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Jul 03, 2017 - FDA Delays Enforcement of DSCSA November Deadline

As you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug packages and verification requirements for one year, but it also contains cascading enforcement delays (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”). This is a major move by the FDA and it will have important consequences for the industry. Let’s break it down. The draft guidance will officially be published in the Federal Register today but the early announcement of it was published last Friday. The FDA will collect comments on the draft from the public for sixty days, and then they will (probably) publish a final version at some time after that. Technically it does not take effect until the final guidance is published, but in this case, I think it is reasonable assume the enforcement delays spelled out in the draft will remain when the final version comes out. But, be aware, that is always a possibility that they won’t, or that the FDA will never publish a final document. Keep that in the back of your mind when you think about submitting a comment. Do you like the delay? Do you want a longer delay? If so, then you should submit a comment to let them know. SERIALIZATION AND VERIFICATION DELAYED The main purpose of this draft guidance is to propose a delay in enforcement of the requirement to apply the new DSCSA product identifier on drug packages and homogeneous cases (see “The DSCSA Product Identifier On Drug Packages”). But once the FDA does that, they must also delay enforcement of a number of other manufacturer requirements, including the need to begin verifying drug packages and homogeneous cases using the Standardized Numerical Identifier (SNI) contained in the new product identifier, rather than just the lot number. The SNI contains the serial number (see “FDA Aligns with GS1 SGTIN For SNDC”). In fact, almost all of the manufacturer requirements set to go into effect on November 27, 2017 would not be enforced for the proposed one year delay. It is easier to list the requirements that will still go into effect on that date than to list those that are affected by the delay. Here are all of the new DSCSA manufacturer requirements that would still go into effect on that date and be fully enforced: Manufacturers must begin to provide the transaction information, transaction history and transaction statement in electronic format only, except when selling directly to a licensed healthcare practitioner who is authorized to prescribe medication under State law, or to other licensed individuals who are under the supervision or direction of such a practitioner who dispenses product in the usual course of professional practice. [see Section 582(b)(1)(C)] That’s it. CASCADING ENFORCEMENT DELAYS By not enforcing the manufacturer’s requirement to apply the new DSCSA product identifier on all drug packages by this November the FDA is forced to soften some of the deadlines for other segments of the supply chain. And here is where things get a little complex. Repackagers, wholesale distributors and dispensers each have their own DSCSA requirement not to engage in transactions that involve products that do not have the DSCSA product identifier on them. And each segment also has enhanced requirements for verification of suspect product and saleable returns (see “DSCSA: Saleable Returns Verification”). Those requirements all kick in on November 27 of 2018, 2019 and 2020 respectively. Rather than not enforce these deadlines for a comparable one year delay, the new draft guidance makes it clear that these deadlines will still be enforced for product that the manufacturer introduced into commerce with the new DSCSA product identifier before November 27, 2017. For example, as the FDA puts it for the enhanced verification requirements, “If a product has a product identifier, FDA expects manufacturers, and downstream trading partners to use it in verification” (see “Drug Verification: EU Vs US”). Interestingly, this draft guidance would not affect the requirement for repackagers to apply a DSCSA product identifier to repackaged products by November 27, 2018. That deadline would still stand (for now at least) (see “Repackaging Drugs Under A Serialization Regulation”). So now, according to the draft, enforcement or non-enforcement of subsequent deadlines on downstream trading partners will depend on whether or not the product without a DSCSA product identifier was first introduced into commerce by the manufacturer between November 27, 2017 and November 26, 2018. If it was, then the FDA will not enforce those specific downstream requirements. If the product was introduced into commerce after November 26, 2018 (or if the product has a DSCSA product identifier on it) then the full DSCSA requirements would be enforced. That means we need a way to identify exactly when a given product was first introduced into commerce by the manufacturer. FDA proposes two ways to do that. One is to use the Transaction Information documents contained within the Transaction History to determine the date of first introduction into commerce by the manufacturer (see “DSCSA: Transaction Information” and “DSCSA: Transaction History”). The other is use non-DSCSA documentation that clearly describes the products and indicates when the manufacturer introduced them into commerce. These may include things like bills of lading, commercial invoices and shipping invoices, but could include other types not listed. Companies buying drugs after their DSCSA deadline would need to study these documents to determine if products that do not have a DSCSA product identifier on them would be in compliance. You might want to ask ahead of time so you don’t receive shipments containing non-compliant drugs. How will all this impact “grandfathering” (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”)? Hard to say, but at least the FDA recognizes that things will now be more complex. The last section of the draft guidance indicates that the FDA intends to address that impact someday when they finally publish the mandated grandfathering guidance document. That will be interesting. Why doesn’t the FDA just announce new deadlines for these sections of the DSCSA? Because the DSCSA is a law and the dates of each deadline contained within it were set by Congress (see “Will President Trump Eliminate The DSCSA?”). Only Congress can change the dates, but because the FDA is the agency that enforces this law, they can choose to enforce it selectively—particularly “[t]o minimize possible disruptions in the distribution of prescription drugs in the United States”. There is a lot I haven’t covered in this brief look at the draft guidance. I’ll have more to say about it in the coming weeks. Make sure you read it and submit a comment so the FDA knows how you feel about it. Also, notice that this still isn’t one of the four guidance documents that were due back on November 27, 2015 (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”), but maybe this indicates that some internal logjam has been broken. Maybe we’ll start seeing one DSCSA guidance each week. Still not holding my breath.

