Contains Nonbinding Recommendations 

GUIDANCE FOR INDUSTRY 

Prescription Drug Marketing Act (PDMA) 

Requirements 

_______________________________ 

Questions and Answers 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research 

Office of the Commissioner 

Office of Regulatory Affairs 

November 2006 

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Contains Nonbinding Recommendations 

GUIDANCE FOR INDUSTRY 

Prescription Drug Marketing Act (PDMA) 

Requirements 

________________________________ 

Questions and Answers

Additional copies are available from: 

Additional copies are available from: 

Office of Training and Communications 

Division of Communications Management 

Drug Information Branch, HFD-210 

Center for Drug Evaluation and Research 

Food and Drug Administration 

5600 Fishers Lane, Rockville, MD 20857 

(Phone 301-827-4573)

Internet: http://www.fda.gov/cder/guidance/index.htm

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research 

Office of the Commissioner 

Office of Regulatory Affairs 

November 2006 

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Contains Nonbinding Recommendations 

Guidance for Industry1

Introduction

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It 

does not create or confer any rights on any person and does not operate to bind FDA or the public. You 

can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 

If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this 

guidance. If you cannot identify the appropriate staff, call the appropriate number listed on the title 

page of this guidance. 

I. Introduction

The Prescription Drug Marketing Act of 1987 (PDMA), amended by the Prescription 

Drug Amendments of 1992 (PDA), requires, among other things, that certain wholesalers 

provide a statement (also known as a pedigree) prior to each wholesale distribution of 

prescription drugs. This guidance provides questions and answers relating to the 

requirements set forth in 21 CFR Parts 203 and 205, and other Parts related to the PDMA. 

FDA’s guidance documents, including this guidance, do not establish legally 

enforceable responsibilities. Instead, guidances describe the Agency’s current thinking 

on a topic and should be viewed only as recommendations, unless specific regulatory or 

statutory requirements are cited. The use of the word should in Agency guidances means 

that something is suggested or recommended, but not required. 

II. Background 

The PDMA excludes manufacturers and authorized distributors of record from the 

requirement to provide a pedigree prior to each wholesale distribution. The PDMA 

defines authorized distributor of record as a wholesale distributor that has an ongoing 

relationship with the manufacturer. The PDMA does not define “ongoing relationship.” 

On December 4, 1999, FDA published in the Federal Register (64 FR 67720) final 

regulations regarding the PDMA that, among other things, defined “ongoing relationship” 

(21 CFR § 203.3(u)) and described what information must be included in the pedigree 

(21 CFR § 203.50). Due to concerns raised at the time, FDA delayed the effective date of 

 

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 This guidance has been prepared by the Office of Policy in the Office of the Commissioner, the Office of 

Compliance in the Center for Drug Evaluation and Research (CDER), and the Office of Regulatory Affairs 

at the Food and Drug Administration, in conjunction with the Agency’s Counterfeit Drug Task Force. The 

Agency may revise this guidance as we receive additional comments and questions. 

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these two provisions. On June 14, 2006, FDA announced in a Notice in the Federal 

Register that it would no longer delay the effective date of 21 CFR §§ 203.3(u) and 

203.50. (71 Fed. Reg. 34249). The reasons for the agency's decision are described in 

that Federal Register Notice and its Counterfeit Drug Task Force 2006 Update. After the 

Federal Register Notice was published, FDA received a number of questions related to 

implementation of these provisions and the PDMA generally. This guidance is intended 

to address many of the questions raised. 

III. Questions and Answers 

A. Authorized Distributor of Record (ADR) Status

1. What information should be in the written agreement between a manufacturer 

and an ADR? 

The written agreement should include: 

• A list of the specific products that the wholesale distributor is authorized 

to distribute or a statement that the wholesale distributor is an ADR for the 

manufacturer’s entire product line. Specific products should be identified 

by either a) the name, dosage form, and strength of the drug, or b) the 

NDC number; and 

• The period of time the wholesale distributor is granted ADR status or the 

number of shipments for which the wholesale distributor is an ADR. 

2. Would a series of invoices, transactions, or distributions constitute a written 

agreement? 

