Ultrasound-Guided Injection of Joints in Horses for Therapeutic Purposes

By Dr. Zubair Khalid, DVM, MS, PhD · 2026-08-11

Key Takeaways

• Ultrasound guidance significantly enhances the accuracy of intra-articular injections in equine joints with inconsistent palpable landmarks or deep synovial recesses, such as the cervical facet joints (72% intra-articular accuracy in one cadaveric study) and shoulder region (100% intra-synovial placement with ultrasound vs. 58% with blind technique).
• Real-time needle visualization relative to the joint capsule and adjacent neurovascular structures, selection of optimal synovial pouch access, and immediate confirmation of injectate distribution via echogenic turbulence are key advantages of ultrasound guidance over blind techniques.
• Operator experience is a critical determinant of accuracy, with studies recommending cadaver practice and the use of 3D printed models for skill acquisition before clinical application to minimize iatrogenic tissue damage and improve therapeutic efficacy.
• Specific anatomical challenges exist, such as the sacroiliac joint where even ultrasound guidance may result in per articular deposition (within 2 cm of margins in most attempts) rather than true intra-articular placement, and the coxofemoral joint where aspiration is crucial to avoid sciatic nerve anesthesia.
• Reliable needle visualization relies on aligning the needle parallel to the transducer face, utilizing echogenic needle tips, and employing strategies like injecting local anesthetic to confirm tip location, with the in-plane approach generally preferred for enhanced safety.
• Documentation of ultrasound-guided injections should meticulously record the joint, approach, transducer parameters, needle details, injectate, and any complications, supported by archived images or video clips, to ensure continuity of care and medicolegal defense.

Ultrasound-guided intra-articular injection in horses is a procedural skill that combines diagnostic imaging with therapeutic delivery. This article describes the principles, evidence base, and practical execution of ultrasound-guided joint injection for therapeutic purposes in equine practice. It is written for practicing veterinarians who already perform routine arthrocentesis and wish to extend their capabilities to joints where blind techniques are unreliable or where ultrasound guidance offers measurable advantages in accuracy and safety.

The clinical question this article addresses is straightforward: when should the equine practitioner choose ultrasound guidance for therapeutic joint injection, and how should the procedure be executed to maximize intra-articular delivery while minimizing complications? The answer draws on cadaveric accuracy studies, comparative technique trials, and the established physics of ultrasound-guided needle placement. Diagnostic arthrocentesis and image interpretation are outside the scope of this article, as are the specific pharmacological properties of individual therapeutic agents.

At a Glance

Rationale for Ultrasound Guidance

Blind arthrocentesis relies on palpable bony landmarks and known joint recesses. For many equine joints, including the scapulohumeral joint, bicipital bursa, infraspinatus bursa, cervical articular process joints, and coxofemoral joint, these landmarks are inconsistent or deeply covered by muscle. A comparative study of the shoulder region found that ultrasound-guided injection achieved intra-synovial placement in all 24 targeted structures, whereas conventional blind techniques succeeded in only 14 of 24, with fewer needle repositioning attempts required in the ultrasound-guided group ultrasound-guided versus blind techniques for shoulder region injections. This difference is clinically meaningful because each failed needle pass damages tissue, increases the risk of inadvertent extracapsular deposition of medication, and prolongs procedure time.

Ultrasound guidance offers three distinct advantages over blind techniques. First, it permits real-time visualization of the needle tip relative to the joint capsule, synovial recess, and adjacent neurovascular structures. Second, it allows the operator to select the most accessible synovial pouch instead of relying on a fixed anatomical approach. Third, it provides immediate confirmation of injectate distribution when the echogenic turbulence of the medication is observed within the joint space.

Evidence Base for Accuracy

The published evidence for ultrasound-guided equine joint injection consists primarily of cadaveric studies and small clinical case series. A study of cervical facet joint injections in horses reported that 72% of injections were intra-articular and 98% were within 1 mm of the joint capsule, with a marked effect of operator experience on accuracy accuracy of ultrasound-guided cervical facet joint injection in horses. The authors advised practising on cadaver specimens before applying the technique in live horses, a recommendation that reflects the steep learning curve associated with small, deeply located joints.