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Jul 03, 2017 - FDA Guidance Document Regarding Serialization

A. Compliance Policy for Manufacturers 102 103 Under section 582(b)(2)(A) of the FD&C Act, manufacturers are required to “affix or imprint a 104 product identifier to each package and homogenous case of a product intended to be introduced 105 in a transaction into commerce” beginning not later than November 27, 2017. As a result, FDA 106 expects that, under the statute any package or homogenous case of product that is introduced in a 107 transaction into commerce by a manufacturer as of November 27, 2017, must be encoded with a 108 product identifier. For the purpose of this draft guidance, we consider a product to be 109 “introduced in a transaction into commerce” when the manufacturer first engages in a transaction 110 involving that product. 111 112 Additionally, section 582(b)(4) of the FD&C Act requires that a manufacturer verify the product 113 at the package level, including the standardized numerical identifier, which is part of the product 114 identifier, when they determine that product in their possession or control is suspect or they receive a verification request from FDA.17 115 A manufacturer is also required, upon receiving a 116 request from an authorized trading partner that believes a product in its possession or control was 117 manufactured by the manufacturer, to verify whether the product identifier affixed or imprinted 118 on the product in such trading partner’s possession or control corresponds to the product identifier affixed or imprinted by the manufacturer. 18 119 Manufacturers also must verify a product 120 identifier on a saleable returned product before the manufacturer further distributes such product.19 121 122 123 1. Affixing or Imprinting Product Identifiers to Each Package or Homogenous Case 124 of Product by Manufacturers 125 126 FDA does not intend to take action against manufacturers who do not, prior to November 27, 127 2018, affix or imprint a product identifier to each package and homogenous case of product 128 intended to be introduced in a transaction into commerce as required by section 582(b)(2)(A) of 129 the FD&C Act. 130 131 2. Verification of Packages or Homogenous Cases of Product Without Product 132 Identifiers by Manufacturers 133 134 As explained above, section 582(b)(4) of the FD&C Act establishes several requirements for manufacturers relating to the verification20 135 of product identifiers that take effect on November 136 27, 2017. Under the policy outlined in this draft guidance, FDA does not intend to take action 137 against a manufacturer that does not verify the product identifier in instances where such 138 verification is required by section 582(b)(4) because the package or homogenous case does not 139 bear a product identifier. Specifically, beginning November 27, 2017, FDA does not intend to take action against a manufacturer who initially introduces product in a transaction into 141 commerce without a product identifier between November 27, 2017, and November 26, 2018, 142 and: 143 • does not verify product without a product identifier, at the package level, in situations 144 where such verification is required by section 582(b)(4)(A)(i)(II) of the FD&C Act ( i.e., 145 the manufacturer has determined that such product is a suspect product or it has received 146 a verification request for such product from the FDA); 147 • does not, upon receiving a request from an authorized trading partner, verify a product 148 without a product identifier, as required by section 582(b)(4)(C) of the FD&C Act (i.e., 149 the manufacturer has received a request for verification from an authorized trading 150 partner that is in possession or control of a product that such trading partner believes to 151 be manufactured by such manufacturer); or 152 • does not verify a package or sealed homogenous case of product without a product 153 identifier that is intended for further distribution as a saleable returned product, as 154 required by section 582(b)(4)(E) of the FD&C Act. 155 156 A manufacturer must still validate any applicable transaction history and transaction information 157 in its possession if the manufacturer has determined that a product in its possession or control is 158 a suspect product or if the manufacturer receives a verification request from the FDA or an authorized trading partner that is in possession or control of such product. 21 159 160 161 Moreover, this compliance policy applies solely to product without a product identifiers that was 162 first introduced in a transaction into commerce by a manufacturer between November 27, 2017, 163 and November 26, 2018, and the requirements for manufacturers to verify the product identifier 164 on such products as described in section 582(b)(4)(A)(i)(II), (b)(4)(C), and (b)(4)(E) of the 165 FD&C Act. The compliance policy does not apply to any other provisions of section 582(b)(4). 