No. An invoice simply documents drug distributions or transactions. A distribution or 

transaction is not a written agreement. 21 CFR § 203.3(u) specifically requires a written 

agreement between a manufacturer and a wholesaler that documents the wholesaler’s 

status as an authorized distributor. FDA recognizes that there may be situations where a 

wholesaler buys prescription drugs directly from the manufacturer, yet the manufacturer 

does not make the wholesaler an ADR. In this situation, although the wholesaler is not 

an ADR, the wholesaler is in a position to create and further provide a pedigree because 

the wholesaler would have all the information required by 21 CFR § 203.50(a) since they 

purchased the prescription drugs directly from the manufacturer. In light of the 

December 1, 2006, implementation of 21 CFR §203.3(u), FDA urges manufacturers to 

closely examine their business relationships with wholesalers, and if there is an ongoing 

relationship by virtue of direct, continued sales, enter into a written agreement to grant 

these wholesalers ADR status. See Addendum Question E at the end of this document. 

3. Who should maintain the written agreement? The manufacturer? The 

wholesaler? Both? 

Both. Pursuant to 21 CFR §§ 203.50(b) and 203.60(d), persons required to create or 

maintain records under PDMA, PDA, or Part 203 of the regulations shall retain them for 

at least 3 years after the date of their creation. The written agreement falls under this 

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section. Furthermore, pursuant to 21 CFR §203.60(e), FDA can look to both parties for 

documentation of the written agreement. 

4. If a wholesaler has ADR status, is that wholesaler an ADR for all products that 

the manufacturer sells? 

It depends. The written agreement required pursuant to 21 CFR § 203.3(u) should clearly 

state whether a wholesaler is an ADR for all products that the manufacturer sells or only 

for certain products that the manufacturer sells. 

5. What information about the ADR does a manufacturer have to make available 

on the list? 

Pursuant to 21 CFR § 203.50(d)(1), a manufacturer shall specify whether each listed 

distributor is authorized to distribute the manufacturer's full product line or only 

particular, specified products. 

6. How often should manufacturers update their list of ADRs? 

Pursuant to 21 CFR § 203.50(d)(2), manufacturers are required to update the list on a 

continuing basis. Therefore, to keep the list current, manufacturers should maintain lists 

in a format that allows them to be updated when the ADR status of a distributor changes. 

7. Is placing the list of ADRs on the manufacturer’s web site adequate to meet the 

provision of making the list available on request to the public, pursuant to 21 CFR § 

203.50(d)? 

Yes. We highly encourage manufacturers to post their ADR list on their website in a 

place and manner that is readily accessible, although they are not required to do so. We 

note that 21 CFR § 203.50(d) requires the list to be maintained at the manufacturer's 

corporate offices even when the list is posted on a website. 

8. Where can a pharmacist find the list of ADRs? 

Pursuant to 21 CFR § 203.50(d)(3), manufacturers are required to make their list of 

ADRs available to the public upon request. However, we recognize that it may be time 

consuming to get this information from manufacturers’ corporate offices. Therefore, we 

highly encourage manufacturers to post it on their website in a place and manner that is 

readily accessible. FDA will monitor the accessibility of these lists and determine 

whether further measures are needed to make this information more readily available to 

pharmacies. 

9. What information does a manufacturer have to provide to a wholesaler to enable 

that wholesaler to comply with the PDMA? 

Manufacturers are not required under the PDMA to provide any specific information to 

wholesale customers. However, the information required under 21 CFR § 203.50(a) for a 

pedigree statement may be included in the invoice or similar document that would 

typically accompany or be associated with any shipment of prescription drug products 

from a manufacturer to a wholesale distributor. FDA encourages manufacturers to do 

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their part to protect public health by furnishing pedigree information to all of their supply 

chain partners. See Addendum Question E at the end of this document. 

10. What information does an ADR have to provide to a non-ADR to enable that 

non-ADR to comply with the PDMA (e.g., to pass a pedigree that lists all prior 

transactions back to the manufacturer)? 

ADRs are not required to provide a pedigree, whether they obtained the drug directly 

from a manufacturer, from an ADR, or from a non-ADR. However, to further advance 

the shared goals of protecting the public health, FDA encourages all parties in the 

prescription drug supply chain to cooperate fully by providing pedigrees and information 

to trading partners for each sale, transfer, or trade of prescription drugs. Therefore, when 

an ADR sells prescription drugs to another ADR or to a non-ADR, the ADR is 

encouraged to provide pedigree information obtained at the time of the original purchase 

of the prescription drugs to its wholesale customers. Each wholesale customer of that 

ADR, in turn, could then provide updated pedigree information with each successive 

wholesale distribution. See Addendum Question E at the end of this document. 

