Blog Post

Pharmaceutical Compliance in 2026
What’s New and How PrimeRx Can Help

Introduction

Pharmacists will ring in 2026 with a series of regulatory and compliance changes that ensure a busy start to the new year. And even more changes may be on the horizon, with healthcare spending and drug pricing currently front burner issues for both the U.S. Congress and the Trump Administration. It’s essential that pharmacists keep pace, and take advantage of the many tools available to help ensure full regulatory compliance.

What is pharmacy compliance and why does it matter in 2026?

A traditional definition of “pharmacy compliance,” developed by Verisk data management company, refers to “an ongoing commitment to abide by all laws, regulations, and professional standards that guide how a pharmacy operates.” Several categories fall under the broad “compliance” heading including:

Legal compliance – Adherence with all federal, state, and local laws and regulations that affect pharmacy operations.
Safety compliance – Ensuring all storage, handling, and dispensing protocols are followed.
Billing compliance – Ensuring all claims include accurate information and are filed in accordance with payer requirements.
Data privacy compliance –Meeting all requirements for maintaining the confidentiality of patient health data, protecting patient records and signatures, and adherence with all Health Insurance Portability and Accountability Act (HIPAA) regulations.
Audit compliance. Responding to all requests for records, including copies of prescriptions, patient signatures, dispensing histories, payment records, and many other types of information.

While compliance has always been an integral part of pharmacy operations, the volume and scope of regulatory mandates has increased significantly in recent years. There are many reasons for this. For one thing, pharmacists have assumed a greater role in patient care and taken on new responsibilities, which trigger new regulatory requirements. At the same time, changes in federal and state healthcare practices have created new regulatory protocols that directly affect pharmacy operations.

Pharmacy compliance can be a confusing, time-consuming process. But given the high costs of non-compliance, proper adherence must be a priority. Some of the risks of non-compliance include:

o Increased audit risks.

o Steep fines.

o Dispensing errors.

o Increased risk to patient health.

o Potential risk to pharmacy’s license.

o Reputational damage.

With so much at stake, it’s essential for a pharmacy to understand its compliance obligations, and to keep informed about new and changing requirements.

Compliance in 2026 -What Regulations are Changing?

A few key compliance changes taking effect in 2026 include:

Lower Negotiated Medicare Part D Drug Prices.

The 2022 Inflation Reduction Act

includes provisions intended to lower prescription drug costs for Medicare beneficiaries. Specifically, a key drug-related provision requires the Secretary of the Department of Health and Human Services to negotiate with drug companies to reduce costs for Part D-covered medications. Beginning in 2026, prices will be reduced for ten medications. An additional 15 drugs will be affected in 2027. A listing of drugs selected for reduced pricing in 2026 includes:

o Eliquis

o Enbrel

o Entresto

o Farxiga

o Fiasp and NovoLog

o Imbruvica

o Januvia

o Jardiance

o Stelara

o Xarelto

In a statement, the National Community Pharmacists Association (NCPA) notes that the price reductions, which will be reflected in wholesale acquisition costs (WACs), reflect “the biggest WAC reductions in the history of the pharmaceutical industry,” amounting to as much as $50 billion. NCPA notes that pharmacies should have received notices from their wholesaler(s) about the coming WAC decreases and recommends pharmacies evaluate anticipated near-term demand as a way to avoid “getting stuck” with inventory purchased at a higher cost.

Medicare Part D Out-of-Pocket Costs.

Patients will face higher out-of-pocket costs for Part D drugs, with the cap increasing from $2,000 to $2,100.

Expiration of Drug Supply Chain Security Act (DSCSA) waiver for community pharmacies. The Drug Supply Chain Security Act (DSCSA) includes numerous pharmacy-related provisions, all in support of the legislation’s goal of ensuring the safety of the nation’s drug supply. For pharmacies, the law includes multiple compliance requirements, including the ability to track, trace, and document every drug in its inventory, along with adoption of a new standardized technology platform. The law, which was passed in 2014, was scheduled to be fully implemented in 2024. However, its effect on community pharmacies, especially the technology components, proved to be so onerous that the compliance deadline was extended to November 2026. Pharmacists must ensure full compliance with the law’s system requirements by that time.