166 If a product has a product identifier, FDA expects manufacturers and downstream trading 167 partners to use it in verification. 168 169 B. Compliance Policy for Repackagers, Wholesale Distributors, and Dispensers 170 171 After products with product identifiers are introduced in a transaction into commerce, the 172 requirements for how other trading partners engage in transactions involving such products and 173 use the product identifier are phased-in over 3 years. Beginning November 27, 2018, 174 repackagers are generally required by section 582(e)(2)(A)(iii) of the FD&C Act to engage only 175 in transactions involving products that bear a product identifier. Parallel requirements go into 176 effect for wholesale distributors and dispensers on November 27, 2019, and November 27, 2020, 177 respectively, under section 582(c)(2) and (d)(2). Repackagers, wholesale distributors, and 178 dispensers, starting November 27, 2018, November 27, 2019, and November 27, 2020, 179 respectively, are required to verify product in certain circumstances at the package level, 180 including the standardized numerical identifier, under section 582(e)(4)(A)(i)(II), (c)(4)(A)(i)(II), and (d)(4)(A)(ii)(II). For a saleable returned product that wholesale distributors or repackagers 182 intend to further distribute, the wholesale distributor or repackager must verify the product 183 identifier, including the standardized numerical identifier, of each package or sealed 184 homogenous case of such product, under section 582(c)(4)(D) and (e)(4)(E), respectively. 185 186 1. Engaging in Transactions Involving Product Without a Product Identifier 187 188 FDA notes that there may be product in the supply chain that was introduced into the 189 pharmaceutical supply chain by a manufacturer between November 27, 2017, and November 26, 190 2018, and that does not contain a product identifier affixed or imprinted on the package and/or 191 homogeneous case of product by the manufacturer. FDA does not intend to take action against: 192 193 • any repackager who, on or after November 27, 2018, accepts ownership of such product 194 in a transaction, even though it lacks a product identifier, as addressed by section 195 582(e)(2)(A)(iii) of the FD&C Act; 196 • any wholesale distributor who, on or after November 27, 2019, engages in a transaction 197 involving such product, even though it lacks a product identifier, as addressed by section 198 582(c)(2) of the FD&C Act; or 199 • any dispenser who, on or after November 27, 2020, engages in a transaction with such 200 product, even though it lacks a product identifier, as addressed by section 582(d)(2) of the FD&C Act. 22 201 202 203 This compliance policy does not affect the requirement that begins November 27, 2018, for 204 repackagers to affix or imprint a product identifier on each package or homogenous case of product intended to be introduced in a transaction into commerce. 23 205 Consequently, beginning 206 November 27, 2018, wholesale distributors and dispensers who purchase products from a 207 repackager should ensure that they bear product identifiers. 208 209 2. Verification of Packages or Homogenous Cases of Product Without Product 210 Identifiers by Repackagers, Wholesale Distributors, and Dispensers 211 212 FDA recognizes that packages and homogenous cases of product introduced in a transaction into 213 commerce by a manufacturer between November 27, 2017, and November 26, 2018, without a 214 product identifier will not be able to be verified using a product identifier at the package level by 215 trading partners due to the products’ lack of a product identifier. Therefore, FDA does not intend 216 to take action against: 217 • any repackager who does not use a product identifier to verify such product at the 218 package level, including the standardized numerical identifier, beginning November 27, 219 2018, as required by section 582(e)(4)(A)(i)(II) of the FD&C Act; 220 • any wholesale distributor who does not use a product identifier to verify such product at 221 the package level, including the standardized numerical identifier, beginning November 222 27, 2019, as required by section 582(c)(4)(A)(i)(II) of the FD&C Act; or 223 • any dispenser who does not verify that the product identifier, including the standardized 224 numerical identifier, of at least 3 packages or 10 percent of such product, whichever is 225 greater, or all packages, if there are fewer than 3, corresponds with the product identifier 226 for such product, beginning November 27, 2020, as required by section 582(d)(4)(A)(ii)(II) of the FD&C Act.24 227 228 229 However, repackagers, wholesale distributors, and dispensers must still validate any applicable 230 transaction history and transaction information for such product that is in their possession and 231 otherwise investigate the product to determine if it is suspect; the compliance policy does not extend to these requirements.25 232 Similarly, where product does have a product identifier, FDA 233 expects trading partners to use it in verifying product. 