11. If a wholesaler has ADR status for a particular drug product, but it buys that 

drug from a non-ADR, is the wholesaler still an ADR for that specific quantity of 

drugs? 

Yes. If the specific quantity of drugs purchased from the non-ADR falls within the 

description contained in the written agreement between that purchasing ADR and the 

manufacturer, then that purchasing wholesaler would have ADR status for that specific 

quantity of drugs. However, even though the ADR is not required to provide the 

pedigree when the product is further distributed, to further advance the shared goals of 

protecting the public health, FDA encourages all parties in the prescription drug supply 

chain to cooperate fully by providing pedigree documents and information to trading 

partners for each sale, transfer, or trade of prescription drugs. See Addendum Question E 

at the end of this document. 

12. What definition is used to determine who is a manufacturer and, thus, exempt 

from providing a pedigree? 

For purposes of the PDMA, “manufacturer” is defined under 21 CFR § 203.3(s), which 

incorporates the definition from 21 CFR § 201.1. 

13. Are contract manufacturers considered “manufacturers” under the PDMA? 

Yes. A contract manufacturer falls within the definition of a "manufacturer" under 21 

CFR § 203.3(s), which incorporates by reference the definition of "manufacturer" set 

forth in 21 CFR § 201.1. FDA has received several inquiries regarding the status of an 

NDA-holder under 21 CFR §§ 203.3(s)/201.1 when that NDA-holder's prescription drugs 

are made by a contract manufacturer. Unless the NDA-holder has performed the 

operations necessary to achieve "manufacturer" status under 21 CFR § 201.1, that NDA6 
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holder is not technically a "manufacturer" of the drugs within the meaning of the 21 CFR 

§ 203.3(s). In such instances, the NDA-holder would therefore not be exempt from the 

pedigree requirements on the grounds that it was a manufacturer. Thus, for purposes of 

the PDMA pedigree requirements only, FDA intends to exercise its enforcement 

discretion as follows: In those instances where a third party contract manufacturer 

manufactures prescription drugs for an NDA-holder, that NDA-holder may also be 

regarded as a manufacturer of those drugs for purposes of that NDA-holder's compliance 

with § 503(e)(1)(A) of the Act, entering into ADR agreements for those prescription 

drugs, and for purposes of pedigrees created for those prescription drugs. This exercise 

of enforcement discretion is not intended to relieve the contract manufacturer of its 

obligations as a manufacturer, including its obligation to register under § 510 of the Act, 

nor is it intended to require the NDA-holder to file such a registration unless the NDAholder would otherwise be obligated to do so. 

14. Is a repackager or relabeler exempt from providing a pedigree? 

No. Relabelers and repackagers are not considered to be manufacturers under 21 CFR 

§ 201.1. Therefore, unless a repackager or relabeler has ADR status with the 

manufacturer of that product, they are required to provide a pedigree identifying each 

prior sale, purchase, or trade of the drug. See Addendum Question E at the end of this 

document. 

 

15. Is a pedigree required if an exclusive distribution agreement exists? 

No, so long as the agreement is in writing. By definition, an exclusivity agreement is a 

written agreement under which the distributor is authorized to distribute the 

manufacturer's products for a period or time or for a specified volume of products. 

Accordingly, such a written agreement would satisfy the requirements related to ADR 

status in 21 C.F.R. 203.3(u). Please note that, in such instances, the wholesale distributor 

named in the agreement would have to be included in the manufacturer's list of ADRs 

under 21 CFR § 203.50(d). 

B. Pharmacy/End User Responsibilities

16. Do non-ADRs have to provide a pedigree if the customer is a physician’s office? 

Yes. The Federal Food, Drug, and Cosmetic Act (the Act) requires non-ADRs to provide 

a pedigree before each wholesale distribution of a drug. Pursuant to 21 CFR § 203.3(cc), 

wholesale distribution is defined as the distribution of prescription drugs to persons other 

than a consumer or patient. Although a physician’s office is not explicitly mentioned in 

21 CFR § 203.50, which discusses pedigree, it is contemplated within the scope of the 

language set forth in § 503(e)(1)(A) of the Act that a pedigree would be provided because 

physicians offices are not specifically excluded. 

17. Are pharmacies required to provide a pedigree when they transfer drug 

product between pharmacies? 

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For transfers other than intra-company transfers, unless the transfer of prescription drug 

product from one pharmacy to another is for a documented medical emergency (see 21 

CFR § 203.3(cc)(5)), or the sale is of minimal quantities of drugs by retail pharmacies to 

licensed practitioners for office use (see 21 CFR § 203.3(cc)(10)), retail pharmacies that 

are not ADRs for the prescription drug products sold or transferred to other retail 

pharmacies will have to provide a pedigree. 

