NMBOP: 16.19.08 WHOLESALE PRESCRIPTION DRUG DISTRIBUTION

Question 1

Q: What are the conditions under which a drug is considered adulterated?

Answer 1

A: A drug is considered adulterated if it:

1. Consists in whole or part of any filthy, putrid, or decomposed substance;
2. Has been produced, prepared, packed, or held under unsanitary conditions that may have contaminated it with filth or rendered it injurious to health;
3. Uses methods or facilities for manufacture, processing, packing, or holding that do not conform to current good manufacturing practices, thus not meeting safety, identity, strength, quality, or purity requirements;
4. Has a container composed in whole or part of any poisonous or deleterious substance that may render its contents injurious to health;
5. Bears or contains a color additive that is unsafe within the meaning of the Federal Act or is unsafe for the purpose of coloring only;
6. Purports to be or is represented as a drug recognized in an official compendium but its strength, quality, or purity differs from or falls below the standards set forth in the compendium, unless the standard is plainly stated on its label;
7. If not subject to Paragraph (6) and its strength differs from or its purity or quality falls below what it purports or is represented to possess;
8. Has any substance mixed or packed with it that reduces its quality or strength or substitutes it wholly or in part.

Question 2

Define

“Affiliate”

Answer 2

means a business entity that has a relationship with a second business entity if, directly or indirectly:

(1) one business entity controls, or has the power to control, the other business entity; or

(2) a third-party controls, or has the power to control, both of the business entities

Question 3

Define

“Authorized”

Answer 3

(1) in the case of a manufacturer or repackager, having a valid registration as a drug establishment with the FDA under Section 510 of the Federal Act;

(2) a licensed wholesale distributor, who is compliant with the licensure reporting requirements under section 503(e) of the Federal Act;

(3) a licensed third-party logistics provider, who is compliant with the licensure reporting requirements under section 584(b) of the Federal Act;

(4) in the case of a dispenser, having a valid license under New Mexico state law.

Question 4

Define

“Co-licensed partner or product”

Answer 4

means an instance where two or more parties have the right to engage in the manufacturing or marketing of a prescription drug, consistent with FDA’s implementation of the Drug Supply Chain Security Act (DSCSA).

Question 5

Define

“Common carrier”

Answer 5

means any person or entity who undertakes, whether directly or by any other arrangement, to transport property including prescription drugs for compensation.

Question 6

Define

“Counterfeit drug”

Answer 6

means a drug that is deliberately and fraudulently mislabeled with respect to its identity, ingredients or sources. Types of such pharmaceutical counterfeits may include:
(1) identical copies: which are counterfeits made with the same ingredients, formulas and packaging as the originals but not made by the original manufacturer;

(2) look-alikes: which feature high-quality packaging and convincing appearances but contain little or no active ingredients and may contain harmful substances;

(3) rejects: which are drugs that have been rejected by the manufacturer for not meeting quality standards;

(4) re-labels: which have passed their expiration dates or have been distributed by unauthorized foreign sources and may include placebos created for late-phase clinical trials.

Question 7

Define

“Counterfeit prescription drug”

Answer 7

means a dangerous drug which, or the container or labeling of which, without authorization:
(1) bears the trademark, trade name, or other identifying mark, print, device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packaged, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by such other drug manufacturer, processor, packer, or distributor;
(2) from the original manufacturer is an imitation of another dangerous drug or has been deliberately mislabeled (for example, as to its strength or expiration date) but it shall not include a dangerous drug or placebo intended for use in a clinical trial that is intentionally labeled or marked to maintain proper blinding of the study.

Question 8

Define

Q: What is a “dangerous drug” also known as a “prescription drug,” and under what conditions can it be dispensed?

Answer 8

A: A “dangerous drug,” also known as a “prescription drug,” is a drug other than a controlled substance enumerated in Schedule I of the Controlled Substance Act, that:

1. Because of potential harmful effects, method of use, or collateral measures necessary for its use, is not safe except under the supervision of a practitioner licensed by law to direct its use, and hence adequate directions for use cannot be prepared for safe layman use;
2. Must be dispensed only upon the prescription of a practitioner licensed by law to administer or prescribe the drug if it:(1) Is a habit-forming drug and contains any quantity of a narcotic or hypnotic substance or a chemical derivative of such substance found habit-forming under the Federal Act and by the board;(2) Because of its toxicity or potential for harmful effects, method of use, or collateral measures necessary, is not safe for use except under the supervision of a practitioner licensed by law to administer or prescribe the drug;(3) Is limited by an approved application by Section 505 of the Federal Act to use under the professional supervision of a practitioner licensed by law to administer or prescribe the drug;(4) Bears the legend “Caution: federal law prohibits dispensing without prescription”;(5) Bears the legend “Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian”;(6) Bears the legend “RX only”;(7) Has been declared a dangerous drug by the board of pharmacy.

Question 9

“Designated representative”

Answer 9

means an individual designated by the wholesale distributor, third-party logistics provider, or repackager who will serve as the responsible individual of the wholesale distributor, third-party logistics provider, or repackager with the board who is actively involved in and aware of the actual daily operation of the wholesale distributor, third-party logistics provider, or repackager. The designated representative is responsible for all aspects of the facility operations.

Question 10

“Dispenser”

Answer 10

(1) a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and

(2) does not include a person who dispenses only products to be used in animals in accordance with Section 512(a)(5) of the Federal Act.

Question 11

Define

“Disposition”

Answer 11

with respect to a product within the possession or control of an entity, means the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal or other appropriate handling and other actions, such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency.

Question 12

Define

“Drug sample”

Answer 12

means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug as defined by the Prescription Drug Marketing Act of 1987.

Question 13

“Exclusive distributor”

Answer 13

means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer’s product to a subsequent repackager, wholesale distributor, or dispenser.

Question 14

“Facility”

Answer 14

means facility of a wholesale distributor, repackager, or third-party logistics provider where prescription drugs are stored, handled, repackaged or offered for sale.

Question 15

“FDA”

Answer 15

means food and drug administration, a federal agency within the United States department of health and human services, established to set safety and quality standards for drugs, food, cosmetics and other consumer products.

Question 16

“Federal Act”

Answer 16

means the Federal Food, Drug and Cosmetic Act.

Question 17

“Homogeneous case”

Answer 17

means a sealed case containing only product that has a single NDC number belonging to a single lot.

Question 18

“Illegitimate product”

Answer 18

means a product for which credible evidence shows that the product:
(1) is counterfeit, diverted, or stolen;
(2) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(3) is the subject of a fraudulent transaction; or
(4) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

Question 19

Q: What does “licensed” mean in the context of wholesale distributors and third-party logistics providers?

Answer 19

A:

1. For a wholesale distributor:
   
   • (a) Having valid licensure with the board; and
   • (b) For facilities located outside of New Mexico:
     
     • (i) Having valid licensure by the state from which the drug is distributed; or
     • (ii) If the state from which the drug is distributed has not established a licensure requirement, being licensed by the FDA (beginning when federal regulations are promulgated to implement Section 583 of the Federal Act).
2. For a third-party logistics provider:
   
   • (a) For facilities located outside of New Mexico:
     
     • (i) Having valid licensure by the state from which the drug is distributed when required by that state; and
     • (ii) Having a valid registration with the FDA (beginning when federal regulations are promulgated to implement Section 584 of the Federal Act), unless the FDA has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and publishes notice thereof; or
     • (iii) Having valid licensure with the board.
   • (b) For facilities located in New Mexico: Having valid licensure with the board.

