved purposes and conditions for that feed (including any special labeling or requirement that use be supervised by a licensed veterinarian), plus any other information the Secretary thinks is needed for safe and effective use. If the approval is later withdrawn or suspended, or a section 360ccc conditional approval isn't renewed, the Secretary must promptly revoke or suspend that published regulation to the extent it rested on the approval. (j) Research exemption — As far as it's consistent with public health, the Secretary must make regulations exempting from this section new animal drugs and drug-containing feed meant only for investigational use by qualified experts. These regulations may condition the exemption on the manufacturer or study sponsor keeping records and reporting investigational data to the Secretary, so the Secretary can later evaluate the drug if an approval application is filed. The regulations must also set out any conditions under which treated animals, or products from them, may be sold for food. (k) Food isn't "adulterated" because of an approved drug — While an approval for a new animal drug is in effect, food isn't considered "adulterated" under section 342(a)(1) just because it contains that drug, or a substance the drug's approved use formed in or on the food. (l) Records and reports (1) For any drug with an approval in effect under (b) or section 360ccc, the applicant must keep records and report to the Secretary data about the drug's real-world experience (including experience from (a)(4)(A) different uses) and other information it receives or obtains — as the Secretary requires by regulation or order, based on a finding this is needed to determine whether grounds exist to invoke (e) or (m)(4). Where appropriate, the regulation or order must let the regulated party see similar information the Secretary holds, on request. (2) Anyone required to keep such records, and anyone with custody of them, must give a Secretary-designated officer or employee reasonable access to copy and verify them. (3) For drugs containing an antimicrobial active ingredient: (A) the sponsor must file an annual report on how much of each antimicrobial ingredient was sold or distributed for use in food-producing animals, including under any distributor's own label; (B) the report must break the amounts down by container size, strength, and dosage form; by domestic versus exported quantities; and by dosage form, listing the target animals, indications, and production classes on the approved label; (C) each report is due by March 31, covers the prior calendar year, and must include separate monthly figures; (D) the Secretary may share this data with the Antimicrobial Resistance Task Force under 42 U.S.C. 247d–5; and (E) the Secretary must make summaries of this data public, but grouped by antimicrobial class, leaving out any class with fewer than 3 separate sponsors, and reported in a way that protects national security and confidential business information. (m) Feed mill licenses (1) Anyone may apply for a license to manufacture animal feed containing new animal drugs, submitting: (A) the specific facility's business name, address, and registration number; (B) the name and signature of the person or people responsible there; (C) a certification that the feed is made and labeled according to the (i) regulations — or, for index-listed drugs, according to the section 360ccc–1(e)(2) listing and the section 360ccc–1(h) labeling rules; and (D) a certification that its manufacturing methods, facilities, and controls follow current good manufacturing practice, as described in section 351(a)(2)(B). (2) Within 90 days of filing (or a longer agreed period), the Secretary must either (A) approve the application if none of the grounds in paragraph (3) applies, or (B) offer the applicant a hearing on whether it's approvable, using the same hearing procedure described in (c)(1)'s last two sentences. (3) After notice and a hearing, based on the application, a preapproval inspection, or any other information, the Secretary must refuse the license if: (A) the application is incomplete, false, or misleading in any respect; (B) the manufacturing methods, facilities, or controls are inadequate to preserve the drug's identity, strength, quality, and purity; or (C) the facility actually manufactures or labels the feed in a way that doesn't match the specifications published under (i) or an index listing under section 360ccc–1(e). If none of those apply after notice and a hearing, the Secretary must approve the license. An approved license only lets a facility make feeds whose drug use is covered by (i) regulations or a section 360ccc–1(e) index listing. (4)(A) After notice and a hearing, the Secretary must revoke a feed-mill license if: (i) the application contained an untrue statement of material fact; or (ii) the licensee made changes that would make the application untrue, or that affect the feed's safety or effectiveness, without filing and getting approval of a supplemental application. If there's an imminent hazard to human or animal health, the Secretary (or acting Secretary) may suspend the license immediately, with prompt notice and a chance for an expedited hearing — a power that can't be delegated. (B) The Secretary may also revoke the license, after notice and a hearing, if: (i) the licensee never set up required recordkeeping, repeatedly or deliberately failed to keep records or report as required, or refused record access; (ii) new information combined with the original shows the manufacturing methods, facilities, or controls are inadequate, and weren't fixed within a reasonable time after written notice; (iii) new information combined with the original shows the feed's label is false or misleading, and wasn't corrected within a reasonable time after written notice; or (iv) new information combined with the original shows the facility made or held feed that was adulterated under section 351(a)(6), and didn't stop within a reasonable time after written notice. (C) The Secretary may also revoke a license if the licensee tells the Secretary it's discontinuing all feed manufacture under the license and waives its right to a hearing. (D) Any order under this paragraph must state its findings. (5) Once a license is issued: (A) the licensee must keep records and report to the Secretary — or, at the Secretary's choice, to the holder of the drug's approved application — as the Secretary requires, to help determine whether grounds exist for action under (e) or (4); and (B) record custodians must give a Secretary-designated officer or employee reasonable access to copy and