234 235 3. Saleable Returns by Wholesale Distributors or Repackagers 236 237 A wholesale distributor or repackager may receive a returned product without a product 238 identifier if the returned product was introduced in a transaction into commerce by a 239 manufacturer prior to November 27, 2018. For these saleable returned products, FDA does not 240 intend to take action against: 241 242 • any wholesale distributor who does not verify the product identifier of a saleable returned 243 package or sealed homogenous case of such product without a product identifier that is 244 intended for further distribution, as required by section 582(c)(4)(D) of the FD&C Act; or 245 • any repackager who does not verify the product identifier of a saleable returned package 246 or sealed homogeneous case of such product without a product identifier that is intended 247 for further distribution, as required by section 582(e)(4)(E) of the FD&C Act. 250 4. Documentation of the Date of Introduction in a Transaction Into Commerce 251 252 The compliance policy described in this draft guidance for packages and homogeneous cases of 253 products only applies to product without a product identifier that is introduced by a manufacturer 254 in a transaction into commerce between November 27, 2017, and November 26, 2018. Trading 255 partners who believe that product may be subject to this compliance policy should take steps to 256 determine that the product was introduced in a transaction into commerce by the manufacturer in 257 this time frame. FDA recommends that a trading partner make such a determination for a 258 product without a product identifier based on the following: 259 260 • At least one of the transaction information documents that compose the transaction 261 history for the product describes an initial transaction date from the manufacturer that 262 occurs between November 27, 2017, and November 26, 2018; or 263 264 • There is other documentary evidence created by a trading partner in the ordinary course 265 of business and containing a product description that matches the package or 266 homogenous case of product that is not labeled with a product identifier. In addition, this 267 other documentary evidence should contain a date from which it can be determined that 268 the product was introduced in a transaction into commerce by the manufacturer between 269 November 27, 2017, and November 26, 2018. Examples of such documents may include, 270 but are not limited to, bills of lading, commercial invoices, and shipping invoices. 271 272 273 C. Compliance Policy Regarding Product Misbranded for Failure To Bear a 274 Product Identifier 275 276 Under this compliance policy, FDA does not intend to take action against a manufacturer, 277 repackager, or wholesale distributor who engages in prohibited acts involving products that are 278 misbranded based on lack of product identifier alone, where the package and/or homogeneous 279 case of product that lacks a product identifier was introduced in a transaction into commerce by a 280 manufacturer between November 27, 2017, and November 26, 2018. 281 282 As previously stated, a package or homogeneous case of product that does not have a product 283 identifier as required under section 582 of the FD&C Act is misbranded under section 502(cc) of 284 the FD&C Act. The FD&C Act describes several prohibited acts involving misbranded drugs, 285 which include introduction or delivery for introduction into interstate commerce of a drug that is 286 misbranded, receipt in interstate commerce of a misbranded drug and the delivery or proferred 287 delivery thereof, and the doing of an act that causes a drug to become misbranded while held for sale after shipment in interstate commerce. RELATIONSHIP TO “GRANDFATHERED” PRODUCTS UNDER SECTION 292 582(a)(5) OF THE FD&C ACT 293 294 This compliance policy addresses products a manufacturer introduces in a transaction into 295 commerce without product identifiers between November 27, 2017, and November 26, 2018. In 296 the future, FDA intends to issue additional guidance that will outline FDA’s current thinking on 297 the “grandfathering product” provision of section 582(a)(5)(A) of the FD&C Act regarding 298 products not labeled with a product identifier that are in the pharmaceutical distribution supply 299 chain at the time of the effective date of the requirements of section 582. In that guidance, FDA 300 intends to address the relationship of the compliance policy set forth in this guidance with 301 “grandfathered” products.