HIPAA/Health Data Protections. In late 2024, the Department of Health and Human Services (HHS) proposed significant changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Although those changes have not been finalized, there is speculation that a final rule could be issued at any time, with implementation of several provisions likely for 2026. Key provisions will tighten security protocols and revise patient privacy notices. According to Chess Health Solutions, new requirements may include:

o Revised content requirements for all Notices of Privacy Practices (NPPs). [Note: This provision has been finalized and will take effect on February 16, 2026.]

o Multi-factor authorization (MFA) for system access – not just for remote access.

o Encryption of electronic personal health records (ePHIs).

o Documented risk analysis to proactively identify vulnerabilities.

o Comprehensive listing of all systems, software and devices with access to ePHIs.

o 24-hour breach reporting obligations.

Worth noting, NCPA strongly opposed many of these changes, citing the significant compliance costs to pharmacies. The Department of Health and Human Services, according to NCPA, estimates the new requirements will cost a small business $1,235 per year. NCPA however, claims that figure is “grossly underestimated,” and notes that pharmacies “already on the verge of closure because of unfair reimbursement, cannot absorb further costs to comply with the proposed rule’s requirements.”

Pharmacy Benefit Manager Reform. Although the U.S. Congress failed to implement meaningful PBM reform during 2025, several states succeeded in passing laws to address specific PMB practices. Laws set to take in 2026 include: o Alabama – Prohibition on spread pricing and patient steering. o Arkansas – Ban on PBM ownership of pharmacies. o Iowa – Limits on patient steering and under-reimbursement. o California – Prohibition on spread-pricing and rebate-retention models. The law also restricts PBM preferences for favored pharmacies, and aligns patients costs at the pharmacy counter with the amount paid by plans and insurers.

Electronic Prescribing, Real-time Drug Pricing, Prior Authorization. Prescription drug reforms were finalized by HHS during 2025 and became effective on October 1. According to HHS, the new requirements ensure “that health care providers using certified health IT systems are able to submit prior authorizations electronically, select drugs consistent with a patient’s insurance coverage, and exchange electronic prescription information with pharmacies and insurance plans.” The agency notes that with these changes, “millions of Americans for the first time will be able to compare drug prices, view out-of-pocket costs, and access prior authorization requirements.” However, as discussed below, these capabilities have long been available to pharmacies through the PrimeRx pharmacy management system.

Compliance can be Overwhelming. Technology can Help.

Compliance affects the typical pharmacy in many ways. Pharmacists must spend time learning about specific compliance requirements, providing staff members with necessary training, and ensuring protocols are in place to satisfy reporting procedures. And most of all, compliance typically comes at a cost. Sometimes at a steep cost, as noted by NCPA in its opposition to the Department of Health and Human Services’ proposed HIPAA changes.

Pharmacies can look to technology for relief from time-consuming and costly compliance requirements. This includes the PrimeRx pharmacy management system, which offers extensive compliance-related functionality. A few PrimeRx capabilities include:

Record and document management. All compliance mandates include documentation and recordkeeping requirements, and the ability to produce needed documentation quickly and accurate. PrimeRx serves as an electronic repository for all patient and pharmacy records and offers pharmacists peace of mind that information is safely stored and easily accessible.

The system allows comprehensive record maintenance that helps pharmacies meet compliance requirements for state and federal mandates including the Drug Supply Chain Safety Act, the Controlled Substances Act, automatic refill programs, and audit inquiries, among the pharmacy’s many compliance requirements.

Real Time Prescription Benefit Review, E-Prescriptions, and Prior Authorizations. New HHS guidance requires that certified technology systems offer key capabilities, including access to a real-time prescription benefit solution, e-prescribing, and electronic prior authorization processing. PrimeRx has long-recognized the importance of each of these capabilities and for several years, has offered direct integration with industry-leading solutions.

Surescripts Real-Time Prescription Benefit Review. The forward-looking Surescripts solution allows real-time information about patient drug coverage, and identifies lower-cost alternatives to help manage patient out-of-pocket costs. o Electronic prior authorization processing. Covermymeds automates the prior authorization process. Requests are transmitted electronically, which dramatically reduces processing time, with all transaction records seamlessly stored within PrimeRx.
Electronic prescribing. PrimeRx pharmacies can integrate directly with Surescripts, the industry leader in electronic prescription processing.

Controlled Substances — Prescriber validation. Before a pharmacy can process a prescription for a controlled substance, the pharmacist must first validate the prescriber’s DEA authority. PrimeRx seamlessly performs this credential check as a routine part of filling a controlled substance prescription.

