FDA Announces New Surveys of Foodborne Illness Risk Factors in Restaurants, Retail Food Stores, and Foodservice Institutions

By Robert A. Hahn

FDA has published notices announcing that, over the next 10 years, it plans to conduct surveys on the occurrence of foodborne illness risk factors in restaurants, retail food stores, and foodservice institutions (e.g., hospitals, schools).

Pursuant to the Paperwork Reduction Act, FDA is required to provide a 60-day notice of a proposed collection of information before submitting it to the Office of Management and Budget for approval.  FDA is requesting comments, which are due February 9, 2015 and February 17, 2015, respectively.  See 79 Fed. Reg. 73596 (Dec. 11, 2014) (Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types) and 79 Fed. Reg. 75158 (Dec. 17, 2014) (Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types).

The restaurant survey will span 10 years (2013-2022) and will include data collections in 2013-14 (data already collected and currently being analyzed), 2017-18, and 2021-22.  It will cover both full-service restaurants and fast food restaurants; the latter category includes both quick service restaurants and fast casual restaurants.  FDA’s 25 Regional Retail Food Specialists will contact a random sample of restaurants in its sampling zone, but industry participation is voluntary.

The retail food store and institutional foodservice study will also span 10 years (2015-2025), and will include data collections in 2015-16, 2019-20, and 2023-24.  It will cover: supermarkets and grocery stores that have a deli department or operation, public and private schools for grades K-12 that serve prepare and serve meals to students, and hospitals and long-term care facilities that prepare and serve meals to highly susceptible populations.  The survey will not cover facilities that handle only prepackaged foods or that conduct low-risk food preparation activities.  In the case of grocery stores, FDA will collect data on: deli departments, seafood departments, cheese departments, fresh produce departments, salad bars, pizza stations, and other areas where foods are prepared and offered as ready to eat.  Each of FDA’s 25 Regional Retail Food Specialists will contact a random sample of retail stores and foodservice establishments in its sampling zone, but industry participation is voluntary.

The two studies will look at “foodborne illness risk factors,” which are preparation practices and employee behaviors that are most commonly reported as contributing factors to foodborne illness outbreaks at the retail level.  The five key risk factors are: food from unsafe sources, poor personal hygiene, inadequate cooking, improper holding/time and temperature, and contaminated equipment/cross-contamination.

The objectives of the studies are to:

  • Identify foodborne illness risk factors that need priority attention;
  • Track trends in the occurrence of foodborne illness risk factors over time;
  • Examine potential correlations between the operational characteristics of food establishments (g., corporate ownership versus independent ownership) and the control of foodborne illness risk factors;
  • Examine potential correlations between the elements of a regulatory retail food protection program (g., inspection frequency, grading, posting of scores) and the control of foodborne illness risk factors; and
  • Evaluate the impact of industry food safety management systems (g., written standard operating procedures, training) on the control of foodborne illness risk factors.

FDA intends to use the study results to:

  • Assist FDA in developing retail food safety initiatives and policies;
  • Identify retail food safety work plan priorities to assist with allocation of resources;
  • Track changes in the occurrence of foodborne illness risk factors in retail and foodservice establishments; and
  • Inform recommendations to industry and to state, local, tribal, and territorial regulators.

Although not stated by FDA, the survey results could lead to changes in the Retail Food Code.

These studies represent a continuation of FDA’s previous 10-year studies of retail food safety risk factors initiated in 1998.  In 2010, FDA released two reports on those studies: FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2009) and FDA Trend Analysis Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (1998-2008).

Don’t Rush the Holiday Preparations – Make Certain the Meat is Properly Cooked

By Barbara J. Masters, D.V.M.

Getting ready for holiday “get togethers”, one often finds themselves in a rush or behind on preparing the food for the party.  Don’t let tardiness be the reason the party attendees end up with a case of foodborne illness.  Don’t rush cooking of product; I am certain the guests would rather wait a few minutes than risk the potential of being sick because the product was not properly cooked.