For the coxofemoral joint, a retrospective case series described an ultrasound-guided cranioventral approach in horses with distension of the joint capsule, using a low-frequency curvilinear transducer and spinal needles placed cranial to the transducer ultrasound-guided cranioventral approach to the coxofemoral joint. The authors emphasized that aspiration should be performed to confirm intrasynovial placement and to avoid inadvertent sciatic nerve anesthesia, a complication specific to this joint.

The sacroiliac joint region presents particular challenges. A cadaveric comparison of cranial and caudomedial ultrasound-guided approaches found that both deposited injectate within 2 cm of the joint margins in most attempts, but intra-articular contrast was detected in only 15 of 40 injections ultrasound-guided injection techniques for the sacroiliac joint region. This finding underscores that per articular deposition may be the realistic goal for some joints, and that the therapeutic effect of medication placed adjacent to the joint capsule may differ from true intra-articular delivery.

Training and Skill Acquisition

Ultrasound-guided injection is a psychomotor skill that improves with deliberate practice. The evidence from the cervical facet joint study indicates that operator experience significantly influences accuracy, and the authors explicitly recommended cadaver-based training before clinical application accuracy of ultrasound-guided cervical facet joint injection in horses. Three-dimensional printed models of equine cervical articular process joints have been shown to reproduce the ultrasonographic characteriztics of bone sufficiently well to serve as training simulators, offering an alternative to cadaver specimens that is repeatable, portable, and free of biosafety concerns 3D printed models of equine cervical articular process joints as ultrasound training simulators.

A structured approach to skill acquisition should include the following stages. First, practice transducer orientation and needle alignment on ultrasound phantoms or 3D printed models. Second, perform guided injections on cadaver limbs with dye or contrast medium, followed by dissection to verify placement. Third, observe and then perform injections on clinical cases under supervision. Fourth, maintain proficiency through regular use, as skills decay without practice.

Principles of Needle Visualization

Reliable needle visualization is the technical foundation of ultrasound-guided injection. The needle is best seen when it lies parallel to the transducer face, because the ultrasound beam reflects off the needle shaft back to the transducer. Steeper needle angles cause the beam to reflect away, making the tip difficult to identify. Several strategies improve visualization. An echogenic needle tip, available from several manufacturers, increases reflectivity. Rotating the needle or gently moving the hub can help distinguish the tip from surrounding tissue. Injecting a small volume of local anesthetic or saline creates echogenic turbulence that confirms tip location before the therapeutic agent is delivered.

The operator must also decide between in-plane and out-of-plane approaches. In-plane placement, where the needle is aligned with the long axis of the transducer, allows continuous visualization of the entire needle shaft and tip. Out-of-plane placement, where the needle crosses the beam perpendicularly, shows only a hyperechoic dot and requires more skill to track. For most equine joint injections, the in-plane approach is preferred because it provides greater safety when neurovascular structures lie near the target.

Limitations and Uncertainties

The evidence base for ultrasound-guided equine joint injection has important limitations. Most accuracy data come from cadaveric studies, which do not account for patient movement, muscle tone, or the distensibility of synovial structures in live animals. The sacroiliac joint study explicitly noted that safety and efficacy could not be established from cadaveric work ultrasound-guided injection techniques for the sacroiliac joint region. Clinical case series are small and often retrospective, and comparative trials against blind techniques are scarce outside the shoulder region.

The temporomandibular joint literature, while drawn from human medicine, illustrates a broader principle relevant to equine practice: image-guided injection techniques generally outperform anatomical landmark techniques in accuracy, but the quality of evidence varies considerably scoping review of intra-articular injections in the temporomandibular joint inferior joint space. Practitioners should therefore evaluate the evidence for each joint individually instead of assuming that ultrasound guidance is superior in all locations.

Patient Assessment and Joint Selection

The decision to use ultrasound guidance begins before the transducer contacts the skin. A full lameness evaluation, including regional and intrasynovial analgesia, should establish which joint or synovial structure is the suspected source of pain. Ultrasound guidance adds the most value when the target is deep, poorly palpable, or adjacent to neurovascular structures. Superficial joints with reliable landmarks, such as the distal interphalangeal joint, rarely require ultrasound assistance in a cooperative patient.

Patient temperament and body condition alter the approach. A heavily muscled or obese horse may have impalpable bony landmarks, making blind injection unreliable. A fractious horse may not tolerate the prolonged positioning required for ultrasound-guided placement, and sedation protocols should be planned accordingly. The same equipment and technique that works in a standing sedated horse may require general anesthesia in a foal or a horse with severe pelvic pain.

