5.01.31	Within every prescription drug outlet as defined in CRS 12-22-102(30.2), there shall be one area designated as the principal compounding/dispensing area. In addition to the principal compounding/dispensing area there may be one or more satellite compounding/dispensing areas (“satellites”) which are located in the same building as the principal compounding/dispensing area.  The principal compounding/dispensing area and any satellite shall comply with the following conditions:   
	f.	There shall be a professional reference library available in the prescription drug outlet or electronically.   If an electronic library is provided, workstations must be provided in a compounding/dispensing area and must be readily available for use by staff, interns and Board personnel.   This library shall contain current copies of the following references which shall be maintained and readily available for use by staff and inspection by the Board:
	1)	All parts of CRS Title 12, Article 22; the Pharmaceuticals and Pharmacists Act.
	2)	CRS Title 18, Article 18, the Uniform Controlled Substances Act of 1992;
	3)	The current rules and regulations of the Board of Pharmacy;
	4)	The current edition of 21 Code of Federal Regulations (“CFR”) Part 1300 to End containing Drug Enforcement Administration rules relating to controlled substances;
	5)	Any other references that the pharmacist manager of the prescription drug outlet may deem necessary.

15.00.00	WHOLESALERS.
15.01.11 Minimum required information for registration.   

(a)	The following minimum information shall be required from each wholesaler as part of the registration.
(1)	The name, full business address, and telephone number of the applicant;
(2)	All trade or business names used by the applicant;
(3)	Addresses, telephone numbers, and the names of contact persons for all facilities used by the applicant for the storage, handling and distribution or prescription drugs;
(4)	The type of ownership or operation (i.e., partnership, corporation, sole proprietorship, limited liability company, or government entity); and
(5)	The name(s) of the owner and operator of the applicant including:
(a)	If a person, the name of the person;
(b)	If a partnership, the name of each partner, the name of the partnership, and the federal employer identification number (FEIN);
(c)	If a corporation, the name and title of each corporate officer and director, the name of the parent company,  the corporate names, the federal employer identification number of the business, and the name of the state of incorporation; and
(d)	Name of the business entity.  If a sole proprietorship, the full name of the sole proprietor, and the name and federal employer identification number of the business entity.
(e)	If a government entity, identify the name of director and the name of the governmental agency he/she represents.
(6)	A list of the licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.
(7)	A list of the licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.
(8)	The name of the applicant’s designated representative, who must meet the following requirements:
(a)	Be at least twenty-one years of age;
(b)	Have at least three years of full-time employment history with a pharmacy or a wholesaler in a capacity related to the dispensing and distribution of and the recordkeeping related to prescription drugs;
			(c)	Be employed by the applicant in a full-time managerial position;
(d)	Be actively involved in and aware of the actual daily operation of the wholesaler;
(e)	Be physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized, including, but not limited to, sick leave and vacation leave;
(f)	Serve in the capacity of a designated representative for only one applicant or wholesaler at a time, except where more than one licensed wholesaler is co-located in the same facility and the wholesalers are members of an affiliated group as defined by section 1504 of the federal “Internal Revenue code of 1986.”
(g)	Not have any convictions under federal, state, or local law relating to wholesale or retail prescription drug distribution or controlled substances;
(h)	Not have an felony convictions pursuant to federal, state, or local law; and
(i)	Undergo a background check as required by CRS 12-22-803.

(9)	Wholesalers that distribute animal drugs exclusively are exempt from the requirements of 10.01.11(a)(8).
(b)	Changes in any information in section 15.01.11 shall be submitted to the Colorado Board of Pharmacy within fourteen calendar days thereof.
(c)	Any registered wholesale drug distributor that is accredited by a board approved accreditation body shall inform the board, in writing, within 72 hours if its accreditation is:
(1)	Expired;
(2)	Suspended;
(3)	Revoked; or
(4)	Withdrawn.
15.01.12  Minimum Qualifications.   
d.	The Board may suspend, revoke, refuse to renew, or otherwise discipline the registration of any wholesale drug distributor if its Board approved accreditation has been suspended, revoked, or withdrawn.  
15.09.11	Records in general. All wholesalers registered by the Board shall maintain such records and inventories of prescription drugs as may be required by these regulations or any other state or federal law or regulation pertaining to such drugs. Such records shall be maintained on a current basis and shall be complete and accurate for all drugs which the outlet manufactures, receives, distributes or otherwise disposes of in any other manner. Records, including pedigrees, and inventories of controlled substances shall be deemed to be “complete”  only if each individual record and inventory contains all required information regarding each specific transaction, and if the set of records and inventories contains all information and documents required to be kept by state and federal laws, rules, and regulations. A record or inventory shall be deemed to be “accurate” only if it is a complete, true and factual statement regarding or reflecting each specific transaction. A set of records or inventories shall be deemed to be “accurate” only if they are complete, and when considered as a whole, they demonstrate that the controlled substances and/or the records and inventories pertaining thereto have been handled in compliance with all applicable laws or regulations and that all such controlled substances are properly accounted for.
a.	All such records, including pedigrees, shall be retained for a period of at least three years after the date of any transaction relating to such record or inventory by any process providing an exact duplicate of the original order in a reproducible quality acceptable to the Board. Records shall be retained in a format that cannot be altered. 
b.	A wholesaler in the possession of a pedigree (a document or electronic file containing information that records each distribution of any given prescription drug that leaves the normal distribution channel) for a prescription drug shall verify that each transaction on the pedigree has occurred prior to distributing the prescription drug.
c.	The pedigree shall include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer through the acquisition and sale by a wholesaler until final sale to a pharmacy or other person dispensing or administering the prescription drug.  When a wholesaler distributes a product to another wholesaler, both the distributing and receiving wholesaler shall maintain a copy of the pedigree.  The pedigree shall include at least the following:
(1)	The name, address, telephone number, and if available, the e-mail address of each owner of the prescription drug and each wholesaler of the drug;
(2)	The name and address of each location from which the prescription drug was shipped, if different from that of the owner;
(3)	The transaction dates;
(4)	Certification that each recipient has authenticated the pedigree;
(5)	The name of the prescription drug;
(6)	The dosage form and strength of the prescription drug;
(7)	The size and number of containers;
(8)	The lot number of the prescription drug; and
(9)	The name of the manufacturer of the finished dosage form.