Always read the product label for specific cooking instructions and follow them!  Be sure to verify whether the product has been pre-cooked and simply needs to be re-heated, or if the product is raw and needs to be thoroughly cooked.   All of this information will be included on the product label.  If there are questions on what temperature to cook a specific product to, USDA’s Food Safety and Inspection Service provides a chart that includes safe minimum internal cooking temperatures:

Cook all food to these minimum internal temperatures as measured with a food thermometer before removing food from the heat source. For reasons of personal preference, consumers may choose to cook food to higher temperatures.

Product Minimum Internal Temperature & Rest Time
Beef, Pork, Veal & Lamb
Steaks, chops, roasts
145 °F (62.8 °C) and allow to rest for at least 3 minutes
Ground meats 160 °F (71.1 °C)
Ham, fresh or smoked (uncooked) 145 °F (60 °C) and allow to rest for at least 3 minutes
Fully Cooked Ham
(to reheat)
Reheat cooked hams packaged in USDA-inspected plants to 140 °F (60 °C) and all others to 165 °F (73.9 °C).


Product Minimum Internal Temperature
All Poultry (breasts, whole bird, legs, thighs, and wings, ground poultry, and stuffing) 165 °F (73.9 °C)
Eggs 160 °F (71.1 °C)
Fish & Shellfish 145 °F (62.8 °C)
Leftovers 165 °F (73.9 °C)
Casseroles 165 °F (73.9 °C)

Source: Food Safety and Inspection Service

You can not see or smell bacteria that may be on raw products.  It is important to follow the manufacturer’s cooking instructions to ensure the safety of the product.

FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

By Tish Pahl

In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA). FDA, the pharmaceutical supply chain, and other stakeholders have been working very hard to implement the DSCSA as quickly as possible. In the Draft Guidance, FDA aims to advise industry, States, and local governments on the effect of §585(a) upon State drug product tracing requirements, and the effect of §585(b) upon State wholesale drug distributor and third-party logistics provider (3PL) licensing standards and requirements. Unfortunately, the Draft Guidance falls short of this goal.

FDA’s analysis of §585(a) is limited to repeating the statutory language which, although technically correct, is not especially useful to helping States understand the full extent of the DSCSA’s preemption of their product traceability requirements. Section 585(b) is far more problematic, as FDA erroneously concludes that §585(b)(1) only establishes a minimum set of standards for wholesale distributor and 3PL licensure that States may exceed. In fact, §585(b)(1) precludes States from implementing licensure requirements that enlarge what the DSCSA requires.

Congress Intended to Bring National Uniformity to Licensure

The Draft Guidance ignores Congress’ clearly expressed intent to establish uniform, national licensure standards for wholesalers and 3PLs, with a well-defined floor under and ceiling upon State regulation. Sections 583 and 584 are both entitled “National Standards” for wholesale distributors and 3PLs respectively. Section 585 is entitled “National Uniform Policy.” To “ensur[e] uniformity,” States must meet the standards FDA establishes. See §503(e)(1)(B); §583(b). According to the House Energy & Commerce Committee fact sheet on the DSCSA, “[t]he bill would … [c]reate floor and ceiling licensure standards for wholesale distributors and 3PLs while preserving state authority for licensure issuance and fee collection.” Members of Congress clearly and repeatedly stated that they intended for the DSCSA to replace the patchwork of multiple and conflicting State laws with a uniform national standard for licensure. (See statements in the Congressional Record by Congressman Bob Latta (R-OH) here and Senator John Isakson (R-GA) here).

Congress achieved this national uniformity in §585(b)(1) by using well-known and frequently interpreted statutory language.

What Does §585(b) Say?

Section 585(b)(1) provides that no State or political subdivision may establish or continue any standards, requirements, or regulations “with respect to” wholesale prescription drug distributor or 3PL licensure that “are inconsistent with, less stringent than, directly related to, or covered by” the DSCSA’s standards and requirements. FDA states that this phrase means simply that State licensure standards must not “fall below the minimum standards established by federal law.” See, e.g., Draft Guidance at lines 135, 148-49 (wholesale distributors); line 183 (3PL). This is in error as the language of §585(b) establishes both a minimum floor and a maximum set of standards for wholesale distributor and 3PL licensure that States may not exceed.