Joint selection also depends on the specific pathology. For the cervical articular process joints, ultrasound guidance is particularly valuable because the joints are deep, the overlying epaxial musculature is substantial, and the spinal cord and vertebral artery lie in close proximity. A cadaveric study of ultrasound-guided cervical facet joint injection reported 72% intra-articular placement, with a further 17% intracapsular, and 98% of injections within 1 mm of the joint capsule Accuracy of ultrasound-guided intra-articular injection of cervical facet joints in horses. The same study noted a marked effect of operator experience, supporting supervised practice before clinical application.

Equipment and Consumable Selection

The transducer should be prepared with a sterile sleeve and sterile coupling gel. A needle guide attached to the transducer can improve accuracy for steeply angled approaches, but freehand technique offers more flexibility when the target is small or the needle must be redirected. The operator should choose the approach that keeps the needle parallel to the face of the transducer, because the ultrasound beam is thin and a needle angled steeply out of plane is difficult to visualize.

Step-by-Step Technique for Common Joints

Cervical Articular Process Joints

Position the horse standing with the head slightly lowered and the neck relaxed. Clip the region from the caudal aspect of the skull to the first thoracic vertebra, extending ventrally over the transverse processes. Place the transducer in a transverse plane over the articular process joints, which appear as a chain of rounded hyperechoic bony contours with a thin hypoechoic cleft representing the joint space.

Insert the needle cranial to the transducer and advance it in plane, directing it caudally and slightly ventrally toward the joint cleft. The needle tip should be visualized entering the hypoechoic space between the articular processes. Resistance is felt as the needle penetrates the joint capsule, and a slight pop may be appreciated. Aspiration is not always productive because the joint space is small, but the absence of blood confirms that the needle has not entered a vessel.

Scapulohumeral Joint and Shoulder Bursae

The shoulder region presents three synovial structures that are difficult to inject blindly: the scapulohumeral joint, the bicipital bursa, and the infraspinatus bursa. A comparative study of ultrasound-guided versus blind injection of these structures reported successful intrasynovial placement in all 24 synovial structures using ultrasound guidance, compared with 14 of 24 using conventional methods Comparison of ultrasound-guided vs. blind techniques for intra-synovial injections of the shoulder area in horses. The ultrasound-guided approach also required fewer needle repositioning attempts.

For the scapulohumeral joint, place the transducer over the cranial aspect of the shoulder, identifying the humeral head and the joint space between it and the glenoid cavity. The needle is inserted cranially and directed caudally into the joint space. For the bicipital bursa, the transducer is placed over the intertubercular groove, and the needle is directed into the bursa between the biceps tendon and the bone. The infraspinatus bursa lies deep to the infraspinatus tendon as it passes over the caudal aspect of the humeral head.

Sacroiliac Joint Region

The sacroiliac joint is among the most challenging targets in equine practice. Two ultrasound-guided approaches have been described: a cranial parasagittal approach using a curved 18 gauge, 25 cm spinal needle, and a caudomedial approach using a straight 18 gauge, 15 cm spinal needle Comparison of two ultrasound-guided injection techniques targeting the sacroiliac joint region in equine cadavers. In a cadaveric comparison, both approaches deposited injectate within 2 cm of the sacroiliac joint margins in most specimens, but intra-articular contrast was detected in only 15 of 40 injections. The cranial approach frequently contacted the lumbosacral intertransverse joints, while the caudomedial approach was perivascular in 16 of 20 injections.

These findings carry practical implications. Ultrasound guidance improves the accuracy of injectate deposition relative to blind techniques, but it does not guarantee intra-articular placement in the sacroiliac joint. The clinician should consider whether the therapeutic goal requires intra-articular deposition or whether periaricular infiltration of the joint region is acceptable. The proximity of vascular structures in the caudomedial approach mandates careful aspiration before injection.

Coxofemoral Joint

The coxofemoral joint is normally inaccessible to ultrasound-guided injection because the femoral head lies deep within the acetabulum. However, in horses with cranioventral distention of the joint capsule, an alternative approach becomes feasible. A retrospective study of 13 horses with cranioventral coxofemoral distention described ultrasound-guided injection using a low-frequency curvilinear transducer placed ventral to the cranial joint margins, with spinal needles advanced caudomedially into the distended recess Ultrasound-guided injections in horses with cranioventral distention of the coxofemoral joint capsule. Aspiration was recommended to confirm intrasynovial placement and to avoid sciatic nerve anesthesia.

