Pharmacy compounding ohio law

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Pharmacy Compounding and Ohio Law1

2

Objectives3

After completing this lesson, the pharmacist will be able to:4

1. Differentiate between five different types of compounding.5

2. Describe legal requirements for preparing non-sterile Compounded Drugs for Administration6

to Patients by Prescribers.7

3. Describe legal requirements for preparing sterile Compounded Drugs for Administration to8

Patients by Prescribers.9

4. Discuss limits of preparing batches of compounded drugs.10

5. Discuss using a prescriber’s location as a pick-up-station.11

12

Introduction13

The matter of regulating compounding pharmacies (or compounding by pharmacies) and14

manufacturers recently gained renewed attention when an operation in Massachusetts allegedly15

prepared and distributed corticosteroids that were administered to patients who subsequently16

developed serious fungal infections. Some of these patients died. According to reports from the17

Centers for Disease Control and Prevention, the New England Compounding Center and its sister18

company (Ameridose) were involved in the production and eventual recall of19

methylprednisolone acetate (MPA) and other products in September 2012. Centers for Disease20

Control and Prevention. CDC responds to multistate outbreak of fungal meningitis and other21

infections. http://m.cdc.gov/en/HealthSafetyTopics/DiseasesConditions/Meningitis/current-22

situation Accessed November 10, 2012. The methylprednisolone was particularly prone to23

sterility concerns because it was produced without antimicrobial preservatives, a common24

practice for medications injected into the fluid of the central nervous system.25

26

The law regulating compounding includes a series of state and federal regulatory schemes.27

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Compounding Defined1

Ohio state law defines compounding in ORC 4729.01(C) as one or more of five activities.2

“Compounding” means the preparation, mixing, assembling, packaging, and labeling of one or3

more drugs in any of the following circumstances:4

Pursuant to a prescription issued by a licensed health professional authorized to prescribe5

drugs; [ORC 4729.01(C) (1)]6

Pursuant to the modification of a prescription made in accordance with a consult7

agreement; [ORC 4729.01(C) (2)]8

As an incident to research, teaching activities, or chemical analysis; [ORC 4729.01(C)9

(3)]10

In anticipation of orders for drugs pursuant to prescriptions, based on routine, regularly11

observed dispensing patterns; [ORC 4729.01(C) (4)]12

Pursuant to a request made by a licensed health professional authorized to prescribe drugs13

for a drug that is to be used by the professional for the purpose of direct administration to14

patients in the course of the professional’s practice, if all of the following apply: [ORC15

4729.01(C) (5)]16

(a) At the time the request is made, the drug is not commercially available regardless of17

the reason that the drug is not available, including the absence of a manufacturer for the18

drug or the lack of a readily available supply of the drug from a manufacturer.19

(b) A limited quantity of the drug is compounded and provided to the professional.20

(c) The drug is compounded and provided to the professional as an occasional exception21

to the normal practice of dispensing drugs pursuant to patient-specific prescriptions.22

23

Type of Compounding ORC Section Defined

Traditional Prescription ORC 4729.01(C) (1)

Consult agreement ORC 4729.01(C) (2)

Research ORC 4729.01(C) (3)

Batch ORC 4729.01(C) (4)

Prescriber for Direct Administration ORC 4729.01(C) (5)

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Compounded Drugs for Administration to Patients by Prescribers OAC 4729-9-251

In addition to complying with ORC 4729.01 (C) (5) as discussed above, compounded drugs must2

also comply with OAC 4729-5-25 and OAC 4729-9-25. The Board does not want to see3

pharmacies compounding drugs for administration to patients by prescribers as a major type of4

routine compounding practice. The pharmacy is limited to five percent (5%) of total5

compounding sales, within a twelve (12) month period. See OAC 4729-9-25 (A) (1).6