Prescription Drug Monitoring Programs (PDMPs). Every state maintains a PDMP that requires pharmacies to submit regular – in some cases daily – reports about controlled substance prescription activity. Even if a pharmacy fills no prescriptions for a controlled substance, a zero-submission form may still be required. Pharmacies are required to provide data on prescriptions dispensed including the name of the prescribing physician and their DEA number, the date the prescription was written, and where and when the prescription was dispensed. PrimeRx automates the PDMP reporting process, allowing pharmacies to seamlessly comply with this important requirement.

Inventory management. PrimeRx helps pharmacies manage their controlled substance inventory holdings, as required by the Drug Supply Chain Security Act (DSCSA). This includes the ability to track each medication based on unique elements including drug lot/expiration numbers, GTIN numbers, NDCs, and serial numbers. PrimeRx also supports the DSCSA requirement that all product identifiers be accessible in 2D barcode format. [See below for more information about the DSCSA.]

Medication Procurement. PrimeRx MARKET helps pharmacies identify low-cost suppliers for prescription medications, including Medicare Part D medications scheduled for January 2026 price reductions. PrimeRx MARKET is a leading online marketplace that allows pharmacies direct access to more than 40 major wholesalers. Pharmacies can receive real-time price information for specific medications and submit order requests with multiple suppliers. The system integrates directly with PrimeRx so that pharmacists can accomplish these critical tasks without having to leave a workflow or access a separate screen.

HIPAA Compliance. PrimeRx helps pharmacies meet changing HIPAA requirements with capabilities that include:

System compatibility. PrimeRx is continually updated to ensure full alignment with HIPAA technology requirements. This avoids service disruptions and minimizes the risk of data loss.
System controls. PrimeRx includes multiple security features that ensure only authorized users have access to patient information and pharmacy records.
Electronic signature capture and validation. Consistent with HIPAA requirements, signatures are automatically date/time stamped at point of collection.
Security-focused backup solution. The system offers an industry-leading remote backup solution (RBS) that utilizes the durability and security of Amazon’s EC2 Cloud Server and goes the extra mile by establishing a firewall to protect all data. The combination of Amazon security, and the added firewall protection help minimize the chance of a data breach and keep pharmacy data secure and continually backed up.
Data Conversion. PrimeRx technicians work with each customer to ensure that all data conversions and migrations are highly secure and seamless. This ensures data integrity, and the safe transfer of data by credentialed employees.

DSCSA Compliance. The Drug Supply Chain Security Act (DSCSA) includes several provisions that directly affect pharmacists. Most of these provisions are now in effect, with the previously noted exemption issued to community pharmacies with regard to technology. That exemption is set to expire in November 2026, meaning all pharmacies must be in full compliance by that time. PrimeRx facilitate compliances with the DSCSA through direct integration with third-party technology provider InfiniTrak, an industry leader in developing DSCSA-specific track-and-trace solutions.

Key InfiniTrak capabilities:
- EPCIS-ready. The solution supports the DSCSA-mandated Electronic Product Code Information Services (EPCIS) data protocol.
- Easy capture of transaction data elements including drug lot/expiration numbers, GTIN numbers, NDCs, and serial numbers.
- Real-time verification of trading partner licensing authority.
- Workflows that support the identification and verification of suspicious products, product quarantines, and guidance for notifying the Food and Drug Administration.
- Ability to search for products by date, supplier, description, NDC, invoice number, lot, status, and type.
- Ability to coordinate global location numbers (GLN) for interoperability.
- Ability to store – and easily access – DSCSA compliance reviews and inspection documentation as needed.
PrimeRx capabilities:
- 2D Barcodes: The DSCSA requires all product identifiers to be available in 2D format. PrimeRx supports this requirement and allows users to capture data elements that include:
  - Drug Lot
  - Expiration Date
  - Serial Numbers
  - Global Trade Item Number (GTIN)
  - National Drug Code.

Pharmacies can also rely on PrimeRx to meet DSCSA compliance requirements regarding recordkeeping, and report generation as discussed above.

Regulatory compliance is, unfortunately, an unavoidable part of owning a pharmacy. It’s time-consuming, administrative, and expensive. But since it’s also mandatory, pharmacies should focus on finding ways to turn compliance to their advantage. This can be done by using the technology-based tools discussed above to add efficiency and help manage costs. Pharmacies can also build trust with patients, namely by highlighting their commitment to medication safety, and protecting patient data.

Like it or not, pharmacies will ring in 2026 with a wide range of new regulatory mandates. A good New Year’s resolution then, might be to focus on minimizing disruption to pharmacy operations while ensuring full compliance. As always, PrimeRx will be ready to help pharmacies meet those resolutions.