Question 20

“Manufacturer” means:

Answer 20

(1) a person that holds an application approved under Section 505 of the Federal Act or a license issued under Section 351 of the Federal Public Health Service Act for such drug, or if such drug is not the subject of an approved application or license, the person who manufactured the drug;
(2) a co-licensed partner of the person described in Paragraph (1) that obtains the drug directly from a person described in Paragraph (1) or (3) of this subsection; or
(3) an affiliate of a person described in Paragraph (1) or (2) of this subsection that receives the product directly from a person described in Paragraph (1) or (2) of this subsection.

Question 21

“Manufacturing”

Answer 21

means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis; and includes packaging or repackaging, labeling or relabeling and the promotion and marketing of such drugs or devices; also included is the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, licensed practitioners or other persons.

Question 22

“Misbranded”

Answer 22

means a label to an article that is misleading. In determining whether the label is misleading there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device or any combination of the foregoing, but also the extent to which the label fails to reveal facts material in the light of such representations or material with respect to consequences that may result from the use of the article to which the label relates under the conditions of use prescribed in the label or under such conditions of use as are customary or usual.

Question 23

“Official compendium”

Answer 23

means the official USP-NF or the official homeopathic pharmacopoeia of the United States or any supplement to either of them.

Question 24

“Package”

Answer 24

means the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product. An individual saleable unit is the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser.

Question 25

“Prescription drug”

Answer 25

means any human drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 503(b) of the Federal Food, Drug and Cosmetic Act.

Question 26

“Product”

Answer 26

means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but does not include:

(1) blood or blood components intended for transfusion;

(2) radioactive drugs or radioactive biological products that are regulated by the Nuclear Regulatory Commission or by the state pursuant to an agreement with such commission under Section 274 of the Atomic Energy Act of 1954
(3) imaging drugs;

(4) an intravenous product

(5) any medical gas

(6) homeopathic drugs marketed in accordance with applicable guidance under the federal act; or

(7) a drug compounded in compliance with Section 503A or 503B of the Federal Act.

Question 27

“Product identifier”

Answer 27

means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product, meeting the requirements of the DSCSA.

Question 28

“Product tracing information”

Answer 28

means, for each transaction: the recorded transaction history, transaction information, and transaction statement meeting the requirements of the DSCSA.

Question 29

“Quarantine”

Answer 29

means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.

Question 30

“Repackage”

Answer 30

means repackaging or otherwise changing the container, wrapper or labeling to further the distribution of a prescription drug excluding that completed by the pharmacists responsible for dispensing product to the patient.

Question 31

“Repackager”

Answer 31

“Repackager” means a person who owns or operates a facility that repackages and re-labels a product or package for:
(1) further sale; or
(2) distribution without a further transaction.

Question 32

“Return”

Answer 32

“Return” means providing product to the authorized immediate trading partner from which such

product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product.

Question 33

“Returns processor or reverse logistics provider”

Answer 33

means a person who owns or

operates an establishment that dispositions or otherwise processes saleable or non-saleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution.

Question 34

“Selling of drugs, devices or cosmetics”

Answer 34

shall be considered to include the manufacture, production, processing, packing, exposure, offer, possession and holding of any such article for sale and the sale and the sale and the supplying or applying of any such article in the conduct of a drug or cosmetic establishment.

Question 35

“Significant loss”

Answer 35

“Significant loss” means any loss of a prescription drug that exceeds a reasonable level established by like persons which requires that loss to be reported to the board or as required by the DEA or other state or federal agencies for prescription drugs and controlled substances.

Question 36

“Specific patient need”

Answer 36

means the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need

Question 37

“Standardized numerical identifier”

Answer 37

“Standardized numerical identifier” means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the NDC that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.

Question 38

“Suspect product”

Answer 38

“Suspect product” means a product for which there is reason to believe:
(1) is potentially counterfeit, diverted, or stolen;
(2) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(3) is potentially the subject of a fraudulent transaction; or
(4) appears otherwise unfit for distribution such that the product would result in serious
adverse health consequences or death to humans.

Question 39

“Third-party logistics provider”

Answer 39

“Third-party logistics provider” means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.

Question 40

“Trading partner”

Answer 40

“Trading partner” means:
(1) a manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or
(2) a third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product.

Question 41

Q: What does “transaction” mean in terms of product transfer, and what does it exclude?

Answer 41

A:

A “transaction” means the transfer of product between persons in which a change of ownership occurs. However, it does not include:

1. Intracompany Distribution:
   
   • (1) The intracompany distribution of any product between members of an affiliate or within a manufacturer.
2. Distribution Among Common Control Entities:
   
   • (2) The distribution of a product among hospitals or other health care entities that are under common control. “Common control” means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise.
3. Emergency Medical Distribution:
   
   • (3) The distribution of a product for emergency medical reasons including a federal or state declared public health emergency, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason.
4. Prescription Dispensing:
   
   • (4) The dispensing of a product pursuant to a prescription executed in accordance with Section 503(b)(1) of the Federal Act.
5. Product Samples Distribution:
   
   • (5) The distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with Section 503(d) of the Federal Act.
6. Blood and Blood Components:
   
   • (6) The distribution of blood or blood components intended for transfusion.
7. Minimal Quantities by Retail Pharmacy:
   
   • (7) The distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use.
8. Charitable Organization Transactions:
   
   • (8) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code of 1986 to a nonprofit affiliate of the organization to the extent otherwise permitted by law.
9. Pharmacy or Distributor Sale or Merger:
   
   • (9) The distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors, except that any records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors.
10. Approved Animal Drug Product:
    
    • (10) The dispensing of an approved animal drug product approved under Section 512(c) of the Federal Act.
11. Nuclear Regulatory Commission Licensed Locations:
    
    • (11) Products transferred to or from any location that is licensed by the Nuclear Regulatory Commission or by the state pursuant to an agreement with such commission under Section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021).
12. Combination Products:
    
    • (12) A combination product that is not subject to approval under Section 505 or licensure under Section 351 of the Public Health Service Act, and that is:
      
      • (a) A product comprised of a device and one or more other regulated components (such as a device and a drug, biologic, or drug and biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
      • (b) Two or more separate products packaged together in a single package or as a unit and comprised of a drug and device or device and biological product; or
      • (c) Two or more finished medical devices plus one or more drug or biological products that are packaged together in what is referred to as a “medical convenience kit” as described in Paragraph (13) below.
13. Medical Convenience Kits:
    
    • (13) The distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this paragraph as a “medical convenience kit”) if:
      
      • (a) The medical convenience kit is assembled in an establishment that is registered with the FDA as a device manufacturer in accordance with Section 510(b)(2) of the Federal Act;
      • (b) The medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970;
      • (c) In the case of a medical convenience kit that includes a product, the person that manufactures the kit:
        
        • (i) Purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and
        • (ii) Does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and
      • (d) In the case of a medical convenience kit that includes a product, the product is:
        
        • (i) An intravenous solution intended for the replenishment of fluids and electrolytes;
        • (ii) A product intended to maintain the equilibrium of water and minerals in the body;
        • (iii) A product intended for irrigation or reconstitution;
        • (iv) An anesthetic;
        • (v) An anticoagulant;
        • (vi) A vasopressor; or
        • (vii) A sympathomimetic.
14. Intravenous Products for Fluid Replenishment:
    
    • (14) The distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids).
15. Intravenous Products for Water and Mineral Equilibrium:
    
    • (15) The distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions.
16. Irrigation Products:
    
    • (16) The distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection.
17. Medical Gas Distribution:
    
    • (17) The distribution of a medical gas (as defined in Section 575 of the Federal Act).
18. Licensed Medical Devices:
    
    • (18) The distribution or sale of any licensed product under section 351 of the Public Health Service Act that meets the definition of a medical device under Section 201(h) of the Federal Act.