18. Does a chain pharmacy warehouse have to provide a pedigree for drugs that it 

sends to its retail outlets? 

No. Pursuant to 21 CFR § 203.33(cc)(1), intra-company sales are excluded from the 

definition of wholesale distribution. FDA considers intra-company transfers, such as 

those from a chain pharmacy warehouse to its own retail outlets, to fall within the scope 

of an intra-company sale.

19. Do pharmacies have to verify the accuracy and authenticity of the pedigree? If 

so, how should they do this? 

No. Pharmacies do not have this express responsibility under the PDMA, but they are 

encouraged to perform due diligence in verifying the accuracy of the information and 

integrity of the source of the drug product. 

C. Recordkeeping Requirements

20. What are the recordkeeping requirements for pedigree recipients? 

Pursuant to 21 CFR § 203.50(b), the pedigree is subject to the record retention 

requirements in 21 CFR § 203.60, and must be retained by all wholesale distributors 

involved in the distribution of the drug product, whether ADR or non-ADR, for 3 years. 

If the pharmacy receiving the pedigree will not itself engage in further distribution of the 

product to persons other than a consumer or patient, then the pharmacy is not required to 

maintain that pedigree under 21 CFR § 203.60. However, consistent with the spirit of the 

PDMA, FDA encourages pharmacies and other end users to retain the pedigree for 3 

years. As a result, if there is any question about the source or history of the product, it 

can be traced back through the drug supply chain. 

21. If an ADR obtains drugs from a non-ADR, is the ADR required to maintain the 

pedigree? 

Yes. Although an ADR is not required to provide a pedigree, pursuant to 21 CFR 

§§ 203.50(b), and 203.60(d), an ADR is required to retain the pedigree for 3 years. 

D. PDMA Scope

22. Does PDMA apply to veterinary prescription drugs? 

No. PDMA applies only to prescription drugs intended for use by man. However, FDA is 

aware that many human prescription drugs are sold to veterinarians. Given that the 

human drugs are subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act, 

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the pedigree requirements apply to them under section 503(e). Accordingly, wholesale 

distributors who are not ADRs must provide a pedigree prior to wholesale distribution of 

human prescription drugs to veterinarians. 

23. Is a pedigree required for the distribution of drug samples? 

No. Pursuant to 21 CFR § 203.3(cc)(7), the distribution of drug samples by 

manufacturers and authorized distributor's representatives is exempt from the definition 

of wholesale distribution, so the pedigree requirement does not apply. However, those 

distributing drug samples must comply with the separate requirements set forth in 21 

USC §§ 353(c) and (d) and 21 CFR Part 203.. 

24. Is a pedigree required for medical kits that contain prescription drugs, 

sometimes referred to as convenience kits? 

Yes. "Medical kits" that contain devices and prescription drugs are combination products 

under 21 CFR §3.2(e)(2), which are defined as “two or more separate products packaged 

together in a single package or as a unit and comprised of a drug and device products, 

device and biological products, or biological and drug products.” The "medical kits" 

referred to in the question consist of separable finished devices and drugs that are 

combined in a kit for ready availability and use together in a medical setting. The drug 

product in the kit retains its separate form and individual packaging. Although these kits 

may be assigned to FDA’s Center for Devices and Radiological Health (CDRH) as the 

lead Center for regulatory review when the primary mode of action of the kit is 

attributable to its device component, regulations for the drug and the device components 

continue to apply. Because a prescription drug component of a convenience kit is 

separable, and in the same form as when distributed independently, it is subject to the 

same pedigree requirements as when it is independently distributed. The pedigree must 

contain the drug’s lot or control number(s), pursuant to 21 CFR §203.50(a). We 

recognize that the convenience kit itself may have a lot or control number that is different 

than that on the prescription drug component. The outer container of the kit should also 

list the lot or control number of the prescription drug component so that the integrity of 

the kit's seal would not have to be compromised to confirm that the drug's lot number is 

the same as that listed in the pedigree. See Addendum Question E at the end of this 

document. 

25. Does PDMA apply to bulk drug substances? 

Yes. The PDMA applies to drugs subject to § 503(b) of the Act (i.e., prescription drugs). 

Pursuant to 21 CFR § 203.1, the requirements in 21 CFR Part 203 apply to wholesale 

distribution of bulk drug substances. 