What Does §585(b) Mean?

“With respect to”

Section 585(b)(1) provides that State standards, requirements, and regulations “with respect to” wholesale distributor and 3PL licensure are preempted. “With respect to” means that the DSCSA preempts State requirements that “concern” wholesale distributor or 3PL licensure. See Dan’s City Used Cars, Inc. v. Pelkey, 133 S.Ct. 1769, 1778 (2013).

“Inconsistent with” and “Less stringent than”

Section 585(b)(1) preempts any State standards, requirements, or regulations with respect to licensure that “are inconsistent with, less stringent than, directly related to, or covered by” the DSCSA’s standards and requirements. The phrases “inconsistent with” and “less stringent than” are interpreted as setting a minimum “floor” that State licensure requirements must meet. Jones v. Rath Packing Co., 430 U.S. 519, 540 (1977). Congress, however, added two additional phrases, “directly related to” and “covered by,” and these provisions significantly expand the scope of the State laws displaced by §585(b)(1).

“Directly related to” and “Covered by”

The phrase “related to” is broadly preemptive. A State law “relates to” a federal requirement, and so is preempted, if it makes “reference to” or has a “connection with” the federal requirement. Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 96 (1983). As the DSCSA preempts only State requirements “directly related to” DSCSA requirements, courts would likely turn to ordinary definitions of the modifier “directly.” See, e.g., CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664-65 (1993). In Black’s Law and Webster’s, “directly” means, among other things, in a “straightforward” or “direct manner.”

A phrase similar to the DSCSA’s “covered by” is also broadly preemptive. The Supreme Court has interpreted the Federal Railroad Safety Act (FRSA), which provided that a federal requirement “covering the subject matter” of a State requirement preempted that State requirement if the federal requirement “comprised,” included,” or “embraced” the State requirement, or if the State requirement was “substantially subsumed by” the federal requirement. Easterwood, 507 U.S. at 664-65. The “covering” language “must be read both “establishing a ceiling” and “precluding additional state regulation.” Id. at 674. Where a federal statute employs “covering the subject matter” preemption language, the federal interest in “consistency and uniformity” means that a State “cannot enlarge or enhance” its requirements “to impose burdens more onerous than those of the federal requirements on matters addressed by the federal regulations.” Drake v. Laboratory Corp. of America Holdings, 488 F.3d 48, 65 (2d Cir. 2006) (interpreting similar “covering” preemption under the Federal Aviation Act).

What Does §585(b)(1) Preempt?

Based upon the foregoing, the Draft Guidance clearly does not reflect the full preemptive scope of §585(b)(1). The DSCSA sets both minimum and maximum limits upon State licensure requirements. Any State requirement that is comprised, included, embraced, or substantially subsumed in, the DSCSA is preempted. Any State requirement that is substantial enough to impede national uniformity or that imposes burdens more onerous than what the DSCSA imposes is also preempted.

And so, for example, States could not continue to require third-party accreditation, such as VAWD, as a condition of licensure as this would impose a burden upon a wholesale distributor more onerous than the DSCSA-required mandatory physical inspection after submission of an initial application under §583(b)(6)). Further, wholesale distributors and 3PLs would be held to DSCSA inspectional standards alone; during inspections States could not impose requirements and burdens beyond what the DSCSA mandates. Similarly, a State could not mandate a longer period of time for maintenance of distribution records as these are “directly related” to the DSCSA-mandated maintenance of records of distributions under §583(b)(2).

When coupled with the savings clauses also in §585, the section may be read as permitting States to continue to regulate in areas that are tangential to and not concerned with licensure, such as assessment of fees for licensure, the scheduling of controlled substances, and the conduct of prescription drug monitoring programs.