This approach is reserved for joints with identifiable distention. In the absence of a distended recess, the coxofemoral joint remains a blind or fluoroscopically guided procedure, and the clinician should weigh the risks of needle trauma to the sciatic nerve against the benefits of intrasynovial therapy.

Monitoring and Documentation

During the procedure, continuous ultrasound visualization of the needle tip is the primary safety monitor. Loss of needle tip visualization should prompt immediate cessation of advancement until the tip is re-identified. Aspiration before injection confirms that the needle is not intravascular. After injection, the appearance of hyperechoic microbubbles within the joint space confirms delivery, although this finding is not always present with clear solutions.

Documentation should include the joint injected, the approach used, the transducer frequency and orientation, the needle gauge and length, the volume and type of medication delivered, and any complications encountered. Images or video clips of the needle tip within the joint space should be archived. This record supports subsequent injections, facilitates communication with referral colleagues, and provides a basis for outcome assessment.

Adapting Technique to Patient and Setting

The correct approach depends on the joint, the patient, and the available equipment. Standing sedation is appropriate for most cervical, shoulder, and distal limb injections. The sacroiliac and coxofemoral joints may require general anesthesia in uncooperative patients or when the operator needs prolonged time for needle placement. Foals and miniature breeds may require smaller needles and higher-frequency transducers to resolve the smaller joint spaces.

Practice setting also matters. A referral hospital with access to fluoroscopy may prefer that modality for the sacroiliac joint, while a field practice with only ultrasound will rely on the ultrasound-guided approaches described above. The evidence base for ultrasound-guided sacroiliac injection is limited to cadaveric studies, and the clinician should acknowledge this uncertainty when discussing the procedure with the owner Comparison of two ultrasound-guided injection techniques targeting the sacroiliac joint region in equine cadavers. Similarly, the temporomandibular joint inferior joint space has been studied primarily in human medicine, and extrapolation to horses requires caution given the differences in anatomy and the limited equine-specific evidence Intra-articular injections in the TMJ inferior joint space.

Complications and Failure Modes

Ultrasound-guided joint injection carries the same inherent risks as blind arthrocentesis, with the addition of equipment-related hazards. Recognized complications include iatrogenic infection, hemorrhage, needle breakage, cartilage damage, and inadvertent injection into non-synovial structures. Infection remains the most serious concern. Early detection depends on serial clinical assessment in the 48 to 72 hours after injection. Heat, marked effusion, severe lameness, or systemic signs such as pyrexia should prompt immediate synovial sampling for cytology and culture. Perineural or perivascular injection is a particular risk at sites where nerves and vessels lie close to the joint capsule. The sciatic nerve sits adjacent to the coxofemoral joint, and aspiration before injection is recommended to confirm intrasynovial placement and avoid sciatic nerve anesthesia Whitcomb et al., cranioventral coxofemoral injection feasibility study. Transient post-injection flare can mimic infection and typically resolves within 24 hours, but any worsening clinical picture should be treated as sepsis until proven otherwise.

Needle breakage is rare with modern needles but can occur if the needle is bent during repositioning or if the horse moves suddenly. Using the largest gauge appropriate for the target structure, avoiding excessive bending, and withdrawing the needle before changing direction reduce this risk. Cartilage damage is minimized by visualizing the needle tip at all times and stopping advancement once the tip enters the joint space instead of driving it to bone.

Common Errors and Corrective Actions

Less experienced operators make characteriztic mistakes that ultrasound guidance can expose and correct. The most frequent is losing sight of the needle tip during advancement. The tip, not the shaft, must remain visible throughout. If the tip disappears, stop advancing, rotate the transducer to reacquire the needle, or use a slight rocking motion to bring the tip back into the imaging plane. A second common error is advancing the needle too far and penetrating the far joint capsule or underlying cartilage. The echogenic bright line of the far capsule should be identified before injection, and the needle tip should rest just inside the near capsule.

