This issue covers U.S. Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and U.S. Health and Human Services (HHS) developments spanning inspections, enforcement, transparency, and emerging product categories. FDA’s drug center and inspections office have updated their framework for coordinating facility evaluations and inspections (ConOps 2.0), and FDA has changed how it processes post-approval facility withdrawals for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). FDA also released a Transparency Roadmap that includes expanding public access to inspection records, while recent warning letters show continued enforcement of current Good Manufacturing Practice (cGMP) requirements on data integrity and quality systems. Separately, DEA, acting on an HHS recommendation, has moved to temporarily schedule concentrated 7-OH and related kratom alkaloids under the Controlled Substances Act, and HHS announced a draft enforcement discretion policy for compounding certain peptides, which we covered in a recent Advisory and summarize here.

FDA Announces Updated Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations: ConOps 2.0

ConOps is an agreement among FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII) that outlines how they coordinate marketing application assessments, inspections, and related compliance activities. ConOps covers preapproval, postapproval, surveillance, and for-cause inspections for human drugs. The original ConOps was published in June 2017, and this new ConOps 2.0 became effective on October 21, 2026. Notable updates include alignment with the October 2024 FDA reorganization, incorporation of Remote Regulatory Assessments (RRAs) and Mutual Recognition Agreement (MRA) inspection reports as evaluation tools, and clarified roles and responsibilities across inspection types. Note that RRAs conducted under FDA’s Federal Food, Drug, and Cosmetic Act (FD&C Act) section 704(a)(4) authority do not satisfy inspection requirements, while MRA inspection reports (such as those issued by the EU, Switzerland, and the UK regulatory authorities) can fulfill inspection requirements under section 510(h) of the FD&C Act.

FDA notes that the revised operating model will help FDA handle complexity of the drug manufacturing landscape and meet new challenges, by, among other things, ensuring consistency, efficiency, and transparency in establishment evaluations, inspections, and regulatory decision-making, alignment between CDER and OII through updated and clarified roles and responsibilities, and enhancing collaboration and reducing redundancies between CDER and OII, following the reorganization. 

FDA Announces Transparency Roadmap With a Focus on Increased Access to Inspection Records

On October 2, 2026, FDA released its Transparency Roadmap, highlighting Fiscal Year (FY) 2026 accomplishments and FY 2027 priorities across five focus areas. Consistent with the 2025 MAHA Commission’s call for “radical transparency across federal health agencies” and recognizing transparency as a core governance value, as well as a driver of innovation, the roadmap outlines five key focus areas.¹ Alongside efforts to increase transparency in complete response letters, investigational-stage and marketing application disclosures, novel development tools, and patient- and consumer-centered labeling, FDA plans to expand public access to inspection records by proactively publishing redacted Forms 483 and additional establishment inspection reports (EIRs), where appropriate.²

FDA explained that broader disclosure would help the public and foreign regulators understand the information underlying its compliance decisions. Foreign regulators routinely seek FDA inspection records when making market access determinations. For regulated companies, greater predictability about how and when findings become public is intended to support proactive remediation and a clearer understanding of regulatory expectations. The roadmap does not specify a publication schedule or commit to releasing every Form 483 or EIR.³

Indeed, the agency has started releasing batches of previously issued Form 483s through the Office of Inspections and Investigations FOIA Reading Room, with the most recent batch published on October 26, 2026. But as noted above, not all Form 483s will be released. Form 483s meeting the “proactive disclosure” or “three or more rule” criteria are those that are eligible. Records released pursuant to proactive disclosure are those for which FDA is authorized to release without an existing FOIA request, and which FDA has determined that the public has a meaningful interest in the information and that sharing it serves the goals of transparency and accountability. This disclosure is selective and made on a case-by-case basis. Under the “three or more rule,” FDA will post records online when three or more people or organizations have separately requested the same record through FOIA. In terms of what will not be disclosed, among other criteria, inspections that are open or where FDA is actively pursuing compliance action are withheld. 

HHS Draft Enforcement Discretion Policy for Compounding Using Certain Peptides

On October 28, 2026, HHS, rather than FDA, announced a draft policy under which it does not intend to take enforcement action against a state-licensed pharmacy, federal facility, or licensed physician that compounds a drug under section 503A of the Federal Food, Drug, and Cosmetic Act using one of six peptide bulk drug substances (BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500) when 10 conditions are met. The conditions include sourcing from an FDA-registered facility with a valid certificate of analysis, single-ingredient products, reporting of serious adverse events and product quality issues to MedWatch and the states, specified labeling, and patient-specific prescriptions. The policy follows the July 2026 meeting of FDA’s Pharmacy Compounding Advisory Committee, which voted in favor of listing the peptides, and would remain in effect until each peptide is addressed in a final rule on the 503A Bulks List. The policy does not cover 503B outsourcing facilities, does not approve any peptide or add any peptide to the list, and does not bind the agency or the public. Comments are due November 13, 2026.⁴

Section 503A limits the bulk drug substances that may be used in compounding. A substance must comply with an applicable United States Pharmacopeia or National Formulary monograph, if one exists. If no monograph exists, it must be a component of an FDA-approved drug or appear on the 503A Bulks List. None of the covered peptides meets these criteria, and adding a substance to the 503A Bulks List requires notice-and-comment rulemaking; no proposed rule has been issued for these peptides. FDA staff had initially placed the peptides in Category 2 under FDA’s interim policy, reflecting significant safety risks, but those nominations were withdrawn in April 2026.