Question 42

“Transaction history”

Answer 42

means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

Question 43

“Transaction information”

Answer 43

“Transaction information” means:
(1) the proprietary or established name or names of the product;
(2) the strength and dosage form of the product;

(3) the NDC number of the product;

(4) the container size;

(5) the number of containers;

(6) the lot number of the product;
(7) the date of the transaction;

(8) the date of the shipment, if more than 24 hours after the date of the transaction;

(9) the business name and address of the person from whom ownership is being transferred; and

(10) the business name and address of the person to whom ownership is being transferred.

Question 44

“Transaction statement”

Answer 44

“Transaction statement” means a statement, in paper or electronic form, that the entity transferring ownership in a transaction:

(1) is authorized as required under the DSCSA;

(2) received the product from a person that is authorized as required under the DSCSA;

(3) received transaction information and a transaction statement from the prior owner of the product, as required under Section 582 of the Federal Act;

(4) did not knowingly ship a suspect or illegitimate product;

(5) had systems and processes in place to comply with verification requirements under Section 582 of the Federal Act;

(6) did not knowingly provide false transaction information; and

(7) did not knowingly alter the transaction history.

Question 45

“USP-NF standards”

Answer 45

“USP-NF standards” means standards published in the current official United States Pharmacopeia-National Formulary.

Question 46

“Verification or verify”

Answer 46

means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager

Question 47

“Wholesale distributor”

Answer 47

“Wholesale distributor” means a person or entity (other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or repackager) engaged in wholesale drug distribution.

Question 48

Q: What does “wholesale drug distribution” mean, and what does it exclude?

Answer 48

A:

“Wholesale drug distribution” means the distribution of a prescription drug to a person other than a consumer or patient, or receipt of a prescription drug by a person other than the consumer or patient. It does not include:

1. Intracompany Distribution:
   
   • (1) Intracompany distribution of any drug between members of an affiliate or within a manufacturer.
2. Distribution Among Common Control Entities:
   
   • (2) The distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control.
3. Emergency Medical Distribution:
   
   • (3) The distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a federal or state declared public health emergency, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason.
4. Prescription Dispensing:
   
   • (4) The dispensing of a drug pursuant to a prescription.
5. Minimal Quantities by Retail Pharmacy:
   
   • (5) The distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use.
6. Charitable Organization Transactions:
   
   • (6) The distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law.
7. Purchase by Health Care Entities:
   
   • (7) The purchase or other acquisition by a dispenser, hospital, or other health care entity of a drug for use by such dispenser, hospital, or other health care entity.
8. Manufacturer Distribution:
   
   • (8) The distribution of a drug by the manufacturer of such drug.
9. Authorized Third-Party Logistics Provider:
   
   • (9) The receipt or transfer of a drug by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership of the drug.
10. Common Carrier Transport:
    
    • (10) A common carrier that transports a drug, provided that the common carrier does not take ownership of the drug.
11. Authorized Repackager Distribution:
    
    • (11) The distribution of a drug, or an offer to distribute a drug by an authorized repackager that has taken ownership or possession of the drug and repacks it in accordance with Section 582(e) of the Federal Act.
12. Saleable Drug Returns:
    
    • (12) Saleable drug returns when conducted by a dispenser.
13. Medical Convenience Kits:
    
    • (13) The distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to as a “medical convenience kit”) if:
      
      • (a) The medical convenience kit is assembled in an establishment that is registered with the FDA as a device manufacturer in accordance with Section 501(b)(2) of the Federal Act;
      • (b) The medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.];
      • (c) In the case of a medical convenience kit that includes a product, the person that manufactures the kit:
        
        • (i) Purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and
        • (ii) Does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and
      • (d) In the case of a medical convenience kit that includes a product, the product is:
        
        • (i) An intravenous solution intended for the replenishment of fluids and electrolytes;
        • (ii) A product intended to maintain the equilibrium of water and minerals in the body;
        • (iii) A product intended for irrigation or reconstitution;
        • (iv) An anesthetic;
        • (v) An anticoagulant;
        • (vi) A vasopressor; or
        • (vii) A sympathomimetic.
14. Intravenous Products for Fluid Replenishment:
    
    • (14) The distribution of an intravenous drug that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids).
15. Intravenous Products for Water and Mineral Equilibrium:
    
    • (15) The distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions.
16. Irrigation Products:
    
    • (16) The distribution of a drug that is intended for irrigation, or sterile water, whether intended for such purposes or for injection.
17. Medical Gas Distribution:
    
    • (17) The distribution of medical gas, as defined in Section 575 of the Federal Act.
18. Administrative Services:
    
    • (18) Facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments.
19. Product Transfer for Repackaging:
    
    • (19) The transfer of a product by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital or other health care entity, to a repackager described in Section 581(16)(B) and registered under Section 510 of the Federal Act for the purpose of repackaging the drug for use by that hospital or other health care entity and other health care entities that are under common control, if ownership of the drug remains with the hospital or other health care entity at all times.

Question 49

Q: What is required for a wholesale drug distributor to operate in this state?

Answer 49

A:
Every wholesale drug distributor, wherever located, who engages in wholesale distribution into, out of, or within this state must be licensed by the board in accordance with the laws and regulations of this state before engaging in wholesale distribution of prescription drugs.

Question 50

Q: Can wholesale distributors operate from a place of residence?

Answer 50

A:
No, wholesale distributors cannot operate from a place of residence.

Question 51

Q: What is required if wholesale distribution operations are conducted at more than one location?

Answer 51

A:
Where wholesale distribution operations are conducted at more than one location, each such location shall be licensed by the board of pharmacy.

Question 52

Q: Where must a wholesale distributor located in New Mexico be situated in relation to pharmacies?

Answer 52

A:
A wholesale distributor located in New Mexico shall be located apart and separate from any pharmacy.

Question 53

Q: Are common or contract carriers or warehousemen required to obtain a wholesale drug distributor license from the board?

Answer 53

A:
Common or contract carriers or warehousemen, or an employee thereof, whose involvement in the wholesale distribution of prescription drugs occurs in the usual course of his business or employment shall not be required to obtain a wholesale drug distributor license from the board.

Question 54

Q: What must a wholesale distributor submit to the board to obtain licensure?