Another error is misidentifying the target recess. Synovial folds, bursal extensions, and anechoic fluid in adjacent soft tissues can mimic a joint recess. Confirming the location by observing the needle tip entering the expected space and by noting the characteriztic distension of the target structure during injection helps avoid this mistake. In the sacroiliac region, injectate distribution varies by approach, and both cranial and caudomedial techniques deposit contrast within 2 cm of the joint margins in most cases, but intra-articular placement is confirmed in fewer than half of injections comparison of ultrasound-guided sacroiliac injection techniques in equine cadavers. Operators should recognize that perivascular deposition is common with the caudomedial approach and should aspirate before injecting.

The table below summarizes common observations, their likely causes, and the discriminating check.

Limitations of the Evidence

The evidence base for ultrasound-guided joint injection in horses is largely cadaveric and experimental. Accuracy data from cadaver studies do not translate directly to live horses, as noted in the cervical facet joint injection study, which reported 72% intra-articular placement and 98% of injections within 1 mm of the joint capsule accuracy of ultrasound-guided cervical facet joint injection in horses. Live animals introduce movement, muscle tone, and tissue compliance that alter needle behavior. The shoulder region study found ultrasound-guided techniques successful in all 24 synovial structures compared with 14 of 24 using blind methods, but this was also a cadaveric comparison ultrasound-guided versus blind shoulder region injection techniques. Clinical outcome data comparing ultrasound-guided therapeutic injections with blind techniques are sparse, and expert opinion still differs on whether ultrasound guidance improves long-term therapeutic response or only improves placement accuracy.

Training simulators offer a partial solution. Three-dimensional printed models of cervical articular process joints can reproduce bone ultrasonographic characteriztics sufficiently for practice, and six of thirteen printed models were judged similar to a dissected cervical spine by boarded radiologists 3D printed models of equine cervical articular process joints as ultrasound-guided injection simulators. These models are useful for developing hand-eye coordination but cannot replicate the complications of live tissue.

Referral, Consultation, and Reporting

Referral to a boarded radiologist or experienced equine surgeon is warranted when repeated attempts fail to achieve intrasynovial placement, when the target joint is deeply located or anatomically distorted by chronic disease, or when the operator lacks confidence in the relevant approach. The coxofemoral joint and sacroiliac region are particularly challenging, and specialist referral should be considered early instead of after multiple failed attempts. Laboratory involvement is indicated when synovial fluid analysis is needed to distinguish sepsis from flare, and culture results should guide antimicrobial selection. Regulatory reporting obligations vary by jurisdiction. Reportable events may include suspected adverse drug reactions, medication errors, or complications that result in significant harm. Practitioners should consult their professional body and local regulatory authority for current requirements AVMA practice resources and WOAH terrestrial animal health standards. Documentation of the procedure, including images, needle gauge, injectate volume, and any complications, supports both clinical continuity and medicolegal defense.

Frequently Asked Questions

How Should I Choose Between Ultrasound Guidance and a Blind Technique for a Given Joint?

Choose ultrasound guidance when the target structure is deep, variably positioned, or adjacent to neurovascular structures, and when prior blind attempts have failed. The shoulder region is a clear example, where ultrasound-guided injection succeeded in all 24 synovial structures tested compared with 14 of 24 using conventional methods in one comparative study comparison of ultrasound-guided versus blind techniques for shoulder injections. For superficial, readily palpable joints such as the distal interphalangeal joint, blind injection remains acceptable in experienced hands. Consider ultrasound when the patient is obese, when periarticular soft tissue swelling distorts landmarks, or when you need to document injectate placement for medicolegal reasons.

What Can I Do When a High-Frequency Linear Transducer Is Unavailable?

A low-frequency curvilinear transducer is an acceptable alternative for deep joints, although image resolution is reduced. The coxofemoral joint approach described in one retrospective series used a low-frequency curvilinear transducer placed ventral to the cranial joint margins, which proved feasible for accessing the cranioventral recess ultrasound-guided cranioventral approach to the coxofemoral joint. For superficial joints, a higher-frequency probe is preferable, but a microconvex probe can serve both superficial and deep structures. Optimize machine settings by increasing gain and reducing depth to the minimum that still displays the target. If image quality remains inadequate, revert to a landmark-based approach or refer the case instead of attempting blind needle placement into a high-risk region.

How Should I Document the Procedure in the Medical Record?