7

Which compounded drugs may be provided by a pharmacy to the prescriber? The pharmacy8

shall only provide those compounded drugs that are not commercially available to a prescriber9

which are needed: See OAC 4729-9-25 (A) (2).10

To treat an emergency situation; See OAC 4729-9-25 (A) (2) (a).11

For an unanticipated procedure for which a time delay would negatively affect a patient12

outcome; See OAC 4729-9-25 (A) (2) (b).13

For diagnostic purposes. See OAC 4729-9-25 (A) (2) (c).14

15

Board rules also limit the pharmacy to supplying an amount which will last the prescriber only16

seventy-two (72) hours – about three days. See OAC 4729-9-25 (B). The prescriber also may17

not have on hand more than a supply that will last the prescriber seventy-two (72) hours. The18

rule seems to place the burden on the prescriber for determining the amount that will last the19

prescriber for seventy-two (72) hours, since the rule reads that the amount “shall be determined20

by previous administration patters provided by a prescriber to the pharmacist.” See OAC 4729-21

9-25 (B). Indeed, it would be difficult if not impossible for a pharmacist alone to know or22

accurately estimate this amount.23

24

The seventy-two (72) hour supply limitation does not apply to the following supplied to a25

prescriber, meaning the following two categories of compounded preparations may be provided26

even if the supply may last more than seventy-two (72) hours:27

Small amounts sixty (60) grams or sixty (60) milliliters of non-sterile topical28

preparations. See OAC 4729-9-25 (B) (1).29

Non-sterile preparations intended to treat individuals in the event of an emergency. See30

OAC 4729-9-25 (B) (2).31

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1

Pharmacies may not sell a compounded drug to another pharmacy or wholesaler. See OAC2

4729-9-25 (C). “Sale” and “sell” include delivery, transfer, barter, exchange, or gift, or offer3

therefor, and each such transaction made by any person, whether as principal proprietor, agent,4

or employee. ORC 4729.01 (J). A prescriber may only administer compounded drugs directly to5

patients of the prescriber. Prescribers are not permitted to do any of the four acts: OAC 4729-9-6

25 (D)7

Dispense a compounded drug to a patient – administration is allowed. See OAC 4729-9-8

25 (D) (1)9

Sell a compounded drug to another prescriber. See OAC 4729-9-25 (D) (2)10

Sell a compounded drug to a pharmacy. See OAC 4729-9-25 (D) (3)11

Return a compounded drug to the supplying pharmacy. See OAC 4729-9-25 (D) (4)12

13

For compounded drugs provided to prescribers for patients, beyond-use dates are required. See14

OAC 4729-9-25 (E). For non-sterile compounded drugs, “testing pursuant to acceptable practice15

standards” is required. Two types of standards are provided:16

published peer reviewed pharmaceutical literature that have been critically reviewed by17

unbiased independent experts. See OAC 4729-9-25 (E) (1)18

current edition of an official compendium, such as the United States Pharmacopoeia19

(USP) or National Formulary (NF). See OAC 4729-9-25 (E) (1)20

Beyond-use dates for sterile compounded drugs must be determined by the compounding21

pharmacy through one of the two following types of standards:22

drug product testing pursuant to acceptable practice standards. See OAC 4729-9-25 (E)23

(2)24

United States Pharmacopoeia (USP) or National Formulary (NF) standards. OAC 4729-25

9-25 (E) (2)26

The standards account for level of risk of contamination by antimicrobials.27

The United States Pharmacopoeia (USP) or National Formulary (NF) standards are further28

refined to include low, medium, and high risk level compounded drug preparations as follows:29

Low Risk - beyond use date of not more than forty-eight (48) hours when stored at30

controlled room temperature at twenty to twenty-five degrees Celsius, or fourteen (14)31

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days when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen1

state at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (a).2

An example of low risk preparations includes using sterile syringes with sterile needles3

to conduct single sterile dose transfers from the manufacturer’s original packaging such4

as bottles, bags and vials in an ISO Class 5 cleanroom. An ISO class 5 cleanroom5

contains at most 105 (or 100,000) particles per cubic meter. See OAC 4729-19-01 (A) (2).6

To give perspective, the ambient air outside in a typical urban environment contains7