15.09.14  Receipts.
a.	In-state prescription drug wholesalers shall only receive prescription drugs and controlled substances from an entity that is registered by the Colorado State Board of Pharmacy. This section shall not apply to intracompany or reverse distribution transactions. 

22.00.00	INITIAL DECISIONS
22.00.10	Written form, service, and filing requirements.
a.	All designations of record, requests, exceptions, and responsive pleadings (“pleadings”) must be in written form, mailed with a certificate of mailing to the board and the opposing party.  
b.	All pleadings must be filed with the board by 5:00 pm on the date the filing is due.  These rules do not provide for any additional time service by mail.
c.	Any pleadings must be served on the opposing party by mail or by hand delivery on the date on which the pleading is filed with the Board.
d.	All pleadings must be filed with the board and not with the Office of Administrative Courts.  Any pleadings filed with the Office of Administrative courts will not be considered. 
22.00.20	Authority to review.
a.	The board hereby preserves the Board’s option to initiate a review of an initial decision on its own motion pursuant to  § 24-4-105(14)(a)(ii) and (b)(iii), C.R.S. beyond thirty days after service of the initial decision upon the parties without requiring a vote for each case.
b.	This option to review shall apply regardless of whether a party files exceptions to the initial decision.
22.00.30	Designation of record and transcripts.
a.	Any party seeking to reverse or modify the initial decision of the administrative law judge shall file with the Board a designation of the relevant parts of the record for review (“designation of record”).  Designations of record must be filed with the Board within twenty days of the date on which the Board mails the initial decision to the parties’ address of record with the Board.
b.	Even if no party files a designation of record, the record shall include the following:
	(1)	All pleadings;
(2)	All applications presented or considered during the hearing;
(3)	All documentary or other exhibits admitted into evidence;
(4)	All documentary or other exhibits presented or considered during the hearing;
(5)	All matters offically noticed;
(6)	Any findings of fact and conclusions of law proposed by any party; and
(7)	Any written brief filed.
c.	Transcripts:  Transcripts will not be deemed as part of a designation of record unless specifically identified and ordered.  Should a party wish to designate a transcript or portion thereof, the following procedures will apply:
(1)	The designation of record must identify with specificity the transcript or portion thereof to be transcribed.  For example, a party may designate the entire transcript, or may identify witness(es) whose testimony is to be transcribed, the legal ruling or argument to be transcribed, or other information necessary to identify a portion of the transcript.
(2)	Any party who includes a transcript or a portion thereof as part of the designation of record must order the transcript or relevant portions by the date on which the designation of record must be filed (within twenty days of date on which the Board mails the initial decision to the parties).
(3)	When ordering the transcript, the party shall request the court reporter to prepare the transcript within thirty days.  The party shall timely pay the necessary fees to obtain and file with the board an original transcription and one copy within thirty days.
(4)	The ordering party shall direct the court reporter to complete and file with the board the transcript and one copy of the transcript within thirty days.
(5)	If a party designates a portion of the transcript, the opposing party may also file a supplemental designation of record, in which the opposing party may designate additional portions of the transcript.  This supplemental designation of record must be filed with the board within ten days after the date on which the original designation of record was due.
(6)	An opposing party filing a supplemental designation of record must order and pay for such transcripts or portions thereof within the deadlines set forth above.  An opposing party must also cause the court reporter to complete and file with the board the transcript and one copy of the transcript within thirty days.
(7)	Transcripts that are ordered by either party and not filed with the Board in a timely manner by the reporter due to non-payment, insufficient payment or failure to direct as set forth above will not be considered by the Board.
22.00.40	Filing of exceptions and responsive pleadings
a.	Any party wishing to file exceptions shall adhere to the following timelines:
(1)	If no transcripts are ordered, exceptions are due within thirty days from the date on which the Board mails the initial decision to the parties.  Both parties’ exceptions are due on the same date.  
(2)	If transcripts are ordered by either party, the following procedure shall apply.  Upon receipt of transcripts identified in all designations of record, the Board shall mail notification to the parties stating that the transcripts have been received by the Board.  Exceptions are due within thirty days from the date on which such notification is mailed.  Both parties’ exceptions are due on the same date.  
b.	Either party may file a responsive pleading to the other party’s exceptions.  All responsive pleadings shall be filed within 12 days of the date on which the exceptions were due with the Board.  No other pleadings will be considered except for good cause shown.
c.	The Board may in its sole discretion grant an extension of time to file exceptions or responsive pleadings, or may delegate the discretion to grant such an extension of time to the board’s program director.
22.00.50	Request for oral argument
a.	All requests for oral argument must be in writing and filed by the deadline for responsive pleadings.  Requests filed after this time will not be considered.
b.	It is within the sole discretion of the Board to grant or deny a request for oral argument.  If oral argument is granted, both parties shall have the opportunity to participate.
c.	Each side shall be permitted five minutes for oral argument unless such time is extended by the Board or its program director.