E. Returns

26. Is a pedigree required for prescription drugs that are returned from a 

pharmacy or a physician’s office to a wholesaler? 

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Pursuant to the definition of wholesale distribution and other relevant provisions under 

§ 503(e) of the Act and 21 CFR Part 203, a pedigree is required for returns from a 

pharmacy or physician’s office to a wholesaler unless that pharmacy or physician’s office 

is an ADR for those prescription drugs. Prescription drugs generally are returned for two 

reasons: (1) the pharmacy or physician’s office ordered too much and returns the drug to 

the wholesaler or manufacturer from whom they purchased the drugs, or (2) the drug is 

expired or close to expiring, in which case the product is returned to the wholesaler or 

manufacturer from which it was purchased, or to a reverse distributor for destruction. 

Pharmacies and physicians’ offices generally are not ADRs, and they would find it 

extremely difficult to provide a pedigree when they return prescription drugs because 

they would not have received a pedigree if the drugs were purchased from an ADR. 

FDA recognizes the disruption that this could cause to the more than 55,000 pharmacies 

and the hundreds of thousand physicians’ offices in the United States. Therefore, FDA 

intends to exercise its enforcement discretion to allow pharmacies and physicians’ offices 

to return drugs that are expired, damaged, recalled, or in some other non-saleable 

condition, without having to provide a pedigree, provided that (1) they return the drugs to 

the wholesaler or manufacturer from which they purchased the drugs, or to a licensed 

reverse distributor for destruction, and (2) they maintain for a period of three years 

records that document each return and the source from which the pharmacy or physician's 

office originally purchased the drugs. If the returned prescription drugs are in saleable 

condition and may subsequently be sold, purchased, or traded by the wholesaler or 

reverse distributor, then that wholesaler or reverse distributor would be required and 

expected to pass a pedigree if they are not an ADR for those prescription drugs. Any 

subsequent pedigree should reflect that the drugs were sold, purchased, or traded to the 

pharmacy or physician’s office and subsequently returned. Because the wholesaler to 

which the drugs are returned originally sold them to the pharmacy or physician’s office, 

the wholesaler would have all the necessary information to provide a pedigree, even 

without the pedigree from the pharmacy or physician’s office. 

FDA intends to monitor the drug distribution system for abuses or exploitation of this 

exercise of enforcement discretion. 

We note that pursuant to 21 CFR § 203.3(cc)(9), returns by hospitals, health care entities, 

and charitable institutions are excluded from the definition of wholesale distribution, 

provided that the returns comply with 21 CFR § 203.23. 

F. Shipping/Delivery Arrangements

27. Is a pedigree required if a manufacturer drop ships on behalf of a non-ADR 

directly to the pharmacy or customer (i.e., ships the product directly to the nonADR’s customer)? 

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Yes. Pursuant to 21 CFR § 203.50, the non-ADR seller must provide a pedigree to the 

purchaser. 

28. Is a pedigree required if an ADR drop ships on behalf of a non-ADR directly to 

the pharmacy or customer? 

Yes. Pursuant to 21 CFR § 203.50, the non-ADR seller must provide a pedigree to the 

purchaser. 

29. What is the status of third party logistics providers (TPLP or 3PLs) in the 

context of PDMA? For example, is a TPLP considered to be a distributor or 

contractor for the manufacturer for whom the TPLP works? 

Based on comments that FDA received from a TPLP, TPLPs typically act as distributors 

for manufacturers. Therefore, unless the TPLP has ADR status with the manufacturer 

(which should be posted on the manufacturer's website and reflected in a written 

contract), the TPLP would be required to provide a pedigree prior to each wholesale 

distribution. Because of the unique ongoing relationship between a TPLP and a 

manufacturer, most, if not all, TPLPs distributing prescription drugs on behalf of a 

manufacturer would be able to obtain ADR status from the manufacturer with which they 

are doing business. Therefore, the TPLP would be listed on any subsequent pedigree 

because the TPLP was involved in the prior sale, purchase, or trade of the prescription 

drug. See Addendum Question E at the end of this document. 

G. Inventory

30. Is a pedigree required for products already in the supply chain as of December 

1, 2006? 

