DRUG ENFORCEMENT AGENCY (DEA) … safety testing laboratory perspective ... distributors, and...

DRUG ENFORCEMENT AGENCY (DEA) INSPECTIONS FROM A NON CLINICAL SAFETY TESTING LABORATORY PERSPECTIVEStacy Wilson

Senior Manager, Regulatory Compliance

Charles River Horsham

29 March 2017

EVERY STEP OF THE WAY

EVERY STEP OF THE WAY

DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE- CFR PART 1300-1321

2 EVERY STEP OF THE WAY

PART 1300 ‐ DEFINITIONS

PART 1301 ‐ REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

PART 1302 ‐ LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES

PART 1303 ‐ QUOTAS

PART 1304 ‐ RECORDS AND REPORTS OF REGISTRANTS

PART 1305 ‐ ORDER FORMS

PART 1306 ‐ PRESCRIPTIONS

PART 1307 ‐ MISCELLANEOUS

PART 1308 ‐ SCHEDULES OF CONTROLLED SUBSTANCES

PART 1309 ‐ REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALSPART 1310 ‐ RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINESPART 1311 ‐ REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONSPART 1312 ‐ IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCESPART 1313 ‐ IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALSPART 1314 ‐ RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTSPART 1315 ‐ IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINEPART 1316 ‐ ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURESPART 1317 ‐ DISPOSALPART 1321 ‐ DEA MAILING ADDRESSES

OBJECTIVES


•Highlight Key Regulations•Review the Differences

between Schedule I vs. II‐V Registrations

•Security Requirements and Reporting Loss

•Inspection Tips

UNITED STATES CODE OF FEDERAL REGULATIONS


United States Code ‐ Section 802 (6) The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.

Key Regulations Drug Enforcement Administration, Department of

Justice

SCHEDULED DRUGS


Schedule I: Drugs that have no accepted medical use in the United States andhave high abuse potential. Ex. heroin, lysergic acid diethylamide (LSD),marijuana (cannabis), peyote and Ecstasy.

Schedule II: Drugs that have a high abuse potential with severe psychological orphysical dependence liability Ex. Phenobarbital.

Schedule III: Drugs with less abuse potential than those in in schedule I and IIEx. Ketamine.

Schedule IV: Drugs with an abuse potential less than those in Schedule III.

Schedule V: Drugs with less abuse potential than those in Schedule IV; theyinclude preparations that contain limited quantities of narcotics and aregenerally used as antidiarrheals.

KEY REGULATIONS


(a) A separate registration is requiredfor each principal place of businessor professional practice at onegeneral physical location where controlledsubstances are manufactured,distributed, imported, exported, or dispensedby a person.

Controlled substances must be stored at the DEA registrants “registered address”.

You can remove from one building for use but any remaining must be returned.

1301.12 Separate registrations for separate locations.

KEY REGULATIONS§1304.11 Inventory requirements


(b) Initial inventory date. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with paragraph (e) of this section as applicable. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.

(c) Biennial inventory date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.

KEY REGULATIONS


DEA can watch on site disposal

Or

Reverse distributor‐ defined as "a person who receives controlled substances acquired from another DEA registrant for the purpose of returning unwanted, unusable, or outdated controlled substances to the manufacturer or the manufacturer's agent, or, where necessary, processing such substances or arranging for ...

1307.21 ‐Disposal

Schedule I vs. Schedule II-V

REGISTRATION – RESEARCHERS REGISTRATION II-VDEA Form 225


One researchers registration is needed for II‐V drugs.

Any person who does not currently possess a DEA registration to conduct business with controlled substances in the following categories can apply using form 225 include manufacturers, distributors, researchers, canine handlers, analytical laboratories, importers, and exporters.

Federal registration by DEA is based upon the applicant's compliance with applicable state and local laws.

SCHEDULE II-V Researchers Reregistration


1301.13 b) Any person who is registered may

apply to be reregistered not more than

60 days before the expiration date of

his/her registration, except that a bulk

manufacturer of Schedule I or II controlled

substances or an importer of

Schedule I or II controlled substances

may apply to be reregistered no more

than 120 days before the expiration

date of their registration.

What can go wrong?

Don’t mess up!!

Hint‐ Don’t let it lapse

If you do make a mistake you will need to send a letter retracting this submission.

SCHEDULE I


You must submit a Schedule I 225 form for each drug and provide all of the required documents. 21 CFR 1301.18

You cannot apply online for your initial application.

Application will result in an on site DEA inspection.

SCHEDULE I RESEARCHER CHECKLIST


Provide letter from dept. head/chair or supervisor granting permission to conduct researchProvide brief synopsis of research (2 paragraphs)Proposed use of controlled substancesWhere will research take placeHours of OperationBiography of researcher (Name, DOB, SSN, Address, Telephone Number)

• Have you ever been registered as a researcher anywhere else? If yes, where and DEA#

Approximate amount of the controlled substance to be used annually• Include the name, strength, and the schedule



Access/Handlers of the controlled substances• Name, Title, DOB, SSN, Home Address, and Telephone Number

Power of Attorney – i.e. who will sign DEA 222 forms• Name, Title, DOB, SSN, Home Address, Telephone Number‐highlight regulations

Supplier(s) for the controlled substances• Name, DEA registration #, Business Address, Telephone Number



Initial Inventory

Biennial Inventory – Must include date, BOB or COB, drug name, drug strength, dosage form, quantity, and initial/signature of who took the inventory.