The Draft Guidance’s assertion that §585(b)(1) establishes only minimum standards is simply incorrect. Congress employed well-known, well-litigated, well-understood terms in the DSCSA to ensure national, uniform licensure of wholesale distributors and 3PLs. The comment period on the Draft Guidance closed last week, with one comment already raising the same concerns presented here; as more comments are posted to the docket, others are likely to concur. We hope that FDA will carefully consider Congress’ clearly expressed intent, the language it used to express that intent, and the decades of case law interpreting the language Congress carefully selected, and correct the Draft Guidance as soon as possible so that it accurately reflects the DSCSA’s full displacement of State licensure laws.

Congress Approves Agriculture, FDA Funding as Part of Consolidated Appropriations Act of 2015

By Roger R. Szemraj

Congress has completed action on the Consolidated Appropriations Act of 2015 (the Act), which funds eleven of the twelve regular Appropriation bills through September 30, 2015, the balance of fiscal 2015.  Funding for the Homeland Security bill is provided under a Continuing Resolution through February 27.  The House approved the Act on Thursday, December 11, by a vote of 219-206.  The Senate then approved the Act on Saturday, December 13, by a vote of 56-40.  Details of the Agriculture, Rural Development, and FDA portion of the agreement can be found in Division A of the Act and Division A of the Explanatory Statement (the Statement), and in a summary of key provisions.

The full House Appropriations Committee approved and reported HR 4800 (House Report 113-468), the FY 2015 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill on May 29, 2014, by a vote of 31-18.

The full Senate Appropriations Committee approved and reported S. 2389 (Senate Report 113- 164), the FY 2014 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill (Senate Report ) on May 22, by a voice vote.

Neither the House nor the Senate actually completed action on the above reported bills.

As noted in the Statement, “The House and Senate report language that is not changed by the explanatory statement is approved and indicates congressional intentions. The explanatory statement, while repeating some report language for emphasis, does not intend to negate the language referred to above unless expressly provided herein.” 


The legislation provides $147.581 billion in both mandatory and discretionary funding.  This is an increase of nearly $2 billion over FY 2014 and $17.9 billion below the Administration’s FY 2015 request.  It includes $25 million in emergency funding for FDA work on the Ebola Response and Preparedness.  The mandatory funding in the Act is nearly $126.492 billion, of which more than $103 billion goes for food assistance programs including the Supplemental Nutrition Assistance (SNAP, previously Food Stamps) Program and the Child Nutrition Programs.  The summary says that discretionary spending will be $20.6 billion in FY 2015, $305 million below FY 2014.

The following table provides funding by Title, and compares the Act’s 2015 amounts with the 2014 enacted amounts.

(In thousands of dollars)
Title Description 2014 Enacted 2015 Consolidated Act 2015 Compared with 2014
I Agricultural Programs $29,938,096 $30,182,115 $244,019
II Conservation Programs $825,832 $859,326 $43,656
III Rural Economic and Community Development Programs $2,397,709 $2,403,423 $172,544
IV Domestic Food Programs $108,585,603 $110,190,881 $1,605,278
V Foreign Assistance and Related Programs $1,838,472 $1,835,325 -$3,147
VI Related Agencies and Food and Drug Administration $2,551,905 $2,588,536 $36,631
VII General Provisions -$708,429 -$512,404 -$196,025
VIII Ebola Response and Preparedness (emergency) $25,000 $25,000
Total, New Budget Authority $145,652,976 $147,580,990 $1,928,014

GMO Hearing

By Peter B. Matz

Yesterday, the House Energy and Commerce Subcommittee on Health held a hearing to examine FDA’s role in the regulation of genetically engineered foods (commonly, but inaccurately, referred to as “genetically modified organisms” or “GMOs”).  Congressman Mike Pompeo’s (R-KS) Safe and Affordable Food Act (H.R. 4432), which would preempt state GMO labeling laws and require labeling only if a food product were deemed unsafe or materially different by the FDA, was also a major focus of the hearing.  While the bill will die at the end of this Congress, it is expected to be reintroduced in the 114th Congress.  Following are a few key takeaways:

  • There was general consensus among Committee Members from both parties that a federal GMO labeling standard applied nationwide would be more sensible than state-by-state regulations.
  • When Rep. Pompeo asked the second panel, which included two GMO labeling advocates, to answer with a yes or no whether they agreed GE foods are as safe as their conventional counterparts, all four witnesses answered, “yes.”
  • Several Members, on a bipartisan basis, expressed concern that a mandatory label disclosing the inclusion of GE ingredients which present no health or safety risk could be inherently misleading.  For example, Full Committee Ranking Member Henry Waxman (CA) argued that a label could unintentionally appear to imply that the foods are somehow less safe than conventional varieties.
  • Michael Landa, FDA’s Director of the Center for Food Safety and Applied Nutrition, discussed the consultation process in which FDA reviews GMO foods before they go to market.  While it is technically voluntary, he explained that biotechnology companies comply with it because they know farmers will not buy GM seeds unless FDA has given the manufacturer a “no questions letter,” because they would never want to risk growing a product that FDA could later deem unsafe.
  • While the two GMO labeling proponents argued that consumers have a right to know what is in their food to be able to make informed decisions, University of California-Davis’ Dr. Alison Van Eenennaam asserted this issue is not about consumers’ right to know what is in their food, but rather how the food was produced.  “There is no science-based reason to single out foods derived from and feed crops that were developed using the GE breeding method for mandatory process-based labeling,” she stated.  Her written testimony is a powerful endorsement of agricultural biotechnology rebutting the concept of and need for mandatory GMO labeling.
  • In his opening statement, Chairman Joe Pitts (PA) quoted President Obama, who said “advances in the genetic engineering of plants have provided enormous benefits to American farmers” and that “investment in enhanced biotechnology is an essential component of the solution to some of our planet’s most pressing agricultural problems.”

The witness list, written testimony and archived webcast of the hearing can be found here.

Free Webinar on Big Data and Unmanned Aerial Vehicles

OFW Law’s John Dillard will be kicking off this year’s Ohio Food, Agriculture and Environmental Law Webinar Series with a discussion on two cutting-edge topics affecting agriculture: agricultural drones and “big data.” Mr. Dillard’s webinar will provide a brief primer on the current and potential applications for drone technology in agriculture. He will also discuss legal aspects related to drones, including their current regulatory status with the Federal Aviation Administration as well as privacy laws. Next, Mr. Dillard will address privacy issues associated with the emergence of “big data” developed for precision agriculture systems.

The webinar is hosted by Ohio State University’s Extension on Friday, December 12th from 1 PM to 2 PM EST. The live webinar is free and participants will have the opportunity for Q&A. For more information on this webinar, please click here.



FTC Reminds Us That HHS’s Office for Civil Rights Not Only One Watching Medical Privacy

By Jonathan M. Weinrieb

Seasons greetings from the Federal Trade Commission (FTC).

Yesterday, the FTC published its Agreement Containing Consent Order and attendant press release regarding its settlement with a medical billing company (PaymentsMD) and the company CEO for alleged failure to adequately inform patients regarding the company’s collection of their medical records.  Although not arising under HIPAA (which is separately regulated by HHS’s Office for Civil Rights), FTC’s enforcement of consumer privacy rights here emphasizes the federal government’s emphasis on the importance and sensitivity of patient medical records, particularly in cases where there is a high probability of consumer/patient confusion or lack of transparency.

Notably, the settlement arose amid allegations that PaymentsMD failed to provide adequate notice and “authorization” to obtain individuals’ medical records: “The complaints allege that the company altered the registration process for the billing portal to include permission for the company and its partners to contact healthcare providers to obtain their medical information.”  FTC Press Release (Dec. 3, 2014) (“Press Release”).  It appears that the critical facts (in FTC’s view) were the arguably misleading manner in which the company obtained four separate authorizations with a single on-screen check box, allowing only for a very limited display of the authorization text at any one time, and doing so in the context of the patients’ request only to use an online billing portal:

According to the complaints, consumers consented to the collection of their health information by signing off on four authorizations that were presented in small windows on the webpage, displaying only six lines of the extensive text at a time, and could be accepted by clicking one box to agree to all four authorizations at once.  Consumers registering for the Patient Portal billing service would have reasonably believed that the authorizations were to be used for just that – billing, according to the complaint.  [paragraph]  The complaint alleges that PaymentsMD used the consumers’ registrations to gather sensitive health information from pharmacies, medical testing companies and insurance companies to create a patient health report. The information requested included the prescriptions, procedures, medical diagnoses, lab tests performed and the results of the tests, and more.  The complaints allege the company contacted pharmacies located near the consumers, without knowing whether the consumers in question were customers of the particular pharmacy.

Press Release (emphasis added).

The settlement firmly underscores the importance of maintaining clarity and transparency in all patient communications, particularly when any use or disclosure of PHI is contemplated.  Following OCR’s implementation of the HITECH Act, of course, both HIPAA Covered Entities and their Business Associates should consider these issues carefully.

So double check those authorizations, consent forms, and other patient communications.  No one needs a stocking stuffed by FTC (or HHS).

Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act

A Complimentary Webinar Presented by OFW Law’s Tish Pahl and the Food Marketing Institute

Thursday, December 4th, 2014

3:00 pm – 4:00 pm US/Eastern

Please join FMI on a webinar with Tish Pahl —Under the Drug Supply Chain Security Act (DSCSA), beginning January 1, 2015, manufacturers, wholesaler drug distributors, and repackagers, must provide transaction data about prescription drugs each time the product is sold in the U.S. market.  Suppliers will begin providing this information to dispensers on January 1 and, beginning July 1, 2015, dispensers must be able to receive this transaction data from their suppliers for each prescription drug they purchase.  Transaction data will also have to be provided with drop shipments and for many prescription drug product returns to suppliers.

Additionally, beginning on January 1, 2015, all supply chain participants, including dispensers, must have systems and processes in place to be able to comply with new DSCSA requirements regarding suspect and illegitimate products.  Dispensers and other supply chain participants may only trade with authorized trading partners.

With the January 1 deadline fast approaching, many questions remain unanswered about how to implement the DSCSA.  Supply chain entities may be unaware of the DSCSA’s requirements or mistakenly believe that the law will not apply to them for many years.  Tish Pahl of OFW Law will be providing a webinar for FMI members to discuss what the DSCSA means for dispensers.  She will provide an overview of how and when the law applies to dispensers, and will discuss the latest implementation information available from FDA.  She will then be available to answer your DSCSA questions.

We look forward to your participation.


FDA Opens Portal For Wholesale Distributor and 3PL Reporting

By Tish Eggleston Pahl

While you were sitting in traffic, making pie crust, or absorbing the menu and vending labeling rules

FDA Opens Portal For Wholesale Distributor and 3PL Reporting

At OFW Law, we hope you all had a terrific Thanksgiving.  (If you followed the advice of our food safety expert, Dr. Barb Masters, there should not have been any unwelcome microbial problems, either!)

As we reported on Wednesday, FDA came in under the wire with the release of its Drug Supply Chain Security Act (DSCSA) Standards Draft Guidance.  However, unless you were haunting the FDA website, you would have missed another, very important DSCSA update that appeared with no fanfare on Wednesday afternoon.

FDA added an option in the CDER Direct Electronic Submissions Portal and updated its DSCSA webpage with information on wholesale distributor and third-party logistics provider (3PL) annual reporting.  The DSCSA requires that wholesale distributors and 3PLs make an annual report to FDA with facility and State licensure information.  Reporting for wholesale distributors begins on January 1, 2015.  The issue of reporting for 3PLs was becoming especially urgent as it was to begin last Friday, on November 27, the anniversary of the DSCSA.

The CDER Direct Electronic Submissions Portal provides a tutorial for wholesalers and 3PLs in a .pdf format, which you can find in a drop down menu on the right of the portal page.  We’ve noticed some difficulty downloading the tutorial from different browsers, so we’ve provided a copy of the file here.