verify those records. (6) As far as it's consistent with public health, the Secretary may exempt certain feed-manufacturing facilities from this subsection by regulation. (n) Abbreviated (generic) applications (1) An abbreviated application must include: (A) proof the proposed label's conditions of use match those already approved for the reference drug, and proof the proposed withdrawal period keeps residues within the reference drug's established tolerances — using the same withdrawal period as the reference drug, or, if different, proof that the different period still keeps residues within tolerance; (B) proof the active ingredients match the reference drug's — and, if the reference drug has more than one active ingredient and one differs under an approved (n)(3) petition, proof the remaining ingredients match, proof the different ingredient is itself part of an approved drug (or doesn't meet the "new drug" definition in section 321(v)), and any other information the Secretary requires about it; (C) similarly, if the reference drug is approved for combined feed use with other drugs, proof the proposed combined uses match — or, where one combined drug differs under an approved petition, proof of the differing drug's own approval status (or that it doesn't meet section 321(v)), proof the rest match, and other required information; (D) proof the route of administration, dosage form, and strength match the reference drug — or, if different under an approved petition, whatever information the Secretary requires about the difference; (E) proof of bioequivalence to the reference drug — or, if filed under a petition for a different-ingredient or different-combination reason, proof the active ingredients share the reference drug's pharmacological or therapeutic class and would work the same way when used as labeled; (F) proof the proposed label matches the reference drug's label, except for approved differences, a different withdrawal period, or a different manufacturer; (G) the same samples, method descriptions, and tolerance/withdrawal proposals required under (b)(1)(B) through (F); (H) a good-faith certification for each patent claiming the reference drug or a use the applicant is seeking approval for: (i) that no patent information was filed, (ii) that the patent has expired, (iii) the date the patent will expire, or (iv) that the patent is invalid or won't be infringed by this drug; and (I) if a method-of-use patent was filed for the reference drug that doesn't cover a use the applicant is seeking, a statement saying so. The Secretary may not demand information beyond what (A) through (I) call for. (2)(A) An applicant making the "patent invalid or not infringed" certification must promise to notify each patent owner (or its designated representative) and the reference drug's approved-application holder (or its representative). (B) That notice must say that an application containing bioequivalence data has been filed, seeking approval to sell the drug before the patent expires, and must give a detailed factual and legal explanation for why the applicant believes the patent is invalid or won't be infringed. (C) If an application is later amended to add this certification, notice must go out when the amendment is filed. (3) To file an abbreviated application whose ingredients, route, dosage form, strength, or combined feed use differs from the reference drug, the applicant must first petition the Secretary for permission. The Secretary must approve the petition unless the Secretary finds that studies are still needed to show the difference is safe and effective in the animals treated, or that studies are needed to show the resulting food residues are safe for people to eat. The Secretary must approve or deny the petition within 90 days of its submission. (4)(A) Within 60 days of November 16, 1988, the Secretary had to publish a public, alphabetical list of every animal drug approved for safety and effectiveness before that date, and must update it every 30 days after that to add newly approved drugs — including, when due, their published patent information. (B) A drug approved before November 16, 1988, or approved later, counts as "published" on its approval date or on November 16, 1988, whichever is later. (C) A drug can't be listed — or must be removed immediately if already listed — if its approval was withdrawn or suspended for safety grounds, or the Secretary found it pulled from sale for safety or effectiveness reasons; removal lasts for the same period as the withdrawal or suspension, or, if pulled from sale, for that period (or less, once the Secretary decides the withdrawal wasn't about safety or effectiveness). Any removal must be published in the Federal Register. (5) If an application relies only on the studies, labeling, and tolerance/withdrawal information required by (b)(1)(A), (G), and (H) — and that information didn't come from studies the applicant itself conducted, sponsored, or has rights to — the application is treated as an abbreviated application under (b)(2). (o) "Patent" defined — In this section, "patent" means a patent issued by the U.S. Patent and Trademark Office. (p) Safety and effectiveness data (1) Safety and effectiveness data submitted in a (b)(1) or section 360ccc(a) application, and not already made public, must be released to the public on request — unless extraordinary circumstances apply — once: (A) no more work is being done, or will be done, to get the application approved; (B) the Secretary decided it's not approvable and every appeal is exhausted; (C) its approval was withdrawn and every appeal is exhausted; (D) the Secretary decided the drug isn't actually a "new drug"; or (E) the first referencing (b)(2) approval takes effect, or could have taken effect if one had been filed. (2) Anyone requesting this data must include a signed, verified statement promising not to pass it on to anyone else for the purpose of helping get rights to make, use, or sell the drug outside the United States — unless that other person first gives an identical verified statement, a copy of which goes to the Secretary. (q) Date of approval when Controlled Substances Act controls are recommended (1) If the Secretary tells a sponsor the Secretary intends to recommend controls on the drug under the Controlled Substances Act, the drug's (b) approval doesn't take effect until the CSA interim final rule controlling the drug is issued under CSA section 201(j) (21 U.S.C. 811(j)). (2) For such a drug, "date of approval" means whichever comes later: (A) the date the (b) application is approved under (c); or (B) the date the CSA interim final rule is issued.