It depends. A pedigree would be required for prescription drug products that are sold, 

purchased, or traded by a non-ADR after December 1, 2006. In order to give 

wholesalers sufficient time to prepare and deplete stock that would require a pedigree 

after December 1, FDA provided 6 months’ notice that the stay would expire on 

December 1, 2006. However, FDA recognizes that there may be some situations where a 

wholesaler has prescription drugs in stock that were purchased while the wholesaler 

considered itself an ADR, yet the wholesaler clearly will not be an ADR for those drugs 

under 21 C.F.R. § 202.3(u) after December 1, 2006. FDA intends to exercise its 

enforcement discretion until April 1, 2007 regarding the pedigree requirement for such 

drugs, provided that the wholesaler can furnish documentation that the drugs were 

purchased prior to December 1, 2006, and that it had purchased the same type of drugs 

from the manufacturer on at least two prior occasions in the previous 24 months. Bills of 

sale or invoices could be used for this documentation. Wholesalers that cannot meet this 

criteria with respect to their inventories will be expected to provide a pedigree for those 

drugs. FDA believes that the combination of the six month notice that the stay would 

expire, along with additional four months of enforcement discretion, as described above, 

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provides the wholesalers described above with sufficient time to deplete their preDecember 1, 2006 inventories. 

31. If there are two products on a shelf in a pharmacy, with the same lot number, 

but one was purchased from an ADR and the other was not, how would the 

pharmacy know which product came from the ADR and which product came from 

the non-ADR? 

Inventory control is a business process. FDA expects firms to be able to identify and 

differentiate drug products that have been obtained from different sources and maintain 

appropriate records in compliance with PDMA. 

32. Is a pedigree required for inventory acquired through a pharmacy acquisition, 

merger, or buyout?

No. The purchase of a pharmacy by another pharmacy would not be considered a 

wholesale distribution, provided that the drugs purchased by the second pharmacy are 

dispensed or distributed by that pharmacy in the normal practice of retail pharmacy. 

Therefore, no pedigree would be required. However, the sale, purchase, or trade of those 

drugs to another pharmacy or wholesale distributor would be considered a wholesale 

distribution and a pedigree must be provided if that other pharmacy or distributor is not 

an ADR. If pedigrees are part of the record for the inventory, they must be provided with 

the sale, purchase, or trade of the product and retained for the appropriate length of time, 

as required under 21 CFR §§203.50(b) and 203.60(d). 

H. Pedigrees

33. What does "date of each previous transaction" refer to in 21 C.F.R. 

§ 203.50(a)(7)? 

“Date of each previous transaction” refers to the date of each prior sale, purchase, or 

trade of the product. See Addendum Question E at the end of this document. 

I. Electronic Pedigrees

34. Will electronic pedigrees that conform to the EPCglobal electronic drug 

pedigree standards be considered PDMA-compliant? At the time of printing, these 

standards have not been officially adopted or recognized. Therefore, it is premature for 

FDA to comment on whether they comply with PDMA requirements. 

35. Can paper or electronic pedigrees be used? 

 Section 203.60(a)(2) states that "combinations of paper records and electronic records, 

electronic records and handwritten signatures executed on paper, or paper records and 

electronic signatures or handwritten signatures executed to electronic records, may be 

used to meet any of the record and signature requirements of the PDMA." Both paper 

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and electronic documents and signatures may be used to meet the pedigree requirement 

of the Act, provided that the requirements of 21 CFR § 203.60 are met. 

36. Is RFID the only way to achieve an electronic pedigree? 

No. The PDMA and existing regulations do not require any particular technology for 

pedigrees. Although FDA has stated on several occasions that RFID is the most 

promising means to achieve an electronic pedigree, electronic pedigree can also be 

accomplished using bar codes or other track and trace technologies. 

J. Compliance/Enforcement

37. Where should a report be sent if there are concerns regarding a pedigree that 

has been received? 

Criminal activity, possible fraud, diversion, counterfeiting, or any other suspicious 

activity associated with a pedigree should be reported to FDA’s Office of Criminal 

Investigations at rxdrugcops@oci.fda.gov. 

38. What are some examples of issues that might raise questions about the 

pedigree? 

• Drugs that are sold below market price 

• Unexplained gaps in the pedigree 

• Unexplained differences in ordered product vs. shipped product 

• Unexplained, unexpected, or unusual changes in supplier chain 

• Unusual variety of lot numbers relative to the size of the shipment 

• Multiple, unknown wholesalers from various states listed on the pedigree 

• Incomplete paperwork, invoices, or other materials that do not match pedigree 

• Pattern of discrepancies in ordered vs. shipped product 

• Discrepancies in or missing covert/overt anti-counterfeiting measures

• Supplier refuses to provide a wholesale license from the state licensing authority 

• Supplier wants payment in cash only 

• A non ADR refuses to provide pedigree documentation 

• Supplier refuses to divulge source of the prescription drug 

 

39. If a company says that it is an ADR and not required to provide a pedigree, yet 

the purchaser has reason to believe that the company is not an ADR, what should 

the purchaser do? 