Reviewing the tutorial and webpages, we did have some questions and concerns.

  • Although reporting of a suspended or revoked license is clear enough, what is meant by “other” disciplinary action?
  • The submission process could prove cumbersome for larger operations if the interface does not allow for entry from a single facility screen of multiple (which could be dozens of) State licenses and numbers.
  • How long do facilities have to register? Obviously, latitude and flexibility by the agency will be necessary as facilities storm the CDER portal to make their submissions, some of which will be very large.  Any problems reporters have with the actual interface should be reported to FDA.
  • More publicity of this important update would be very welcome.
  • New §503(e)(2)(B) requires FDA to establish by January 1, 2015, a public, searchable database that identifies each authorized wholesale distributor by name, including contact information and each State where the wholesale distributor is licensed. FDA states it will provide this information “in the future.”

The February 2014 CDER Annual Guidance Agenda had stated that the agency intends to issue a Guidance on Reporting Licensure by Wholesale Drug Distributor and Third-Party Logistic Providers.  Some questions might be answered if, and when, that Guidance issues.

With steps 1-5 of FDA’s DSCSA implementation plan complete, FDA’s focus may shift to national licensure standards for wholesale distributors and 3PLs, with proposed rules slated to be issued in March 2015.  The agency has done a terrific job in meeting these official milestones so far; our holiday wish list includes a hope that the pace continues and that the agency finds time to address some of the significant DSCSA questions and concerns that stakeholders have posed.

The DSCSA Standards Guidance is here! 1

By Tish Eggleston Pahl

This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information.  FDA is to be commended for both getting the Draft Guidance posted by the DSCSA’s statutory deadline of November 27, and for not unduly upsetting the Thanksgiving of everyone in the pharmaceutical supply chain.  (Our food colleagues are deep into the menu and vending labeling final rules FDA also announced this week.)

With trading partners required on January 1, 2015, to begin exchanging transaction data when covered pharmaceuticals change owners, guidance from the agency was imperative. FDA specifically recognizes that, although the guidance is a “draft,” “the DSCSA clearly intends for stakeholders to rely upon this draft guidance document before finalization.”  As such, FDA is immediately implementing the Draft Guidance.

The Draft Guidance is very brief even though it was preceded by establishment of a docket and request for comments, 79 Fed. Reg. 9745 (Feb. 20, 2014), a two-day public workshop, and a call for more comments arising from that workshop, 79 Fed. Reg. 18562 (April 2, 2014).  For the most part, the agency quotes the DSCSA and directs stakeholders to relevant statutory requirements and definitions.

FDA does offer significant comfort to pharmaceutical supply chain trading partners in that it specifically acknowledges that trading partners can utilize “current” methods for the interoperable exchange of transaction data to provide product tracing information to subsequent supply chain purchasers.  Acceptable methods for this data exchange include, but are not limited to:

  • Paper or electronic versions of invoices;
  • Paper versions of packing slips;
  • Electronic Data Interchange (EDI) standards, such as 856 Advance Ship Notice (ASN), which is currently used to provide the receiving entity with advance data on shipments;
  • EPCIS (Electronic Product Code Information Services), which defines a data-sharing interface that enables supply chain partners to capture and communicate data about the movement and status of objects in the supply chain; and
  • Email or Web-based platforms (such as Web portals).

This is the first time that FDA has specifically endorsed specific methods and systems as appropriate for the interoperable exchange of transaction data.  In the long run, paper-based systems are not interoperable or feasible.  Paper is, at best, a stop-gap measure until trading partners move toward the DSCSA’s ultimate goal of a true, interoperable, electronic system that can trace individually serialized prescription pharmaceuticals through the supply chain.

The Draft Guidance is a good first step, with much more work still to be done, and many questions still unanswered.  FDA’s next tasks are to establish systems to accept facility and other information from third-party logistics providers and wholesale distributors.  There is definitely more to come in the weeks and months ahead.   FDA is accepting comments on the Draft Guidance for 60 days.