Answer 54

A:
Every wholesale distributor who engages in the wholesale distribution of drugs shall be licensed with the board by submitting an application and providing the following information required by the board:

1. Applicant’s full name; all trade or business names used by the licensee (includes “is doing business as” and “formerly known as”) which cannot be identical to the name used by another unrelated wholesale distributor, third-party logistics provider, or repackager licensed by the board; full business address and telephone number.
2. Type of ownership, e.g., individual, partnership, limited liability company, or corporation.
3. Name(s) of the owner(s) of the applicant, including:
   
   • If a person, the name, address, social security number or Federal Employer Identification Number (FEIN), and date of birth.
   • If other than a person, the name, address, social security number, and date of birth of each partner, limited liability company member, or corporate officer and corporate director and the federal employer identification number.
   • If a corporation, the state of incorporation.
   • If a publicly traded corporation, the information in Subparagraph (b) of this paragraph is not required for corporate officers and corporate directors.
   • Any other relevant information that the board requires.
4. Name(s), business address(es), telephone number(s) of a person(s) to serve as the designated representative(s) for each facility of the wholesale distributor that engages in the distribution of drugs.
5. Evidence of criminal background checks and fingerprinting of the applicant, if a person, and of the applicant’s designated representative; the background check shall be sufficient to include all states of residence since the person has been an adult.
6. A list of all state and federal licenses, registrations, or permits, including the license, registration, or permit numbers issued to the wholesale drug distributor by any other state and federal authority that authorizes the wholesale distributor to purchase, possess, and distribute drugs.
7. A list of all disciplinary actions or any other sanction by state and federal agencies against the wholesale distributor as well as any such actions against principals, owners, directors, or officers.
8. A full description of each facility and warehouse located in New Mexico, including all locations utilized for drug storage or distribution; the description must include the following:
   
   • Square footage.
   • Security and alarm system descriptions.
   • Terms of lease or ownership.
   • Address.
   • Temperature and humidity controls.
9. A description of the wholesale distributor’s drug import and export activities.
10. A copy of the wholesale distributor’s written policies and procedures as required in Subsection I of 16.19.8.13 NMAC (Written policies and procedures).
11. A facility located outside of New Mexico shall submit a copy of a current satisfactory inspection report issued by the FDA, or state licensing authority, or by a third-party inspection service approved by the FDA or the state authority licensing such wholesale distributor, or by the board.
12. The information collected pursuant to Paragraphs (5), (8), and (10) of this subsection shall be made available only to the board, and to state and federal law enforcement officials; the board shall make provisions for protecting the confidentiality of the information collected under this section.
13. Renewal applications shall be on a form furnished by the board.

Question 55

Q: What fee is required for wholesale drug distributor licensure?

Answer 55

A:
Every wholesale drug distributor who engages in wholesale distribution shall submit a reasonable fee to be determined by the board.

Question 56

Q: What is required for each facility located in New Mexico that engages in wholesale drug distribution?

Answer 56

A:
Each facility located in New Mexico that engages in wholesale drug distribution must undergo an inspection by the board for the purpose of inspecting the wholesale drug distribution facility and operations prior to initial licensure. Manufacturing facilities located outside of this state are exempt from inspection by the board if the manufacturing facilities are currently registered with the Food and Drug Administration in accordance with Section 510 of the Federal Act.

Question 57

Q: What must wholesale distributors publicly display or have readily available?

Answer 57

A:
All wholesale distributors must publicly display or have readily available all licenses and the most recent inspection report administered by the board.

Question 58

Q: How should changes in information be handled by wholesale distributors?

Answer 58

A:
Changes in any information in this section shall be submitted to the board within 30 days of such change unless otherwise noted.

Question 59

Q: How is trade secret or proprietary information handled by the board?

Answer 59

A:
Information submitted by the wholesale drug distributor to the board that is considered trade secret or proprietary information as defined under this state’s privacy and trade secret or proprietary statutes shall be maintained by the board as private or trade secret proprietary information and be exempt from public disclosure.

Question 60

Q: What authority does the board have regarding third-party accreditation and inspection?

Answer 60

A:
The board shall have the authority to recognize a third-party to accredit and inspect wholesale distributors.

Question 61

Q: Under what conditions may the board license a wholesale distributor by reciprocity?

Answer 61

A:
The board may license by reciprocity a wholesale distributor that is licensed under the laws of another state if:
1. The applicant submits documentation of a current satisfactory inspection conducted by the FDA, or state licensing authority, or by a third-party inspection service approved by the FDA or the state authority licensing such wholesale distributor, or the board.
2. The requirements of that state are deemed by the board to be substantially equivalent.

Question 62

Q: What are the bonding or security requirements for wholesale distributors?

Answer 62

A:
Every wholesale distributor must furnish a bond or other equivalent means of security as follows:
1. For the issuance or renewal of a wholesale distributor license, an applicant that is not a government-owned and operated wholesale distributor shall submit a surety bond of $100,000 or other equivalent means of security acceptable to the board.
2. The board may accept a surety bond in the amount of $25,000 if the annual gross receipts of the previous tax year for the wholesaler are $10,000,000 or less.
3. If a wholesale distributor can provide evidence that it possesses the required bond in a state, the requirement for a bond in New Mexico shall be waived.

Question 63

Q: What are the reasons the board will prohibit a person from receiving or maintaining licensure for wholesale distribution?

Answer 63

A:
The board shall prohibit a person from receiving or maintaining licensure for wholesale distribution if the person:

1. Has been convicted of any felony for conduct relating to wholesale distribution, any felony violation of Subsection (i) or (k) of Section 301, or any felony violation of Section 1365 of Title 18, United States Code, relating to product tampering.
2. Has engaged in a pattern of violating the requirements of this section, or state requirements for licensure, that presents a threat of serious adverse health consequences or death to humans.

Question 64

Q: What factors does the board consider when reviewing the qualifications of persons who engage in wholesale distribution of prescription drugs?

Answer 64

A:
The board shall consider, at a minimum, the following factors:

1. Any conviction of the applicant under federal, state, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances.
2. Any felony convictions of the applicant under federal, state, or local law.
3. The applicant’s past experience in the manufacture or distribution of prescription drugs, including controlled substances.
4. The furnishing by the applicant of false or fraudulent material in any application.
5. Suspension, revocation, or any other sanction by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances.
6. Compliance with regulatory and licensing requirements under previously granted licenses, if any.
7. Compliance with requirements to maintain or make available to the board or to federal, state, or local law enforcement officials those records required under 16.19.8 NMAC.
8. Any findings by the board that the applicant has violated or been disciplined, or the subject of administrative action or other sanction, by a regulatory or licensing agency in any state for violating federal, state, or local laws relating to drug or device wholesale distribution.
9. Any other factors or qualifications the board considers relevant to and consistent with the public health and safety.

Question 65

Q: What background checks are required for applicants or designated representatives?

Answer 65

A:
The board shall consider the results of a criminal and financial background check and fingerprinting of the applicant and designated representative to determine if an applicant or others associated with the ownership, management, or operations of the wholesale distributor have committed criminal acts that would constitute grounds for denial of licensure. Manufacturers licensed by the FDA in accordance with Section 510 of the Federal Act shall be exempt from criminal and financial background checks.

Question 66

Q: What must the applicant provide regarding past criminal convictions and violations?

Answer 66

A:
The applicant shall provide and attest to a statement providing a complete disclosure of any past criminal convictions and violations of state and federal laws regarding drugs or devices or an affirmation and attestation that the applicant has not been involved in, or convicted of, any criminal or prohibited acts.

Question 67

Q: Under what circumstances can the board deny a license based on public interest?

Answer 67

A:
The board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest. Public interest considerations shall be based upon factors and qualifications that are directly related to the protection of the public health and safety.