Safety and quality concerns remain. FDA’s Center for Drug Evaluation and Research recommended against adding each covered peptide to the 503A Bulks List, finding the peptides poorly characterized, with missing endotoxin, impurity, and microbial data, and flagging immunogenicity concerns. The policy’s conditions rely largely on supplier certificates of analysis, FDA inspects bulk drug substance manufacturers and 503A pharmacies infrequently, and 503A pharmacies generally have no federal adverse event reporting obligation. Enforcement discretion also does not bind state boards of pharmacy or medicine and can be withdrawn without notice and comment, leaving compounders and prescribers exposed to state-law and private litigation risk. The Partnership for Safe Medicines has already filed a citizen petition asking FDA not to permit compounding of these peptides through enforcement discretion. FDA is also taking enforcement action against online peptide sellers. In an August 24, 2026 warning letter to Peak Performance Peptides, FDA identified several products as unapproved new drugs and emphasized that injectable products “bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.”⁵

Read more in Arnold & Porter’s Advisory, HHS Announces Draft Enforcement Discretion Policy Paving Way for Pharmacies to Compound Certain Peptides While FDA Rulemaking Is Pending.

FDA’s Continued Focus on Quality Systems and Data Integrity Evident in Recent Warning Letters 

In addition to common cGMP-related observations arising from FDA inspections of drug manufacturing facilities (e.g., inadequate environmental monitoring, inadequate aseptic practices), FDA recently cited several firms for data integrity lapses, recordkeeping gaps, and ineffective quality systems.

For example, in a warning letter arising from an inspection of Curia New York, Inc.’s Rensselaer, New York facility, FDA found that Curia’s laboratory control records were incomplete, such that not all of the test results generated by its equipment were being accounted for when deciding whether a batch of ingredients met quality standards. Laboratory analysts routinely conducted unexplained injections in HPLC and UPLC equipment without adequate supervision or documentation to ensure that product samples were not being tested. The laboratory analysts also performed thousands of unexplained injections using chromatographic data processing and analysis software, including dozens of trial injections under the software’s “Developer” role instead of the “Operator” role. The Company could not explain why those tests were run or tie them back to any actual product or sample nor were records maintained in the laboratory notebooks. FDA also found the Company’s response inadequate because it lacked a full investigation of all unexplained injections and their associated cGMP risk.

In addition, FDA found that Curia’s quality unit failed to maintain adequate control over laboratory records. Investigators discovered original data sheets — including signed instrument printouts and review checklists — discarded in laboratory shred bins, with the Company unable to explain who discarded them, why, or how they related to specific product batches. Investigators also found that laboratory personnel were reviewing photocopies of notebook pages rather than original records before signing off, a practice the Company acknowledged violated its own procedures. FDA deemed the Company’s corrective response inadequate, noting that its review of the discarded records was incomplete and that the Company could not determine the scope of records potentially lost through prior destruction practices. FDA ultimately concluded that the Company’s quality system failed to ensure the integrity of the data underlying its manufactured drug substances.

In other warning letters, in addition to data integrity deficiencies, FDA also specifically cited Quality System deficiencies. For example, FDA noted that firms did not operate an effective quality system in accordance with cGMPs in cases where they lacked effective management oversight of production and laboratory operations, and/or the Quality Unit lacks authority to exercise proper authority and/or has insufficiently implemented its responsibilities. FDA directed executive management to evaluate these deficiencies. Firms were also directed to comprehensively assess and remediate the Quality Unit and convey how top management supports quality.

FDA to Acknowledge and Retain Post-Approval Facility Withdrawal Notifications and Submissions to NDAs and ANDAs

FDA has updated its processes for supplements to withdraw a facility from an NDA or ANDA. Effective as of November 2, 2026, supplements only seeking to withdraw a facility from the application for an NDA or ANDA will receive an “acknowledge and retain” letter instead of an action letter. If a supplement includes other changes in addition to a facility withdrawal, FDA will acknowledge the facility withdrawal in the initial communication, with the following statement: “We acknowledge receipt of the facility(ies) withdrawal request included in this supplement. This 21 CFR 314.70 minor reportable change will be documented as withdrawn and maintained in our administrative records. No further regulatory action with respect to this change will be taken for this supplement.” The facility withdrawal will not be referenced in any subsequent action letter for that supplement. 

DEA Moves to Temporarily Schedule Concentrated 7-OH and Related Kratom Substances

DEA issued a notice of intent (NOI) to publish a temporary order to schedule certain concentrated versions of kratom and mitragynine (7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl) in Schedule I of the Controlled Substances Act. The NOI follows an October 8, 2026 letter from the Assistant Secretary for Health at HHS recommending controlling 7-hydroxymitragynine and mitragynine pseudoindoxyl when either substance alone, or their combined amount if both are present, is above the specified threshold in Schedule I.

Under the notice of intent, Schedule I controls would apply if either of the following is met:

• The substance exceeds 1 mg/g (solids) or 1 mg/mL (liquids)
• The mass of mitragynine divided by the mass of 7-OH (or of mitragynine pseudoindoxyl, or of both combined) is less than 100

DEA intends to issue the temporary order as soon as possible after the expiration of 30 days from the date of publication of the notice of intent. When that occurs, 7-hydroxymitragynine and mitragynine pseudoindoxyl when present in the amounts noted above will be subject to the CSA’s Schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession. The practical impact of this threshold-based approach is that substances below this threshold will remain unscheduled.

Note that DEA previously issued a notice of intent related to 7-OH in July 2026, and this notice is being withdrawn. Additionally, the August 2026 temporary order placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in Schedule I without a threshold, however, will remain in effect until it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.