Record the joint injected, the approach used, the transducer orientation, the needle gauge and length, the volume and identity of all medications delivered, and the number of needle passes. Note whether synovial fluid was aspirated before injection and describe its character. Document any immediate complications, such as hemorrhage or patient resistance. Include representative ultrasound images with labels identifying the needle tip and joint space. The American College of Veterinary Radiology resources provide guidance on image archiving standards that support defensible records. If contrast was used to confirm placement, record the volume and the imaging findings. This documentation supports continuity of care, outcome assessment, and medicolegal defense if a complication arises later.

What Is the Most Efficient Way to Build Competence in These Techniques?

Practice on cadaver specimens before attempting live patients. One cadaveric study of cervical facet joint injections found that 72 percent of injections were intra-articular and 98 percent were within 1 mm of the joint capsule, with a marked effect of gained experience on accuracy accuracy of ultrasound-guided cervical facet joint injection in horses. Three-dimensional printed models of cervical articular process joints can reproduce relevant ultrasonographic characteriztics and provide a low-cost, repeatable training platform 3D printed models of equine cervical articular process joints for injection training. Seek supervised instruction from a boarded radiologist or an experienced colleague for your first 10 to 20 injections per joint. Record your success rate and review failures systematically to identify recurring errors in needle alignment or transducer handling.

How Do I Explain the Value of Ultrasound Guidance to a Client Who Is Concerned About Cost?

Frame the discussion around accuracy and complication avoidance instead of technical sophistication. Ultrasound guidance reduces the number of needle passes and improves the likelihood that medication reaches the intended synovial structure, which matters for joints where blind injection frequently misses. In the shoulder region, for example, blind techniques failed to reach the target in 10 of 24 injections in one study comparison of ultrasound-guided versus blind techniques for shoulder injections. A missed injection wastes the cost of the medication and the examination fee, and it delays effective treatment. Explain that the additional charge reflects equipment use, additional time, and the expertise required, and that it may reduce the need for repeat injections.

When Should I Refer a Case instead of Attempt Ultrasound-Guided Injection Myself?

Refer when you lack the transducer frequency needed for the target depth, when you have not performed the specific approach before, or when the patient is fractious and sedation would compromise positioning. Refer also when the joint shows severe osseous remodelling that obscures normal landmarks, or when a prior injection attempt produced unexpected hemorrhage or neurological signs. The sacroiliac region is particularly challenging, with one cadaveric study showing intra-articular contrast in only 15 of 40 injections despite ultrasound guidance comparison of two ultrasound-guided sacroiliac injection techniques in equine cadavers. If the clinical question requires diagnostic confirmation before committing to therapy, referral to a specialty center with advanced imaging and interventional expertise is appropriate. Document your assessment and the reason for referral in the record.

Related Clinical & Scientific Guides

• MRI Monitoring of Brain Tumor Response to Therapy in Dogs
• Ultrasound-Guided Drainage of Abscesses in Small Animals
• Radiographic Monitoring of Total Hip Replacement in Dogs

References and Further Reading

• Accuracy of ultrasound-guided intra-articular injection of cervical facet joints in horses: a cadaveric study.. 2003.
• Various 3D printed materials mimic bone ultrasonographically: 3D printed models of the equine cervical articular process joints as a simulator for ultrasound guided intra-articular injections.. 2019.
• Comparison of ultrasound-guided vs. 'blind' techniques for intra-synovial injections of the shoulder area in horses: scapulohumeral joint, bicipital and infraspinatus bursae.. 2012.
• ULTRASOUND-GUIDED INJECTIONS IN HORSES WITH CRANIOVENTRAL DISTENSION OF THE COXOFEMORAL JOINT CAPSULE: FEASIBILITY FOR A CRANIOVENTRAL APPROACH.. 2016.
• Intra-articular injections in the TMJ inferior joint space: A scoping review.. 2023.
• Comparison of two ultrasound-guided injection techniques targeting the sacroiliac joint region in equine cadavers.. 2016.
• American College of Veterinary Radiology Resources. American College of Veterinary Radiology.
• MSD Veterinary Manual, Professional Edition. MSD Veterinary Manual.
• American Veterinary Medical Association Practice Resources. American Veterinary Medical Association.

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This article is educational professional reference material for veterinary audiences. It is not a substitute for veterinary diagnosis, individual clinical judgment, current product labeling, or applicable regulatory requirements.