Question 68

Q: What information must be provided for a request for an alternative reduced wholesale license fee?

Answer 68

A:
The board shall collect the full license fee as set by the board unless the board determines that collection of the license fee would be inconsistent with the public interest. The applicant/petitioner shall provide the board with any information necessary to make that determination, including:

1. Business/organization profit status under federal and state code.
2. Impact on the health and safety of New Mexico citizens.
3. Volume of distribution in New Mexico.
4. Sole source of dangerous drugs.
5. Financial hardship for applicant/registrant.

Question 69

PERSONNEL

Q: What is required of each person employed in prescription drug wholesale distribution activities?

Answer 69

A:
As a condition of receiving and retaining a wholesale drug distributor license, the licensee shall require each person employed in any prescription drug wholesale distribution activity to have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions in such a manner as to provide assurance that the drug product quality, safety, and security will at all times be maintained by law.

Question 70

PERSONNEL

Q: What must each wholesale distributor designate when applying for an initial or renewal license?

Answer 70

A:
Each person that is issued an initial or renewal license as a wholesale distributor, whether in state or out of state, must designate in writing on a form required by the board a person for each facility to serve as the designated representative(s) of the wholesale distributor.

Question 71

PERSONNEL

Q: What are the requirements to be certified as a designated representative?

Answer 71

A:
To be certified as a designated representative, a person must:

1. Submit an application on a form furnished by the board and provide information that includes:
   
   • Evidence of a criminal background check and fingerprinting, including all states of residence since the person has been an adult.
   • Date of birth and social security number.
   • Occupations, positions of employment, and offices held during the past seven years.
   • Whether the person has been enjoined, temporarily or permanently, by a court from violating any state or federal laws regulating the possession, control, or wholesale distribution of prescription drugs or devices during the past seven years, including details of such events.
   • Whether the person has been the subject of any proceeding for the revocation of any professional or business license or any criminal violation during the past seven years, including the nature of the proceeding and its disposition.
   • Description of any involvement with any business, other than the ownership of stock in a publicly traded company or mutual fund during the past seven years, that manufactured, administered, prescribed, wholesale distributed, or stored prescription drugs and devices, including any lawsuits involving such businesses.
   • Description of any criminal offense (excluding minor traffic violations) of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere. If the person indicates a criminal conviction is under appeal, a copy of the final written order of disposition must be submitted within 15 days after the appeal’s disposition.
   • Any other information the board deems relevant.
2. Serve as the designated representative for only one wholesale distributor at any one time, except where more than one licensed wholesale distributor is co-located in the same facility and such wholesale distributors are members of an affiliated group as defined in Section 1504 of the Internal Revenue Code.
3. Be actively involved in and aware of the actual daily operations, purchasing, and inventory control of the wholesale distributor by:
   
   • Being employed full-time in a managerial position by the wholesale distributor.
   • Being physically present at the wholesale distributor during normal business hours, except for authorized absences.
   • Being knowledgeable about all policies and procedures pertaining to the operations of the wholesale distributor.

Question 72

PERSONNEL

Q: How is the criminal and financial information collected regarding designated representatives handled?

Answer 72

A:
The criminal and financial information collected pursuant to this section shall be made available only to the board, a third-party recognized by the board, and to state and federal law enforcement officials. The board and the third-party recognized by the board shall make provisions for protecting the confidentiality of the information collected under this section.

Question 73

PERSONNEL

Q: What must a licensed wholesale distributor located outside of the state do to wholesale distribute prescription drugs in this state?

Answer 73

A:
Each licensed wholesale distributor located outside of this state that wholesale distributes prescription drugs in this state shall designate a registered agent in this state for service of process. If the distributor does not designate a registered agent, the secretary of state of this state shall be deemed the true and lawful attorney upon whom all legal processes can be served. A copy of such service or process shall be mailed to the wholesale distributor by the board by certified mail, return receipt requested, at the address designated on its application for licensure in this state. If the wholesale distributor is not licensed in this state, service on the secretary of state alone shall be sufficient service.

Question 74

Q: What training programs must a designated representative complete?

Answer 74

A:
A designated representative must complete training programs that address applicable state and federal laws and are provided by qualified in-house specialists, outside counsel, or counseling specialists with capabilities to help ensure compliance.

Question 75

Q: What are the facility requirements for storing, warehousing, handling, or displaying prescription drugs?

Answer 75

A:
All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

1. Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations.
2. Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security.
3. Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, counterfeit or suspected of being counterfeit or adulterated, suspect or illegitimate, otherwise unfit for distribution or wholesale distribution, or that are in immediate or sealed secondary containers that have been opened.
4. Be maintained in a clean and orderly condition.
5. Be free from infestation by insects, rodents, birds, or vermin of any kind.
6. Be a commercial location and not a personal dwelling or residence.
7. Provide for the secure and confidential storage of information with restricted access and policies and procedures to protect the integrity and confidentiality of the information.
8. Provide and maintain appropriate inventory controls to detect and document any theft, counterfeiting, or diversion of prescription drugs or devices.
9. Controlled substances must be isolated from non-controlled substance drugs and stored in a secure area in accordance with DEA security requirements and standards.

Question 76

Q: What security and anti-counterfeiting measures are required for facilities used for wholesale drug distribution?

Answer 76

A:
All facilities used for wholesale drug distribution shall be secure from unauthorized entry:

1. Access from outside the premises shall be kept to a minimum and be well-controlled.
2. The outside perimeter of the premises shall be well-lighted.
3. Entry into areas where prescription drugs are held shall be limited to authorized personnel.
4. All facilities shall be equipped with an alarm system to detect entry after hours.
5. All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion, including protection against theft or diversion facilitated by tampering with computers or electronic records.
6. All facilities shall be equipped with a security system that will provide suitable protection against, detect, and document any instances of theft, diversion, or counterfeiting.

Question 77

Q: What are the storage requirements for prescription drugs?

Answer 77

A:
All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements in the labeling of such drugs or in compliance with standards in the current edition of an official compendium, such as the USP-NF.

1. If no storage requirements are established for a prescription drug, the drug may be held at “controlled” room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.
2. Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be utilized to document proper storage of prescription drugs.

Question 78

Q: What procedures must be followed for the examination of materials upon receipt and shipment?

Answer 78

A:
Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or drugs otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination, adulteration, misbranding, counterfeiting, contraband, or other damage.

Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.

Question 79

Q: What is required for reporting theft or loss of prescription drugs?

Answer 79

A:
A wholesale distributor shall have and follow a diversion detection and prevention plan that includes prescription drugs. Wholesale distributors shall report any theft, suspected theft, diversion, or other significant loss of any prescription drug or device to the board and, where applicable, to the DEA.

Question 80

Q: What are the product tracing, product identifier, and verification requirements for wholesale distributors?

Answer 80

A:
Wholesale distributors licensed by the board shall comply with the requirements for tracing products through the distribution system as defined in Sections 353 and 360eee, et seq., of the DSCSA, 21 U.S.C. 301, et seq., and successor FDA regulations. This includes requirements related to transaction history, transaction information, or transaction statement of a product as it changes ownership in the supply chain, and verification, investigation, disposition, notification, or recordkeeping relating to such systems, including paper or electronic pedigree systems or for tracking and tracing drugs throughout the distribution system.