35,000,000 particles per cubic meter.8

Medium Risk - beyond use date of not more than thirty (30) hours when stored at9

controlled room temperature at twenty to twenty-five degrees Celsius, or nine (9) days10

when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen state11

at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (b). An12

example of medium risk preparations includes preparation of Total Parenteral Nutrition13

(TPN) solutions using automated or manual compounders.14

High Risk - beyond use date of not more than twenty-four (24) hours when stored at15

controlled room temperature at twenty to twenty-five degrees Celsius, or three (3) days16

when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen state17

at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (c). An18

example of high risk preparations includes dissolving non-sterile bulk drug powders for19

solution preparation that will be terminally sterilized.20

Labeling a Compound Drug for Administration by Prescriber OAC 4729-9-25 (F) (1-10)21

The labeling of a compounded drug preparation must contain the following:22

(1) The statement “For direct patient administration only” displayed prominently;23

(2) The statement “Not for resale” displayed prominently;24

(3) Proper storage conditions;25

(4) Beyond use dates pursuant to OAC 4729-9-25 (E);26

(5) The name(s) of the active and inactive ingredients;27

(6) The amount or percentage of active drug ingredients;28

(7) The quantity of compounded drug provided;29

(8) The route of administration;30

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(9) The pharmacy name, address, and telephone number;1

(10) The pharmacy control number assigned to the compounded drug preparation.2

3

For a container that is too small, it is permissible for the labeling to omit the quantity of drug4

provided [OAC 4729-9-25 (F) (7)] and the notation “for direct patient administration only”5

[OAC 4729-9-25 (F) (1)]. In all cases, a complete label meeting the requirements of paragraph6

(F) of this rule must be applied to the outside container in which such compounded preparation is7

supplied. OAC 4729-9-25 (G).8

9

The sale of a compounded drug preparation to a prescriber is considered a wholesale sale as10

defined in section 4729.01 of the Revised Code. OAC 4729-9-25 (H). A pharmacy is required to11

follow record keeping requirements for wholesale sales. See OAC 4729-9-16 (H). The types of12

records include:13

source of the drugs, including the name and principle address of the seller or transferor,14

and the address of the location from which the drugs were shipped. OAC 4729-9-16 (H)15

(1) (a)16

identity and quantity of the drugs received and distributed or disposed of. OAC 4729-9-17

16 (H) (1) (b)18

dates of receipt and distribution of the drugs. OAC 4729-9-16 (H) (1) (c)19

system of records and procedures which prevent the sale or other distribution of20

dangerous drugs to any person not authorized by division (B) of section 4729.51 of the21

Revised Code. OAC 4729-9-16 (H) (1) (d)22

These records must be retained for at least three years. OAC 4729-9-16 (H) (2)23

24

Drugs Compounded in a Pharmacy for Dispensing to Patients OAC 4729-9-2125

Most community pharmacists are primarily concerned with compounding relatively small26

amounts of non-sterile preparations, for specific patients, having a prescription from a physician.27

These are typically oral or topical preparations provided directly to patients, not physicians.28

29

For all compounded prescriptions, the pharmacist must:30

Inspect and approve the compounding process. OAC 4729-9-21 (C) (1)31

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Perform the final check of the finished product. OAC 4729-9-21 (C) (2)1

Maintain all compounding records. OAC 4729-9-21 (D) (1)2

Ensure the proper maintenance, cleanliness, and use of equipment. OAC 4729-9-21 (D)3

(2)4

5

Personnel engaged in the compounding of drugs need to wear clean appropriate clothing – for6

protection and to prevent contamination. See OAC 4729-9-21 (E). The prescription must be7

compounded and dispensed only pursuant to a specific order for an individual patient issued by a8

prescriber. A limited quantity may be compounded in anticipation of prescription drug orders9

based on routine, regularly observed prescribing patterns. See OAC 4729-9-21 (F). Containers10

for compounded prescriptions dispensed must be labeled in the same matter as any other11

prescription medication dispensed. See OAC 4729-9-21 (G) and OAC 4729-5-16 [labeling of12

drugs dispensed on prescription].13

14

The pharmacist may need a substantial amount of chemicals and time to prepare a batch of some15

compounded medications. Likewise, the equipment and compounding process involved may16

dictate that compounding small quantities are simply impractical. For example, if a pharmacist17

wants to prepare medicated suppositories, a melt-able solid medium must be heated and melted18

in a receptacle. Active ingredients must be obtained, weighed, and added to the melted medium.19