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Apr 04, 2016 - FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs

For years FDA has responded to several breaches in the U.S. drug supply chain by rogue distributors who target doctors' offices and clinics offering unapproved, counterfeit, or otherwise unsafe prescription drugs. Doctors who purchase and administer these drugs are putting their patients at risk because these drugs may: Be fake, contaminated, ineffective, or otherwise unsafe; Not have been evaluated by FDA for safety and efficacy; Not contain the appropriate amount of active ingredients; or Contain harmful ingredients. To reduce the public health threat posed by these potentially dangerous drugs FDA issues letters to inform doctors that may have obtained counterfeit or unapproved drugs from a rogue distributor, and provide tips on safe purchasing practices. For information on safe purchasing practices, see FDA’s Know Your Source campaign. Under the Drug Supply Chain Security Act, as of January 1, 2015, all health care providers who dispense or administer prescription drugs to patients are required to purchase their prescription drug products only from authorized trading partners licensed by or registered with the state or federal government, as applicable. This will help ensure that these prescription drugs are purchased from legitimate sources who are subject to oversight by the state or federal government. To verify a wholesale drug distributor is licensed in the state(s) where it is conducting business, see Verify Wholesale Drug Distributor Licenses. FDA encourages health care professionals to report any suspected criminal activity to FDA’s Office of Criminal Investigations (OCI)

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Apr 01, 2016 - More than 39 Unapproved Drugs Purchased from Gallant Pharmaceutical International or Gallant Medical International

On April 1, 2015, FDA sent more than 300 letters to medical practices in the United States that may have purchased unapproved prescription drugs, or unapproved/uncleared injectable devices, from a foreign supplier, Gallant Pharmaceutical International, Inc., also known as Gallant Medical International, Inc. Several individuals associated with Gallant, including a doctor and an office manager, have been convicted for their roles in distributing illegal drugs and devices

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Jan 06, 2015 - Industry Move to Product Serialization

The FDA - Drug Supply Chain Security Act (DSCSA) will require all sales of drugs in the U.S. pharma supply chain to be accompanied by specific data...