Question 81

Q: What written policies and procedures must wholesale drug distributors establish and maintain?

Answer 81

A:
Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory, and distribution of prescription drugs. These policies and procedures shall include:

1. A procedure whereby the oldest approved stock of a prescription drug product is distributed first; deviation from this requirement may be permitted temporarily and appropriately.
2. A procedure for handling recalls and withdrawals of prescription drugs, including those initiated by the FDA, other government agencies, voluntary actions by manufacturers, or actions to promote public health and safety.
3. A procedure to ensure preparation for, protection against, and handling of crises affecting security or operations due to strike, fire, flood, or other emergencies.
4. A procedure to ensure outdated prescription drugs are segregated from other drugs and either returned to the manufacturer or destroyed, with documentation maintained for three years after disposition.
5. A procedure for the destruction of outdated prescription drugs in accordance with state and federal laws, including all necessary documentation, maintained for a minimum of three years.
6. A procedure for disposing and destroying containers, labels, and packaging to ensure they cannot be used in counterfeiting activities, with documentation maintained for a minimum of three years.
7. A procedure for identifying, investigating, and reporting significant inventory discrepancies involving counterfeit, contraband, or suspect drugs, with reporting to the board and appropriate federal or state agency within 10 business days.
8. A procedure for reporting criminal or suspected criminal activities involving prescription drugs to the board, FDA, and if applicable, DEA, within three business days.
9. A procedure ensuring all common carriers conduct a criminal background check and drug screen of employees handling prescription drugs.
10. A procedure for conducting periodic assessments of the security provisions of common carriers, specifying vehicle security, avoiding unapproved stops, and ensuring the vehicle is not left running in the absence of the driver.
11. A procedure or set procedures for addressing high-risk deliveries, including making deliveries only to highly-visible, well-lit locations during prescribed times and using varied routing.

Question 82

Q: What are the requirements for maintaining responsible persons in wholesale drug distribution?

Answer 82

A:
Wholesale drug distributors shall establish and maintain lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

Question 83

Q: How must wholesale drug distributors comply with federal, state, and local laws?

Answer 83

A:
Wholesale drug distributors shall operate in compliance with applicable federal, state, and local laws and regulations:

1. Permit board-authorized personnel and authorized federal, state, and local law enforcement officials to enter and inspect premises and delivery vehicles, audit records and written operating procedures, and confiscate prescription drugs and records as authorized by law.
2. Wholesale drug distributors that deal in controlled substances shall register with the board and with the DEA and comply with all applicable state, local, and DEA regulations.
3. Distribute only to authorized trading partners and deliver product only to the licensed address of the authorized trading partner.
4. Distribute controlled substances only to persons in this state who are registered by the board and the DEA to possess controlled substances.

Question 84

Q: What are the requirements for salvaging and reprocessing of prescription drugs?

Answer 84

A:
Wholesale drug distributors shall be subject to applicable federal, state, or local laws or regulations relating to prescription drug product salvaging or reprocessing, including Subsection I of 16.19.8.13 NMAC (Written Policies and Procedures).

Question 85

Q: What is required for a third-party logistics provider to operate in this state?

Answer 85

A:
Every third-party logistics provider, regardless of location, who engages in providing third-party logistics into, out of, or within this state must be licensed by the board in accordance with the laws and regulations of this state before engaging as a third-party logistics provider of prescription drugs.

Question 86

Q: Can third-party logistics providers operate from a place of residence?

Answer 86

A:
No, third-party logistics providers cannot operate from a place of residence.

Question 87

Q: What is required if third-party logistics operations are conducted at multiple locations?

Answer 87

A:
If third-party logistics operations are conducted at more than one location, each such location must be licensed by the board.

Question 88

Q: What is a specific requirement for third-party logistics providers located in New Mexico?

Answer 88

A:
A third-party logistics provider located in New Mexico must be located apart and separate from any pharmacy.

Question 89

Q: What information is required for licensing a third-party logistics provider?

Answer 89

A:
Every third-party logistics provider, whether located in New Mexico or in another state and not licensed as a third-party logistics provider by the FDA, must submit an application and provide the following information to the board:

1. Applicant’s Information:
   
   • Full name and all trade or business names (including “doing business as” and “formerly known as” names) that cannot be identical to names used by other unrelated licensed entities.
   • Full business address and telephone number.
2. Type of Ownership:
   
   • Ownership type (e.g., individual, partnership, limited liability company, or corporation).
3. Owner(s) Information:
   
   • If a person: Name, address, social security number or FEIN, and date of birth.
   • If not a person: Names, addresses, social security numbers, and dates of birth of each partner, LLC member, corporate officer, and corporate director, as well as the federal employer identification number.
   • If a corporation: State of incorporation.
   • For publicly traded corporations: Information in Subparagraph (b) is not required for corporate officers and directors.
   • Any other relevant information required by the board.
4. Designated Representative(s):
   
   • Names, business addresses, and telephone numbers of persons serving as designated representatives for each facility.
5. Criminal Background Checks:
   
   • Evidence of criminal background checks and fingerprinting for the applicant and designated representatives, including all states of residence since adulthood.
6. Licenses and Permits:
   
   • List of all state and federal licenses, registrations, or permits, including numbers, issued to the third-party logistics provider.
7. Disciplinary Actions:
   
   • List of all disciplinary actions or sanctions by state and federal agencies against the third-party logistics provider or its principals, owners, directors, or officers.
8. Facility Descriptions:
   
   • Description of each facility and warehouse in New Mexico, including square footage, security and alarm systems, lease or ownership terms, address, and temperature and humidity controls.
9. Drug Import and Export Activities:
   
   • Description of the third-party logistics provider’s drug import and export activities.
10. Written Policies and Procedures:
    
    • A copy of the written policies and procedures required in Subsection D of 16.19.8.18 NMAC.
11. Inspection Reports:
    
    • For facilities located outside New Mexico, a copy of a current satisfactory inspection report issued by the FDA, state licensing authority, or an approved third-party inspection service.
12. Confidentiality:
    
    • Information collected pursuant to Paragraphs (5), (8), and (10) shall be made available only to the board and to state and federal law enforcement officials, with provisions for confidentiality.
13. Renewal Applications:
    
    • Must be on a form furnished by the board.

Question 90

Q: What fee is required for third-party logistics provider licensure?

Answer 90

A:
Every third-party logistics provider required to be licensed by the board must submit a reasonable fee, as determined by the board.

Question 91

Q: What is required for facilities located in New Mexico?

Answer 91

A:
Each facility located in New Mexico that engages in third-party logistics must undergo an inspection by the board before initial licensure.

Question 92

Q: What are the display requirements for third-party logistics providers?

Answer 92

A:
All third-party logistics providers must publicly display or have readily available all licenses and the most recent inspection report administered by the board.

Question 93

Q: How should changes in the provided information be handled?

Answer 93

A:
Changes in any information provided in Subsection A of 16.19.8.15 NMAC must be submitted to the board within 30 days of such change unless otherwise noted.

Question 94

Q: How is trade secret or proprietary information handled?

Answer 94

A:
Information considered trade secret or proprietary under state privacy and trade secret statutes shall be maintained as private or trade secret/proprietary information by the board and be exempt from public disclosure.

Question 95

Q: Under what condition will the board not license a third-party logistics provider?

Answer 95

A: The board will not license a third-party logistics provider when the FDA has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and published notice thereof.