If a purchaser has reason to believe that the wholesaler is not an ADR, FDA recommends 

that the purchaser contact the manufacturer to determine whether the entity is an ADR for 

that product. This is an especially important action to take in those instances where 

unsolicited offers are received from unfamiliar companies that meet some of the above 

mentioned causes for concern. In addition, report any concerns as suggested in Question 

38. 

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40. Does the PDMA Compliance Policy Guide 160.900 apply to pharmacies and 

chain pharmacy warehouses? 

Yes. CPG 160.900 relates to the PDMA pedigree requirements. Retail pharmacies and 

chain pharmacy warehouses are included in the definition of wholesale distributors at 21 

CFR § 203.3(dd) and are required to comply with the PDMA. Please see Addendum at: 

http://www.fda.gov/cder/regulatory/PDMA/PDMA_addendum.pdf

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ADDENDUM to FDA’s Guidance for Industry: PDMA Pedigree Requirements – 

Questions and Answers Related to the Preliminary Injunction ordered 12/5/06 in 

RXUSA Wholesalers, Inc. v. HHS 

12.15.06 

A. What is affected by the preliminary injunction? 

• 21 CFR § 203.50(a). The court order enjoins FDA from implementing 21 CFR § 

203.50(a). 21 CFR § 203.50(a)(6), states that information regarding “each prior 

transaction involving the drug, starting with the manufacture” be included in the 

pedigree. However, while the preliminary injunction is in effect, pedigrees shall 

include information regarding prior transactions going back to the manufacturer 

or the last ADR that sold, purchased, or traded the prescription drugs. FDA 

encourages wholesalers to include information regarding each prior transaction 

going back to the manufacturer when that information is available. 

• 21 CFR § 203.50(a)(1)-(5). The court order also enjoins FDA from implementing 

the language in 21 CFR § 203.50 that requires pedigrees to include lot and control 

numbers, dosage, container size, and number of containers. As described in more 

detail below, however, the preliminary injunction does not affect the statutory 

requirement that pedigrees contain the dates of all listed transactions and the 

names and addresses of all parties involved in those transactions. In addition, 

since the court did not enjoin implementation of 21 CFR § 203.3(u), a written 

agreement between a manufacturer and a wholesaler may limit ADR status to a 

particular lot number(s), dosage, or the number or size of the containers of 

prescription drugs. We also note that, without the lot number on the pedigree, it 

would be extremely difficult to track the inventory that matches the pedigree if 

the inventory is further sold, purchased or traded. Therefore, FDA recommends 

that the lot or control number, dosage, and the number and size of the prescription 

drug containers be included on the pedigree even though it is not required while 

the preliminary injunction is in effect. 

• Pedigrees for all current and future inventory are affected by the preliminary 

injunction as long is it remains in effect. 

B. What is not affected by the preliminary injunction? 

Pedigrees still must be passed by non-authorized distributors of record (non-ADR) prior 

to each wholesale distribution. In addition, the court does not mention other pedigreerelated regulations or other agency-issued documents relating to the pedigree 

requirement. Accordingly, those regulations and documents, some of which are 

described below, are not affected by the preliminary injunction. 

• 21 CFR § 203.3(u). This regulation, which went into effect on December 1, 2006, 

defines "ongoing relationship" for the purposes of determining who qualifies as 

an authorized distributor of record (ADR.) As of December 1, 2006, only those 

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wholesale distributors who have an ongoing relationship (including a written 

agreement) with the manufacturer, as that term is defined by this regulation, are 

exempt from the pedigree requirement. 

 

• Compliance Policy Guide (CPG) 160.900, which issued in November 2006, 

remains in effect until December 1, 2007. The CPG describes how FDA intends 

to prioritize its enforcement efforts regarding the pedigree requirements in the 

first year after the effective date of 21 CFR §§ 203.3(u) and 203.50. However, 

FDA will not enforce 203.50(a) as long as the preliminary injunction remains in 

effect. 

• All other definitions in 21 CFR Part 203 that relate to the pedigree requirement, 

including but not limited to, the definitions of manufacturer and wholesale 

distribution, have been in effect since December 2000 and remain in effect despite 

the injunction. 

