Porzio Compliance Digest (PCD): is the first Internet-based fully interactive database specifically designed to enable life sciences manufacturers, distributors and labelers to master the myriad state and federal laws, pending legislation, governing sample distribution, mid-level practitioners and marketing disclosures and prohibitions. PCD is now comprised of nine distinct databases with the recent addition of our Enforcement Action Databases:
Sales and Marketing Regulatory Compliance Databases
Distribution: Trade and Sample - Legend Drug Database: This database contains all statutes, regulations and pending legislation, nationwide, governing the distribution of trade product and drug samples by companies and their representatives as it relates to legend drugs. It contains all federal and state requirements concerning licensing, sales representative registration, company registration and theft/loss reporting.
Distribution: Trade and Sample - Controlled Substance Database: This database contains all statutes, regulations and pending legislation, nationwide, governing the distribution of trade product and drug samples by companies and their representatives as it relates to controlled substances. It contains all federal and state requirements concerning licensing, sales representative registration, company registration and theft/loss reporting.
Distribution: Prescription Device Database: This database includes nationwide statutes, regulations and pending legislation governing the distribution of prescription devices, as both trade product and samples, by companies and their representatives. State issues covered in this database include, but are not limited to, licensing requirements, storage and handling requirements, record keeping requirements and theft/loss reporting. The database also includes information concerning certain aspects of federal device distribution requirements, such as registration, reporting and device classification.
Transparency and Limitations Database: This database provides in-depth information concerning current laws and pending legislation regarding the marketing and sales practices of life sciences companies and their interaction with healthcare professionals. Topics include gifts to physicians, drug price reporting, excessive drug pricing, clinical trials, pharmacy benefit managers, prescriber data and direct-to-consumer advertising. This database also includes medical school and health care institution interaction policies, as well as federal legislation, industry codes of conduct and industry guidance documents.
Mid-level Regulations Legend Drug Database: This database synthesizes key provisions of statutes, regulations and pending legislation governing sampling legend drugs to mid-levels, so you can comply with both the Prescription Drug Marketing Act and related requirements of all 50 states plus Washington, D.C. This database provides complete sampling and prescribing authority as it relates to legend drugs for 40 classes of mid-level practitioners, plus dentists, podiatrists and veterinarians.
/PCD-MapInterface864x700-(1).aspx?width=150&height=121)
Mid-level Regulations Controlled Substance Database: This database synthesizes key provisions of statutes, regulations and pending legislation governing sampling controlled substances to mid-levels, so you can comply with both the Prescription Drug Marketing Act and related requirements of all 50 states plus the District of Columbia. This database provides complete sampling and prescribing authority as it relates to controlled substances for 40 classes of mid-level practitioners, plus dentists, podiatrists and veterinarians.
Enforcement Action Databases
FDA PDMA Inspections: This database contains information on Established Inspection Reports (EIRs) related to Prescription Drug Marketing Act (PDMA) inspections. Based on EIRs that PPS acquires from various government agencies, this database catalogues and synthesizes violations noted by FDA inspectors, summarizing relevant elements into a useful, searchable format.
Government Prosecutions: This database provides a comprehensive snapshot of federal government actions against Life Sciences companies that have allegedly violated Anti-Kickback laws, FDA regulations, the PDMA, and/or the False Claims Act, among others. It summarizes the evolving compliance requirements these companies have agreed to undertake as a result of corporate integrity agreements. The database also provides insight into the violations that are most often pursued by the federal government, as well as access to relevant documents, when available.
OPDP Promotional Violations: This database contains searchable summaries of Untitled and Warning letters issued to life sciences companies by the FDA’s OPDP Promotional Violations Database (OPDP). Letters are categorized in a variety of ways, including date of issuance, type of promotional material, and identified violation. This database also contains copies of the issued letters and the associated materials, when available. The functionality of this database gives users the ability to search for specific Untitled and Warning letters and related violations and assess prescription drug advertising and promotional labeling enforcement trends.
Porzio Compliance Digest > Benefits (read more)