Question 96

Q: What factors does the board consider when reviewing the qualifications of persons engaging in third-party logistics of prescription drugs within the state?

Answer 96

A: The board shall consider, at a minimum, the following factors:

1. Any conviction of the applicant under any federal, state, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances.
2. Any felony convictions of the applicant under federal, state, or local law.
3. The applicant’s past experience in the manufacture or distribution of prescription drugs, including controlled substances.
4. The furnishing by the applicant of false or fraudulent material in any application.
5. Suspension, revocation, or any other sanction by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances.
6. Compliance with regulatory and licensing requirements under previously granted licenses, if any.
7. Compliance with requirements to maintain or make available to the board or to federal, state, or local law enforcement officials those records required under this part.
8. Any findings by the board that the applicant has violated or been disciplined, or the subject of administrative action, by a regulatory or licensing agency in any state for violating any federal, state, or local laws relating to drug or device distribution.
9. Any other factors or qualifications the board considers relevant to and consistent with the public health and safety.

Question 97

Q: What must the board consider regarding background checks for applicants?

Answer 97

A: The board shall consider the results of a criminal and financial background check and fingerprinting of the applicant and designated representative responsible for facility operations, to determine if an applicant or others associated with the ownership, management, or operations of the third-party logistics provider have committed criminal acts that would constitute grounds for denial of licensure.

Question 98

Q: What is required of the applicant in terms of disclosure and attestation?

Answer 98

A: The applicant shall provide and attest to a statement providing a complete disclosure of any past criminal convictions and violations of the state and federal laws regarding drugs or devices or an affirmation and attestation that the applicant has not been involved in, or convicted of, any criminal or prohibited acts.

Question 99

Q: Can the board deny a license even if the applicant meets all other requirements?

Answer 99

A: Yes, the board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest. Public interest considerations shall be based upon factors and qualifications that are directly related to the protection of the public health and safety.

Question 100

Q: What is required of each person employed in any prescription drug third-party logistics activity?

Answer 100

A: Each person employed in any prescription drug third-party logistics activity must have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions in such a manner as to provide assurance that the drug product quality, safety, and security will at all times be maintained by law.

Question 101

Q: What must each third-party logistics provider do when issuing an initial or renewal license?

Answer 101

A: Each third-party logistics provider, whether in state or out of state, must designate in writing on a form required by the board a person for each facility to serve as the designated representative of the third-party logistics provider.

Question 102

Q: What are the requirements for a person to be certified as a designated representative?

Answer 102

A: To be certified as a designated representative, a person must:

1. Submit an application on a form furnished by the board and provide information that includes:
   
   • Evidence of criminal background check and fingerprinting, the background check shall be sufficient to include all states of residence since the person has been an adult.
   • Date of birth and social security number.
   • Occupations, positions of employment, and offices held during the past seven years.
   • Whether the person during the past seven years has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any state or federal laws regulating the possession, control, or wholesale distribution of prescription drugs or devices, together with details of such events.
   • Whether the person has been during the past seven years the subject of any proceeding for the revocation of any professional or business license or any criminal violation, and if so, the nature of the proceeding and the disposition of the proceeding.
   • Description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund during the past seven years, which manufactured, administered, prescribed, distributed, or stored prescription drugs and devices in which such businesses were named as a party in a lawsuit.
   • Description of any criminal offense (not including minor traffic violations) of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere; if the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of the criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the board a copy of the final written order of disposition.
   • Any other information the board deems relevant.
2. May serve as the designated representative for only one third-party logistics provider at any one time, except where more than one licensed third-party logistics provider is co-located in the same facility and such third-party logistics providers are members of an affiliated group as defined in Section 1504 of the Internal Revenue Code.
3. Be actively involved in and aware of the actual daily operations and inventory control of the third-party logistics provider by:
   
   • Being employed full-time in a managerial position by the third-party logistics provider.
   • Being physically present at the third-party logistics provider during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence.
   • Being aware of and knowledgeable about all policies and procedures pertaining to the operations of the third-party logistics provider.

Question 103

Q: How should criminal and financial information collected from applicants be handled?

Answer 103

A: The criminal and financial information collected shall be made available only to the board, a third-party recognized by the board, and to state and federal law enforcement officials. The board and a third-party recognized by the board shall make provisions for protecting the confidentiality of the information collected.

Question 104

Q: Can a third-party logistics provider have as an owner or designated representative someone convicted of specific offenses?

Answer 104

A: No, a third-party logistics provider shall not have as an owner or designated representative anyone convicted of any felony violation of Subsection (i) or (k) of Section 301 or any violation of Section 1365 of title 18, United States Code relating to product tampering.

Question 105

Q: What must a licensed third-party logistics provider located outside of the state do regarding service of process?

Answer 105

A: Each licensed third-party logistics provider located outside of this state that distributes prescription drugs into this state shall designate a registered agent in this state for service of process. If the provider does not designate a registered agent, it shall be deemed to have designated the secretary of state of this state as its true and lawful attorney. A copy of any such service of process shall be mailed to the third-party logistics provider by the board by certified mail, return receipt requested, postage prepaid, at the address designated on its application for licensure in this state. If the provider is not licensed in this state, service on the secretary of state only shall be sufficient service.

Question 106

Q: What training programs must a designated representative complete?

Answer 106

A: A designated representative must complete training programs that address applicable state and federal laws and are provided by qualified in-house specialists, outside counsel, or counseling specialists with capabilities to help ensure compliance.

Question 107

Q: What are the reporting requirements for facilities of a third-party logistics provider? Q: What are the reporting requirements for facilities of a third-party logistics provider?

Answer 107

A: Each facility of a third-party logistics provider shall comply with the FDA annual reporting requirements.

Question 108

Q: What are the minimum standards for storage practices and facilities for third-party logistics providers?

Answer 108

A: All third-party logistics provider facilities at which prescription drugs are stored, warehoused, handled, held, or displayed shall:

1. Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations.
2. Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security.
3. Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, counterfeit or suspected of being counterfeit or adulterated, suspect or illegitimate, otherwise unfit for distribution, or in immediate or sealed, secondary containers that have been opened.
4. Be maintained in a clean and orderly condition.
5. Be free from infestation by insects, rodents, birds, or vermin of any kind.
6. Be a commercial location and not a personal dwelling or residence.
7. Provide for the secure and confidential storage of information with restricted access and policies and procedures to protect the integrity and confidentiality of the information.
8. Provide and maintain appropriate inventory controls in order to detect and document any theft, counterfeiting, or diversion of prescription drugs or devices.
9. Control substances must be isolated from non-controlled substance drugs and stored in a secure area in accordance with DEA security requirements and standards.

Question 109

Q: What are the security and anti-counterfeiting requirements for facilities used for third-party logistics drug storage or distribution?

Answer 109

A: All facilities used for third-party logistics drug storage or distribution shall:

1. Be secure from unauthorized entry.
2. Keep access from outside the premises to a minimum and well-controlled.
3. Have the outside perimeter of the premises well-lighted.
4. Limit entry into areas where prescription drugs are held to authorized personnel.
5. Be equipped with an alarm system to detect entry after hours.
6. Be equipped with a security system that provides suitable protection against theft and diversion, including protection against tampering with computers or electronic records when appropriate.
7. Be equipped with a security system that detects and documents any instances of theft, diversion, or counterfeiting.