The melted mixture must be poured into a suppository mold and allowed to cool. The cooled20

product must be removed from the mold. The mold and other equipment must be cleaned and21

stored. All this takes time. Suppose the mold may be adapted to form no less than one hundred22

(100) units at a time. Does the pharmacist have to postpone compounding activities until one or23

more prescriptions are in hand for exactly one hundred suppositories – and then compound only24

exactly one hundred suppositories?25

26

Fortunately, the answer is “no.” A limited quantity may be compounded in anticipation of27

prescription drug orders based on routine, regularly observed prescribing patterns. See OAC28

4729-9-21 (F). If a batch is made, the portion dispensed to patients and the stored portion must29

be labeled. See OAC 4729-9-21 (H). Labels for the stored medication must contain at least the30

following information:31

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The name, strength, and quantity of each drug used in the compounded prescription.1

OAC 4729-9-21 (H) (1)2

The identification of the repackager by name or by the final seven digits of its terminal3

distributor of dangerous drugs license number. OAC 4729-9-21 (H) (2)4

Pharmacy control number. OAC 4729-9-21 (H) (3)5

The pharmacy’s expiration date or beyond use date. OAC 4729-9-21 (H) (4)6

7

Using a Prescriber’s Location as a Pick-Up-Station See OAC 4729-5-108

Suppose the pharmacist wants to compound a drug for a patient that is not going to be picked up9

at the pharmacy. It is also not going to be administered to a patient by the prescriber. Can it be10

delivered to a prescriber’s office and picked up by a patient there? Yes. See OAC 4729-5-10.11

To offer this service, a request form (available on the Board website at12

http://pharmacy.ohio.gov/) must be completed and approved by the Board. Basically, there are13

five requirements for such a pick-up station:14

The site is appropriately licensed pursuant to Chapter 4729 of the Revised Code. See15

OAC 4729-5-10 (B) (1).16

The receipt, storage, control, and distribution of prescriptions or drugs are in the full and17

actual charge of a health care professional licensed pursuant to Ohio Revised Code18

Chapter 4715 [dentist], 4723 [nurse], 4729 [pharmacist], 4730 [physician assistant], 473119

[physician], or 4741 [veterinarian]. See OAC 4729-5-10 (B) (2).20

An appropriate recordkeeping system is in place that will provide accountability for21

proper receipt, delivery, and return of all prescription medications. See OAC 4729-5-1022

(B) (3).23

There is a documented method in place to ensure compliance with rule 4729-5-22 of the24

Administrative Code. See OAC 4729-5-10 (B) (4).25

The state board of pharmacy has approved the site for such activity due to clear and26

convincing evidence that delivery of prescription medication directly to the patient would27

result in:28

o Danger to public health or safety, [See OAC 4729-5-10 (B) (5) (a)] or29

o Danger to the patient without increased involvement by a health care professional30

in the patient’s drug therapy. [See OAC 4729-5-10 (B) (5) (b)]31

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CPE Quiz1

Questions – credit will be provided with correct responses to at least seven questions:2

1. The labeling of compounded drugs sold to physician for administration to a patient of the3

physician must contain name of patient.4

a) true5

b) false6

7

2. Compounding a drug in batches can be done in anticipation of prescriptions:8

a) Based on routine prescribing patterns9

b) Based on regularly observed patterns10

c) Based on buying patterns11

d) Both A and B are correct12

13

3. Compounding a drug in a pharmacy for administration to a patient by a prescriber is14

permitted when:15

a) The drug is commercially available – false16

b) The drug is provided as a principal source of income for the pharmacy – false17