• The names and addresses of all parties to the transaction and the date of the 

transactions are required by the statute and must be included in the pedigree. 

• 21 CFR § 203.50(b). This regulation, which went into effect on December 1, 

2006, requires all wholesale distributors (both ADRs and non-ADRs) involved in 

the distribution of a prescription drug to retain a copy of the pedigree for three 

years. Accordingly, all wholesale distributors that provide or receive pedigrees 

after December 1, 2006, must retain copies of the pedigrees for three years. 

• 21 CFR § 203.50(c). This regulation, which also went into effect on December 1, 

2006, provides that a manufacturer that subjects a drug to additional 

manufacturing processes is not required to provide a pedigree identifying previous 

sales of the drug or its components. 

• 21 CFR § 203.50(d). This regulation also went into effect on December 1, 2006, 

and requires manufacturers to maintain a current written list of all ADRs, to 

specify whether each ADR is authorized to distribute all of the manufacturer's 

drug products or only particular products, to update its list of ADRs on a 

continuing basis, and to make its list of ADRs available for public inspection or 

copying. Accordingly, as of December 1, 2006, all manufacturers should have 

available for public inspection a current list of ADRs that indicates which drug 

products the ADR is authorized to distribute. 

• 21 CFR § 203.60. This regulation sets forth certain requirements with respect to 

the use of electronic records and signatures, record retention, and the availability 

of records for review and reproduction by FDA and other federal, state, and local 

regulatory and law enforcement officials. This regulation has been in effect since 

December 2000 and remains in effect despite the injunction. 

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C. Since the court's order only applies to 21 CFR § 203.50(a), does this mean that 

the statutory requirement that non-ADRs provide pedigrees that include "each 

prior sale, purchase, or trade" of the drugs is still in effect? 

• Yes. The court order does not enjoin FDA from enforcing the statute. The court 

order affects only the regulations at 21 CFR § 203.50(a). It has been FDA's longstanding position, consistent with the language of the PDMA and its legislative 

history, that, 21 CFR § 203.50 notwithstanding, the statute itself requires nonADRs to provide pedigrees that documents each prior transaction going back to 

the manufacturer. FDA recognizes, however, that confusion regarding the 

pedigree requirement could cause disruptions or delays in the nation's drug 

distribution system. Accordingly, as long as the court order remains in effect, 

FDA intends to exercise enforcement discretion, as described below. To this end, 

FDA does not intend to enforce the statute insofar as it requires pedigrees to 

contain information regarding each transaction going back to the manufacturer. 

Rather, FDA intends to permit non-ADRs to provide pedigrees that include 

information regarding transactions going back to the manufacturer or the last 

ADR that handled the prescription drugs. FDA, however, encourages all 

wholesalers to provide complete pedigrees documenting each prior transaction 

involving the prescription drug when that information is available. 

D. How will FDA apply the court’s order outside of the Eastern District of New 

York (EDNY) and to wholesale distributors that are not plaintiffs in the lawsuit? 

• FDA believes that limiting application of the preliminary injunction to either the 

named plaintiffs or the EDNY could lead to confusion and possible disruptions or 

delays in the nation’s drug distribution system and could provide undue advantage 

to certain wholesale distributors. Accordingly, to the extent that it could be 

argued that the injunction should be limited in scope, FDA intends to exercise 

enforcement discretion in a manner that is consistent with the court’s opinion. To 

this end, as long as the court's order is in effect, FDA does not intend to initiate 

any enforcement actions against any wholesalers solely for (1) failing to include 

lot numbers, dosage, container size, or number of containers on a pedigree; or (2) 

failing to provide a pedigree that goes back to the manufacturer so long as the 

pedigree otherwise identifies the last authorized distributor of record that handled 

the drugs. 

E. How does the court’s order impact what FDA said in the Guidance to Industry: 

PDMA Pedigree Requirements – Questions and Answers 

(http://www.fda.gov/cder/regulatory/PDMA/PDMA_qa.pdf)? 

• To the extent that Questions 2, 9, 10, 11, 14, 24, 29, and 33 refer to 21 CFR § 

203.50(a), as long as the preliminary injunction is in effect, such references are 

limited to the scope of the court’s order. For example, if the question states that a 

pedigree include information about each prior transaction going back to the 

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manufacturer, then the answer would be limited to including information going 

back to the manufacturer or the last ADR that handled the drugs. 

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