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Dec 29, 2014 - FDA Postpones Enforcement of DSCSA

In a direct response to concerns expressed by the Healthcare Distribution Management Association (HDMA) and others the FDA posted new guidance that states their intention to postpone enforcement of just the requirements for manufacturers, wholesale distributors and repackagers to provide and capture Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS)...

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Dec 19, 2014 - DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

The FDA posted draft guidance for Prescription Drug wholesale distributors and third-party logistics providers to meet their obligation to register their licensing information annually...

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Mar 07, 2014 - Co-Leader of Illegal Drug Company Gallant Pharma Sentenced to 3 Years

ALEXANDRIA, Va. - Talib Khan, 43, of Montreal, Quebec and Barbados, co-founder of Gallant Pharma International Inc., an unlicensed wholesale drug distributor headquartered in Arlington, Va., was sentenced today to 3 years in prison, 2 years of supervised release, and $3.4 million in forfeiture and restitution to victims. Dana J. Boente, Acting United States Attorney for the Eastern District of Virginia; Antoinette V. Henry, Special Agent in Charge of the Food and Drug Administration's (FDA) Office of Criminal Investigations; Gary Barksdale, Inspector in Charge of the Washington Division of the U.S. Postal Inspection Service; Scot R. Rittenberg, Acting Special Agent in Charge of U.S. Immigration and Customs Enforcement (ICE), Homeland Security Investigations (HSI), Washington; and M. Douglas Scott, Arlington County Chief of Police, made the announcement after sentencing by United States District Judge Claude M. Hilton. On Oct. 15, 2013, Khan pleaded guilty to conspiracy and sale of misbranded drugs. According to court documents, between August 2009 and August 2013, Gallant Pharma smuggled into the United States and sold more than $12.4 million in non-FDA-approved chemotherapy drugs and injectable cosmetic drugs and devices, generating profits of $3.4 million. Many of these drugs were subject to strict temperature controls to protect drug potency. Gallant Pharma shipped and received such drugs with ice packs, not dry ice used by legitimate distributors, and on at least one occasion, a shipment containing such drugs took more than two weeks to arrive in Virginia from overseas during a July 2012 heat wave. Many drugs sold by Gallant Pharma also were required to carry a FDA "black box" warning, which indicates that a drug carries a significant risk of serious or life-threatening adverse effects. The versions sold by Gallant Pharma did not meet this or other FDA labeling requirements. Also sentenced today was Gallant Pharma sales representative Harvey Whitehead, 68, of Cadillac, Michigan. Whitehead, was sentenced to 2 years of probation, to include 6 months of home confinement, following his Oct. 3, 2013 guilty pleas to unlicensed wholesale prescription drug distribution and sale of misbranded drugs. Whitehead also agreed to pay $36,795.85 in restitution to victims. Nine additional co-defendants, including co-founder Syed "Farhan" Huda, 38, of Arlington, Va., previously pleaded guilty, and eight are awaiting sentencing. A jury trial is scheduled for March 31, 2014, for alleged co-conspirators Anoushirvan Sarraf, 48, and Eva Montejo Pritchard, 48, both of Rockville, Md. Sarraf, the owner of Aphrodite Skin Care Clinic in McLean, Va., and Pritchard, the office manager, are alleged to have knowingly received illegal shipments intended for Gallant Pharma, in exchange for a discounted price on non-FDA-approved drugs and devices that they used on Aphrodite patients without the patients' knowledge or consent. This case was investigated by FDA's Office of Criminal Investigations, the Drug Enforcement Agency's Group 33 Diversion Task Force, HSI Washington and the U.S. Postal Inspection Service, with assistance from the Arlington County Police Department. Assistant United States Attorneys Lindsay Kelly, Maya Song and Jay Prabhu are prosecuting the case on behalf of the United States. A copy of this press release may be found on the website of the United States Attorney's Office for the Eastern District of Virginia at http://www.justice.gov/usao/vae. Related court documents and information may be found on the website of the District Court for the Eastern District of Virginia at http://www.vaed.uscourts.gov or on https://pcl.uscourts.gov.

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