c) A supply of the drug is not readily available from a manufacturer18

d) The drug is provided directly to the patient – false19

20

4. Compounding a drug in a pharmacy for administration to a patient by a prescriber is21

permitted when the compounded drug is to be used:22

a) To treat an emergency situation.23

b) For an unanticipated procedure for which a time delay would negatively affect a patient24

outcome.25

c) For diagnostic purposes.26

d) All of the above27

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5. Compounding a drug in a pharmacy for administration to a patient by a prescriber may be1

supplied in an amount that will last more than seventy-two (72) hours when:2

a) No more than sixty (60) grams of a non-sterile topical preparation is supplied to the3

prescriber.4

b) No more than sixty (60) milliliters of a non-sterile topical preparation is supplied to the5

prescriber.6

c) A non-sterile preparation intended to treat individuals in the event of an emergency is7

supplied to the prescriber.8

d) All of the above9

10

6. When labeling a compound drug for administration to a patient by a prescriber in a11

container that is too small to bear a complete label, the label must still include all but:12

a) the statement, “for direct patient administration only”13

b) the statement, “not for resale”14

c) the route of administration15

d) the pharmacy name16

17

7. A pharmacy is required to follow record keeping requirements for wholesale sales,18

including sales of a compounded drug preparation to a prescriber, including all except:19

a) source of the drugs20

b) collection of sales taxes and amounts21

c) identity and quantity of the drugs received and distributed or disposed of22

d) dates of receipt and distribution of the drugs23

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8. When acting as a wholesaler, a pharmacy is required to retain records for sales of a25

compounded drug preparation to a prescriber for five years.26

a) True27

b) False28

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9. For all compounded prescriptions, the pharmacist must do all of the following except:1

a) Inspect and approve the compounding process2

b) Personally perform every step in the compounding process3

c) Maintain all compounding records4

d) Ensure the proper maintenance, cleanliness, and use of equipment5

6

10. For a limited quantity of drug compounded in anticipation of receiving a prescription,7

when a batch is made, the stored portion must be labeled with all but the following:8

a) The name, strength, and quantity of each drug used in the compounded prescription.9

b) The initials of the pharmacist.10

c) Pharmacy control number.11

d) The pharmacy’s expiration date or beyond use date.12

13

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Lesson number 036-368-13-001-H03 Answer Sheet: Expires April 18, 20151Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board of Pharmacy2

Pharmacy Compounding and Ohio Law3Answer Sheet – circle the one best answer4Question Answer Question Answer

1 True False 6 A B C D

2 A B C D 7 A B C D

3 A B C D 8 True False

4 A B C D 9 A B C D

5 A B C D 10 A B C D

5Please return by mail with check for $20.00 payable to James Lindon at:6Pharmacy Law, 35104 Saddle Creek, Avon, Ohio 44011-4907, 440-333-0011, 419-710-4925 (fax)7You may also send payment via PayPal (account not needed) to [email protected] may also send credit card number, expiration and CVV to [email protected]

10Please fax or e-mail [circle one, please] my continuing education certificate to:11

12Pharmacist Name ___________________________________13

14Street Address _____________________________15

16City ________________________ State _________ Zip _______17

18E-Mail for CPE Certificate ___________________________________ Fax ______________________19

20Phone ___________________________________21

22Ohio Pharmacist License Number _____________________23

24NABP ID Number _____________________25

26After completing this lesson I can achieve the lesson objectives: Yes No27This program was an effective way for me to learn: Yes No28I liked the program’s format: Yes No29This program fostered my mental participation: Yes No30This was a “user-friendly” way for me to learn: Yes No31I could sense some commercialism in this program: Yes No32If yes, please describe: ______________________________________________33The faculty quality was: Great OK Needs to Improve34The learning material quality was: Great OK Needs to Improve35How long did it take to complete this program? _______________________36What other topics would you like to see? ____________________________37Comments welcome: ____________________________________________38

39Any views expressed are not necessarily those of the author or Lindon & Lindon, LLC.40Copyright 2013 James Lindon, Lindon & Lindon LLC (may freely copy and distribute, in whole)41

Pharmacy compounding ohio law

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