Question 110

Q: What written policies and procedures must each third-party logistics provider have?

Answer 110

A: Each third-party logistics provider must have written policies and procedures to:

1. Address receipt, security, storage, inventory, shipment, and distribution of a product.
2. Identify, record, and report confirmed significant losses or thefts in the United States.
3. Correct errors and inaccuracies in inventories.
4. Provide support for manufacturer recalls.
5. Prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the facility, such as a strike, fire, or flood.
6. Ensure that any expired product is segregated from other products and returned to the manufacturer, repackager, or their agent, or destroyed.
7. Maintain the capability to trace the receipt and outbound distribution of a product, and supplies and records of inventory.
8. Quarantine or destroy a suspect product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency.

Question 111

Q: What are the storage requirements for prescription drugs?

Answer 111

A: All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or in compliance with standards in the current edition of an official compendium, such as the USP-NF.

1. If no storage requirements are established for a prescription drug, the drug may be held at “controlled” room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.
2. Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be utilized to document proper storage of prescription drugs.

Question 112

Q: What are the inspection requirements for third-party logistics provider facilities located in New Mexico?

Answer 112

A: Each third-party logistics provider facility located in New Mexico shall be inspected as a condition of initial licensure and periodically inspected to ensure compliance with board regulations.

Question 113

Q: What must a third-party logistics provider provide to the board upon request?

Answer 113

A: A third-party logistics provider must provide the board, upon a request by the board, a list of all product manufacturers, wholesale distributors, and dispensers for whom the third-party logistics provider provides services at such facility.

Question 114

Q: What are the compliance requirements for third-party logistics providers regarding federal, state, and local laws?

Answer 114

A: Third-party logistics providers shall operate in compliance with applicable federal, state, and local laws and regulations.

1. Third-party logistics providers shall permit board authorized personnel and authorized federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, audit their records and written operating procedures at reasonable times and in a reasonable manner, to the extent authorized by law, and to confiscate prescription drugs and records to the extent authorized by law or rules. Such officials shall be required to show appropriate identification prior to being permitted access to third-party logistics providers’ premises and delivery vehicles.
2. Third-party logistics providers that deal in controlled substances shall register with the board as required, and with the DEA, and shall comply with all applicable state, local, and DEA regulations.
3. A third-party logistics provider may distribute only to authorized trading partners. Product shall be shipped only to the address listed on the licensee’s license.
4. Controlled substances may only be distributed or delivered to persons in this state who are registered by the board and the DEA to possess controlled substances.

Question 115

Q: What are the licensing requirements for a repackager distributing prescription drugs into, out of, or within the state?

Answer 115

A: Every repackager must be licensed by the board in accordance with state laws and regulations before engaging in repackaging or distribution of prescription drugs. Additionally, the repackager must have valid registration with the FDA as a drug establishment under section 510 of the Federal Act. Repackagers cannot operate from a place of residence. If repackaging operations are conducted at more than one location, each location must be licensed by the board. The repackaging facility must be located apart and separate from any pharmacy licensed by the board.

Question 116

Q: What is required for a repackager to obtain licensure from the board?

Answer 116

A: A repackager must submit an application to the board with the following:
1. Applicant’s full name; all trade or business names used (including “doing business as” and “formerly known as”); full business address and telephone number.
2. Type of ownership (e.g., individual, partnership, LLC, or corporation).
3. Names and details of the owners, including social security numbers or FEIN, and date of birth. For corporations, the state of incorporation is required; for publicly traded corporations, this information is not required for officers and directors.
4. Names, business addresses, and telephone numbers of designated representatives for each facility.
5. Proof of valid FDA registration as a drug establishment.
6. List of all state and federal licenses, registrations, or permits.
7. List of all disciplinary actions or sanctions by state and federal agencies.
8. Description of each facility and warehouse in New Mexico, including square footage, security system descriptions, lease or ownership terms, address, and temperature/humidity controls.
9. Description of drug import and export activities.
10. Copy of written policies and procedures as required.
11. For out-of-state facilities, a copy of a satisfactory inspection report from FDA, state authority, or an approved third-party inspection service.
12. Information in items 8 and 10 is confidential and protected.
13. Renewal applications must be on a board-provided form.

Question 117

Q: What are the additional requirements for repackager licensure?

Answer 117

A:
1. Submit a reasonable fee determined by the board.
2. Facilities in New Mexico must undergo an inspection by the board prior to initial licensure.
3. Display or have available all licenses and the most recent board inspection report.
4. Notify the board of any changes in the information within 30 days.
5. Information considered trade secrets or proprietary must be kept private by the board.
6. The board may recognize a third-party for inspections.
7. Repackagers licensed in another state may be licensed by reciprocity if documentation of a satisfactory inspection is provided and the requirements are deemed substantially equivalent.

Question 118

Q: What are the minimum qualifications for repackager licensure?

Answer 118

A: The board will prohibit licensure if the person:
1. Has been convicted of certain felonies related to manufacturing or distribution or product tampering.
2. Has engaged in a pattern of violations that threaten serious health consequences.

The board will consider factors including:
1. Convictions related to drug manufacture, distribution, or controlled substances.
2. Felony convictions under any law.
3. Past experience in drug manufacture or distribution.
4. Submission of false or fraudulent information.
5. Previous sanctions or license issues.
6. Compliance with previous regulatory requirements.
7. Maintenance of required records.
8. Findings of violations by regulatory agencies.
9. Any other relevant qualifications for public health and safety.

Question 119

Q: What personnel requirements must a repackager meet?

Answer 119

A:
1. Each person employed in repackaging or distribution must have sufficient education, training, and experience to ensure drug quality, safety, and security.
2. Repackagers must designate a representative for each facility in writing.
3. Out-of-state repackagers must designate a registered agent in the state for service of process. If not designated, the secretary of state is deemed the attorney for service of process.
4. Designated representatives must complete training programs on state and federal laws provided by qualified specialists.

Question 120

Q: What are the minimum standards for repackagers?

Answer 120

A:
1. Compliance: Repackagers must comply with federal, state, and local laws, including the Federal Food, Drug, and Cosmetic Act and Good Manufacturing Practices.
2. Inspection: Repackagers must allow inspections by authorized personnel and provide records for a period of three years.
3. Controlled Substances: Repackagers dealing with controlled substances must register with the board and DEA and comply with regulations.
4. Distribution: Products may only be distributed to authorized trading partners at the licensed address.
5. Theft or Loss: Repackagers must have a diversion detection plan and report thefts or losses to the board and DEA.
6. Policies and Procedures: Repackagers must maintain written procedures for drug distribution, recalls, outdated drug handling, and destruction of products and packaging.
7. Responsible Persons: Lists of officers, directors, managers, and their duties must be maintained.
8. Salvaging and Reprocessing: Repackagers must follow applicable laws regarding salvaging or reprocessing drugs.

Question 121

Q: What are the requirements for manufacturers regarding product tracing and compliance?

Answer 121

A:
1. Product Tracing: Manufacturers must comply with DSCSA requirements for product tracing, including transaction history, information, and statement, as well as verification, investigation, and recordkeeping.
2. Authorized Trading Partners: Manufacturers can only trade with authorized partners.
3. Compliance: Manufacturers must operate in compliance with federal, state, and local laws. Those dealing in controlled substances must register with the board and DEA and comply with relevant regulations.