Receiving Records – Must contain the suppliers name, address and DEA number, and your name, address, and DEA number. Notate the quantity received, date received, and signature of whomever received the controls.



Dispensing Records – Must include drug name, drug strength, quantity dispensed/administered, date, and initials/signature of individual dispensing the drugs.

Theft/Loss Records – Significant theft or loss must be reported to DEA within 24 hours and followed up with a DEA form 106.

Drug Destruction Records – Expired or unwanted drugs must be handled by a DEA approved reverse distributor and a DEA Form 41 must be completed.*All Records Are Required To Be Maintained for 2 Years, Must Be Readily Retrievable, Complete and Accurate At All Times

Person(s) responsible for recordkeeping• Name, Title, DOB, SSN, Home Address, Telephone Number



How/where the controlled substances will be stored• Provide dimensions of the safe, steel cabinet, etc.• Who is responsible? – Name, Title, DOB, SSN, Home Address, Telephone Number

• Describe security of building – cameras, key fobs, security guards, campus/local police (how far from the office?), etc.

Describe drug destruction/return proceduresIndividuals with access to controlled substances



Hint‐ Keep records for each registration separate. Inspection are done on each registration.

Must provide signed final protocols.

If dose levels change or quantity to be received at the laboratory you must provide amendments to the agency.

SCHEDULE I 1301.18 Research Protocols


Don’t forget the DEA is communicating with

The FDA.

The applicant, when applying for

registration with the Administration,

shall indicate that such notice has

been submitted to the Food and Drug

Administration by submitting to the

Administration with his/her DEA Form

225 three copies of the following certificate:

Make sure to get copy of the sponsors DEA registration.

I hereby certify that on _______

(Date), pursuant to 21 U.S.C. 355(i) and 21

CFR 130.3, I, _____(Name and

Address of IND Sponsor) submitted a Notice

of Claimed Investigational Exemption for a

New Drug (IND) to the Food and Drug Administration

for:

________

(Name of Investigational Drug).

_______

(Date)

________

(Signature of Applicant).

FORM 222Schedule I and II


DEA Form 222 is required for purchase or transfer of Schedule I or II Controlled substances.

The blue copy (Purchaser’s copy) is kept on file in Purchasing with the other PO documentation. The joined brown and green copies (Supplier and DEA copies) must remain attached to each other and are forwarded to the supplier/vendor. If the brown and green copies are not joined when they reach the vendor, the order will not be honored.

Must fill out a 222 when transferring materials from the sponsor to ‐ shipping source and the contact info.

WHO CAN SIGN YOUR FORMS? 1305.05 Power of attorney


(a) A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant's behalf by executing a power of attorney for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with other order records.

(b) A registrant may revoke any power of attorney at any time by executing a notice of revocation.

(c) The power of attorney and notice of revocation must be similar to the following format:

Must be done exactly as the regulations indicate

OK GO?


Schedule I Registration can take up to 6‐8 weeks per protocol

Researchers II‐V – up to 4‐6 weeksRe registration is considered continuous

EXAMPLE REGISTRATION


Registration will indicate drug codes for which you are approved.

Security Requirementsand Reporting Loss

1301.71‐1301.93

SECURITY REQUIREMENTS


When the substance is not in use, it must be secured in a secure storage area.

The structure housing the controlled substances needs to be a substantially constructed cabinet or safe. If the safe is less than 750 lbs. it must be bolted to the floor.


SECURITY ACCESS

Only Authorized Research personnel are allowed to access controlled substances.



Controlled substances from Schedule I and II must be stored separately from those of Schedules III‐V. This can be comprised of a separate shelf or separate tray container within the safe.



The controlled substance handlers must maintain physical control of the controlled substance at all times.

All Safe(s), Storage Cabinet, Lockboxes and other secure storage areas will be approved by Management and must remain locked at all times with the exception of accessing controlled substance for use.

REPORTING LOSS


Federal regulations require that registrants notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substance within one business day of discovery of such loss or theft. The registrant shall also complete and submit to the Field Division Office in their area, DEA Form 106, "Report of Theft or Loss of Controlled Substances" regarding the theft or loss. (21 C.F.R. § 1301.76(b))

https://www.deadiversion.usdoj.gov/21cfr_reports/theft/

What is significant Loss?

Inspection Tips

DEA INSPECTION TEAM


Do you have a team?

Members

•Testing Facility Management • Human Resources•Quality Assurance •Legal •Operations •Archives

THE INSPECTION


Their visits can be announced or unannounced.

Keep an inventory and copies of all items sent to the agency or given to the agency during an inspection.

Know in advance who will be attending the opening meeting.

Communicate this to the inspector if possible.

THE INSPECTION


Keep a daily summary and report to management.

The DEA wants to hear from you!

Any citations will come in the form a letter . The letter requests that you “ please reply in writing to confirm receipt of this letter.”

REFERENCES


https://www.deadiversion.usdoj.gov

And a big shout out to Paul Lehmann!!

QUESTIONS


DRUG ENFORCEMENT AGENCY (DEA) … safety testing laboratory perspective ... distributors, and...

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